The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

Regulation 4(1)

SCHEDULE 1 U.K. Information to be contained in pharmaceutical needs assessments

Necessary services: current provision U.K.

1.  A statement of the pharmaceutical services that the HWB has identified as services that are provided—

(a) in the area of the HWB and which are necessary to meet the need for pharmaceutical services in its area; and

(b) outside the area of the HWB but which nevertheless contribute towards meeting the need for pharmaceutical services in its area (if the HWB has identified such services).

Necessary services: gaps in provision U.K.

2.  A statement of the pharmaceutical services that the HWB has identified (if it has) as services that are not provided in the area of the HWB but which the HWB is satisfied—

(a) need to be provided (whether or not they are located in the area of the HWB) in order to meet a current need for pharmaceutical services, or pharmaceutical services of a specified type, in its area;

(b) will, in specified future circumstances, need to be provided (whether or not they are located in the area of the HWB) in order to meet a future need for pharmaceutical services, or pharmaceutical services of a specified type, in its area.

Other relevant services: current provision U.K.

3.  A statement of the pharmaceutical services that the HWB has identified (if it has) as services that are provided—

(a) in the area of the HWB and which, although they are not necessary to meet the need for pharmaceutical services in its area, nevertheless have secured improvements, or better access, to pharmaceutical services in its area;

(b) outside the area of the HWB and which, although they do not contribute towards meeting the need for pharmaceutical services in its area, nevertheless have secured improvements, or better access, to pharmaceutical services in its area;

(c) in or outside the area of the HWB and, whilst not being services of the types described in sub-paragraph (a) or (b), or paragraph 1, they nevertheless affect the assessment by the HWB of the need for pharmaceutical services in its area.

Improvements and better access: gaps in provision U.K.

4.  A statement of the pharmaceutical services that the HWB has identified (if it has) as services that are not provided in the area of the HWB but which the HWB is satisfied—

(a) would, if they were provided (whether or not they were located in the area of the HWB), secure improvements, or better access, to pharmaceutical services, or pharmaceutical services of a specified type, in its area,

(b) would, if in specified future circumstances they were provided (whether or not they were located in the area of the HWB), secure future improvements, or better access, to pharmaceutical services, or pharmaceutical services of a specified type, in its area.

Other NHS services U.K.

5.  A statement of any NHS services provided or arranged by a local authority, [F1 NHS England], [F2 an integrated care board], an NHS trust or an NHS foundation trust to which the HWB has had regard in its assessment, which affect—

(a) the need for pharmaceutical services, or pharmaceutical services of a specified type, in its area; or

(b) whether further provision of pharmaceutical services in its area would secure improvements, or better access, to pharmaceutical services, or pharmaceutical services of a specified type, in its area.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F2 Words in Regulations substituted (1.7.2022) by The Health and Care Act 2022 (Consequential and Related Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/634), reg. 1(2), Sch. para. 1

How the assessment was carried out U.K.

6.  An explanation of how the assessment has been carried out, and in particular—

(a) how it has determined what are the localities in its area;

(b) how it has taken into account (where applicable)—

(i) the different needs of different localities in its area, and

(ii) the different needs of people in its area who share a protected characteristic; and

(c) a report on the consultation that it has undertaken.

Map of provision U.K.

7.  A map that identifies the premises at which pharmaceutical services are provided in the area of the HWB.

Regulation 10(7)

SCHEDULE 2 U.K. Applications in respect of pharmaceutical lists and the procedures to be followed

PART 1 U.K. Information to be included in routine and excepted applications

Information to be included in all routine and excepted applications U.K.

1.—(1) The information mentioned below in this paragraph must be included in all routine and excepted applications.

(2) The name of the relevant HWB.

(3) The type of application being made (for example, the application is for inclusion in a pharmaceutical list and a change of ownership application), including a statement of whether the application is a routine or an excepted application.

(4) The name and address of the applicant (A).

(5) If A is an individual or a partnership carrying on a retail pharmacy business, A or each partner's registration number in the GPhC register.

(6) If A is a body corporate carrying on a retail pharmacy business, the name and registration number in the GPhC register of A's superintendent.

(7) If A is seeking the listing of premises not already listed in relation to A (whether or not A is already listed)—

(a) either—

(i) the address of the premises, or

(ii) if the address is not known and it is a routine application, A's best estimate of where the proposed premises will be;

(b) whether the applicant is currently in possession of the premises;

(c) the proposed core opening hours in respect of the premises; and

(d) the total proposed opening hours for the premises (having regard to both the proposed core opening hours and any supplementary opening hours).

(8) If A is seeking to provide directed services—

(a) details of the directed services to be provided;

(b) confirmation that A is accredited to provide the services, where that accreditation is a prerequisite for the provision of those services;

(c) confirmation that the premises are accredited in respect of the provision of the services, where that accreditation is a prerequisite for the provision of those services; and

(d) a floor plan showing the consultation area where A proposes to offer directed services (where relevant, unless one cannot be provided for reasons that are good cause).

(9) A is not entitled to ask for a routine application to be considered, in the alternative, as an excepted application, or for an excepted application to be considered, in the alternative, as a routine application.

(10) An estimate of the location of premises is only a “best estimate” for the purposes of sub-paragraph (7)(a)(ii) if [F1 NHS England] is satisfied that—

(a) it is the best estimate that A can reasonably make at the time of the application of the location of the premises; and

(b) its reasons for granting or refusing the application would be essentially the same if the applicant located, if the application was granted, at any location within the range of possible locations covered by the estimate.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Information to be included in all routine and excepted applications for inclusion in a pharmaceutical list U.K.

2.—(1) The information mentioned below in this paragraph must be included in all routine and excepted applications for inclusion in a pharmaceutical list.

(2) If the applicant (A) is an individual or a partnership—

(a) A's or each partner's full name;

(b) A's or each partner's sex;

(c) A's or each partner's date of birth;

(d) A's or each partner's private address and telephone number;

(e) a declaration that A or each partner is a registered pharmacist, if A is seeking entry in the list mentioned in regulation 10(2)(a);

(f) if A is a partnership, a declaration that A is, or is entitled to be, lawfully conducting a retail pharmacy business in accordance with section 69 of the 1968 Act M1 (general provisions), if A is seeking entry in the list mentioned in regulation 10(2)(a); and

(g) if A is already included in Part 3 of the GPhC register in respect of any premises, A's registration number in that Part of the GPhC register, if A is seeking entry in the list mentioned in regulation 10(2)(a).

(3) If A is a body corporate—

(a) A's registered name and any other name under which A trades;

(b) A's company registration number;

(c) A's registered office and any fixed line telephone number relating to that office;

(d) the private address and date of birth of A's superintendent (if A is seeking entry in the list mentioned in regulation 10(2)(a));

(e) the name and date of birth of each director of A (who is not A's superintendent), and if any director of A (who is not A's superintendent) is a registered pharmacist, that director's registration number in the GPhC register;

(f) a declaration that A is, or is entitled to be, lawfully conducting a retail pharmacy business in accordance with section 69 of the 1968 Act, if A is seeking entry in the list mentioned in regulation 10(2)(a); and

(g) if A is already included in Part 3 of the GPhC register in respect of any premises, A's registration number in that Part of the GPhC register, if A is seeking entry in the list mentioned in regulation 10(2)(a).

(4) If the services that A undertakes to provide consists of or includes the supply of appliances, the appliances A undertakes to supply.

Marginal Citations

M1 Section 69 has been amended by the Statute Law (Repeals) Act 1993 (c. 50), Schedule 1, Part 12, and by S.I. 1976/1213, 2007/289 and 3101 and 2010/231.

Fitness information about individuals: routine and excepted applications for inclusion in a pharmaceutical list U.K.

3.—(1) Subject to paragraph 5, the information mentioned below in this paragraph must be included in all routine and excepted applications for inclusion in a pharmaceutical list, as regards any person (P) who is—

(a) the individual who is making the application;

(b) a partner in the partnership that is making the application; or

(c) a director or (if A is seeking entry in the list mentioned in regulation 10(2)(a)) superintendent of the body corporate that is making the application.

(2) Details of whether P—

(a) has been convicted of any criminal offence in the United Kingdom;

(b) has been bound over following a criminal conviction in the United Kingdom;

(c) has accepted a police caution in the United Kingdom;

(d) has, in summary proceedings in Scotland in respect of an offence, been the subject of an order discharging P absolutely (without proceeding to conviction); or

(e) has accepted and agreed to pay either a procurator fiscal fine under section 302 of the Criminal Procedure (Scotland) Act 1995 M2 (fixed penalty: conditional offer by procurator fiscal) or a penalty under section 115A of the Social Security Administration Act 1992 M3 (penalty as alternative to prosecution).

(3) Details of whether P has at any time been convicted of an offence elsewhere than in the United Kingdom where the originating events, if they took place in England (at the time of the application), could lead to a criminal conviction in England.

(4) Details of any criminal proceedings to which P is currently subject—

(a) in the United Kingdom; or

(b) elsewhere than the United Kingdom if the originating events, if they took place in England, could lead to a criminal conviction in England.

(5) If P is, to P's knowledge, or has been subject to any investigation into, or proceedings relating to, P's fitness to practise by a licensing body—

(a) if the investigation or proceedings have not yet reached their final outcome, details of that investigation or proceedings; or

(b) if the investigation or proceedings have reached a final outcome that was adverse, details of the final outcome of that investigation or proceedings.

(6) If P is, to P's knowledge, or has been subject to any investigation into, or proceedings relating to, P's professional conduct by an employer—

(a) if the investigation or proceedings have not yet reached their final outcome, details of that investigation or proceedings; or

(b) if the investigation or proceedings have reached a final outcome that was adverse, details of the final outcome of that investigation or proceedings.

(7) If P is a pharmacist, details of P's—

(a) pharmaceutical qualifications (including where obtained); and

[F3 (b) personal work history for the previous 7 years from the date on which the application is submitted, together with a declaration by P (where it can be made, in the case of sub-paragraphs (ii) and (iii)) that—

(i) the details provided are a complete and accurate account of that personal work history,

(ii) P has not been dismissed in that time, and if P cannot make this declaration, the reasons for being unable to do so must be covered in P’s personal work history,

(iii) P has not had a break of more than 6 months from work in that time, and if P cannot make this declaration, the reasons for being unable to do so must be covered in P’s personal work history, and

(iv) if P is an NHS chemist, or is a partner in or a director or superintendent of a NHS chemist, P or the NHS chemist in which P is a partner or of which P is a director or superintendent, has complied with the requirements of paragraph 31 of Schedule 4 and paragraph 21 of Schedule 5 that are applicable to P.]

(8) If P is a pharmacist, names and addresses of 2 referees who are willing to provide references in respect of 2 recent posts (which may include any current post) as a pharmacist which lasted at least 3 months without a significant break, or where this is not possible, details of why and the names and addresses of alternative referees who are acceptable to [F1 NHS England].

(9) If P is, to P's knowledge, or has been subject to any investigation or proceedings that could lead or could have led to P's removal from a relevant list for a reason relating to unsuitability, fraud or efficiency of service provision, details of that investigation or those proceedings, and of any final outcome to that investigation or those proceedings.

(10) If P is, to P's knowledge, or has been where the outcome was adverse, the subject of any investigation by the NHS BSA (or any body that preceded it which had, or outside England which has, primary responsibility for investigating fraud in the health service) in relation to fraud.

(11) If P has been refused inclusion in, or conditionally included in, or contingently removed or suspended from, any relevant list for a reason relating to unsuitability, fraud or efficiency of service provision, details of same.

(12) If P is in the process of applying to be included in another relevant list and proceedings relating to the application have not yet reached their final outcome (including where an application has been deferred), details of that application and the reasons for—

(a) any deferment of that application; or

(b) refusal or conditional inclusion where the refusal or conditional inclusion has not yet reached its final outcome.

(13) If P—

(a) is the person making the application; and

(b) qualified as a pharmacist in Switzerland or an EEA State other than the United Kingdom,

details that demonstrate that P has the level of knowledge of English which, in the interests of P and the persons making use of the services to which the application relates, is necessary for the provision of those services in the area of the relevant HWB.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F3 Sch. 2 para. 3(7)(b) substituted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 6

Marginal Citations

M2 1995 c. 46. Section 302 has been amended by: the Communications Act 2003 (c. 21), Schedule 17, paragraph 133; the Wireless Telegraphy Act 2006 (c. 36), Schedule 7, paragraph 16; the Criminal Proceedings etc. (Reform) (Scotland) Act 2007 (asp 6), section 50(1); and the Criminal Justice and Licensing (Scotland) Act 2010 (asp 13), section 70(3).

M3 1992 c. 5. Section 115A was inserted by the Social Security Administration (Fraud) Act 1997 (c. 47), section 15, and amended by the Social Security Fraud Act 2001 (c. 11) (“the 2001 Act”), section 14. The amendments made by the 2001 Act are to be repealed by, and other amendments to section 115A are to be made by, the Welfare Reform Act 2012 (c. 5), sections 113 to 115, and Schedule 14, Part 1.

Fitness information about corporate bodies: routine and excepted applications for inclusion in a pharmaceutical list U.K.

4.—(1) Subject to paragraph 5, the information mentioned below in this paragraph must be included in all routine and excepted applications for inclusion in a pharmaceutical list by a body corporate (C1)—

(a) as regards C1; or

(b) as regards any other body corporate (C2) of which a director or superintendent of C1—

(i) is a director or superintendent or has been a director or superintendent in the 6 months prior to the date of the application, or

(ii) has been a director or superintendent for more than 6 months prior to the date of the application, where they were a director or superintendent of C2 at the time of the originating events to which the information relates.

(2) Details of any convictions that C1 or C2 has for offences committed in the United Kingdom that are not spent convictions.

(3) Details of whether C1 or C2 (being corporate bodies registered within the United Kingdom) has at any time been convicted of an offence elsewhere than in the United Kingdom where the originating events, if they took place in England (at the time of the application), could lead to a criminal conviction in England.

(4) Details of any criminal proceedings to which C1 or C2 is currently subject—

(a) in the United Kingdom; or

(b) elsewhere than in the United Kingdom if the originating events, if they took place in England, could lead to a criminal conviction in England.

(5) Details of any investigation to which C1 or C2—

(a) is, to its knowledge, subject by the General Pharmaceutical Council in relation to an entry in Part 3 of the GPhC register; or

(b) has been subject by the General Pharmaceutical Council, the Royal Pharmaceutical Society of Great Britain or the Pharmaceutical Society of Northern Ireland in relation to an entry in the register required to be kept under section 75 of the 1968 Act M4 (registration of premises), the outcome of which was adverse.

(6) If C1 or C2, to its knowledge, is or has been subject to any investigation or proceedings that could lead or could have led to its removal from a relevant list, details of that investigation or those proceedings, and of any final outcome to that investigation or those proceedings.

(7) If C1 or C2 is, to its knowledge, or has been where the outcome was adverse, the subject of any investigation by the NHS BSA (or any body that preceded it which had, or outside England which has, primary responsibility for investigating fraud in the health service) in relation to fraud.

(8) If C1 or C2 has been refused inclusion in, or conditionally included in (other than by reason of a condition imposed under Part 9), a relevant list, details of that refusal or conditional inclusion.

(9) If C1 or C2 is in the process of applying to be included in another relevant list and proceedings relating to the application have not yet reached their final outcome (including where an application has been deferred), details of that application and the reasons for—

(a) any deferment of that application; or

(b) any refusal or conditional inclusion, where the refusal or conditional inclusion has not yet reached its final outcome.

[F4 (10) Details of any case in which an application by C1 or C2 has lapsed by virtue of regulation 35(8).]

Textual Amendments

F4 Sch. 2 para. 4(10) inserted (1.3.2015) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015 (S.I. 2015/58), regs. 1(1), 6(a) (with reg. 10)

Marginal Citations

M4 Amended by S.I. 1968/1699 and 2010/231.

Fitness information that has already been provided under pharmaceutical or local pharmaceutical services U.K.

5.—(1) If information mentioned in paragraph 3 or 4 has already been provided to [F1 NHS England] (or a home Primary Care Trust) on a previous occasion pursuant to regulations under Part 7 of the 2006 Act, an applicant need not provide that information again to [F1 NHS England] in relation to the current application.

(2) An applicant relying on paragraph (1) must, when making its application—

(a) confirm to [F1 NHS England] that [F1 NHS England] already has all the information required under paragraphs 3 and 4; or

(b) if there is any missing information required under those paragraphs—

(i) confirm to [F1 NHS England] what information [F1 NHS England] already has, and

(ii) provide the missing information.

[F5 (3) Unless sub-paragraph (4) applies, information is only to be considered missing for the purposes of sub-paragraph (2)(b) if, having regard to the fact that the fitness of the applicant to be included in a pharmaceutical list has already been established (or if the applicant’s fitness is under investigation, that investigation is being taken forward separately), it is nevertheless material to the consideration of the application.

(4) Information is to be considered missing for the purposes of sub-paragraph (2)(b) if it has previously been provided to NHS England or a Primary Care Trust by the applicant, but more than 7 years prior to the date of the application.

(5) If a declaration that is required to be included in an application has never previously been provided to NHS England or has previously been provided but it is no longer up to date—

(a) an up to date declaration, together with any information that the applicant needs to provide in support of that declaration; or

(b) any information that needs to be provided because the applicant is unable to make that declaration,

is to be considered as missing information for the purposes of sub-paragraph (2)(b).]

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F5 Sch. 2 para. 5(3)-(5) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 7

[F6 Updating of information about or relating to a superintendent U.K.

5A.— (1) Where, in the case of a body corporate making an application for inclusion in a pharmaceutical list, there is a change to the superintendent of the body corporate before the applicant is included in a pharmaceutical list or the application cannot be further proceeded with, the applicant must update the application as soon as is reasonably practicable with—

(a) the details about that superintendent that the applicant would have been required to submit under paragraph 3; and

(b) the details about any other body corporate that the applicant would have been required to submit under paragraph 4 because of that superintendent being that other body corporate’s superintendent,

had the superintendent been in post at the time the application was submitted.

(2) If—

(a) the application has been determined by NHS England but—

(i) there are proceedings relating to the application that have not yet reached their final outcome, or

(ii) in the case of an application that has been granted, there are no such proceedings but the applicant has not yet been included in a pharmaceutical list; and

(b) NHS England is satisfied, on the basis of the information provided or required to be provided under sub-paragraph (1), that there are grounds for refusing the application under regulation 33 or imposing a condition under regulation 35,

NHS England may redetermine the application, but only for the purpose of refusing it under regulation 33 or imposing a condition under regulation 35 (so there may still be a purpose to any proceedings that have not yet reached their final outcome).]

Textual Amendments

F6 Sch. 2 para. 5A inserted (1.10.2022) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 (S.I. 2022/930), regs. 1(2), 6(2)

Applications seeking the listing of premises that are already, or are in close proximity to, listed chemist premises U.K.

6.  If, as regards a routine or excepted application—

F7 (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F7 (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

the premises which the applicant (A) is seeking to be listed in relation to A are already listed chemist premises or are adjacent to or in close proximity to such premises, A must include with the application details that explain why A believes the application should not be refused pursuant to regulation 31.

Textual Amendments

F7 Sch. 2 para. 6(a)(b) omitted (1.3.2015) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015 (S.I. 2015/58), regs. 1(1), 6(b) (with reg. 10)

Additional information to be included with routine applications U.K.

7.—(1) If an applicant (A) is making a routine application and is seeking to satisfy [F1 NHS England] that granting that application would meet a need for pharmaceutical services, or secure improvements to or better access to pharmaceutical services, in circumstances where—

(a) that need, those improvements or that better access has or have been identified in the pharmaceutical needs assessment of the relevant HWB (or Primary Care Trust), A must include in that application details that explain how A intends to meet that need, or secure those improvements or that better access (in whole or in part); or

(b) that need, those improvements or that better access has or have not been identified in the pharmaceutical needs assessment of the relevant HWB (or Primary Care [F8 Trust),] A must include in that application, details that explain A's belief that regulation 18(1)(b) is satisfied in relation to that application.

(2) Where an applicant includes information in an application pursuant to paragraph (a) but not paragraph (b) of sub-paragraph (1), [F1 NHS England] must not consider whether regulation 18(1)(b) applies in relation to that application when it determines that application.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F8 Word in Sch. 2 para. 7(1)(b) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 17(a)

Additional information to be included with excepted applications U.K.

8.  If the applicant (A) is making an excepted application, A must include in that application details that explain—

(a) A's belief that the application satisfies the criteria included in one of the regulations in Part 4 which need to be satisfied if section 129(2A) of the 2006 Act M5 (regulations as to pharmaceutical services) are not to apply in relation to that application; and

(b) if the regulation includes reasons for which the application must be refused, why the application should not be refused for those reasons.

Marginal Citations

M5 Section 129(2A) was inserted by the Health Act 2009 (c. 21), section 26(3), and has been amended by the Health and Social Care Act 2012 (c. 7), section 207(4), and Schedule 4, paragraph 66(5).

Undertakings U.K.

9.— [F9 (1)] An applicant (A) must provide the following undertakings—

(a) an undertaking to notify [F1 NHS England] within 7 days of any material changes to the information provided in the application that occur before—

(i) the application is withdrawn,

(ii) while the application remains the subject of proceedings, the proceedings relating to the application reach their final outcome and any appeal through the courts has been disposed of, or

(iii) if the application is granted, A commences the provision of the services to which the application relates,

whichever is the latest of these events to take place;

(b) an undertaking to notify [F1 NHS England] if A is included, or applies to be included, in any other relevant list of another primary care organisation before—

(i) the application is withdrawn,

(ii) while the application remains the subject of proceedings, the proceedings relating to the application reach their final outcome and any appeal through the courts has been disposed of, or

(iii) if the application is granted, A commences the provision of the services to which the application relates,

whichever is the latest of these events to take place;

(c) if A is seeking inclusion in a pharmaceutical list or (if A is already listed in that list) the listing of premises in relation to A that are not already listed in relation to A, an undertaking—

(i) to comply with all the obligations that are to be their terms of service under regulation 11 if the application is granted, and

(ii) in particular, in relation to any proposed pharmacy premises, to provide all the services and perform all the activities at those premises that are required under the terms of service to be provided or performed as or in connection with essential services; and

(d) if A is seeking to provide directed services an undertaking—

(i) that A will provide the directed services mentioned in the application, if [F1 NHS England] does commission the services from A within 3 years of the date of either the grant of the application or, if later, the listing in relation to the applicant of the premises to which the application relates,

(ii) if the services are commissioned by [F1 NHS England], that A will provide the services in accordance with an agreed service specification, and

(iii) A's agreement to a service specification will not be unreasonably withheld.

[F10 (2) In relation to a consolidation application, if [F1 NHS England] intends to commission from the applicant enhanced services provided at or from the closing premises, and notifies the applicant of that intention, the applicant is required to provide the undertaking referred to in sub-paragraph (1)(d) in relation to those services, whether or not the applicant is on notice of that intention at the time the applicant makes the consolidation application.]

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F9 Sch. 2 para. 9 renumbered as Sch. 2 para. 9(1) (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 11

F10 Sch. 2 para. 9(2) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 11

Nature of details to be supplied U.K.

10.  Where, pursuant to this Part, a person is required to provide details, that obligation is only discharged if the information or documentation provided is sufficient to satisfy [F1 NHS England], with good cause, that no relevant information or documentation is missing, having regard to the uses that [F1 NHS England] may need to make of the information or documentation when carrying out its functions.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

PART 2 U.K. Preliminary matters

Relevant information or documentation U.K.

11.—(1) As regards any routine or excepted application, if [F1 NHS England] considers that relevant information or documentation is missing—

(a) it may request the missing relevant information or documentation from the applicant; and

(b) the applicant must, within the period reasonably specified by [F1 NHS England] in the request under paragraph (a)—

(i) provide any information or documentation reasonably requested,

(ii) notify [F1 NHS England] that there is to be a delay in providing the requested information or documentation, for specified reasons, and specify a date by which the applicant undertakes to provide the information or documentation, or

(iii) if the applicant considers that any information or documentation has been unreasonably requested, notify [F1 NHS England] of that and seek a review by [F1 NHS England] of the reasonableness of the request.

(2) If an applicant refuses to comply with a request under sub-paragraph (1)(a)—

(a) within the period—

(i) reasonably specified by [F1 NHS England] under paragraph (1)(b), or

(ii) ending on the date specified by the applicant in accordance with paragraph (1)(b)(ii), if [F1 NHS England] is satisfied that a delay beyond the period it specified, and the length of the delay, are for good cause,

unless paragraph (b) applies, the application is to be treated as withdrawn;

(b) in circumstances where the applicant has, in accordance with sub-paragraph (1)(b)(iii), sought a review by [F1 NHS England] of the reasonableness of the request, if the review determines that any or all of the information or documentation requested—

(i) must after all, be provided, the application is to be treated as withdrawn unless the information or documentation that must still be provided is provided within a new period reasonably specified by [F1 NHS England] for the provision of that information or documentation,

(ii) need not be provided by the applicant, the request of [F1 NHS England] is to be treated as withdrawn to the extent that it relates to information or documentation that need not be provided.

(3) [F1 NHS England] may request information or documentation under this paragraph at any time after it receives an application and before its determination of that application, but it must consider whether or not it needs to request information or documentation under this paragraph prior to notifying an application (where it is required to do so) under Part 3.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Failure to provide undertakings or fees U.K.

12.—(1) If, when an applicant (A) submits an application, A fails to provide with the application—

(a) the undertakings referred to in paragraph 9 that are relevant to the application, [F1 NHS England] must, if the application is notifiable prior to notifying the application under Part 3, request that A provide the relevant undertakings within a specified period; or

(b) any fee payable in respect of that application by virtue of directions under section 131 of the 2006 Act (power to charge), [F1 NHS England] must, if the application is notifiable prior to notifying the application under Part 3, request that A provide the fee (or any missing part of the fee) within a specified period.

(2) If A fails to comply with a request under sub-paragraph (1) within a period reasonably specified by [F1 NHS England] under that sub-paragraph, the application is to be treated as withdrawn.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Functions of [F1 NHS England] in relation to fitness information relevant to [F11 applications: aggregation of information] U.K.

13.  Where an applicant (A) is relying on paragraph 5(1), [F1 NHS England] must ensure that the information that it holds about A is aggregated in such a way that it is able to make a reasonable determination as to whether the application should be refused or deferred under regulation 33 or 34.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F11 Words in Sch. 2 para. 13 heading substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 17(b)

Deferral of notifiable applications prior to notification U.K.

14.—(1)  [F1 NHS England], having received—

(a) a routine application, consideration of which may or must be deferred under regulation 14(1) to (3), 16(1) to (4), 19(1) to (4), 21(1) to (4) or 38(4); or

(b) a notifiable application, consideration of which may be deferred under regulation 32 or 34,

must consider, prior to notifying that application under Part 3 and as soon as is practicable, whether or not to defer consideration of that application under those provisions.

(2) If consideration of the application is deferred prior to notification, once [F1 NHS England] no longer has grounds for deferring the application, it must proceed as soon as is practicable with the notification of the application, unless the application has been withdrawn or [F1 NHS England] is required to treat it as withdrawn.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Refusal of notifiable applications prior to notification because of the language requirement for some NHS pharmacists U.K.

15.   [F1 NHS England], having received a notifiable application for inclusion in a pharmaceutical list from a person who is not already included in that list, may without notifying that application under Part 3 (or if no notification is required, as soon as is practicable) decide to refuse that application under regulation 30.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Refusal of notifiable applications on fitness grounds prior to notification U.K.

16.   [F1 NHS England], having received a notifiable application for inclusion in a pharmaceutical list from a person who is not already included in that list, may without notifying that application under Part 3 decide to refuse that application under regulation 33(1).

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Proposed new pharmacy premises in controlled localities: refusal of routine applications because of preliminary matters prior to notification U.K.

17.   [F1 NHS England], having received a routine application where the applicant is seeking the listing of pharmacy premises, must consider, prior to notifying that application under Part 3 and as soon as is practicable, whether or not the application needs to be refused under regulation 40(2).

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

PART 3 U.K. Notification of certain applications

Applications requiring notifications U.K.

18.  An application is a “ notifiable application” for the purposes of this Schedule if—

(a) it is a routine application; or

(b) it is an excepted application pursuant to regulation 24, 25[F12 , 26(2) or 26A],

and [F1 NHS England] has not decided to dispense with the notification pursuant to paragraphs 15 to 17.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F12 Words in Sch. 2 para. 18(b) substituted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 12

Notification procedure for notifiable applications U.K.

19.—(1) As soon as is practicable (having regard to its functions under Part 2), [F1 NHS England] must give notice of a notifiable application to—

(a) any Local Pharmaceutical Committee—

(i) whose area includes the premises or location to which the application relates, or

(ii) any part of whose area is within 2 kilometres of the premises or location to which the application relates;

(b) any Local Medical Committee—

(i) whose area includes the premises or location to which the application relates, or

(ii) any part of whose area is within 2 kilometres of the premises or location to which the application relates;

(c) any person—

(i) included in a pharmaceutical list for the area of the relevant HWB, or

(ii) who is entitled to be included in that pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,

whose interests might, in the opinion of [F1 NHS England], be significantly affected if the application were granted;

(d) any LPS chemist—

(i) with whom [F1 NHS England] has made arrangements for the provision of any local pharmaceutical services in the area of the relevant HWB, and

(ii) whose interests might, in the opinion of [F1 NHS England], be significantly affected if the application were granted;

(e) any Local Healthwatch organisation for the area of the relevant HWB, and any other patient, consumer or community group in that area which, in the opinion of [F1 NHS England], has a significant interest in the outcome of the application;

(f) if the applicant is seeking to locate premises in, or within 1.6 kilometres of, a controlled locality in the area of the relevant HWB—

(i) any provider of primary medical services, or

(ii) any other person on the dispensing doctors list for the area of the relevant HWB if there is one (being a performer but not a provider of primary medical services),

who, in the opinion of [F1 NHS England], has a significant interest in the outcome of the application;

(g) any Local Health Board any part of whose area is within 2 kilometres of the premises or location to which the application relates; and

(h) the relevant HWB and any other HWB any part of whose area is within 2 kilometres of the premises or location to which the application relates.

(2) [F1 NHS England] may also give notice of the notifiable application to any other person who, in the opinion of [F1 NHS England], has a significant interest in the outcome of the application.

(3) If any part (PA) of the area of a notified HWB (HWB2) other than the relevant HWB is within 2 kilometres of the premises or location to which the application relates, [F1 NHS England] must also give notice of the application to—

(a) any Local Pharmaceutical Committee—

(i) whose area includes PA, and

(ii) that is not given notice of the application under paragraph (1)(a);

(b) any Local Medical Committee—

(i) whose area includes PA, and

(ii) that is not given notice of the application under paragraph (1)(b);

(c) any person—

(i) included in a pharmaceutical list for the area of HWB2, or

(ii) who is entitled to be included in that pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,

whose interests might, in the opinion of [F1 NHS England], be significantly affected if the application were granted;

(d) any LPS chemist—

(i) with whom [F1 NHS England] has made arrangements for the provision of any local pharmaceutical services in the area of HWB2, and

(ii) whose interests might, in the opinion of [F1 NHS England], be significantly affected if the application were granted;

(e) any Local Healthwatch organisation for the area of HWB2, and any other patient, consumer or community group in that area which, in the opinion of [F1 NHS England], has a significant interest in the outcome of the application; and

(f) if the applicant is seeking to locate premises within 1.6 kilometres of a controlled locality in the area of HWB2—

(i) any provider of primary medical services, or

(ii) any other person on the dispensing doctors list for the area of HWB2 if there is one (being a performer but not a provider of primary medical services),

who, in the opinion of [F1 NHS England], has a significant interest in the outcome of the application.

(4) Those notified under sub-paragraphs (1) to (3) may make representations in writing about the application that is the subject of the notification to [F1 NHS England], provided they do so within 45 days of the date on which notice of the application was given to them [F13 , or within 30 days in the case of applications pursuant to regulation 26A].

[F14 (5) A relevant HWB that is notified under sub-paragraph (1)(h) in relation to a consolidation application must make representations in writing about the application under sub-paragraph (4) which (in addition to any other matter about which they may wish to make representations) indicate whether, if the application were granted, in the opinion of the relevant HWB the proposed removal of premises from its pharmaceutical list would or would not create a gap in pharmaceutical services provision that could be met by a routine application—

(a) to meet a current or future need for pharmaceutical services; or

(b) to secure improvements, or better access, to pharmaceutical services.]

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F13 Words in Sch. 2 para. 19(4) inserted (1.10.2022) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 (S.I. 2022/930), regs. 1(2), 6(3)

F14 Sch. 2 para. 19(5) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 13

Parallel notifications U.K.

20.—(1) If [F1 NHS England] is considering, as a consequence of a notifiable application, making (including revising) a determination as to whether or not an area is or is not to be part of a controlled locality, it must give notice under this Part at the same time that it gives notice under regulation 38(1).

(2) If, as a consequence of a notifiable application, [F1 NHS England] is required, by virtue of regulation 41 to determine whether or not an area is a reserved location, [F1 NHS England] must consider giving notice under this Part at the same time that it gives notice under regulation 41(4).

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Content of notifications U.K.

21.—(1) A person notified under paragraph 19 (P)—

(a) must be informed—

(i) of P's right to make representations under paragraph 19(4);

(ii) of the circumstances in which notified persons would be permitted, pursuant to paragraph 25, to make oral representations at any oral hearing relating to the application, and

(iii) if [F1 NHS England] intends to consider the application together and in relation to any other application, of that intention;

(b) need not be given the same information as other persons notified under paragraph 19 but, subject to sub-paragraphs (2) to (4), P must be provided with sufficient information, from the information supplied by the applicant, to enable P to make informed representations with regard to whether or not the application should be granted, having regard to P's interest in the matter.

(2) P need not be provided with any information that is published as part of the relevant pharmaceutical needs assessment.

(3) P must not be provided with—

(a) information supplied by the applicant (A) under paragraphs 2 to 4, or which A is exempt from supplying by virtue of paragraph 5; and

(b) any private addresses, private telephone numbers or dates of birth supplied by A.

(4) If A advises [F1 NHS England] that—

(a) information supplied by A is considered by A to be confidential to A; and

(b) A does not consent to the information being disclosed as part of the notification,

[F1 NHS England] must withhold that information from P if it considers that the full disclosure principle does not require it to provide that information to P.

(5) The “full disclosure principle” is that information that is relevant to the determination of an application should be available to any individual who has a significant interest in the outcome of the application, unless it is fair and proper for that information to be withheld from that individual.

(6) If information is being withheld from P under paragraph (4), P must be informed of the nature of the information that is being withheld from P.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

PART 4 U.K. Determination and deferral of applications

Flexibility with regard to determining or deferring applications U.K.

22.—(1) Except in so far as these Regulations provide to the contrary, [F1 NHS England] is to determine or defer routine and excepted applications in such manner (including with regard to procedures) as it sees fit.

(2) [F1 NHS England] may determine a routine or excepted application without hearing any oral representations, if it considers that oral representations are unnecessary.

(3) Where appropriate, [F1 NHS England] may if it thinks fit consider 2 or more applications together and in relation to each other, but where it does so, it must give notice to the applicants of its intention to do so (if it has not already done so under Part 3).

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Additional matters for consideration in relation to applications for inclusion in a pharmaceutical list U.K.

23.—(1) In the case of a routine or excepted application by a person (A) for inclusion in a pharmaceutical list who is not already included in it, [F1 NHS England] must, prior to determining the application—

(a) check with the NHS BSA whether A, and if A is a body corporate whether any director or superintendent of A, has any record of, or is under investigation for, fraud;

(b) check with the Secretary of State whether the Secretary of State holds any information about A, and if A is a body corporate about any director or superintendent of A, that is relevant to its consideration of whether—

(i) the application should be refused or deferred under regulations 33 or 34, or

(ii) conditions should be imposed under regulation 35;

(c) take up references from, and check the references provided by, the referees whose details A is required to provide pursuant to paragraph 3(8).

(2) In such a case, having considered whether—

(a) the application should be refused or deferred under regulations 33 or 34; or

(b) conditions should be imposed under regulation 35,

if it is minded to impose conditions under regulation 35, it must notify A at least 7 days in advance of determining that it is to impose such conditions and consider any representations (which may be at an oral hearing) that A makes prior to the determination with regard to the notification.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Action following deferrals U.K.

24.—(1) Where [F1 NHS England] receives a routine or excepted application, consideration or determination of which may be deferred, if it does decide to defer consideration or determination of that application (whether before or after the application is notified, in the case of a notifiable application), it must—

(a) notify the applicant (A) of its decision and the reasons for it; and

(b) where possible, notify A of the period for which the application is being deferred (if necessary by reference to a future event rather than a period of time).

(2) If the application is—

(a) a routine application, consideration of which may be deferred under regulation 14(1)(a), 16(1)(a), 19(2)(a) or 21(1)(a), it must proceed as soon as is practicable to invite other applications under regulation 14(1)(b), 16(1)(b), 19(2)(b) or 21(1)(b), in such manner as it sees fit;

(b) a routine application, consideration of which may be deferred under regulation 14(2), 16(3), 19(3) or 21(3), it must make arrangements that enable it to consider the other applications at the same time as A's application, as soon as is practicable;

(c) a routine application, consideration of which may be deferred under regulation 14(3), 16(4), 19(4) or 21(4), it must, once the appeal relating to the other application has reached its final outcome, notify A of that outcome and that A must within a specified period (of not less than 30 days)—

(i) update A's application, and

(ii) notify [F1 NHS England] as to whether or not A still wishes to proceed with the application;

(d) a routine application, consideration of which may be deferred under regulation 16(2) or 21(2), it must keep under regular review the issue of whether the future circumstances that gave rise to the deferral have arisen;

(e) a routine application, consideration of which may be deferred under regulation 32, it must—

(i) send A a copy of the designation that led to the decision,

(ii) review that decision once the designation that led to the decision has been cancelled or is varied in a manner which means the application may no longer be deferred under regulation 32,

(iii) notify A of the cancellation or variation, and

(iv) require A within a specified period (of not less than 30 days)—

(aa) to update A's application, and

(bb) to notify [F1 NHS England] as to whether or not A still wishes to proceed with the application;

(f) a routine or excepted application, consideration of which may be deferred under regulation 34, once the outcome of the cause for the deferral is known, [F1 NHS England] must notify A that A must within a specified period (of not less than 30 days)—

(i) update A's application, and

(ii) notify [F1 NHS England] as to whether or not A still wishes to proceed with the application; and

(g) a routine application, consideration of which must be deferred under regulation 38(4), it must proceed, as soon as is practicable, with the determination of whether the relevant area is or is not to be part of a controlled locality.

(3) If A informs [F1 NHS England] within the period specified under sub-paragraph (2)(c), (e)(iv) or (f) that A does not wish to proceed with the application, or fails to respond in the required manner to the notification within the specified period, the application is to be treated as withdrawn.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Oral hearings U.K.

25.—(1) If [F1 NHS England] does decide to hear oral representations, it must—

(a) give the applicant and any additional presenters not less than 14 days notice of the time and place at which the oral representations are to be heard; and

(b) in the case of the applicant, advise the applicant of who apart from the applicant (including other applicants, where the hearing relates to more than one application), has been invited to make representations at the hearing.

(2) For these purposes, a person (P) is an “additional presenter” if—

(a) the application to which the oral hearing relates is a notifiable application;

(b) P was given notice of the application under Part 3 and made representations about the application in accordance with paragraph 19(4), which—

(i) indicated that, if there were to be an oral hearing in relation to the application, P would wish to make oral representations at that hearing, and

(ii) identified a matter about which [F1 NHS England] considers it would be desirable to hear further evidence from P at the oral hearing; and

(c) [F1 NHS England] is satisfied that P made a reasonable attempt to express P's views on the application adequately in P's written representations.

(3) If [F1 NHS England] decides at or after an oral hearing that an application is to be deferred, it may (but need not) hold a further oral hearing once the period for which the application is deferred expires.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Persons barred from taking part in decision making on routine and excepted applications U.K.

26.—(1) No person is to take part in determining or deferring any routine or excepted application who—

(a) is a person who is included in a pharmaceutical list or is an employee of such a person;

(b) assists in the provision of pharmaceutical services under Chapter 1 of Part 7 of the 2006 Act (pharmaceutical services and local pharmaceutical services – provision of pharmaceutical services);

(c) is an LPS chemist, or provides or assists in the provision of local pharmaceutical services;

(d) is a provider of primary medical services;

(e) is a member of a provider of primary medical services that is a partnership or a shareholder in a provider of primary medical services that is a company limited by shares;

(f) is employed or engaged by a primary medical services provider; or

(g) is employed or engaged by an APMS contractor in any capacity relating to the provision of primary medical services,

whether or not their involvement would give rise to a reasonable suspicion of bias.

(2) No other person is to take part in determining or deferring a particular routine or excepted application if because of an interest or association they have, or because of a pressure to which they may be subject, their involvement would give rise to a reasonable suspicion of bias.

Timetable for determining applications U.K.

27.  As regards any routine or excepted application—

(a) [F1 NHS England] must endeavour to determine it as soon as is practicable; and

(b) unless consideration of it is deferred in accordance with these Regulations or there is other good cause for delay, in the case of—

(i) a notifiable application, [F1 NHS England] must determine it within 4 months of the date on which it received from the applicant all the information and documentation the applicant is required to submit in relation to it, or

(ii) an application which is not a notifiable application, [F1 NHS England] must determine it within 30 days of the date on which it received from the applicant all the information and documentation the applicant is required to submit in relation to it.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

PART 5 U.K. Notification, taking effect of decisions and rights of appeal to the Secretary of State

Notification of decisions on routine and excepted applications U.K.

28.—(1) As regards any routine application, once it has determined the application, [F1 NHS England] must, as soon as is practicable, give notice of its decision to—

(a) the applicant;

(b) any Local Pharmaceutical Committee—

(i) whose area includes the premises or location to which the application relates, or

(ii) any part of whose area is within 2 kilometres of the premises or location to which the application relates;

(c) any Local Medical Committee—

(i) whose area includes the premises or location to which the application relates, or

(ii) any part of whose area is within 2 kilometres of the premises or location to which the application relates;

(d) any person—

(i) included in a pharmaceutical list for the area of the relevant HWB, or

(ii) who is entitled to be included in that pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,

whose interests might, in the opinion of [F1 NHS England], be significantly affected by the decision;

(e) any LPS chemist—

(i) with whom [F1 NHS England] has made arrangements for the provision of any local pharmaceutical services in the area of the relevant HWB, and

(ii) whose interests might, in the opinion of [F1 NHS England], be significantly affected by the decision;

(f) any Local Healthwatch organisation for the area of the relevant HWB, and any other patient, consumer or community group in its area which, in the opinion of [F1 NHS England], has a significant interest in the decision;

(g) if the applicant is seeking to locate premises in or within 1.6 kilometres of a controlled locality in the area of the relevant HWB—

(i) any provider of primary medical services, or

(ii) any other person on the dispensing doctors list for the area of the relevant HWB if there is one (being a performer but not a provider of primary medical services),

who, in the opinion of [F1 NHS England], has a significant interest in the decision;

(h) any person—

(i) whom [F1 NHS England] notified under paragraph 19(2), and

(ii) who made representations in writing about the application under paragraph 19(4);

(i) any Local Health Board any part of whose area is within 2 kilometres of the premises or location to which the decision relates; and

(j) the relevant HWB and any other HWB any part of whose area is within 2 kilometres of the premises or location to which the decision relates.

(2) If any part (PA) of the area of a notified HWB (HWB2) other than the relevant HWB is within 2 kilometres of the premises or location to which the application relates, [F1 NHS England] must also, as soon as is practicable, give notice of the decision to—

(a) any Local Pharmaceutical Committee—

(i) whose area includes PA, and

(ii) that is not given notice of the application under paragraph (1)(b);

(b) any Local Medical Committee—

(i) whose area includes PA, and

(ii) that is not given notice of the application under paragraph (1)(c);

(c) any person—

(i) included in a pharmaceutical list for the area of HWB2, or

(ii) who is entitled to be included in that pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,

whose interests might, in the opinion of [F1 NHS England], be significantly affected by the decision;

(d) any LPS chemist—

(i) with whom [F1 NHS England] has made arrangements for the provision of any local pharmaceutical services in the area of HWB2, and

(ii) whose interests might, in the opinion of [F1 NHS England], be significantly affected by the decision;

(e) any Local Healthwatch organisation for the area of HWB2, and any other patient, consumer or community group in its area which, in the opinion of [F1 NHS England], has a significant interest in the decision; and

(f) if the applicant is seeking to locate premises within 1.6 kilometres of a controlled locality in the area of HWB2—

(aa) any provider of primary medical services, or

(bb) any other person on the dispensing doctors list for the area of HWB2 if there is one (being a performer but not a provider of primary medical services),

who, in the opinion of [F1 NHS England], has a significant interest in the decision.

(3) As regards any excepted application, once it has determined the application, [F1 NHS England] must, as soon as is practicable, give notice of its decision to—

(a) in the case of an application pursuant to regulation 23, the applicant;

(b) in the case of an application pursuant to regulation 24, 25[F15 , 26(2) or 26A]—

(i) the applicant,

(ii) any Local Pharmaceutical Committee whose area includes the premises or location to which the application relates,

(iii) any Local Medical Committee whose area includes the premises or location to which the application relates,

(iv) the relevant HWB, and if the applicant is relocating to different premises in the area of another HWB, the other HWB, and

(v) any (other) person whom [F1 NHS England] notified under paragraph 19 and who made representations in writing about the application under paragraph 19(4);

(c) in the case of an application pursuant to regulation 26(1) or 27 to 29—

(i) the applicant,

(ii) any Local Pharmaceutical Committee whose area includes the premises or location to which the application relates,

(iii) any Local Medical Committee whose area includes the premises or location to which the application relates,

(iv) any person—

(aa) included in a pharmaceutical list for the area of the relevant HWB, or

(bb) who is entitled to be included in that pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,

whose interests might, in the opinion of [F1 NHS England], be significantly affected by the decision;

(v) any LPS chemist—

(aa) with whom [F1 NHS England] has made arrangements for the provision of any local pharmaceutical services in the area of the relevant HWB, and

(bb) whose interests might, in the opinion of [F1 NHS England], be significantly affected by the decision,

(vi) any Local Healthwatch organisation for the area of the relevant HWB, and any other patient, consumer or community group in its area which, in the opinion of [F1 NHS England], has a significant interest in the decision,

(vii) any Local Health Board any part of whose area is within 2 kilometres of the pharmacy premises to which the decision relates, and

(viii) the relevant HWB and any other HWB any part of whose area is within 2 kilometres of the premises or location to which the decision relates.

(4) If, in the case of an application pursuant to regulation 26(1) or 27 to 29, any part (PA) of the area of a HWB (HWB3) notified under sub-paragraph (3)(c) other than the relevant HWB is within 2 kilometres of the premises or location to which the application relates, [F1 NHS England] must also, as soon as is practicable, give notice of the decision to—

(a) any Local Pharmaceutical Committee—

(i) whose area includes PA, and

(ii) that is not given notice of the application under paragraph (3)(c)(ii);

(b) any Local Medical Committee—

(i) whose area includes PA, and

(ii) that is not given notice of the application under paragraph (3)(c)(iii);

(c) any person—

(i) included in a pharmaceutical list for the area of HWB3, or

(ii) who is entitled to be included in that pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,

whose interests might, in the opinion of [F1 NHS England], be significantly affected by the decision;

(d) any LPS chemist—

(i) with whom [F1 NHS England] has made arrangements for the provision of any local pharmaceutical services in the area of HWB3, and

(ii) whose interests might, in the opinion of [F1 NHS England], be significantly affected by the decision; and

(e) any Local Healthwatch organisation for the area of HWB3, and any other patient, consumer or community group in its area which, in the opinion of [F1 NHS England], has a significant interest in the decision.

(5) Where [F1 NHS England] has decided to consider 2 or more applications together pursuant to paragraph 22(3), it must give notice to each applicant of the decision taken with regard to each other application considered together with their application.

(6) Each notification of a decision under this paragraph must include a statement by [F1 NHS England] of the reasons for the decision.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F15 Words in Sch. 2 para. 28(3)(b) substituted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 14

Template notice of commencement to be included with a notice of decision U.K.

29.   [F16 Subject to paragraph 29A,] [F1 NHS England] must send with a notice of decision under paragraph 28 in respect of the grant of an application a template of a notice of commencement, for the applicant to send to it under paragraph 34, in which the applicant is to provide the following information (some of which [F1 NHS England] may have included in the template that it sends)—

(a) the address of the premises to which the application relates;

(b) the services that are to be provided from those premises;

(c) the date of the grant of the application;

(d) a declaration with regard to when the applicant intends to commence the provision of those services at those premises;

(e) in the case of pharmacy premises, the registration number for those premises with the General Pharmaceutical Council; and

(f) a signature on behalf of the applicant and the date of the notice.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F16 Words in Sch. 2 para. 29 inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 15

[F17 Template notice of consolidation U.K.

29A.— (1) This paragraph applies as regards a notice of decision under paragraph 28 in respect of a consolidation application that is granted, in relation to the person who is—

(a) P1 for the purposes of regulation 26A (P1), if regulation 26A(3) applied to that application; or

(b) P2 for the purposes of regulation 26A (P2), if regulation 26A(4) applied to that application.

(2) [F1 NHS England] must send with the notice of decision sent to P1 or P2 a template of a notice of consolidation, for P1 or P2 to send to it under paragraph 34A, in which P1 or P2 is to provide the following information (some of which [F1 NHS England] may have included in the template that it sends)—

(a) the date of the grant of the application;

(b) the address of the premises at which pharmaceutical services are no longer to be provided (“the closing premises”);

(c) the date on which pharmaceutical services are to cease being provided at the closing premises;

(d) the address of the premises at which pharmaceutical services are to continue to be provided (“the continuing premises”);

(e) the registration number of the continuing premises with the General Pharmaceutical Council;

(f) confirmation that reasonable steps have been taken to advise any patients who have nominated the person listed in relation to the closing premises as their nominated dispensing contractor that their nomination will transfer to the person listed in relation to the continuing premises, if the Electronic Prescription Service is available through those premises, unless they change their nomination;

(g) the date on which the consolidation is to take effect;

(h) a signature on behalf of P1 or P2 (whichever has been sent the template) and the date of the notice.]

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F17 Sch. 2 para. 29A inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 16

Third party rights of appeal to the Secretary of State where an application is granted U.K.

30.—(1) A person with third party rights (as provided for in this paragraph) may appeal to the Secretary of State against a decision of [F1 NHS England] to grant a notifiable application, or an application to which regulation 26(1), 27 or 28 applies, provided that the person notifies the Secretary of State with a valid notice of appeal within 30 days of the date on which that person was notified of [F1 NHS England’s] decision under paragraph 28.

(2) For the purposes of this Schedule, a person (P1) is a person with third party rights if—

(a) P1 is a person to whom sub-paragraph (3) applies; or

(b) P1 was entitled to receive notification of the decision to grant the application by virtue of paragraph 28(5).

(3) P1 is a person to whom this sub-paragraph applies if—

(a) P1 was a person whom [F1 NHS England] was required to notify about the decision on the application by virtue of P1 being a person whose interests might, in the opinion of [F1 NHS England], be significantly affected by the decision, and also being—

(i) included in a pharmaceutical list,

(ii) entitled to be included in a pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,

(iii) an LPS chemist, or

(iv) either—

(aa) a provider of primary medical services, or

(bb) another person on the dispensing doctor list for the area of the relevant HWB if there is one (P1 being a performer but not a provider of primary medical services),

but only if the application is in respect of premises in a controlled locality and it was granted partly on the basis that, having regard to regulation 44(3), in the opinion of [F1 NHS England] granting the application would not prejudice the proper provision of relevant NHS services in the area of the relevant HWB or of a neighbouring HWB of the relevant HWB;

(b) in the case of a notifiable application, P1 made representations in writing about the application under paragraph 19(4); and

(c) in the case of a notifiable application but subject to sub-paragraph (6), [F1 NHS England] is satisfied, having regard to those representations in writing and any oral representations made in accordance with paragraph 25, that P1—

(i) made a reasonable attempt to express P1's grounds for opposing the application adequately in P1's representations, and

(ii) has grounds for opposing the application, which—

(aa) do not amount to a challenge to the legality or reasonableness of a pharmaceutical needs assessment, or to the fairness of the process by which a HWB or Primary Care Trust undertook that assessment, and

(bb) are not vexatious or frivolous.

(4) If [F1 NHS England] considers that a person notified under paragraph 28 is a person with third party appeal rights, it must notify that person of that fact when it notifies that person of the determination.

(5) A notice of appeal under sub-paragraph (1) is only valid if it includes a concise and reasoned statement of the grounds of appeal.

(6) A person to whom sub-paragraph (3)(a) and (b) applies (P2) who is not notified by [F1 NHS England] that they are person with third party appeal rights may appeal to the Secretary of State against the determination (D1) by [F1 NHS England] that it is not satisfied as mentioned in sub-paragraph (3)(c), provided that P2—

(a) notifies the Secretary of State within 30 days of the date on which that person was notified of [F1 NHS England’s] decision under paragraph 28 (D2) that P2 wishes to appeal against D1 and D2; and

(b) includes within that notification concise and reasoned statements of P2's grounds of appeal against both D1 and D2,

and if the appeal against D1 is successful, P2 is a person with third party appeal rights in relation to D2 for the purposes of this Schedule.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Conditional grant of applications where the address of the premises is unknown U.K.

31.—(1) As regards any routine application, sub-paragraph (2) applies where—

(a) the applicant (A) is seeking the listing of premises not already listed in relation to A (whether or not A is already included in the pharmaceutical list); and

(b) prior to the determination of the application, A was only able to provide a best estimate of where the proposed listed chemist premises would be (not the address of those premises).

(2) Where this sub-paragraph applies, it is a condition of the grant of that application that A notifies to [F1 NHS England] the address of the premises to be listed within 6 months of—

(a) the date on which A was sent the notice of decision under paragraph 28 (having regard also to paragraph 10(2) of Schedule 3);

(b) if the grant of the application is appealed to the Secretary of State by a person with third party appeal rights, the date on which the appeal is determined by the Secretary of State; or

(c) in a case of an application which is subject to a condition imposed by virtue of paragraph 33(2), the date on which that condition becomes spent,

whichever is the latest.

(3) A notification under sub-paragraph (2) is only valid if [F1 NHS England] is satisfied that the premises are at a location that is within the range of possible locations covered by the estimate referred to in sub-paragraph (1)(b).

[F18 (3A) For the purposes of paragraph (3), premises are not within the range of possible locations covered by the estimate referred to in sub-paragraph (1)(b) if the granted application would have been refused pursuant to regulation 31 if the address of those premises had been included in that application instead of the estimate.]

(4) If [F1 NHS England] receives a purported notification under sub-paragraph (2), it must, within 14 days of receiving that purported notification—

(a) notify A of whether or not it is satisfied that it is a valid notification;

(b) if it is satisfied that it is a valid notification, notify the address to the persons notified of the decision to grant the application; and

(c) if [F1 NHS England] is not satisfied that it is a valid notification, it must include with that notification—

(i) the reasons for its decision, and

(ii) an explanation of how A's rights of appeal under paragraph 36(1)(b) may be exercised.

(5) [F1 NHS England] may not vary or remove a condition imposed by virtue of this paragraph.

(6) If A breaches a condition imposed by virtue of this paragraph, the grant of the application lapses.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F18 Sch. 2 para. 31(3A) inserted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 17(c)

Changes to the premises specified in an application after its grant but before the listing of the premises U.K.

32.—(1) As regards any routine application, sub-paragraph (2) applies where—

(a) the applicant (A) is seeking the listing of premises not already listed in relation to A (whether or not A is already included in the pharmaceutical list); and

(b) prior to the determination of the application, A provided the address of where the proposed listed chemist premises would be.

(2) Where this sub-paragraph applies, A may notify to [F1 NHS England] a different address (“new address”) as the address to which the application relates within—

(a) 4 months of the date on which A was sent the notice of decision under paragraph 28 (having regard also to paragraph 10(2) of Schedule 3); or

(b) if the grant of the application is appealed to the Secretary of State by a person with third party appeal rights, 4 months of the date on which the appeal is determined by the Secretary of State.

(3) A notification under sub-paragraph (2) is only valid if [F1 NHS England] is satisfied that accepting the notification as valid would neither—

(a) result in a significant change to the arrangements that are in place (having regard to the grant of A's application) for the provision of local pharmaceutical services or of pharmaceutical services other than those provided by a person on a dispensing doctor list—

(i) in any part of the area of the relevant HWB, or

(ii) in a controlled locality that is part of the area of a neighbouring HWB of the relevant HWB, where that controlled locality is within 1.6 kilometres of the new address; nor

(b) cause significant detriment to proper planning in respect of the provision of pharmaceutical services in the area of the relevant HWB.

[F19 (3A) A notification under sub-paragraph (2) is not valid if the granted application would have been refused pursuant to regulation 31 if the address of those premises had been included in that application instead of the address mentioned in sub-paragraph (1)(b).]

(4) If [F1 NHS England] receives a purported notification under sub-paragraph (2), it must, within 14 days of receiving that purported notification—

(a) notify A of whether or not it is satisfied that it is a valid notification, together with the reasons for its decision;

(b) if [F1 NHS England] is not satisfied that it is a valid notification, it must include with that notification—

(i) the reasons for its decision, and

(ii) an explanation of how A's rights of appeal under paragraph 36(1)(b) may be exercised.

(c) if it is satisfied that it is a valid notification, notify the new address to the persons notified of the decision to grant the application, and must include with that notification—

(i) the reasons for its decision, and

(ii) if the person has a right of appeal under sub-paragraph (5), an explanation of how that right of appeal may be exercised.

(5) A person (X) who—

(a) is notified under sub-paragraph (4)(c); and

(b) was entitled to be notified of the decision to grant the application—

(i) by virtue of paragraph 28(5), or

(ii) as a person whom [F1 NHS England] was required to notify about the application by virtue of X being—

(aa) an LPS chemist,

(bb) included in a pharmaceutical list, or

(cc) entitled to be included in a pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,

and a person whose interests might, in the opinion of [F1 NHS England], be significantly affected by the decision;

may appeal against a decision by [F1 NHS England] to accept the purported notification as a valid notification, provided X notifies the Secretary of State with a valid notice of appeal within 30 days of the date on which X was notified under sub-paragraph (4)(c).

(6) A notice of appeal under sub-paragraph (5) is only valid if it includes a concise and reasoned statement of the grounds of appeal.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F19 Sch. 2 para. 32(3A) inserted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 17(d)

Conditional grant in cases relating to future needs or future improvements or better access U.K.

33.—(1) Where [F1 NHS England] grants a routine application because doing so—

(a) will meet a future need for pharmaceutical services, or pharmaceutical services of a specified type in its area; or

(b) will secure future improvements or better access to pharmaceutical services, or pharmaceutical services of a specified type, in its area,

sub-paragraph (2) applies.

(2) Where this sub-paragraph applies, [F1 NHS England] may grant the application subject to a condition that pharmaceutical services are not provided at the listed chemist premises to which the application relates (or at any premises to which the business relocates) until—

(a) some or all of the future circumstances, as a consequence of which the application was granted, have arisen; or

(b) a specified date (having regard to when some or all of the future circumstances, as a consequence of which the application was granted, are likely to arise).

(3) [F1 NHS England] may vary or remove a condition imposed by virtue of sub-paragraph (2), but if it varies the condition, the revised condition (which becomes a condition imposed by virtue of sub-paragraph (2)) must be a condition that it also meets the requirements of that paragraph.

(4) The condition imposed by virtue of sub-paragraph (2) becomes spent once—

(a) where a date has been specified, that date passes; or

(b) where the condition relates to future circumstances arising, [F1 NHS England] notifies the successful applicant (P) that the future circumstances have arisen.

(5) P may by a notice request a determination from [F1 NHS England] as to whether the future circumstances have arisen at any time (but only once in any 60 days), and [F1 NHS England] must give notice of that determination within 30 days of that request.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Taking effect of listing decisions: general U.K.

34.—(1)  [F20 Except where paragraph 34A applies,] as regards any application—

(a) for inclusion in a pharmaceutical list by a person who is not already included in it; or

(b) by a person who is included in a pharmaceutical list and who is seeking—

(i) to open, within the area of the relevant HWB, additional premises from which to provide the same or different pharmaceutical services,

(ii) to relocate to different premises, and at those premises to provide the same or different pharmaceutical services, or

(iii) to provide, from the person's listed chemist premises, services that are in addition to those already listed in relation to that person,

if the application is granted, paragraph (2) applies.

(2) Subject to paragraph 35, [F1 NHS England] may only change a pharmaceutical list to give effect to that decision if the successful applicant (P) gives [F1 NHS England] a valid notice of commencement, in the correct form, informing [F1 NHS England] that P is to commence the provision of the services in respect of which the application was made and at the premises to which the application related F21 ....

(3) A notice of commencement is in the correct form if it—

(a) includes the information required under paragraph 29; and

(b) is in the same format as the version of the notice sent by [F1 NHS England] with the notice of decision under paragraph 28.

[F22 (3A) A notice of commencement is invalid unless it is given to [F1 NHS England] no fewer than 30 days prior to the date on which the provision of services is to commence, unless prior to the notified date [F1 NHS England] has agreed with P a shorter period of prior notice.

(3B) P must notify [F1 NHS England] in writing as soon as reasonably practicable of any change to the date included in a notice of commencement as the date on which the provision of services is to commence, and must do so in advance of [F23 the date on which the provision of services is to commence].]

[F24 (3C) A notice of commencement is invalid if the date included in it (on or after 25th May 2023), whether when the notice is given or after a change in accordance with sub-paragraph (3B), as the date on which the provision of services is to commence is more than 60 days after the end of the period within which the notice, if it is to be valid, must be sent, as determined in accordance with sub-paragraph (4).]

(4) A notice of commencement is invalid unless it is sent to [F1 NHS England] within—

(a) if, prior to [F1 NHS England] determining the application—

(i) P undertook to commence the provision of the services in respect of which the application was made within a period of less than 6 months, and

(ii) that undertaking was not withdrawn,

that period;

(b) [F25 12 months] of—

(i) unless paragraph (a) applies, the date on which P was sent the notice of [F1 NHS England’s] decision under paragraph 28 granting the application,

(ii) if the grant was appealed by a person with third party appeal rights, the date on which that appeal is determined by the Secretary of State,

(iii) if, in the course of granting the application, a decision is taken to impose a condition in accordance with regulation 35 and that condition is appealed by P, the date on which that appeal is determined by the First-tier Tribunal (unless regulation 35(8) applies),

(iv) if the grant of the application was subject to a condition imposed by virtue of paragraph 31, the date on which—

(aa) P validly notifies to [F1 NHS England] under a condition imposed by virtue of paragraph 31 of the address of the premises, or

(bb) if P appeals successfully against a decision of [F1 NHS England] that a notification under a condition imposed by virtue of paragraph 31 is invalid, that appeal is determined by the Secretary of State,

(v) if P, pursuant to paragraph 32—

(aa) notifies [F1 NHS England] of a new address,

(bb) [F1 NHS England] does not accept the validity of the notification, and

(cc) P appeals successfully against that decision,

the date on which that appeal is determined by the Secretary of State, or

(vi) if the grant of the application was subject to a condition imposed by virtue of paragraph 33, the date on which the condition imposed by virtue of that paragraph becomes spent or is removed on appeal, or

whichever is the latest; or

(c) such longer period—

(i) not exceeding a further 3 months as [F1 NHS England] may allow, or

(ii) if—

(aa) the grant is appealed by a person with third party appeal rights,

(bb) a decision to accept a notification pursuant to paragraph 32 is appealed by a third party,

(cc) P appeals successfully against a notice under paragraph 35, or

(dd) if P appeals successfully against a decision not to allow a longer period under sub-paragraph (i),

as the Secretary of State may allow when the appeal is determined,

and so once a valid notice of commencement can no longer be sent in relation to an application (having regard also to paragraph 10(2) of Schedule 3), the grant of that application lapses.

(5) A notice of commencement ceases to have effect if the Secretary of State receives a valid notice of appeal—

(a) from a person with third party appeal rights relating to the grant to which the notice of commencement relates; or

(b) from a third party, in a case to which sub-paragraph (4)(c)(ii)(bb) applies.

[F26 (6) In any case where a longer period allowed by virtue of sub-paragraph (4)(c)—

(a) began in the 3 months prior to the coming into force of the Coronavirus Regulations, that longer period is extended so that it ends on the day that is 6 months after the day on which the Coronavirus Regulations came into force; and

(b) ended in the 6 months prior to the coming into force of the Coronavirus Regulations, that longer period is treated as having not ended and is extended so that it ends on the day that is 6 months after the day on which the Coronavirus Regulations came into force.

(7) In this paragraph, “the Coronavirus Regulations” means the National Health Service (Coronavirus) (Charges and Further Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020.]

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F20 Words in Sch. 2 para. 34(1) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 17

F21 Words in Sch. 2 para. 34(2) omitted (9.11.2020) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 4(a)

F22 Sch. 2 para. 34(3A)(3B) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 4(b)

F23 Words in Sch. 2 para. 34(3B) substituted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 8(2)

F24 Sch. 2 para. 34(3C) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 8(3)

F25 Words in Sch. 2 para. 34(4)(b) substituted (14.9.2020) by The National Health Service (Coronavirus) (Charges and Further Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/885), regs. 1(2), 4(3)(a)

F26 Sch. 2 para. 34(6)(7) inserted (14.9.2020) by The National Health Service (Coronavirus) (Charges and Further Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/885), regs. 1(2), 4(3)(b)

[F27 Taking effect of decisions relating to business consolidations U.K.

34A.— (1) This paragraph applies as regards a consolidation application that is granted, in relation to the person who is—

(a) P1 for the purposes of regulation 26A (P1), if regulation 26A(3) applied to that application; or

(b) P2 for the purposes of regulation 26A (P2), if regulation 26A(4) applied to that application.

(2) [F1 NHS England] may only change a pharmaceutical list to give effect to that decision if P1 or P2 gives [F1 NHS England] a valid notice of consolidation, in the correct form, informing [F1 NHS England] of the date on which the consolidation is to take effect in the next 14 days.

(3) A notice of consolidation under this paragraph is in the correct form if it—

(a) includes the information required under paragraph 29A; and

(b) is in the same format as the version of the notice sent by [F1 NHS England] with the notice of decision under paragraph 28.

(4) A notice of consolidation is invalid unless it is sent to [F1 NHS England] within—

(a) 6 months of the date on which the applicant was sent the notice of [F1 NHS England’s] decision under paragraph 28 granting the application;

(b) such longer period—

(i) not exceeding a further 3 months as [F1 NHS England] may allow, or

(ii) if—

(aa) the grant is appealed by a person with third party appeal rights, or

(bb) P1 or P2 appeals successfully against a decision not to allow a longer period under paragraph (i),

as the Secretary of State may allow when the appeal is determined,

(5) A notice of consolidation ceases to have effect if the Secretary of State receives a valid notice of appeal from a person with third party appeal rights relating to the grant to which the notice of consolidation relates.

(6) Once, having regard to sub-paragraph (4), a valid notice of consolidation can no longer be sent in relation to the grant of a consolidation application, the grant of that application lapses.]

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F27 Sch. 2 para. 34A inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 18

Notice requiring the commencement of pharmaceutical services U.K.

35.—(1)  [F1 NHS England], having granted a routine application—

(a) for inclusion in a pharmaceutical list by a person (P) not already included; or

(b) if P is already included in a particular pharmaceutical list, for inclusion in that list also in relation to premises not already listed in relation to P,

may, if the grant has not lapsed and is not under appeal to the Secretary of State, give notice to P requiring P to commence the provision of pharmaceutical services by a date specified in the notice.

(2) If [F1 NHS England] gives notice under sub-paragraph (1) but afterwards a valid notice of appeal is given against the grant, the notice under sub-paragraph (1) lapses.

(3) A notice under sub-paragraph (1) may not specify a date that is—

(a) earlier than 30 days from the date of the notice under that paragraph; or

(b) later than 9 months after the date on which the grant of the application was notified to P.

(4) [F1 NHS England] may change its pharmaceutical list to give effect to that notice—

(a) on the specified date, unless the decision to give notice under sub-paragraph (1) is appealed; or

(b) if the notice under paragraph (1) is appealed and the appeal is unsuccessful or discontinued—

(i) if the appeal is discontinued, 30 days after P discontinues the appeal,

(ii) if the appeal is unsuccessful, 30 days after the appeal is determined, or

(iii) on the specified date,

whichever is the latest.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Appeals to the Secretary of State by the applicant U.K.

36.—(1) As regards any routine or excepted application, other than an application pursuant to regulation 29, the applicant (A) may appeal to the Secretary of State against a decision by [F1 NHS England]—

(a) to refuse the application on grounds set out in Parts 3 to 5 or 7 of these Regulations;

(b) that a notification pursuant to a condition imposed by virtue of paragraph 31 is invalid;

(c) to refuse to accept that a notification under paragraph 32(2) is a valid notification;

(d) to impose or vary a condition imposed pursuant to paragraph 33;

(e) to refuse to allow A an extension period under paragraph 34(4)(c)(i) [F28 or 34A(4)(b)(i)]; or

(f) to give notice under paragraph 35,

provided A notifies the Secretary of State with a valid notice of appeal within 30 days of the date on which A was notified of the decision that is being appealed.

(2) A notice of appeal under [F29 sub-paragraph] (1) is only valid if it includes a concise and reasoned statement of the grounds of appeal.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F28 Words in Sch. 2 para. 36(1)(e) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 19(a)

F29 Words in Sch. 2 para. 36(2) substituted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 19(b)

Regs 10(8), 45(3), 63(6), 77(4), 98(9)

SCHEDULE 3 U.K. Appeals to the Secretary of State

PART 1 U.K. Preliminary matters

Determination of third party appeal rights in certain cases U.K.

1.—(1) If the Secretary of State has received a notification under paragraph 30(6) of Schedule 2 from a person (P1), the Secretary of State must determine (prior to a notification under Part 2 or a determination under paragraph 2) whether P1 is to have third party appeal rights on the basis that—

(a) P1 is a person to whom paragraph 30(3)(a) and (b) of Schedule 2 applies; and

(b) in relation to P1, [F1 NHS England] should have been satisfied as mentioned in paragraph 30(3)(c) of Schedule 2.

(2) If the Secretary of State has received a notification under regulation 63(5) from a person (P2), the Secretary of State must determine (prior to a notification under Part 2 or a determination under paragraph 2) whether P2 is to have third party appeal rights on the basis that—

(a) P2 is a person to whom regulation 63(3)(a) and (b) applies; and

(b) in relation to P2, [F1 NHS England] should have been satisfied as mentioned in regulation 63(3)(c).

(3) Once the Secretary of State has made a determination under paragraph (1) or (2), the Secretary of State must notify [F1 NHS England] and P1 or P2 of that determination and the reasons for it.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Misconceived appeals U.K.

2.  If the Secretary of State, after considering a valid notice of appeal under regulation 45, 63 or 77, or paragraph 30, 32(5) or 36 of Schedule 2 against a decision, is of the opinion that the notice—

(a) contains no valid grounds of appeal (for example, because it amounts to a challenge to the legality or reasonableness of a HWB's or Primary Care Trust's pharmaceutical needs assessment, or to the fairness of the process by which the HWB or a Primary Care Trust undertook that assessment); or

(b) contains no reasonable grounds for appeal (for example, where it is vexatious or frivolous),

the Secretary of State may determine the appeal by dismissing it (without proceeding to notify the appeal under Part 2).

PART 2 U.K. Notification of appeals

Notification of appeals notices under paragraph 30, 32(5) or 36 of Schedule 2 U.K.

3.—(1) Unless the Secretary of State determines the appeal under paragraph 2, or the appeal relates to an application pursuant to regulation 23, the Secretary of State must send a copy of a valid notice of appeal sent under paragraph 30, 32(5) or 36 of Schedule 2 to—

(a) [F1 NHS England];

(b) in the case of an appeal against the grant of an application, any person who was entitled to receive notification of the decision by virtue of paragraph 28(5) of Schedule 2;

(c) in the case of an appeal in relation to a notifiable application, including against decisions as mentioned in paragraphs 32(4) and 36(1)(b) to (f) of Schedule 2—

(i) the applicant (unless they are the person bringing the appeal),

(ii) any person who was notified in relation to that application under paragraph 19 of Schedule 2 who made representations in writing about the application under paragraph 19(4) of that Schedule (unless they are also the person bringing the appeal), and

(d) in the case of an appeal in relation to an application pursuant to regulation 26(1), 27 or 28 (including against decisions as mentioned in paragraph 36(1)(d) to (f) of Schedule 2), any person notified in relation to the decision on that application under paragraph 28(3)(c) or (4).

(2) Any person to whom a notice of appeal is sent under sub-paragraph (1) may make representations in writing about the appeal, provided they do so within 30 days of the date on which they are sent the notice of appeal by the Secretary of State.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Notification of appeals relating to notices under regulation 45 U.K.

4.—(1) A valid notice of appeal under regulation 45(1)(b) does not need to be notified to others.

(2) The Secretary of State must send a valid notice of appeal—

(a) against a determination under regulation 36(2) to the persons given notice of the proposed determination under regulation 38(1) or (2); or

(b) against a determination under regulation 41(2) or 42(1) to—

(i) the person making the routine application to which the determination relates, and

(ii) any person given notice of the determination who is mentioned in regulation 43(1)(b)(ii),

unless they are the person bringing the appeal.

(3) Any person to whom a notice of appeal was sent under sub-paragraph (2) may make representations in writing about the appeal, provided they do so within 30 days of the date on which they were sent the notice of appeal by the Secretary of State.

Notification of appeals relating to decisions under Part 8 of these Regulations U.K.

5.—(1) A valid notice of appeal under regulation 63(1)(a) does not need to be notified to others.

(2) The Secretary of State must send a valid notice of appeal against—

(a) a decision mentioned in regulation 63(1)(b) to the persons, other than the appellant, given notice of the decision under [F30 regulation 50(7)]; or

(b) a decision or determination mentioned in regulation 63(1)(c) to (f) to—

(i) the person who made the original application for outline consent or premises approval,

(ii) any person who was notified in relation to that application under regulation 52(1) to (3) who made representations in writing about the application under regulation 52(4), and

(iii) if the appeal is against a refusal to grant temporary premises approval, the applicant who made the relevant outstanding pharmacy application,

unless they are person bringing the appeal.

(3) Any person to whom a notice of appeal was sent under sub-paragraph (2) may make representations in writing about the appeal, provided they do so within 30 days of the date on which they were sent the notice of appeal by the Secretary of State.

Textual Amendments

F30 Words in Sch. 3 para. 5(2)(a) substituted (1.3.2015) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015 (S.I. 2015/58), regs. 1(1), 7 (with reg. 10)

Non notification of appeals relating to notices under regulation 77 or 98 U.K.

6.  A valid notice of appeal under regulation 77 or 98 does not need to be notified to others.

PART 3 U.K. Determination of appeals

Flexibility with regard to the manner of determining appeals U.K.

7.—(1) Except in so far as these Regulations provide to the contrary, the Secretary of State is to determine the appeal to which a valid notice of appeal under regulation 45, 63 or 77, or under paragraph 30, 32(5) or 36 of Schedule 2, relates in such manner (including with regard to procedures) as the Secretary of State sees fit.

(2) The Secretary of State may determine the appeal without hearing any oral representations, if the Secretary of State considers that oral representations are unnecessary.

(3) Where appropriate, the Secretary of State may, if the Secretary of State thinks fit, consider 2 or more appeals together and in relation to each other, but where the Secretary of State does so, the Secretary of State must give notice of the Secretary of State's intention to do so to—

(a) [F1 NHS England];

(b) the appellants; and

(c) any other person notified in relation to the appeals under Part 2.

[F31 (4) Where an application for inclusion in a pharmaceutical list has been updated in accordance with paragraph 5A of Schedule 2, the Secretary of State may, on an application from NHS England, defer the Secretary of State’s decision in relation to the application on any ground that NHS England could have relied on for deferring the application pursuant to regulation 34 until—

(a) the reason for the deferral no longer exists; or

(b) the outcome of the cause of the deferral is known and NHS England has—

(i) decided, in the light of that outcome, whether or not to redetermine the application, and

(ii) redetermined the application, if it is to be redetermined.

(5) Where NHS England redetermines an application in accordance with paragraph 5A(2) of Schedule 2 and refuses it, the Secretary of State may direct that the proceedings relating to the appeal are to be brought to an end without a determination of the matter under paragraph 9.]

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F31 Sch. 3 para. 7(4)(5) inserted (1.10.2022) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 (S.I. 2022/930), regs. 1(2), 7

Oral hearings U.K.

8.—(1) If the Secretary of State does decide to hear oral representations, the Secretary of State must give not less than 14 days notice of the time and place at which the oral representations are to be heard to—

(a) [F1 NHS England];

(b) the person who made the original application to which the appeal relates;

(c) if a person other than that applicant is bringing the appeal, the person bringing the appeal;

(d) any Local Pharmaceutical Committee whose area includes all or part of the area, or in whose area is the location or are the premises, to which the decision relates;

(e) any Local Medical Committee whose area includes all or part of the area, or in whose area is the location or are the premises, to which the decision relates; and

(f) any additional presenters,

and they (or their duly authorised representatives) are to be the only persons entitled to make oral representations at the hearing.

(2) For these purposes, a person (P) is an “additional presenter” if—

(a) P was notified of the appeal under Part 2 and has made written representations in accordance with paragraph 3(2), 4(3) or 5(3) F32 ...; and

(b) the Secretary of State is satisfied that P made a reasonable attempt to express P's views on the appeal adequately in P's written representations.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F32 Words in Sch. 3 para. 8(2)(a) omitted (26.11.2018) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 6(2)

Decisions of the Secretary of State U.K.

9.—(1) On determining an appeal relating to a valid notice under paragraph 30 or 36, the Secretary of State may—

(a) if the appeal is an appeal to which paragraph 30 or 36(1)(a) of Schedule 2 applies (that is, against a decision to grant or refuse a routine or excepted application)—

(i) confirm the decision of [F1 NHS England],

(ii) quash the decision and redetermine the application, or

(iii) quash the decision and remit the matter to [F1 NHS England] for it to redetermine the application, where the Secretary of State considers that there should be a (further) notification under paragraph 19 of Schedule 2, subject to such directions as the Secretary of State considers appropriate; or

(b) if the appeal is an appeal to which paragraph 32(5) or 36(1)(b) to (f) applies—

(i) confirm the decision of [F1 NHS England], or

(ii) substitute for that decision any decision that [F1 NHS England] could have taken when it took that decision.

(2) If the Secretary of State grants or confirms the grant of a routine application, the Secretary of State may direct [F1 NHS England]—

(a) to impose a condition under paragraph 33, in circumstances where [F1 NHS England] could have imposed such a decision if it had granted the application; or

(b) to take such action under regulation 50(4) or (5) as the Secretary of State thinks fit.

(3) On determining an appeal relating to a valid notice under regulation 45, the Secretary of State may—

(a) confirm the decision or determination of [F1 NHS England];

(b) substitute for that decision or determination any decision or determination that [F1 NHS England] could have taken when it took that decision or made that determination; or

(c) quash the decision or determination of [F1 NHS England] and remit the matter to it for it to redetermine the decision or determination, subject to such directions as the Secretary of State considers appropriate.

(4) On determining an appeal relating to a valid notice under regulation 63, the Secretary of State may—

(a) in the case of decision or determination mentioned in regulation 63(1)(a), (b), (e) or (f)—

(i) confirm the decision or determination of [F1 NHS England],

(ii) substitute for that decision or determination any decision or determination that [F1 NHS England] could have taken when it took that decision or made that determination, or

(iii) quash the decision or determination of [F1 NHS England] and remit the matter to it for it to redetermine the decision or determination, subject to such directions as the Secretary of State considers appropriate; or

(b) if the appeal is against a decision to grant or refuse an application for outline consent or premises approval—

(i) confirm the decision of [F1 NHS England],

(ii) quash the decision of [F1 NHS England] and redetermine the application, or

(iii) quash the decision of [F1 NHS England] and remit the matter to it for it to redetermine the application, subject to such directions as the Secretary of State considers appropriate.

(5) On determining an appeal relating to a valid notice under regulation 77, the Secretary of State may—

(a) confirm the decision of [F1 NHS England]; or

(b) substitute for that decision any decision that [F1 NHS England] could have taken when it took that decision.

(6) If the Secretary of State grants or confirms the grant of an application for—

(a) outline consent, the Secretary of State may direct [F1 NHS England] to take such action under regulation 53(3) as the Secretary of State thinks fit; or

(b) premises approval, the Secretary of State may direct [F1 NHS England] to take such action under regulation 57 as the Secretary of State thinks fit.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Notification of decisions and subsequent action by [F1 NHS England] U.K.

10.—(1) Once the Secretary of State has determined the appeal, the Secretary of State must notify the following—

(a) [F1 NHS England];

(b) the person who made the original application to which the appeal relates;

(c) if a person other than that person brought the appeal, the person who brought the appeal; and

(d) any person who made written representations relating to the application pursuant to the notification under Part 2,

and must include with that notification a statement of the reasons for the Secretary of State's decision and the Secretary of State's findings of fact.

[F33 (1A) If the Secretary of State has—

(a) granted or confirmed the grant of a consolidation application; or

(b) allowed or refused an appeal against a decision as mentioned in paragraph 36(1)(b) in respect of an extension period under paragraph 34A(4)(b)(i),

the Secretary of State must notify the relevant HWB (under this sub-paragraph or sub-paragraph (1)(d)), and must include with that notification a statement of the reasons for the Secretary of State’s decision and the Secretary of State’s findings of fact.]

(2) If the Secretary of State has granted or confirmed the grant of a routine or excepted application—

(a) [F1 NHS England] must send to the applicant a template of the notice of commencement referred to in paragraph 29 [F34 or a notice of consolidation referred to in paragraph 29A]; and

(b) the time periods in paragraphs 31, 32[F35 , 34 and 34A] thereafter apply as if the references to the applicant being sent notices of [F1 NHS England’s] decision were reference to the applicant being notified by the Secretary of State under [F35 sub-paragraph (1)].

(3) If the Secretary of State has granted or confirmed the grant of—

(a) a routine application, [F1 NHS England] must proceed as soon as is practicable to take such action under regulation 50(4) or (5) as it thinks fit, subject to any directions of the Secretary of State under paragraph 9(2)(b);

(b) an application for outline consent, [F1 NHS England] must proceed as soon as is practicable to make a determination under regulation 53(3), subject to any directions of the Secretary of State under paragraph 9(6)(a); or

(c) an application for premises approval, [F1 NHS England] must proceed as soon as is practicable take such action under regulation 57 as it thinks fit, subject to any directions of the Secretary of State under paragraph 9(6)(b).

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F33 Sch. 3 para. 10(1A) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 20(a)

F34 Words in Sch. 3 para. 10(2)(a) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 20(b)(i)

F35 Words in Sch. 3 para. 10(2)(b) substituted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 20(b)(ii)

Effect of decisions by the Secretary of State U.K.

11.  For the purposes of these Regulations, the Secretary of State's decision becomes [F1 NHS England’s] decision on the matter (but no further appeal to the Secretary of State on that decision is possible), unless the Secretary of State's decision is overruled by a court.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Regulation 11(1)(a)(i)

SCHEDULE 4 U.K. [F1 NHS England’s]Terms of service of NHS pharmacists

PART 1 U.K. General

Responsibilities of NHS pharmacists and pharmacy staff U.K.

1.—(1) To the extent that this Schedule imposes a requirement on an NHS pharmacist in respect of an activity which could only, or would normally, be undertaken by a natural person—

(a) if the NHS pharmacist is a registered pharmacist—

(i) that NHS pharmacist must comply with that requirement, or

(ii) if the NHS pharmacist employs or engages natural persons in connection with the provision of pharmaceutical services, the NHS pharmacist must either comply with that requirement or secure compliance with that requirement by—

(aa) where conformity with the standards generally accepted in the pharmaceutical profession so requires, a registered pharmacist (who is not suspended), or

(bb) in other cases, by the natural persons (including registered pharmacists) whom the NHS pharmacist employs or engages in connection with the provision of pharmaceutical services; or

(b) if the NHS pharmacist is not a natural person, that NHS pharmacist must secure compliance with that requirement by—

(i) where conformity with the standards generally accepted in the pharmaceutical profession so requires, a registered pharmacist (who is not suspended), or

(ii) in other cases, the natural persons (including registered pharmacists) whom the NHS pharmacist employs or engages in connection with the provision of pharmaceutical services.

(2) Where in this Schedule reference is made to an NHS pharmacist—

(a) being the subject of any activity, and it is an activity to which a natural person could only, or would normally, be subject; or

(b) forming a view,

that reference is to be construed as a referring, as appropriate, to the NHS pharmacist (if a natural person) or to the NHS pharmacist's staff.

(3) References in this Schedule to an NHS pharmacist are to be construed in accordance with sub-paragraphs (1) and (2).

Breaches by directors and superintendents U.K.

2.  Where this Schedule imposes a requirement on the director or superintendent of a body corporate that is on a pharmaceutical list, a breach of that requirement is to be deemed to be a breach by the body corporate of its terms of service.

PART 2 U.K. Essential services

Essential services U.K.

3.  For the purposes of these Regulations, “ essential services” means—

(a) the services described in this Part; and

(b) the activities described in this Part to be carried out in connection with those services.

Dispensing services U.K.

4.  An NHS pharmacist must, to the extent that paragraphs 5 to 9 require and in the manner described in those paragraphs, provide proper and sufficient drugs and appliances to persons presenting prescriptions for drugs or appliances ordered by health care professionals in pursuance of their functions in the health service, the Scottish health service or the Northern Ireland health service.

Dispensing of drugs and appliances U.K.

5.—(1) In this Part, “ signed” includes signature with a prescriber's advanced electronic signature.

(2) Subject to the following provisions of this Part, where—

(a) any person presents to an NHS Pharmacist (P) a non-electronic prescription form which contains—

(i) an order for drugs, not being Scheduled drugs, or for appliances, not being restricted availability appliances, signed by a prescriber,

(ii) an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations M6 (drugs, medicines and other substances that may be ordered only in certain circumstances), signed by a prescriber and including the reference “SLS”, or

(iii) an order for a restricted availability appliance, signed by a prescriber and including the reference “SLS”; F36 ...

(b) subject to sub-paragraph (4), P receives [F37 as a nominated dispensing contractor] from the Electronic Prescription Service an electronic prescription form which contains an order of a kind specified in paragraph (a)(i) to (iii) and—

(i) any person requests the provision of drugs or appliances in accordance with that prescription, or

(ii) P has previously arranged with the patient that P will dispense that prescription on receipt[F38 ; or]

[F39 (c) any person—

(i) presents P with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iii), and

(ii) requests the provision of drugs or appliances in accordance with the related electronic prescription form,]

P must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as P supplies in the normal course of business.

(3) Subject to the following provisions of this Part, where—

(a) any person presents to P a non-electronic repeatable prescription which contains—

(i) an order for drugs, not being Scheduled drugs or controlled drugs within the meaning of the Misuse of Drugs Act 1971 M7 , other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 M8 (which relate to controlled drugs excepted from certain prohibitions under the Regulations), signed by a prescriber,

(ii) an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations, not being a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001, signed by a prescriber and including the reference “SLS”,

(iii) an order for appliances, not being restricted availability appliances, signed by a prescriber, or

(iv) an order for a restricted availability appliance, signed by a prescriber, and including the reference “SLS”,

and also presents an associated batch issue; F40 ...

(b) P receives [F41 as a nominated dispensing contractor] from the Electronic Prescription Service an electronic repeatable prescription which contains an order of a kind specified in paragraph (a)(i) to (iv) and—

(i) any person requests the provision of drugs or appliances in accordance with that repeatable prescription, or

(ii) P has previously arranged with the patient that P will dispense that repeatable prescription on receipt[F42 ; or]

[F43 (c) any person—

(i) presents P with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iv), and

(ii) requests the provision of drugs or appliances in accordance with the related electronic repeatable prescription,]

P must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as P supplies in the normal course of business.

(4) P must not provide under an electronic prescription form a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in [F44 Schedules 2 to 5] to the Misuse of Drugs Regulations 2001.

(5) For the purposes of this paragraph, a non-electronic repeatable prescription for drugs or appliances shall be taken to be presented even if the person who wishes to obtain the drugs or appliances does not present that prescription, where—

(a) P has that prescription in P's possession; and

(b) that person presents, or P has in P's possession, an associated batch issue.

Textual Amendments

F36 Word in Sch. 4 para. 5(2)(a) omitted (26.11.2018) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(2)(a)(i)

F37 Words in Sch. 4 para. 5(2)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(2)(a)(ii)

F38 Word in Sch. 4 para. 5(2)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(2)(a)(iii)

F39 Sch. 4 para. 5(2)(c) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(2)(a)(iv)

F40 Word in Sch. 4 para. 5(3)(a) omitted (26.11.2018) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(2)(b)(i)

F41 Words in Sch. 4 para. 5(3)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(2)(b)(ii)

F42 Word in Sch. 4 para. 5(3)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(2)(b)(iii)

F43 Sch. 4 para. 5(3)(c) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(2)(b)(iv)

F44 Words in Sch. 4 para. 5(4) substituted (1.7.2015) by The National Health Service (Amendments to Primary Care Terms of Service relating to the Electronic Prescription Service) Regulations 2015 (S.I. 2015/915), regs. 1, 4(2)

Marginal Citations

M6 Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680 and 1043.

M7 1971 c.38; see section 2(1)(a) of that Act, which defines “controlled drug” for the purposes of that Act.

M8 S.I. 2001/3998. Schedule 4 has been amended by S.I. 2003/1432, 2005/3372, 2007/2154, 2009/3136 and 2012/973, and Schedule 5 has been amended by S.I. 2005/2864.

[F45 Supply in accordance with a SSP U.K.

5A.— (1) This sub-paragraph applies where—

(a) any person requests a drug or appliance from an NHS pharmacist (P) in accordance with a prescription form or repeatable prescription; and

(b) a SSP has effect in respect of—

(i) the requested drug or appliance, or

(ii) drugs or appliances of a specified description, and the requested drug or appliance is of that description.

(2) Where sub-paragraph (1) applies, P must consider whether it is reasonable and appropriate to supply in accordance with the SSP instead of in accordance with the prescription form or repeatable prescription.

(3) Where sub-paragraph (1) applies, P may provide a different product or quantity of product to the product or quantity of product ordered on the prescription form or repeatable prescription, where—

(a) P is able to do so with reasonable promptness;

(b) to do so is in accordance with the SSP; and

(c) the supply of a different product or quantity of product to that ordered by the prescriber is by or under the direct supervision of a registered pharmacist who is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is reasonable and appropriate.

(4) Where P, in accordance with sub-paragraph (3), provides a different product or quantity of product to that ordered by the prescriber—

(a) the registered pharmacist mentioned in sub-paragraph (3)(c) must endorse the prescription or the associated batch issue accordingly (if the manner for making the endorsement is provided for in the Drug Tariff, in the manner provided for in the Drug Tariff), and the prescription or associated batch issue as thus endorsed is treated as being the prescription for product reimbursement purposes (even though the supply is not in pursuance of that prescription); and

(b) if the patient to or for whom the product is provided is on a patient list, and the supply—

(i) by virtue of regulation 226A(5)(c)(iii) of the Human Medicines Regulations 2012 (sale etc. by a pharmacist in accordance with a serious shortage protocol), is of a prescription only medicine that is different to but has a similar therapeutic effect to the product ordered by the prescriber, or

(ii) is of any other type, and the Secretary of State and the person who is, for the time being, the person consulted under section 165(1)(a) of the 2006 Act in respect of pharmaceutical remuneration of NHS pharmacists, acting jointly, have issued and publicised in such manner as they see fit a recommendation to the effect that, for clinical reasons, in the case of supplies of that type, providers of primary medical services should be notified of a supply to a patient on its patient list that is in accordance with a SSP instead of in accordance with a prescription form or repeatable prescription,

P must notify the provider of primary medical services on whose patient list the patient is of the supply in accordance with the SSP instead of in accordance with the prescription form or repeatable prescription.

(5) Where—

(a) sub-paragraph (1) applies;

(b) a registered pharmacist is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate; and

(c) P is able to supply the product or quantity of product ordered by the prescriber within a reasonable timescale but not with reasonable promptness,

the requirements to act with reasonable promptness in paragraph 5(2) and (3) are to be read as requirements to act within a reasonable timescale.]

Textual Amendments

F45 Sch. 4 para. 5A inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 4(2)

[F46 Supply in accordance with a PTP [F47 or a PTPGD] U.K.

5B.— (1) Subject to the following provisions of this Part, where—

(a) an NHS Pharmacist (P) receives, via a secure service approved by [F1 NHS England] for this purpose, an electronic message that amounts to an order for the supply of a drug in accordance with a PTP [F48 or a PTPGD] ; and

(b) a person who is entitled to be supplied with that drug in pursuance of that order requests the provision of the drug in accordance with that order,

P must, with reasonable promptness, provide the drug so ordered.

[F49 (1A) Where P considers—

(a) on the basis of a request for the supply of a drug in accordance with a PTP or a PTPGD that has been approved by [F1 NHS England] as a basis for supply as part of pharmaceutical services;

(b) having made the appropriate checks; and

(c) having regard to what is reasonable and appropriate,

that a person is entitled to be supplied with the drug in accordance with the PTP or PTPGD as part of pharmaceutical services, P must, with reasonable promptness, provide the drug requested.]

(2) If a person who is entitled as mentioned in sub-paragraph (1)(b) [F50 or (1A)] asks P to do so—

(a) P must give an estimate of the time when the drug will be ready; and

(b) if they are not ready by then, P must give a revised estimate of the time when they will be ready (until they are ready).

[F51 (3) Sub-paragraph (1) does not apply where arrangements are in place for the provision of the drug (whether by P or otherwise) ordered pursuant to the PTP or PTPGD as part of a directed service which includes arrangements for the provision of such a drug ordered in accordance with such a PTP or PTPGD.

(4) Sub-paragraph (1A) does not apply where arrangements are in place for the provision of the drug (whether by P or otherwise) requested in accordance with the PTP or PTPGD as part of a directed service which includes arrangements for the provision of such a drug requested in accordance with such a PTP or PTPGD.]]

Textual Amendments

F46 Sch. 4 para. 5B inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 6

F47 Words in Sch. 4 para. 5B heading inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(2)(c)

F48 Words in Sch. 4 para. 5B(1)(a) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(2)(a)

F49 Sch. 4 para. 5B(1A) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(2)(b)

F50 Words in Sch. 4 para. 5B(2) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(2)(c)

F51 Sch. 4 para. 5B(3)(4) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 7(2)

[F52 Supply in accordance with a LPIV U.K.

5C.— (1) Subject to the following provisions of this Part, where—

(a) an NHS Pharmacist (P) receives a LPIV; and

(b) a person who is entitled to be supplied by P with a prescription item ordered on the LPIV requests the provision of the item in accordance with that LPIV,

P must, with reasonable promptness, provide the prescription item so ordered.

(2) If a person who is entitled as mentioned in sub-paragraph (1)(b) asks P to do so—

(a) P must give an estimate of the time when the prescription item will be ready; and

(b) if they are not ready by then, P must give a revised estimate of the time when the item will be ready (until it is ready).

(3) Sub-paragraph (1) does not apply where arrangements are in place for the provision of the item (whether by P or otherwise) ordered on the LPIV as part of a directed service which includes arrangements for the provision of such an item ordered on such a LPIV.]

Textual Amendments

F52 Sch. 4 para. 5C inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 7(3)

Urgent supply without a prescription U.K.

6.—(1) This paragraph applies where, in a case of urgency, a prescriber requests an NHS pharmacist (P) to provide a drug or appliance.

(2) P may provide the drug or appliance requested before receiving a prescription form or repeatable prescription in respect of that drug or appliance, provided that—

(a) in the case of a request for a drug, the drug is neither—

(i) a Scheduled drug, nor

(ii) a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain prohibitions under the Regulations); and

(b) in the case of a request for a drug or an appliance, the prescriber undertakes to—

(i) give P a non-electronic prescription form or non-electronic repeatable prescription in respect of the drug or appliance within 72 hours of the request being made, or

(ii) transmit an electronic prescription to the Electronic Prescription Service within 72 hours of the request being made.

Preliminary matters before providing ordered drugs or appliances U.K.

7.—(1) If a person specified in sub-paragraph (2) asks an NHS pharmacist (P) to do so—

(a) P must give an estimate of the time when the drugs or appliances will be ready; and

(b) if they are not ready by then, P must give a revised estimate of the time when they will be ready (until they are ready).

(2) A person specified in this sub-paragraph is a person—

(a) presenting a non-electronic prescription form or non-electronic repeatable prescription; or

(b) requesting the provision of drugs or appliances in accordance with an electronic prescription form or a repeatable prescription.

(3) Before providing any drugs or appliances in accordance with a prescription form or a repeatable prescription, P must ask any person who makes [F53 or duly completes a declaration as or on behalf of the person named on the prescription form or repeatable prescription] that the person named on the prescription form or the repeatable prescription does not have to pay the charges specified in regulation 3(1) [F54 or (2)] of the Charges Regulations M9 (supply of drugs and appliances by chemists) by virtue of either—

(a) entitlement to exemption under [F55 regulation 10(1)] of the Charges Regulations M10 (exemptions); or

(b) entitlement to remission of charges under regulation 5 of the Remission of Charges Regulations M11 (entitlement to full remission and payment),

to produce satisfactory evidence of such entitlement, unless the declaration is in respect of entitlement to exemption by virtue of sub-paragraph (a), (c), (d), (e), (f) or (g) of [F55 regulation 10(1)] of the Charges Regulations or in respect of entitlement to remission by virtue of regulation 5(1)(e) or (2) of the Remission of Charges Regulations, and at the time of the declaration P already has such evidence available to P.

[F56 (3ZA) For the purposes of sub-paragraph (3), satisfactory evidence includes evidence derived from a check, known as a real time exemption check, of electronic records that are managed by the NHS BSA for the purposes (amongst other purposes) of providing advice, assistance and support to patients or their representatives in respect of whether a charge is payable under the Charges Regulations.]

[F57 (3A) In any case where no satisfactory evidence, as required by sub-paragraph (3), is produced to P, P must ensure before the drugs or appliances are provided that the person who was asked to produce that evidence is advised, in appropriate terms, that checks are routinely undertaken to ascertain entitlement to—

(a) exemption under the Charges Regulations; or

(b) remission of charges under the Remission of Charges Regulations,

where such entitlement has been claimed, as part of the arrangements for preventing or detecting fraud or error in relation to such claims.]

(4) If, in the case of a non-electronic prescription form or non-electronic repeatable prescription, no satisfactory evidence, as required by sub-paragraph (3), is produced to P, P shall endorse the form on which the declaration is made to that effect.

(5) In the case of an electronic prescription, P must [F58 ensure that the following information is duly entered into the records managed by [F59 NHS England] that are accessible as part of the Electronic Prescription Service (if either it is not already recorded in those records or a check, known as a real time exemption check, has not produced satisfactory evidence as mentioned in sub-paragraph (3))]—

(a) in a case where exemption from or remission of charges is claimed for all or some of the items included in the prescription, a record of—

(i) the exemption category specified in [F55 regulation 10(1)] of the Charges Regulations or the ground for remission under regulation 5 of the Remission of Charges Regulations which it is claimed applies to the case, and

(ii) whether or not satisfactory evidence was produced to P as required by sub-paragraph (3);

(b) in any case where a charge is due, confirmation that the relevant charge was paid; and

(c) in a case of a prescription for or including contraceptive substances, confirmation that no charge was payable in respect of those substances.

[F60 (6) Sub-paragraphs (3) to (5) apply to the provision of a drug or appliance in accordance with a SSP as they apply to the provision of a drug or appliance in accordance with a prescription form or a repeatable prescription (or an associated batch issue), and for these purposes, the prescription for product reimbursement purposes, as mentioned in paragraph 5A(4)(a), is treated as being the prescription in accordance with which the drug or appliance is provided (even though the supply is not in pursuance of that prescription).]

Textual Amendments

F53 Words in Sch. 4 para. 7(3) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(3)(a)

F54 Words in Sch. 4 para. 7(3) substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(4)(a)

F55 Words in Sch. 4 para. 7 substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(4)(b)

F56 Sch. 4 para. 7(3ZA) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(3)(b)

F57 Sch. 4 para. 7(3A) inserted (E.) (1.7.2016) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2016 (S.I. 2016/296), regs. 1(1)(b), 4(2)

F58 Words in Sch. 4 para. 7(5) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(3)(c)

F59 Words in Sch. 4 para. 7(5) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 47(3)(a) (with reg. 3)

F60 Sch. 4 para. 7(6) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 4(3)

Marginal Citations

M9 Regulation 3 has been amended by S.I. 2002/2352, 2003/1084, 2004/865, 2005/578, 2008/571, 2009/411, 2010/1727, 2011/518 and 2012/470.

M10 Regulation 7 has been amended by S.I. 2000/3189, 2002/2352, 2004/696, 2005/578 and 2009/29.

M11 Regulation 5 has been amended by S.I. 2004/663 and 936, 2006/562, 2008/1697 and 2009/411.

Providing ordered drugs or appliances U.K.

8.—(1) Where an NHS pharmacist (P) is presented with, or receives from the Electronic Prescription Service, a prescription form or a repeatable prescription, P must only provide the drugs or appliances so ordered—

(a) if the prescription form or repeatable prescription is duly signed and completed as described in paragraph 5(2) or (3); and

(b) in accordance with the order on the prescription form or repeatable prescription,

subject to any regulations in force under the Weights and Measures Act 1985 M12 and the following provisions of this Part.

(2) Drugs or appliances so ordered shall be provided either by or under the direct supervision of a registered pharmacist.

(3) Where the registered pharmacist referred to in sub-paragraph (2) is employed or engaged by P, the registered pharmacist must not be someone—

(a) who is disqualified from inclusion in a relevant list; or

(b) who is suspended from the GPhC register.

(4) If the order is for[F61 , or a product to be provided in accordance with a SSP is,] an appliance of a type requiring measuring and fitting (for example a truss), P must make all necessary arrangements for a registered pharmacist—

(a) to measure the person named on the prescription form or repeatable prescription for the appliance; and

(b) to fit the appliance.

(5) If the order is for[F62 , or a product to be provided in accordance with a SSP is,] a drug or appliance included in the Drug Tariff, the British National Formulary (including any Appendix published as part of that Formulary), the Dental Practitioner's Formulary, the European Pharmacopoeia or the British Pharmaceutical Codex, the drug or appliance provided must comply with any relevant standard or formula specified therein.

(6) If the order—

(a) is an order for a drug; but

(b) is not an order for a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 M13 (which relate to controlled drugs excepted from certain prohibitions under the Regulations),

and does not prescribe its quantity, strength or dosage, P (in this context, a registered pharmacist) may provide the drug in such strength and dosage as in the exercise of their professional skill, knowledge and care P considers to be appropriate and, subject to sub-paragraph (7), in such quantity as P considers to be appropriate for a course of treatment for a period not exceeding 5 days.

(7) Where an order to which sub-paragraph (6) applies is for—

(a) an oral contraceptive substance;

(b) a drug, which is available for supply as part of pharmaceutical services only together with one or more other drugs; or

(c) an antibiotic in a liquid form for oral administration in respect of which pharmaceutical considerations require its provision in an unopened package,

which is not available for provision as part of pharmaceutical services except in such packages that the minimum size available contains a quantity appropriate to a course of treatment for a period of more than 5 days, P may provide the minimum size available package.

(8) Where any drug to which this paragraph applies (that is, a drug that is not one to which the Misuse of Drugs Act 1971 applies, unless it is a drug for the time being specified in Schedule 5 to the Misuse of Drugs Regulations 2001), ordered by a prescriber on a prescription form or repeatable prescription, is available for provision by P in a pack in a quantity which is different to the quantity which has been so ordered, and that drug is—

(a) sterile;

(b) effervescent or hygroscopic;

(c) a liquid preparation for addition to bath water;

(d) a coal tar preparation;

(e) a viscous preparation; or

(f) packed at the time of its manufacture in a special container,

P must provide the drug in the pack whose quantity is nearest to the quantity which has been so ordered.

(9) In this paragraph, “special container” means any container with an integral means of application or from which it is not practicable to dispense an exact quantity.

(10) Subject to sub-paragraph (11), where a drug is ordered by a prescriber on a prescription form or a repeatable prescription[F63 , or is to be provided in accordance with a SSP,] in a quantity that is, or is a multiple of a quantity that is, readily available in a pack size manufactured for a [F64 UK] marketing authorisation holder for the drug, P must provide the drug in an original pack (or in original packs) of that size which has been assembled by a manufacturer of the drug for such a [F64 UK] marketing authorisation holder, unless—

(a) it is not possible for P to obtain such a pack (or packs) with reasonable promptness in the normal course of business; or

(b) it is not practicable for P to provide such a pack (or packs) in response to the order (for example, because of patient needs or the method of administration of the drug).

(11) In the case of oral liquid methadone, P (in practice, a registered pharmacist) must decide whether it would be most appropriate to provide—

(a) each dose in a separate container;

(b) an original pack (or original packs); or

(c) the oral liquid methadone in some other way,

and P must then provide it in packaging that accords with that decision.

(12) P must only provide a Scheduled drug in response to an order by name, formula or other description on a prescription form or repeatable prescription if—

(a) it is ordered as specified in sub-paragraph (13); or

(b) in the case of a drug specified in Schedule 2 to the Prescription of Drugs Regulations M14 (drugs, medicines and other substances that may be ordered only in certain circumstances), it is ordered in the circumstances prescribed in that Schedule.

(13) A Scheduled drug that is a drug with an appropriate non-proprietary name may be provided in response to an order on a prescription form or repeatable prescription for a drug (“the prescribed drug”) that is not a Scheduled drug but which has the same non-proprietary name as the Scheduled drug if—

(a) the prescribed drug is ordered by that non-proprietary name or by its formula;

(b) the prescribed drug has the same specification as the Scheduled drug (so the Scheduled drug may be dispensed generically); and

(c) the Scheduled drug is not in a pack which consists of a drug in more than one strength, and providing it would involve the supply of part only of the pack.

(14) If a Scheduled drug is a combination of more than one drug, it can only be ordered as specified in sub-paragraph (13) if the combination has an appropriate non-proprietary name, whether or not the drugs in the combination each have such names.

(15) P must provide any drug which P is required to provide under paragraph 5 [F65 or 5C] [F66 , or provides under paragraph 5A [F67 or 5B],] in a suitable container.

[F68 (16) Where P provides a drug or appliance under paragraph 5A, P must include in the dispensing label on the packaging of the product, for the patient’s benefit, information to the effect that the product is being supplied in accordance with a SSP, identifying the particular SSP.]

[F69 (17) Sub-paragraphs (5) to (10) apply to the provision of a drug in accordance with [F70 a LPIV,] a PTP [F71 or a PTPGD] as they apply to the provision of a drug in accordance with a prescription form or a repeatable prescription (or an associated batch issue).

(18) Where P provides a drug under paragraph 5B, P must include a dispensing label on the packaging of the product and include in the label (in addition to the particulars required or permitted by Part 2 of Schedule 26 to the Human Medicines Regulations 2012), for the patient’s benefit, information to the effect that the product is being supplied in accordance with a PTP [F72 or a PTPGD], identifying the particular PTP [F73 or PTPGD].]

Textual Amendments

F61 Words in Sch. 4 para. 8(4) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 4(4)(a)

F62 Words in Sch. 4 para. 8(5) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 4(4)(b)

F63 Words in Sch. 4 para. 8(10) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 4(4)(c)

F64 Word in Sch. 4 para. 8(10) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 11(2); 2020 c. 1, Sch. 5 para. 1(1)

F65 Words in Sch. 4 para. 8(15) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 7(4)(a)

F66 Words in Sch. 4 para. 8(15) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 4(4)(d)

F67 Words in Sch. 4 para. 8(15) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 7(a)

F68 Sch. 4 para. 8(16) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 4(4)(e)

F69 Sch. 4 para. 8(17)(18) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 7(b)

F70 Words in Sch. 4 para. 8(17) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 7(4)(b)

F71 Words in Sch. 4 para. 8(17) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(3)(a)

F72 Words in Sch. 4 para. 8(18) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(3)(b)(i)

F73 Words in Sch. 4 para. 8(18) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(3)(b)(ii)

Marginal Citations

M12 1985 c.72.

M13 S.I. 2001/3998. Schedule 4 has been amended by S.I. 2003/1432, 2005/3372, 2007/2154, 2009/3136 and 2012/973, and Schedule 5 has been amended by S.I. 2005/2864.

M14 Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680 and 1043.

Refusal to provide drugs or appliances ordered U.K.

9.—(1) An NHS pharmacist (P) may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription where—

(a) P reasonably believes that it is not a genuine order for the person named on the prescription form or the repeatable prescription (for example because P reasonably believes it has been stolen or forged);

(b) it appears to P that there is an error on the prescription form or on the repeatable prescription or, in the case of a non-electronic repeatable prescription, its associated batch issue (including a clinical error made by the prescriber) or that, in the circumstances, providing the drugs or appliances would be contrary to P's (in practice, a registered pharmacist's) clinical judgement;

(c) P or other persons on the premises are subjected to or threatened with violence by the person presenting the prescription form or repeatable prescription or requesting the provision of drugs or appliances in accordance with an electronic prescription form or a repeatable prescription, or by any person accompanying that person;

(d) the person presenting the prescription form or repeatable prescription or requesting the provision of drugs or appliances in accordance with an electronic prescription form or a repeatable prescription, or any other person accompanying that person, commits or threatens to commit a criminal offence; or

(e) the prescription form or repeatable prescription is incomplete because it does not include the information relating to the identification of the prescriber that [F1 NHS England] (or a person exercising its functions) requires in order to perform its functions relating to—

(i) the remuneration of persons providing pharmaceutical services, and

(ii) any apportionment of, or any arrangements for recharging in respect of, that remuneration,

unless P (or the person who employs or engages P) is to receive no pharmaceutical remuneration of any kind in respect of the drug or appliance.

(2) P must refuse to provide a drug ordered on a prescription form or repeatable prescription where the order is for a prescription only medicine which the prescriber was not entitled to prescribe.

[F74 (2A) P may refuse to provide a drug or appliance ordered on an electronic prescription if the access that P has to the Electronic Prescription Service is not such as to enable P to dispense that prescription promptly (or at all) [F75 , but where P does so, P must take all reasonable steps to ensure that the product ordered by the prescriber is supplied within a reasonable timescale, which may include (depending on what steps or combination of steps the circumstances require)—

(a) providing details of other NHS pharmacists or LPS chemists whose premises are situated in the same area and who may be able to provide the product ordered by the prescriber;

(b) urgent supply without a prescription in accordance with paragraph 6;

(c) arranging for the urgent provision of a non-electronic prescription form by the prescriber.]]

[F76 (2B) P must refuse to provide a drug or appliance ordered on a prescription form or a repeatable prescription where—

(a) a SSP has effect in respect of—

(i) the requested drug or appliance, or

(ii) drugs or appliances of a specified description, and the requested drug or appliance is of that description; and

(b) alternative provision has already taken place in accordance with the SSP.

(2C) P may refuse to provide a drug or appliance ordered on a prescription form or a repeatable prescription where—

(a) a SSP has effect in respect of—

(i) the requested drug or appliance, or

(ii) drugs or appliances of a specified description, and the requested drug or appliance is of that description;

(b) a registered pharmacist is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate; and

(c) P is unable to provide the drug or appliance within a reasonable timescale,

but if P does refuse to do so, P must provide the patient or the person requesting the drug or appliance on behalf of a patient with appropriate advice, as necessary, about reverting to the prescriber for the prescriber to review the patient’s treatment.]

(3) P must refuse to provide drugs or appliances ordered on a repeatable prescription where—

(a) P has no record of that prescription (other than on the first occasion on which the prescription is presented);

(b) P does not, in the case of a non-electronic repeatable prescription, have any associated batch issue and it is not presented to P;

(c) it is not signed by a prescriber;

(d) to do so would not be in accordance with any intervals specified in the prescription;

(e) it would be the first time a drug or appliance had been provided pursuant to the prescription and the prescription was signed (whether electronically or otherwise) more than 6 months previously;

(f) the repeatable prescription was signed (whether electronically or otherwise) more than one year previously;

(g) the expiry date on the repeatable prescription has passed; or

(h) P has been informed by the prescriber that the prescription is no longer required.

(4) Where a patient requests the supply of drugs or appliances ordered on a repeatable prescription (other than on the first occasion that the patient makes such a request), P must only provide the drugs or appliances ordered if P is satisfied—

(a) that the patient to whom the prescription relates—

(i) is taking or using, and is likely to continue to take or use, the drug or appliance appropriately, and

(ii) is not suffering from any side effects of the treatment which indicates the need or desirability of reviewing the patient's treatment;

(b) that the medication regimen of, or manner of utilisation of the appliance by, the patient to whom the prescription relates has not altered in a way which indicates the need or desirability of reviewing the patient's treatment; and

(c) there have been no changes to the health of the patient to whom the prescription relates which indicate the need or desirability of reviewing the patient's treatment.

[F77 (5) P may refuse to [F78 fulfil an order or a request] for a drug that is or is purportedly in accordance with [F79 a LPIV,] a PTP [F80 or a PTPGD] where—

(a) P reasonably believes it is not a genuine order [F81 or valid request] for the person who requests, or on whose behalf is requested, the provision of the drug;

(b) providing it would be contrary to P’s clinical judgement;

(c) P or other persons are subjected to or threatened with violence by the person who requests the provision of the drug, or by any person accompanying that person; or

(d) the person who requests the provision of the drug, or any person accompanying that person, commits or threatens to commit a criminal offence.

(6) P must refuse to provide, pursuant to [F82 a LPIV,] a PTP [F83 or a PTPGD], an order [F84 or a request] for a drug that is or is purportedly in accordance with [F85 the LPIV,] the PTP [F86 or PTPGD] where P is not satisfied that it is in accordance with [F85 the LPIV,] the PTP [F86 or PTPGD] .]

[F87 (7) P may refuse to provide a prescription item ordered on a prescription form or repeatable prescription where—

(a) more than one prescription item has been ordered on the prescription form or repeatable prescription;

(b) at least one of those prescription items is a listed HRT prescription item and at least one of those prescription items is not; and

(c) the person named on the prescription form or repeatable prescription is claiming entitlement to exemption under regulation 10(1)(j) of the Charges Regulations (exemptions) in respect of any of those prescription items which is a listed HRT prescription item.]

Textual Amendments

F74 Sch. 4 para. 9(2A) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(4)

F75 Words in Sch. 4 para. 9(2A) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 8(a)

F76 Sch. 4 para. 9(2B)(2C) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 4(5)

F77 Sch. 4 para. 9(5)(6) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 8(b)

F78 Words in Sch. 4 para. 9(5) substituted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(4)(a)(i)

F79 Words in Sch. 4 para. 9(5) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 7(5)(a)

F80 Words in Sch. 4 para. 9(5) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(4)(a)(ii)

F81 Words in Sch. 4 para. 9(5)(a) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(4)(a)(iii)

F82 Words in Sch. 4 para. 9(6) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 7(5)(b)(i)

F83 Words in Sch. 4 para. 9(6) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(4)(b)(i)

F84 Words in Sch. 4 para. 9(6) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(4)(b)(ii)

F85 Words in Sch. 4 para. 9(6) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 7(5)(b)(ii)

F86 Words in Sch. 4 para. 9(6) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(4)(b)(iii)

F87 Sch. 4 para. 9(7) inserted (1.4.2023) by The National Health Service (Amendments Relating to Pre-Payment Certificates, Hormone Replacement Therapy Treatments and Medicines Shortages) Regulations 2023 (S.I. 2023/171), regs. 1(1), 3

Further activities to be carried out in connection with the provision of dispensing services U.K.

10.—(1) In connection with the services provided under paragraph 4, an NHS pharmacist (P) must—

(a) ensure that appropriate advice is given to patients about any drugs or appliances provided to them—

(i) to enable them to utilise the drugs or appliances appropriately, and

(ii) to meet the patient's reasonable needs for general information about the drugs or appliances;

(b) provide appropriate advice to patients to whom they provide drugs or appliances on—

(i) the safe keeping of the drugs or appliances, and

(ii) returning unwanted drugs or appliances to the pharmacy premises for safe destruction;

(c) when providing drugs to patients in accordance with a repeatable prescription, provide appropriate advice in particular on the importance of only requesting those items which they actually need;

(d) when providing appliances to patients in accordance with a prescription form or repeatable prescription—

(i) provide appropriate advice in particular on the importance of only requesting those items which they actually need, and

(ii) for those purposes, have regard to the details contained in the records maintained under paragraph (f) in respect of the provision of appliances and prescribing pattern relating to the patient in question;

[F88 (da) ensure that appropriate advice about the benefits of repeat dispensing is given to any patient who—

(i) has a long term, stable medical condition (that is, a medical condition that is unlikely to change in the short to medium term), and

(ii) requires regular medicine in respect of that medical condition,

including, where appropriate, advice that encourages the patient to discuss repeat dispensing of that medicine with a prescriber at the provider of primary medical services whose patient list the patient is on;]

(e) provide a patient with a written note [F89 (which may be in an electronic form)] of any drug or appliance which is owed, and inform the patient when it is expected that the drug or appliance will become available;

(f) keep and maintain records—

(i) of drugs and appliances provided, in order to facilitate the continued care of the patient;

(ii) in appropriate cases, of advice given and any interventions or referrals made (including clinically significant interventions in cases involving repeatable prescriptions), and

(iii) of notes provided under sub-paragraph (e);

F90 (g) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(h) if P takes possession of a non-electronic repeatable prescription or an associated batch issue, securely store that repeatable prescription or associated batch issue;

(i) if P provides a drug or appliance under an electronic prescription, provide the patient, if the patient so requests, with a written record of the drugs or appliances ordered on that prescription and, in the case of an electronic repeatable prescription, of the number of occasions on which it can be dispensed;

(j) maintain records of repeatable prescriptions in such a form as to provide a clear audit trail of supplies under the repeatable prescription (including dates and quantities supplied);

(k) destroy any surplus batch issues relating to drugs or appliances—

(i) which are not required, or

(ii) where a patient is refused the drugs or appliances pursuant to paragraph 9;

(l) ensure that where a person is refused drugs or appliances pursuant to paragraphs 9(1)(b), (2), (3) or (4), the patient is referred back to the prescriber for further advice;

(m) where a patient is provided with drugs or appliances under a repeatable prescription, notify the prescriber of any clinically significant issues arising in connection with the prescription and keep a record of that notification;

(n) notify the prescriber of any refusal to provide drugs or appliances pursuant to paragraph 9(4);

(o) when providing appliances, provide a patient with a written note of P's name, address and telephone number; and

(p) when providing specified appliances, comply with the additional requirements set out in paragraph 12.

(2) Where, on presentation of a prescription form or repeatable prescription in connection with the dispensing services under paragraph 4, P is unable [F91 (having regard to any relevant SSP)] to provide an appliance, or stoma appliance customisation is required and P is unable to provide that, P shall—

(a) if the patient consents, refer the prescription form or repeatable prescription to another NHS pharmacist or to an NHS appliance contractor; and

(b) if the patient does not consent to a referral, provide the patient with contact details of at least 2 people who are NHS pharmacists or NHS appliance contractors who are able to provide the appliance or stoma appliance customisation (as the case may be), if these details are known to P.

Textual Amendments

F88 Sch. 4 para. 10(1)(da) inserted (1.3.2015) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015 (S.I. 2015/58), regs. 1(1), 8(2) (with reg. 10)

F89 Words in Sch. 4 para. 10(1)(e) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 9(a)

F90 Sch. 4 para. 10(1)(g) omitted (9.11.2020) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 9(b)

F91 Words in Sch. 4 para. 10(2) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 4(6)

Additional requirements in relation to electronic prescribing U.K.

11.—(1) An NHS pharmacist (P) must, if requested to do so by any person—

F92 (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) where the Electronic Prescription Service is [F93 temporarily unavailable] through P's pharmacy premises, provide that person with contact details of at least 2 NHS pharmacists in the area at whose premises the service is available, if these details are known to P.

(2) F94 ... P must, if requested to do so by any person, enter in that person's PDS patient details—

(a) where the person does not have a nominated dispensing contractor, [F95 a nominated dispensing contractor]; or

(b) where the person does have a nominated dispensing contractor—

(i) a replacement dispensing contractor, or

(ii) a further dispensing contractor,

chosen by that person.

(3) Sub-paragraph (2)(b)(ii) does not apply if the number of nominated dispensing contractors for that person would thereby exceed the maximum number permitted by the Electronic Prescription Service.

(4) Regulation 116(a) to (c) applies to a request under this paragraph as it applies to an application to an NHS chemist for pharmaceutical services.

(5) If P is a nominated dispensing contractor for a person (X) but the nomination was made before P became the person listed in a pharmaceutical list in relation to the pharmacy premises nominated in X's PDS patient details, P must within 6 months of P becoming the person so listed—

(a) explain to X that the ownership of the pharmacy premises has changed; and

(b) ask X whether X wishes to maintain the nomination in respect of those pharmacy premises.

[F96 (6) If P dispenses an electronic prescription or makes an urgent supply without a prescription, P must send the form duly completed by or on behalf of the patient, if one is required under regulation 3(3)(b) or (c), (5C) or (5E) of the Charges Regulations in respect of that prescription (which may be the associated EPS token), to the NHS BSA.]

Textual Amendments

F92 Sch. 4 para. 11(1)(a) omitted (9.11.2020) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 10(a)(i)

F93 Words in Sch. 4 para. 11(1)(b) substituted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 10(a)(ii)

F94 Words in Sch. 4 para. 11(2) omitted (9.11.2020) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 10(b)

F95 Words in Sch. 4 para. 11(2)(a) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(5)(a)

F96 Sch. 4 para. 11(6) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(5)(b)

Additional requirements in relation to specified appliances U.K.

12.—(1) This paragraph sets out the additional requirements referred to in paragraph 10(1)(p) relating to the provision of specified appliances.

(2) An NHS pharmacist (P) who dispenses specified appliances in the normal course of business must provide a home delivery service in respect of those appliances and, as part of that service—

(a) P must offer to deliver the specified appliance to the patient's home;

(b) if the patient accepts that offer, the delivery must be made with reasonable promptness and at such time as is agreed with the patient;

(c) the specified appliance must be delivered in a package which displays no writing or other markings which could indicate its content; and

(d) the manner of delivery of the package and any supplementary items required by sub-paragraph (3) must not convey the type of appliance being delivered.

(3) In any case where a specified appliance is provided (whether by home delivery or otherwise), P must provide a reasonable supply of appropriate supplementary items (such as disposable wipes and disposal bags) and—

(a) must ensure that the patient may, if the patient wishes, consult a person to obtain expert clinical advice regarding the appliance; or

(b) if P believes it is appropriate to do so, must—

(i) refer the patient to a prescriber, or

(ii) offer the patient an appliance use review service.

(4) If P is unable to provide an appliance use review service in accordance with sub-paragraph (3)(b)(ii), P must give the patient the contact details of at least 2 people who are NHS pharmacists or NHS appliance contractors who are able to arrange for the service to be provided, if these details are known to P.

(5) Where P provides a telephone care line in respect of the dispensing of any specified appliance, P must ensure that during out of hours periods—

(a) advice is made available to patients through that telephone care line; or

(b) [F97 telephone or website contact details for providers of NHS services that may be consulted for advice regarding specified appliances during those periods], are made available to patients through that telephone care line.

(6) For the purposes of this paragraph—

“expert clinical advice”, in relation to a specified appliance, means advice which is given by a person who is suitably trained and who has relevant experience in respect of the appliance;

“out of hours periods”, in relation to pharmacy premises, means the periods outside the core opening hours and any supplementary opening hours of the premises.

Textual Amendments

F97 Words in Sch. 4 para. 12(5)(b) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 18

Disposal service in respect of unwanted drugs U.K.

13.  An NHS pharmacist must, to the extent paragraph 14 requires and in the manner described in that paragraph, accept and dispose of unwanted drugs presented to the NHS pharmacist for disposal.

Basic procedure in respect of unwanted drugs U.K.

14.—(1) Subject to paragraph (2), where a person presents to an NHS pharmacist (P) any drugs provided for a patient in, and which have been kept in—

(a) a private household; or

(b) a children's home; or

(c) a residential care home, that is to say an establishment which exists wholly or mainly for the provision of residential accommodation, together with board and personal care, for persons in need of personal care because of—

(i) old age,

(ii) mental or physical disability,

(iii) past or present dependence on alcohol or drugs,

(iv) any past illnesses, or

(v) past or present mental disorder,

P must accept the drugs and dispose of them in accordance with sub-paragraph (3).

(2) P is not required to accept any drugs for disposal unless [F1 NHS England] has made arrangements for the collection and disposal of drugs of that description.

(3) On receipt of the drugs, P must—

(a) where required to do so by [F1 NHS England] or by a waste disposal contractor retained by [F1 NHS England], separate solid drugs or ampoules, liquids and aerosols from each other;

(b) store the drugs in containers provided by [F1 NHS England], or by a waste disposal contractor retained by [F1 NHS England], for the purpose of storing drugs of that description; and

(c) comply with any other statutory requirements in respect of storing or the disposal of drugs of that description (meeting those requirements are therefore an essential service for the purposes of these Regulations),

and shall co-operate with any suitable arrangements that [F1 NHS England] has in place for regular collection of the drugs from P's pharmacy premises by or on behalf of [F1 NHS England].

Further activities to be carried out in connection with the disposal of unwanted drugs U.K.

15.  In connection with the services provided under paragraph 13, an NHS pharmacist (P) must—

(a) ensure that P (including P's staff) is aware of the risks associated with the handling of waste drugs and the correct procedures to be used to minimise those risks; and

(b) ensure that P (including P's staff) has readily available, and close to any place where waste drugs are stored, appropriate protective equipment, including gloves, overalls and materials to deal with spillages.

Promotion of healthy lifestyles U.K.

16.  An NHS pharmacist must, to the extent paragraphs 17 and 18 require, and in the manner set out in those paragraphs, promote public health messages to members of the public.

Prescription linked intervention U.K.

17.—(1) Where a person using a pharmacy—

(a) presents a non-electronic prescription form or non-electronic repeatable prescription to an NHS pharmacist (P) or requests the provision of drugs or appliances in accordance with an electronic prescription; and

(b) it appears to P that the person—

(i) has diabetes,

(ii) is at risk of coronary heart disease, especially those with high blood pressure, or

(iii) smokes or is overweight,

P must, as appropriate, provide advice to that person with the aim of increasing that person's knowledge and understanding of the health issues which are relevant to that person's personal circumstances.

(2) Advice given under sub-paragraph (1) may be backed up, as appropriate—

(a) by the provision of written material (for example leaflets); and

(b) by referring the person to other sources of information or advice.

(3) P must, in appropriate cases, keep and maintain a record of advice given pursuant to this paragraph, and that record must be in a form that facilitates—

(a) auditing of the provision of pharmaceutical services by P; and

(b) follow-up care for the person who has been given the advice.

F98 ... Health campaigns U.K.

18.  An NHS pharmacist (P) must, at the request of [F1 NHS England], ensure that—

(a) P (including P's staff) participates, in the manner reasonably requested by [F1 NHS England], in up to 6 campaigns in each [F99 financial] year to promote F100 ... health messages to users of P's pharmacy;

(b) where requested to do so by [F1 NHS England], P records the number of people to whom P (including P's staff) has provided information as part of one of those campaigns [F101 ; and]

[F102 (c) where requested to do so by [F1 NHS England], P sends to [F1 NHS England] by means of an electronic communication of the type specified in the request—

(i) the number recorded pursuant to sub-paragraph (b), and

(ii) information which is reasonably requested by [F1 NHS England], and which is in an anonymised form if it would otherwise identify any person to whom information was provided as part of the campaign, for the purposes of evaluating the effectiveness of the campaign and policy development.]

Textual Amendments

F98 Word in Sch. 4 para. 18 heading omitted (9.11.2020) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 11(2)

F99 Word in Sch. 4 para. 18(a) substituted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 11(3)(a)

F100 Word in Sch. 4 para. 18(a) omitted (9.11.2020) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 11(3)(b)

F101 Word in Sch. 4 para. 18(b) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 11(4)

F102 Sch. 4 para. 18(c) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 11(5)

Signposting U.K.

19.  An NHS pharmacist must, to the extent paragraph 20 requires and in the manner set out in that paragraph, provide information to users of the NHS pharmacist's pharmacy about other health and social care providers and support organisations.

Service outline in respect of signposting U.K.

20.—(1) Where it appears to an NHS pharmacist (P), having regard to the need to minimise inappropriate use of health and social care services and of support services, that a person using P's pharmacy—

(a) requires advice, treatment or support that P cannot provide; but

(b) another provider, of which P is aware, of health or social care services or of support services is likely to be able to provide that advice, treatment or support,

P must provide contact details of that provider to that person and must, in appropriate cases, refer that person to that provider.

(2) Where, on presentation of a prescription form or repeatable prescription, P is unable to provide an appliance or stoma appliance customisation because the provision of the appliance or customisation is not within P's normal course of business, P must—

(a) if the patient consents, refer the prescription form or repeatable prescription to another NHS pharmacist or to an NHS appliance contractor; and

(b) if the patient does not consent to a referral, provide the patient with contact details of at least 2 people who are NHS pharmacists or NHS appliance contractors who are able to provide the appliance or stoma appliance customisation (as the case may be), if these details are known to P.

(3) Where appropriate, a referral under this paragraph may be made by means of a written referral note.

(4) P must, in appropriate cases, keep and maintain a record of any information given or referral made under this paragraph and that record must be in a form that facilitates—

(a) auditing of the provision of pharmaceutical services by P; and

(b) follow-up care for the person who has been given the information or in respect of whom the referral has been made.

Support for self-care U.K.

21.  An NHS pharmacist must, to the extent paragraph 22 requires and in the manner set out in that paragraph, provide advice and support to people caring for themselves or their families.

Service outline in respect of support for self-care U.K.

22.—(1) Where it appears to an NHS pharmacist (P), having regard to the need to minimise the inappropriate use of health and social care services, that a person (X) using P's pharmacy would benefit from advice from P to help X manage a medical condition (including, in the case of a carer, to help X in assisting in the management of another person's medical condition), P must provide advice to X as regards managing the medical condition, including, as appropriate, advice—

(a) on treatment options, including advice on the selection and use of appropriate drugs which are not prescription only medicines; and

(b) on changes to the patient's lifestyle.

(2) P must, in appropriate cases, keep and maintain a record of any advice given under sub-paragraph (1), and of any drugs supplied when the advice was given, and that record shall be in a form that facilitates—

(a) auditing of the provision of pharmaceutical services by P; and

(b) follow-up care for the person to whom or in respect of whom the advice has been given.

[F103 Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc. U.K.

22A.— (1) Before dispensing any item on a prescription form or supplying it in accordance with a serious shortage protocol, an NHS pharmacist (P) must provide a home delivery option to eligible patients in respect of the item where, as a consequence of a disease being or in anticipation of a disease being imminently—

(a) pandemic; and

(b) a serious risk or potentially a serious risk to human health,

[F1 NHS England] with the agreement of the Secretary of State has made an announcement to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, eligible patients are advised to stay away from pharmacy premises in the area specified, in the circumstances specified and for the duration of the period specified in the announcement.

(2) If P’s pharmacy premises are in the area specified in the announcement, during the period when, in the circumstances specified in the announcement, eligible patients need to stay away from P’s pharmacy, P must ascertain from—

(a) an eligible patient—

(i) who has contacted P about the home delivery of prescription items, or

(ii) who is a person whom P considered, on the basis of the nature of an item on a prescription form, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; or

(b) a person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted P about the home delivery of prescription items,

whether or not the item could be supplied by a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which P must provide.

(3) Where paragraph (2) does not apply, if P’s pharmacy premises are in the area specified in the announcement, during the period when, in the circumstances specified in the announcement, eligible patients need to stay away from P’s pharmacy, the home delivery option that P must provide must comprise—

(a) P delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);

(b) P arranging for an item dispensed by P to be delivered by another NHS pharmacist or by an LPS contractor to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; or

(c) if P is unable to deliver the item or arrange for its delivery by another NHS pharmacist or by an LPS contractor, P arranging for the dispensing or supply of the item by another NHS pharmacist or by an LPS contractor who would be able to deliver the dispensed item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.

(4) Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at P’s pharmacy premises for the purposes of receiving dispensing services.

(5) Notwithstanding the foregoing provisions of this Part, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, P may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale.

(6) Where arrangements are in place which enable an NHS pharmacist to make a delivery as mentioned in sub-paragraph (3)(a) or (b) as part of a directed service, the NHS pharmacist must deliver the item as part of that directed service.

(7) This paragraph does not apply to an NHS pharmacist in respect of distance selling premises.]

Textual Amendments

F103 Sch. 4 para. 22A inserted (27.3.2020) by The National Health Service (Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/351), regs. 1(2), 9(2)

[F104 Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc. U.K.

22AA.— (1) Before dispensing a notified item on a prescription form or supplying it in accordance with a serious shortage protocol, a PTP or a PTPGD, an NHS pharmacist (P) must provide a home delivery option to eligible patients in respect of that item.

(2) For the purposes of this paragraph, a “notified item” is an item that, as a consequence of a disease being or in anticipation of a disease being imminently—

(a) pandemic; and

(b) a serious risk or potentially a serious risk to human health,

is the subject of an announcement made by [F1 NHS England], with the agreement of the Secretary of State, to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, eligible patients are entitled to be provided with a home delivery option in respect of that item, if it is supplied to them as part of pharmaceutical services.

(3) Where P is to, or may be required to, dispense a notified item on a prescription form or supply it in accordance with a serious shortage protocol, a PTP or a PTPGD, P must ascertain from—

(a) an eligible patient—

(i) who has contacted P about the home delivery of a notified item, or

(ii) who is a person whom P considered, on the basis of an order or request for a notifiable item, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; or

(b) a person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted P about the home delivery of a notified item,

whether or not the item could be supplied via a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which P must provide.

(4) Where paragraph (3) does not apply, the home delivery option that P must provide must comprise—

(a) P delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);

(b) P arranging for an item dispensed by P to be delivered by another NHS pharmacist or by an LPS contractor to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; or

(c) if P is unable to deliver the item or arrange for its delivery by another NHS pharmacist or by an LPS contractor, P arranging for the dispensing or supply of the item by another NHS pharmacist or by an LPS contractor who would be able to deliver the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.

(5) Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at P’s pharmacy premises for the purposes of being supplied with the notifiable item.

(6) Notwithstanding the foregoing provisions of this Part, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, P may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale.

(7) Where arrangements are in place which enable an NHS pharmacist to make a delivery as mentioned in sub-paragraph (4)(a) or (b) as part of a directed service, the NHS pharmacist must deliver the item as part of that directed service.

(8) This paragraph does not apply to an NHS pharmacist in respect of distance selling premises.]

Textual Amendments

F104 Sch. 4 para. 22AA inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(5)

[F105 Discharge medicines service U.K.

22B.   An NHS pharmacist (P) must, to the extent that paragraph 22C requires and in the manner set out in that paragraph, provide advice, assistance and support to and in respect of a health service patient—

(a) recently discharged from hospital who is referred to P for advice, assistance and support in respect of the patient’s medication regimen by the staff of the hospital in which the patient stayed; or

(b) who is otherwise referred to P for advice, assistance and support in respect of the patient’s medication regimen by the staff of an NHS trust or NHS foundation trust as part of arrangements linked to the transfer of care between different providers of NHS services.

Textual Amendments

F105 Sch. 4 paras. 22B, 22C inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 12

Service outline in respect of the discharge medicines service U.K.

22C.— (1) An NHS pharmacist (P) must have procedures in place (as part of its standard operating procedures) for checking at appropriate intervals on days on which P’s pharmacy premises are open for business whether P has received any referrals, which are in the form and manner approved for this purpose by [F1 NHS England], for the services set out in this paragraph (“DMS referrals”).

(2) If P receives a DMS referral in respect of a health service patient (X) requesting from P stage 1 of the service (as well as stages 2 and 3), P must, as soon as possible but in any event within 72 hours of receiving the DMS referral (excluding hours of days on which the pharmacy premises are not open for business), as stage 1 of the service—

(a) review the actions requested, and act on those requested actions, to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so;

(b) use the information that P has or is able to access about X’s medication regimen before the discharge or transfer to compare it (so far as is possible) with X’s medication regimen on discharge or transfer;

(c) check any prescriptions for X that P may be asked to dispense (including electronic repeatable prescriptions) or has part dispensed in order to assess whether, in P’s clinical judgement, any changes are appropriate or there are any other issues of concern;

(d) where necessary, discuss changes that may be appropriate or raise any issues of concern identified, to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so with—

(i) the staff of the hospital or other provider of NHS services that made the referral, and

(ii) any provider of primary medical services on whose patient list X is; and

(e) keep and maintain records of the DMS referrals received and of any actions taken, as appropriate (in particular, to support delivery of stages 2 and 3 of the service).

(3) This sub-paragraph applies—

(a) if P receives—

(i) in respect of X an electronic prescription for a medicinal product or is presented by X with a non-electronic prescription form, a non-electronic repeatable prescription or an EPS token in respect of a medicinal product, and

(ii) is on notice as a result of a DMS referral requesting from P stage 2 of the service (whether or not it is the referral mentioned in sub-paragraph (2)) that the prescription is the first prescription for a medicinal product to be dispensed by P to X following X’s discharge from hospital or the transfer of X’s care between different providers of NHS services; or

(b) in the following circumstances—

(i) P receives in respect of a health service patient (Y) an electronic prescription for a medicinal product or is presented by Y with a non-electronic prescription form, a non-electronic repeatable prescription or an EPS token in respect of a medicinal product,

(ii) P is on notice as a result of a DMS referral requesting from P stage 2 of the service (and potentially stage 3) that it is the first prescription for a medicinal product to be dispensed to Y following Y’s discharge from hospital or the transfer of Y’s care between different providers of NHS services (a different NHS pharmacist having provided stage 1 of the service in respect of Y), and

(iii) P is on notice that Y, or where appropriate a carer of Y, wishes P to provide the services described in sub-paragraphs (4) and (5) to or in respect of Y.

(4) Where sub-paragraph (3) applies, P must, as stage 2 of the service, prior to or as part of the process of dispensing the prescription—

(a) review (or further review) the medication regimen of X or Y, using the information that P has or is able to access about that medication regimen, including from the prescription, in order to assess whether, in P’s clinical judgement, appropriate account has been taken of any changes to X’s or Y’s medication regimen during X’s or Y’s stay in hospital or prior to the transfer of X’s or Y’s care between different providers of NHS services;

(b) if any issues of concern are identified, raise these to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so with any provider of primary medical services on whose patient list X or Y is; and

(c) keep and maintain records of any actions taken as part of this stage of the process, as appropriate (in particular, to support delivery of stage 3 of the service).

(5) At the point at which P, in P’s clinical judgement is to, or would normally, discuss the prescription as mentioned in paragraph (3)(a)(i) or (b)(i) with X or Y, or where appropriate with a carer of X or Y, P must, as stage 3 of the service—

(a) engage in a discussion with X or Y, or where appropriate a carer of X or Y, in a manner which is in accordance with P’s duty of confidentiality to X or Y and which is—

(i) to assess their understanding of what medicinal products X or Y should be taking, and

(ii) to offer to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so advice, assistance and support in respect of X’s or Y’s medication regimen;

(b) draw to X’s or Y’s attention (where appropriate via a carer of X or Y)—

(i) P’s disposal service in respect of unwanted drugs, and

(ii) any other pharmaceutical services that P, in the exercise of P’s clinical judgement, considers X or Y may benefit from following X’s or Y’s stay in hospital or the transfer of X’s or Y’s care between different providers of NHS services;

(c) if any issues of concern are identified, raise these to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so with any provider of primary medical services on whose patient list X or Y is; and

(d) keep and maintain records, as appropriate—

(i) of the discussion pursuant to paragraphs (a) and (b), and of any raising of concerns and any actions taken, and

(ii) for service evaluation purposes.

(6) If the DMS referral requesting that P provides services under this paragraph includes circumstances in which P is not to provide, or is to cease to provide, services under this paragraph, P is not to, or is to cease to, provide services under this paragraph in those circumstances (for example, X’s or Y’s admission or re-admission to hospital).]

Textual Amendments

F105 Sch. 4 paras. 22B, 22C inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 12

PART 3 U.K. Hours of opening

Pharmacy opening hours: general U.K.

23.—(1)  [F106 Subject to paragraph 23A,] an NHS pharmacist (P) must ensure that pharmaceutical services are provided at P's pharmacy premises—

(a) for 40 hours each week;

(b) for not less than 100 hours each week, in the case of premises in respect of which a 100 hours condition applies;

(c) if [F1 NHS England] or a Primary Care Trust, or on appeal the Secretary of State, has directed that pharmaceutical services are to be provided at the premises for fewer than 40 hours per week, provided that the person listed in relation to them provides those services at set times and on set days, at the times and on the days so set;

(d) if a Primary Care Trust, or on appeal the Secretary of State, has (under previous Regulations) directed that pharmaceutical services are to be provided at the premises for more than 40 hours per week, and at set times and on set days, at the times and on the days so set [F107 , subject to any variation in respect of a rest break in accordance with sub-paragraph (7)(bd)]; or

(e) if [F1 NHS England] or a Primary Care Trust, or on appeal the Secretary of State, has directed that pharmaceutical services are to be provided at the premises for more than 40 hours each week, but only on set times and on set days as regards the additional opening hours [F108 , or the core opening hours where paragraph 26(4A) applied to the issuing of the direction]—

(i) for the total number of hours each week required by virtue of that direction, and

(ii) as regards the additional opening hours for which the person listed in relation to the premises is required to provide pharmaceutical services by virtue of that direction, at the days on which and times at which that person is required to provide pharmaceutical services during those additional opening hours, as set out in that direction [F109 , subject to any variation in respect of a rest break in accordance with sub-paragraph (7)(bd)],

but [F1 NHS England] may, in appropriate circumstances, agree a temporary suspension of services for a set period, where it has received 3 months notice of the proposed suspension.

(2) The hours during which pharmacy premises must be open by virtue of sub-paragraph (1) are referred to in these Regulations as “core opening hours”.

(3) P must notify [F1 NHS England] of other hours during which P's pharmacy premises are to be open, which are hours in addition to P's core opening hours (and which are referred to in these Regulations as “supplementary opening hours”).

(4) Unless P is a distance selling chemist, at P's pharmacy premises P must exhibit—

(a) a notice specifying the days on which and times at which the premises are open for the provision of drugs and appliances (including times at which P is providing pharmaceutical services during supplementary opening hours); and

(b) at times when the premises are not open, a notice based on information provided by [F1 NHS England], where practicable legible from outside the premises, specifying—

(i) the addresses of other NHS pharmacists and the days on which and times at which drugs and appliances may be obtained from those addresses, and

(ii) the addresses of LPS chemists in the area, the type of local pharmaceutical services which those LPS chemists provide, and the days on which and times at which their premises are open.

(5) P must, on request, submit a return to [F1 NHS England] setting out—

(a) the days on which and times at which pharmaceutical services are provided at P's pharmacy premises (including times at which P is providing pharmaceutical services during supplementary opening hours); and

(b) the pharmaceutical services which P ordinarily provides at those premises.

(6) Where P changes—

(a) the supplementary opening hours of P's pharmacy premises; or

(b) the pharmaceutical services which P ordinarily provides at those premises,

P must supply [F1 NHS England] with a return informing it of the change [F110 before the change takes place].

(7) Where P has notified to [F1 NHS England] (or, before the appointed day, a Primary Care Trust) the days on which and times at which pharmaceutical services are to be provided at P's pharmacy premises (for example, in a return under sub-paragraph (5) or (6) or in an application for inclusion in a pharmaceutical list)—

(a) P must ensure that pharmaceutical services are provided at the premises to which the notification relates on the days and at the times set out in the notification (unless the notification has been superseded by a return, or a further return, under sub-paragraph (6)); F111 ...

[F112 (ba) P must not change the days on which or the times at which pharmaceutical services are to be provided at those premises during core opening hours, except for making a change that—

(i) amounts to the inclusion of a rest break which is no longer than one hour, or a change to such a rest break—

(aa) on a Monday to Saturday, which starts at least 3 hours after the start of the pharmacy’s opening hours and ends at least 3 hours before the end of the pharmacy’s opening hours, or

(bb) on a Sunday, and

(ii) does not change the total number of P’s core opening hours on a particular day,

otherwise than as provided for, and in accordance with the procedures set out in, paragraphs 25 and 26;

(bb) P must not change P’s supplementary opening hours in a way that reduces the time for which P’s pharmacy is open before or after a rest break on a Monday to Saturday to less than 3 hours (if P wants to change the supplementary opening hours affected by this requirement, P must also change the time of the rest break);

(bc) P must not change—

(i) the total number of P’s supplementary opening hours in a way that either reduces or leaves the same the total number of P’s supplementary opening hours, or

(ii) unless the change relates to an increase of the total number of supplementary opening hours, the days on which or the times at which pharmaceutical services are to be provided at P’s premises during supplementary opening hours,

for a period of at least 5 weeks after the day on which that notification was received by NHS England, unless NHS England agrees otherwise; and

(bd) P must not change the days on which or the times at which pharmaceutical services are to be provided at those premises during core opening hours, in the case of making a change that—

(i) amounts to the inclusion of a rest break which is no longer than one hour, or a change to such a rest break—

(aa) on a Monday to Saturday, which starts at least 3 hours after the start of the pharmacy’s opening hours and ends at least 3 hours before the end of the pharmacy’s opening hours, or

(bb) on a Sunday, and

(ii) does not change the total number of P’s core opening hours on a particular day,

for a period of at least 5 weeks after the day on which that notification was received by NHS England, unless NHS England agrees otherwise.]

[F113 (7A) Paragraphs (ba) and (bd) of sub-paragraph (7) do not apply to changes to core opening hours of premises in respect of which a 100 hours condition applies or has ever applied, or in respect of which a direction that replaced (at any distance in succession) a 100 hours condition applies, and accordingly the core opening hours of such premises may only be changed in accordance with paragraph 25 or 26.]

F114 (8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F115 (9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(10) Where there is a temporary suspension in the provision of pharmaceutical services by P [F116 because of illness or another reason] beyond the control of P, P is not in breach of sub-paragraphs (1) and (7), [F117 or of paragraph 23A(5)(a),] provided that—

(a) P notifies [F1 NHS England] of that suspension as soon [F118 as practicable, in the manner required by paragraph 29D(2)(a) and wherever possible before the start of the suspension;]

[F119 (aa) P uses all reasonable endeavours to implement the business continuity plan that P is required to have by virtue of paragraph 29D; and]

(b) P uses all reasonable endeavours to resume provision of pharmaceutical services as soon as is practicable.

(11) Planned refurbishment of pharmacy premises is [F120 not] a “reason beyond the control of P” for the purposes of sub-paragraph (10).

(12) For the purposes of calculating the number of hours that pharmacy premises are open during a week that includes Christmas Day, Good Friday, Easter Sunday or a bank holiday, it is to be deemed that the pharmacy premises were open on that day at the times at which they would ordinarily have been open on that day of the week.

(13) For the purposes of this Part, “additional opening hours”, where they are required, are hours during which P is required to provide pharmaceutical services pursuant to sub-paragraph (1)(e) which are in addition to the hours during which P would be required to provide pharmaceutical services, if P were subject instead to the condition set out in sub-paragraph (1)(a).

Textual Amendments

F106 Words in Sch. 4 para. 23(1) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 9(2)(a)

F107 Words in Sch. 4 para. 23(1)(d) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 9(2)(b)

F108 Words in Sch. 4 para. 23(1)(e) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 9(2)(c)(i)

F109 Words in Sch. 4 para. 23(1)(e)(ii) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 9(2)(c)(ii)

F110 Words in Sch. 4 para. 23(6) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 9(3)

F111 Word in Sch. 4 para. 23(7)(a) omitted (25.5.2023) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 9(4)

F112 Sch. 4 para. 23(7)(ba)-(bd) substituted for Sch. 4 para. 23(7)(b) (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 9(4)

F113 Sch. 4 para. 23(7A) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 9(5)

F114 Sch. 4 para. 23(8) omitted (31.7.2023) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(3), 9(6)

F115 Sch. 4 para. 23(9) omitted (31.7.2023) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(3), 9(6)

F116 Words in Sch. 4 para. 23(10) substituted (31.7.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(3), 9(7)(a)

F117 Words in Sch. 4 para. 23(10) inserted (31.7.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(3), 9(7)(b)

F118 Words in Sch. 4 para. 23(10)(a) substituted (31.7.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(3), 9(7)(c)

F119 Sch. 4 para. 23(10)(aa) inserted (31.7.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(3), 9(7)(d)

F120 Word in Sch. 4 para. 23(11) substituted (31.7.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(3), 9(8)

[F121 Local hours plans U.K.

23A.— (1) Where NHS England is satisfied that people in a particular area are experiencing, or are likely to experience, significant difficulty in accessing pharmaceutical services on a temporary basis for an identified period, NHS England may establish a local hours plan with the NHS pharmacists in that area that are willing to participate in a local hours plan for that area.

(2) NHS England must, prior to establishing a local hours plan, consult any local pharmaceutical committee for the area that comprises or includes the area of the plan, unless NHS England decides that it is not practicable to do so.

(3) NHS England must notify any local pharmaceutical committee for the area that comprises or includes the area of a local hours plan that it establishes of the contents of that plan and any changes to it, including where further NHS pharmacists join or any NHS pharmacists cease to participate in the plan.

(4) The local hours plan is to be of a specified duration, determined by NHS England, and is to contain the temporary opening hours agreed between NHS England and each of the participating NHS pharmacists (each participating NHS pharmacist agrees their own but not other participants’ temporary opening hours).

(5) NHS pharmacists that have agreed to participate in a local hours plan—

(a) must ensure that pharmaceutical services are provided at their pharmacy premises during the agreed temporary opening hours; and

(b) may cease to participate in the plan and return to their core and supplementary opening hours, provided that, subject to sub-paragraph (8), they have given the notice period for doing so that they have each agreed with NHS England as part of the plan.

(6) NHS England may revise a local hours plan from time to time, including by allowing further NHS pharmacists to join, but any change to the plan that is a change to the temporary opening hours of an NHS pharmacist that is participating in the plan, or of their notice period as referred to in sub-paragraph (5)(b), must be agreed with that NHS pharmacist.

(7) A local hours plan ceases to have effect on the expiry of its specified duration, determined by NHS England in accordance with sub-paragraph (4), unless NHS England revises the specified duration, in which case the new specified duration becomes the specified duration of the plan, and further revisions are then also permissible pursuant to this sub-paragraph.

(8) If NHS England revises the specified duration of a local hours plan, an NHS pharmacist may cease to participate in the plan on the date that was the plan’s expiry date, having given prior notice of their intention to do so, which may be of a shorter period than their agreed notice period where—

(a) the NHS pharmacist does not wish to participate in the plan beyond the expiry date that has been extended;

(b) the timing of the revision means it is not possible, or not reasonably practicable, for prior notice to be given for the agreed notice period; and

(c) the NHS pharmacist gives notice of their intention to cease to participate in the plan on the date that was the plan’s expiry date as soon as it is reasonably practicable for them to do so.

(9) While a local hours plan has effect, the core and supplementary opening hours that have temporarily been suspended may be changed in accordance with paragraphs 23(6) and (7), 25 and 26.]

Textual Amendments

F121 Sch. 4 para. 23A inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 10

Matters to be considered when issuing directions in respect of pharmacy premises core opening hours U.K.

24.— [F122 (1) Subject to paragraph 26(2A), where NHS England issues a direction for setting any days or times for opening hours under this Part, or determines them without issuing a direction, it must in doing so seek to ensure that the days and times at which pharmacy premises are open for the provision of pharmaceutical services in the area in which the premises that are the subject of the direction are located are such as—

(a) to maintain as necessary the existing level of service provision for the people in that area or other likely users of the pharmacy premises; or

(b) to maintain a sustainable level of adequate service provision for the people in that area or other likely users of the pharmacy premises, in circumstances where maintaining the existing level of service provision is either unnecessary or not a realistically achievable outcome.]

(2) In considering the matters mentioned in sub-paragraph (1), [F1 NHS England]—

(a) must treat any local pharmaceutical services being provided in its area as if they were pharmaceutical services being so provided; and

(b) may have regard to any pharmaceutical services that are being provided in its area during supplementary opening hours.

(3) [F1 NHS England] may only direct that an NHS pharmacist (P) may provide pharmaceutical services at premises for less than 40 hours in any week if it is satisfied that the provision of pharmaceutical services in its area is likely to be adequate to meet the need for such services at times when P is not providing pharmaceutical services.

(4) Except in the case of premises that have (at any time) been subject to a direction under regulation 65 or regulation 65 of the 2012 Regulations (core opening hours conditions), [F1 NHS England] may only direct that P must provide pharmaceutical services at premises for more than 40 hours in any week where it is satisfied that P is to receive reasonable remuneration in respect of the additional opening hours for which P is required to provide pharmaceutical services (and any additional remuneration payable in accordance with a determination made as mentioned in regulation 91(6) in respect of those hours is “reasonable remuneration” for these purposes).

[F123 (5) Sub-paragraph (4) does not apply in circumstances where the direction is in respect of any premises in respect of which a 100 hours condition applies or has ever applied, or in respect of which a direction that replaced (at any distance in succession) a 100 hours condition applies.]

Textual Amendments

F122 Sch. 4 para. 24(1) substituted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 11(2)

F123 Sch. 4 para. 24(5) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 11(3)

Determination of pharmacy premises core opening hours instigated by [F1 NHS England] U.K.

25.—(1) Where it appears to [F1 NHS England], after consultation with or having considered the matter at the request of the Local Pharmaceutical Committee for the area in which the premises are situated, that the days on which or times at which pharmacy premises are or are to be open for the provision of pharmaceutical services will not, or no longer, meet the needs of—

(a) people in its area; or

(b) other likely users of the pharmacy premises,

for the pharmaceutical services available at or from those premises, it must carry out an assessment as to whether to issue a direction requiring the NHS pharmacist (P) whose premises they are to provide pharmaceutical services at the pharmacy premises at set times and on set days (which may include Christmas Day, Good Friday and bank holidays).

(2) Before concluding the assessment under sub-paragraph (1) [F1 NHS England] must—

(a) give notice to P of any proposed changes to the days on which or times at which the pharmacy premises are to be open; and

(b) allow P 30 days within which to make written representations to [F1 NHS England] about the proposed changes.

(3) When it determines the outcome of its assessment, [F1 NHS England] must—

(a) issue a direction (which replaces any existing direction) which meets the requirements of sub-paragraphs (4) and (5);

(b) confirm any existing direction in respect of the times at which P must provide pharmaceutical services at the pharmacy premises, provided that the existing direction (whether issued under regulation 65, this Part, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations) would meet the requirements of sub-paragraphs (4) and (5); or

(c) either—

(i) revoke, without replacing it, any existing direction in respect of the times at which P must provide pharmaceutical services at the pharmacy premises (whether issued under regulation 65, this Part, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations), or

(ii) in a case where there is no existing direction, issue no direction,

in which case, by virtue of whichever of paragraph 23(1)(a) or (b) applies, the pharmacy will need to be open for 40 hours each week or for at least 100 hours each week.

(4) Where [F1 NHS England] issues a direction under sub-paragraph (3) in respect of pharmacy premises that are to be required to be open—

(a) for more than 40 hours each week, it must set out in that direction—

(i) the total number of hours each week for which P must provide pharmaceutical services at the pharmacy, and

(ii) as regards the additional opening hours, the days on which and the times at which P is required to provide those services during those hours,

but it must not set out in that direction the days on which or times at which P is to provide pharmaceutical services during hours which are not additional opening hours; or

(b) for less than 40 hours each week, it shall set out in that direction the days on which and times at which pharmaceutical services are to be provided at the pharmacy premises.

(5) [F1 NHS England] must not issue a direction under sub-paragraph (3) that has the effect simply of requiring pharmacy premises to be open for 40 hours each week on set days and at set times (that is, the direction must have the effect of requiring pharmacy premises to be open for either more or less than 40 hours each week).

(6) [F1 NHS England] must notify P of any direction issued or any other action taken under sub-paragraph (3), and where it sets new days on which or times at which P is to provide pharmaceutical services at pharmacy premises, it must include with the notification a statement of—

(a) the reasons for the change; and

(b) P's right of appeal under paragraph (7).

(7) P may, within 30 days of receiving notification under sub-paragraph (6), appeal in writing to the Secretary of State against any direction issued or any other action taken under sub-paragraph (3) which sets new days on which or times at which P is to provide pharmaceutical services.

(8) The Secretary of State may, when determining an appeal, either confirm the action taken by [F1 NHS England] or take any action that [F1 NHS England] could have taken under paragraph (3).

(9) The Secretary of State shall notify P of the determination and shall in every case include with the notification a statement of the reasons for the determination.

(10) If the days on which or times at which P is to provide pharmaceutical services at pharmacy premises have been changed in accordance with this paragraph, P must introduce the changes—

(a) if P has not appealed under sub-paragraph (7), not later than 8 weeks after the date on which P receives notification under sub-paragraph (6); or

(b) if P has appealed under sub-paragraph (7), not later than 8 weeks after the date on which P receives notification under sub-paragraph (9).

(11) This paragraph does not apply where regulation 65(5) to (7) applies.

Determination of pharmacy premises core opening hours instigated by the NHS pharmacist U.K.

26.—(1) An NHS pharmacist (P) may apply to [F1 NHS England] for it to change the days on which or times at which P is obliged to provide pharmaceutical services [F124 during core opening hours] at P's pharmacy premises in a way that—

(a) reduces the total number of hours for which P is obliged to provide pharmaceutical services at those premises each week F125 ...; or

(b) keeps that total number of hours the same.

(2) [F126 Except where sub-paragraph (2A) applies,] where P makes an application under sub-paragraph (1), as part of that application P must provide [F1 NHS England] with such information as [F1 NHS England] may reasonably request in respect of [F127 the matters that NHS England must seek to ensure pursuant to paragraph 24(1)].

[F128 (2A) In the case of an application for a direction under sub-paragraph (4) that has the effect of reducing, in the case of any premises in respect of which a 100 hours condition applies or has ever applied, or in respect of which a direction that replaced (at any distance in succession) a 100 hours condition applies, the total number of core opening hours to 72 or above, but without changing any or all of the following—

(a) the core opening hours on a Monday to Saturday at times between 5pm and 9pm;

(b) the core opening hours on a Sunday at times between 11am and 4pm, other than by way of the inclusion of, or a change to, a rest break which—

(i) is no longer than one hour, and

(ii) starts at least 3 hours after the start of the pharmacy’s opening hours and ends at least 3 hours before the end of the pharmacy’s opening hours; and

(c) the total number of core opening hours on a Sunday,

NHS England must grant that application, and paragraph 24(1) does not apply to such an application.

(2B) In the case of a valid application for a direction under sub-paragraph (4) to which sub-paragraph (2A) applies, if—

(a) the date included in the application as the date on which P wishes to change P’s core opening hours is five weeks or more after the day on which the application is received by NHS England; and

(b) NHS England has not determined the application by that date,

pending the determination of the application, P’s core opening hours are the core opening hours that P requested in the application.]

(3) [F1 NHS England] must determine the application within 60 days of receiving it (including any information required of P in accordance with sub-paragraph (2)).

(4) When it determines the application, [F1 NHS England] must—

(a) issue a direction (which replaces any existing direction) which meets the requirements of sub-paragraphs [F129 (4A),] (5) and (6) and which has the effect of either granting the application under this paragraph or granting it only in part;

(b) confirm any existing direction in respect of the times at which P must provide pharmaceutical services at the pharmacy premises, provided that the existing direction (whether issued under regulation 65, this Part, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations) would meet the requirements of sub-paragraphs (5) and (6); or

(c) either—

(i) revoke, without replacing it, any existing direction in respect of the times at which P must provide pharmaceutical services at the pharmacy premises (whether issued under regulation 65, this Part, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations), where this has the effect of granting the application under this paragraph or granting it only in part, or

(ii) in a case where there is no existing direction, issue no direction.

F130 ...

[F131 (4A) NHS England must not issue a direction under sub-paragraph (4), or revoke without replacing it an existing direction under that sub-paragraph, if doing so would have the effect of reducing, in the case of any premises in respect of which a 100 hours condition applies or has ever applied, or in respect of which a direction that replaced (at any distance in succession) a 100 hours condition applies, any or all of the following—

(a) the total number of core opening hours to below 72;

(b) the core opening hours on a Monday to Saturday at times between 5pm and 9pm;

(c) the core opening hours on a Sunday at times between 11am and 4pm, other than by way of the inclusion of, or a change to, a rest break which—

(i) is no longer than one hour, and

(ii) starts at least 3 hours after the start of the pharmacy’s opening hours and ends at least 3 hours before the end of the pharmacy’s opening hours; and

(d) the total number of core opening hours on a Sunday,

and an application seeking such a change is not a valid application for the purposes of sub-paragraph (2B).

(4B) On and after 25th May 2023, NHS England must not issue a direction under sub-paragraph (4), or revoke without replacing it an existing direction under that sub-paragraph, pursuant to an application made before 25th May 2023 for a direction pursuant to this paragraph as it had effect before 25th May 2023, if doing so would have the effect of reducing, in the case of any premises in respect of which a 100 hours condition applies, any or all of the following—

(a) the core opening hours on a Monday to Saturday at times between 5pm and 9pm;

(b) the core opening hours on a Sunday at times between 11am and 4pm, other than by way of the inclusion of, or a change to, a rest break which—

(i) is no longer than one hour, and

(ii) starts at least 3 hours after the start of the pharmacy’s opening hours and ends at least 3 hours before the end of the pharmacy’s opening hours; and

(c) the total number of core opening hours on a Sunday.]

(5) Where [F1 NHS England] issues a direction under sub-paragraph (4) in respect of pharmacy premises that are to be required to be open—

(a) for more than 40 hours each week, it must set out in that direction—

(i) the total number of hours each week for which P must provide pharmaceutical services at the pharmacy premises, and

(ii) as regards any additional opening hours, the days on which and the times at which P is required to provide those services during those hours,

but [F132 except in a case to which sub-paragraph (4A) applies,] it must not set out in that direction days on which or times at which P is to provide pharmaceutical services during hours which are not additional opening hours; or

(b) for less than 40 hours each week, it shall set out in that direction the days on which and times at which pharmaceutical services are to be provided at the pharmacy premises.

(6) [F1 NHS England] must not issue a direction under sub-paragraph (4) that has the effect simply of requiring pharmacy premises to be open for 40 hours each week on set days and at set times (that is, the direction must have the effect of requiring pharmacy premises to be open for either more or less than 40 hours each week).

(7) Where [F1 NHS England] is considering taking action under sub-paragraph (4)(a) or (c)(i), it shall consult the Local Pharmaceutical Committee for the area in which the pharmacy premises are situated before determining the application.

(8) [F1 NHS England] must notify P of any direction issued or any other action taken under sub-paragraph (4), and where this has the effect of refusing an application under this paragraph or granting it in part, it must send P a statement setting out—

(a) the reasons for the refusal or, as the case may be, for granting the application only in part; and

(b) P's right of appeal under sub-paragraph (9).

(9) P may, within 30 days of receiving a notification pursuant to sub-paragraph (8), appeal in writing to the Secretary of State against any action under sub-paragraph (4) which has the effect of refusing an application under this paragraph or granting it only in part.

(10) The Secretary of State may, when determining an appeal, either confirm the action taken by [F1 NHS England] or take any action that [F1 NHS England] could have taken under sub-paragraph (4).

(11) The Secretary of State must notify the pharmacist of the determination and must include with the notification a statement of the reasons for the determination.

(12) If the days on which or times at which P is to provide pharmaceutical services at pharmacy premises have been changed in accordance with this paragraph, P must introduce the changes—

(a) if P has not appealed under sub-paragraph (9), not earlier than 30 days after the date on which P receives notification under sub-paragraph (4); or

(b) if P has appealed under sub-paragraph (9), not earlier than 30 days after the date on which P receives notification under sub-paragraph (11).

(13) This paragraph does not apply where regulation 65(5) to (7) applies.

Textual Amendments

F124 Words in Sch. 4 para. 26(1) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 12(2)(a)

F125 Words in Sch. 4 para. 26(1)(a) omitted (25.5.2023) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 12(2)(b)

F126 Words in Sch. 4 para. 26(2) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 12(3)(a)

F127 Words in Sch. 4 para. 26(2) substituted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 12(3)(b)

F128 Sch. 4 para. 26(2A)(2B) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 12(4)

F129 Word in Sch. 4 para. 26(4)(a) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 12(5)(a)

F130 Words in Sch. 4 para. 26(4)(c) omitted (25.5.2023) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 12(5)(b)

F131 Sch. 4 para. 26(4A)(4B) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 12(6)

F132 Words in Sch. 4 para. 26(5)(a) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 12(7)

Temporary opening hours and closures during an emergency requiring the flexible provision of pharmaceutical services U.K.

27.—(1) Notwithstanding the provisions of this Part, during an emergency requiring the flexible provision of pharmaceutical services, [F1 NHS England] may, on application from an NHS pharmacist (“P”), permit P a temporary change to the days on which or times at which P is obliged to provide pharmaceutical services at pharmacy premises, or permit temporary closure of those premises, if—

(a) P gives at least 24 hours notice of the change or closure; and

(b) the reasons given by P for the request are, in the opinion of [F1 NHS England], adequate reasons.

(2) [F1 NHS England] need not approve the request in advance of the change or closure, but if it does not do so and decides subsequently that P's reasons are not, in its opinion, adequate reasons, then the days on which or times at which P is obliged to provide pharmaceutical services at the premises are to revert to the overridden days or times, from the day after the date on which that decision is given to P.

[F133 Pharmacy opening hours: arrangements while a disease is or in anticipation of a disease being imminently pandemic etc. U.K.

27A.— (1) Notwithstanding the foregoing provisions of this Part, the core or supplementary opening hours of an NHS pharmacist (P) may be changed by [F1 NHS England] where, as a consequence of a disease being, or in anticipation of a disease being imminently—

(a) pandemic; and

(b) a serious risk or potentially a serious risk to human health,

[F1 NHS England] with the agreement of the Secretary of State has made an announcement to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, [F1 NHS England] may, in the area to which the announcement relates and in the circumstances specified in the announcement, notify NHS pharmacists of changes to core and supplementary opening hours for the period specified in the announcement.

(2) Where paragraph (1) applies, where [F1 NHS England] notifies P of changes to P’s core or supplementary hours at P’s pharmacy premises, those are P’s core and supplementary opening hours for the period that [F1 NHS England] specifies in the notification (unless [F1 NHS England] notifies P of further changes to P’s opening hours).]

Textual Amendments

F133 Sch. 4 para. 27A inserted (27.3.2020) by The National Health Service (Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/351), regs. 1(2), 9(3)

[F134 Flexible provision of relevant immunisation services during a pandemic etc. U.K.

27B.— (1) Notwithstanding the forgoing provisions of this Part, in order to assist in the management of a serious risk or potentially serious risk to human health which arises as a consequence of a disease being, or in anticipation of a disease being imminently, pandemic, an NHS pharmacist (P) may, with the agreement of [F1 NHS England], limit for a specified period (within P’s core and supplementary opening hours) the pharmaceutical services provided at or from P’s pharmacy premises to relevant immunisation services.

(2) If [F1 NHS England] has made an announcement to the effect that there are particular arrangements under this paragraph that it is prepared to agree, and P limits P’s provision of pharmaceutical services to relevant immunisation services in a manner that is consistent with that announcement, it is to be assumed (in the absence of a contrary notification from [F1 NHS England] to P) that P has the agreement of [F1 NHS England] to those arrangements.

(3) In this paragraph, “relevant immunisation services” means directed services that provide for the administration of a medicinal product for vaccination or immunisation against coronavirus or influenza virus in accordance with—

(a) a patient group direction that meets the conditions of regulation 233 of the Human Medicines Regulations 2012 (exemption for supply etc under a PGD by a person conducting a retail pharmacy business); or

(b) a protocol that meets the conditions of regulation 247A of the Human Medicines Regulations 2012 (protocols relating to coronavirus and influenza vaccinations and immunisations),

and for these purposes, “coronavirus” has the meaning given in section 1(1) of the Coronavirus Act 2020.]

Textual Amendments

F134 Sch. 4 para. 27B inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 13

PART 4 U.K. Other terms of service

Clinical governance [F135 and the promotion of healthy living] U.K.

28.—(1) An NHS pharmacist (P) must, in connection with the pharmaceutical services provided by P, participate, in the manner reasonably required by [F1 NHS England], in an acceptable system of clinical governance [F136 and for the promotion of healthy living].

(2) For these purposes a system of clinical governance [F137 and for the promotion of healthy living] is “acceptable” if it is considered acceptable by [F1 NHS England] and comprises the following components—

(a) a patient and public involvement programme, which includes—

(i) a requirement that P produces in an approved manner, and makes available in an appropriate manner, a practice leaflet containing approved particulars in respect of P's pharmacy premises,

(ii) a requirement that the pharmacist publicises the essential services and any advanced services[F138 , other than an advanced service in respect of the supply of drugs in accordance with regulation 225 of the Human Medicines Regulations 2012 (emergency sale etc by pharmacist: at patient’s request),] that are available at or from the pharmacist's pharmacy,

(iii) a requirement that where a pharmacist publicises the essential services or any directed services that are available at or from the pharmacist's pharmacy (whether the pharmacist is producing their own publicity material or advertising services in material published by another person), the pharmacist does so in a manner which makes clear that the services are funded as part of the health service,

F139 (iv) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(v) P's monitoring arrangements for drugs or appliances owed to patients but which are out of stock,

(vi) a requirement that P co-operates appropriately with any reasonable inspection or review that [F1 NHS England] or any relevant statutory authority wishes to undertake, F140 ...

(vii) P's monitoring arrangements in respect of P's compliance with the Equality Act 2010; [F141 and]

[F142 (viii) undertaking at least once in each financial year an approved community engagement exercise in relation to the promotion of healthy living.]

[F143 (b) an audit programme, which in each financial year includes at least one clinical audit specified by P, and whichever of the following that [F1 NHS England] specifies—

(i) a clinical audit carried out in a manner which is compatible with [F1 NHS England’s] arrangements for the receiving and processing of data from the audit, or

(ii) a policy based audit (to support the development of the commissioning policies of [F1 NHS England]) carried out in a manner which is compatible with [F1 NHS England]’s arrangements for the receiving and processing of data from the audit;]

(c) a risk management programme, which includes—

(i) arrangements for ensuring that all stock is procured and handled in an appropriate way,

(ii) arrangements for ensuring that all equipment used in the provision of pharmaceutical services is maintained appropriately,

(iii) an approved incident reporting system, together with arrangements for analysing and responding to critical incidents,

(iv) arrangements, including record keeping arrangements, for dealing appropriately and timeously with any communications concerning patient safety from the Secretary of State M15 and [F1 NHS England],

(v) appropriate standard operating procedures, including standard operating procedures in respect of [F144 the discharge medicines service] dispensing drugs and appliances, repeatable prescriptions and providing advice and support to people caring for themselves or their families,

(vi) appropriate waste disposal arrangements (in addition to those required under Part 2) for clinical and confidential waste,

(vii) a clinical governance lead person for each pharmacy, appointed as such by the pharmacist (or who is the pharmacist), who is knowledgeable about both the pharmacy procedures of that pharmacy and the other NHS services that are available in the locality of that pharmacy,

(viii) appropriate safeguarding procedures for service users,

(ix) P's monitoring arrangements in respect of P's compliance with the Health and Safety at Work etc. Act 1974 M16 ;

[F145 (ca) at the request of [F1 NHS England], a pandemic response programme, which includes—

(i) conducting an infection control risk assessment, in the approved manner,

(ii) appropriate infection control measures at P’s pharmacy premises, having regard to that infection control risk assessment and to any approved particulars designed to support, in a proportionate manner, the safety of service users and pharmacy staff in particular in circumstances where services users or pharmacy staff may be, or are known or suspected to be, suffering from the pandemic disease,

(iii) arrangements, which may be approved arrangements, for communicating with potential service users about service availability and service provision at or from P’s pharmacy premises during the pandemic,

(iv) arrangements for appropriate updating of the standard operating procedures mentioned in sub-paragraph (c)(v) and any business continuity plan of P, and

(v) arrangements for appropriate updating of the premises standards programme mentioned in sub-paragraph (g) (including in response to any new approved particulars under sub-paragraph (g)(ii) that are in response to the pandemic),

but prior to making such a request (or revising the terms of such a request), [F1 NHS England] must consult the body that is, for the time being, the body consulted under section 165(1)(a) of the 2006 Act in respect of pharmaceutical remuneration of NHS pharmacists;]

(d) a clinical effectiveness programme, which includes arrangements for ensuring that appropriate advice is given by P—

(i) in respect of the provision of drugs in accordance with a repeatable prescription,

(ii) in respect of the provision of appliances in accordance with a prescription form or repeatable prescription, or

(iii) to people caring for themselves or their families,

and arrangements for ensuring that P, when giving advice to any patient on a matter mentioned in paragraph (d)(ii), has regard to the details contained in the records maintained under paragraph 10(1)(f) in respect of the provision of appliances and the prescribing pattern relating to the patient in question;

(e) a staffing and staff management programme, which includes—

(i) arrangements for appropriate induction for staff (including locums),

(ii) appropriate training for all staff in respect of any role they are asked to perform,

(iii) arrangements for the checking of qualifications and references of all staff engaged in the provision of NHS services,

[F146 (iiia) a requirement that P undertakes an approved workforce survey annually, in an approved manner,]

(iv) arrangements for identifying and supporting the development needs of all staff engaged in the provision of NHS services, including continuing professional development for registered pharmacists and registered pharmacy technicians, and any necessary accreditation [F147 , certification or declarations of competence in respect of any role they are asked to perform],

(v) arrangements for addressing poor performance (in conjunction with [F1 NHS England] as appropriate), and

(vi) arrangements (which must include a written policy) for ensuring that all staff and locums who, arising out of their employment with the pharmacist—

(aa) make what is a protected disclosure within the meaning given in section 43A of the Employment Rights Act 1996 M17 (meaning of protected disclosure) have the rights afforded in respect of such disclosures by that Act, and

(bb) provide information in good faith and not for purposes of personal gain to the General Pharmaceutical Council or to [F1 NHS England] which includes an allegation of a serious nature which they reasonably believe to be substantially true, but disclosure of it is not a protected disclosure within the meaning given in section 43A, have the right not to be subjected to any detriment or to dismissal as a consequence of that act;

(f) an information governance programme, which provides for—

(i) compliance with approved procedures for information management and security, and

(ii) submission of an annual self assessment of compliance (to an approved level) with those procedures via approved data submission arrangements which allow [F1 NHS England] to access that assessment; and

(g) a premises standards programme, which includes—

(i) a system for maintaining cleanliness at the pharmacy which is designed to ensure, in a proportionate manner, that the risk to people at the pharmacy of health care acquired infection is minimised, and

(ii) arrangements for compliance, in the areas of the pharmacy in which patients receive NHS services, with any approved particulars that are designed to ensure, in a proportionate manner, that those areas are an appropriate environment in which to receive health care [F148 and for the promotion of healthy living],

and for the purposes of this sub-paragraph, “approved” means approved by [F1 NHS England].

Textual Amendments

F135 Words in Sch. 4 para. 28 heading inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(2)

F136 Words in Sch. 4 para. 28(1) inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(3)

F137 Words in Sch. 4 para. 28(2) inserted (1.1.2021) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(a)

F138 Words in Sch. 4 para. 28(2)(a)(ii) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 25

F139 Sch. 4 para. 28(2)(a)(iv) omitted (1.10.2022) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 (S.I. 2022/930), regs. 1(2), 8(3)(a)

F140 Word in Sch. 4 para. 28(2)(a)(vi) omitted (1.1.2021) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(b)(i)

F141 Word in Sch. 4 para. 28(2)(a)(vii) inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(b)(ii)

F142 Sch. 4 para. 28(2)(a)(viii) inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(b)(iii)

F143 Sch. 4 para. 28(2)(b) substituted (1.3.2015) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015 (S.I. 2015/58), regs. 1(1), 8(3) (with reg. 10)

F144 Words in Sch. 4 para. 28(2)(c)(v) inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(c)

F145 Sch. 4 para. 28(2)(ca) inserted (1.1.2022) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(b), 8(2)

F146 Sch. 4 para. 28(2)(e)(iiia) inserted (1.10.2022) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 (S.I. 2022/930), regs. 1(2), 8(3)(b)

F147 Words in Sch. 4 para. 28(2)(e)(iv) substituted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(d)

F148 Words in Sch. 4 para. 28(2)(g)(ii) inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(e)

Marginal Citations

M15 The Medicines and Healthcare Products Regulatory Agency, which is an executive agency of the Department of Health, issues safety advice, warnings, alerts and recalls in respect of medical devices on behalf of the Secretary of State, and also safety advice, warnings, alerts and recalls in respect of medicines on behalf of the Secretary of State and the Minister for Health, Social Services and Public Safety, acting jointly. The Department of Health also, separately, issues other communications concerning patient safety, on behalf of the Secretary of State.

M16 1974 c. 37.

M17 1996 c. 18; section 43A was inserted by the Public Interest Disclosure Act 1998 (c. 23), section 1. See also section 43K(1)(c) (i) of the Employment Rights Act 1996 (inserted by the Public Interest Disclosure Act 1998, section 1, and amended by: the National Health Service Reform and Health Care Professions Act 2002 (c. 17), Schedule 2, paragraph 63; the National Health Service (Consequential Provisions) Act 2006 (c. 43), Schedule 1, paragraphs 177 and 178(b); and S.I. 2007/961).

[F149 Premises requirements in respect of consultation rooms U.K.

28A.— (1) An NHS pharmacist must ensure that at pharmacy premises, other than distance selling premises, there is a consultation room which is—

(a) clearly designated as a room for confidential conversations;

(b) distinct from the general public areas of the pharmacy premises; and

(c) a room where both a person accessing pharmaceutical services and a person performing pharmaceutical services are able to be seated together and communicate confidentially.

(2) Where, in the opinion of [F1 NHS England], pharmacy premises other than distance selling premises included on a pharmaceutical list on the relevant day are too small for a consultation room—

(a) the NHS pharmacist in respect of those premises may, with the agreement of [F1 NHS England], comply with paragraph 28B instead of sub-paragraph (1); and

(b) for these purposes, references to distance selling premises in paragraph 28B are to be treated as a reference to the premises about which [F1 NHS England] has formed the opinion that they are too small for a consulting room.

(3) An NHS pharmacist in respect of premises that were on a pharmaceutical list on the relevant day but no advanced services were provided at or from those premises during the year before the relevant day need not comply with sub-paragraphs (1) or (2) in respect of those premises before 1st April 2023.

(4) In this paragraph, “the relevant day” means the day of the coming into force of regulation 15(1) of the National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020.

Textual Amendments

F149 Sch. 4 paras. 28A, 28B inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 15(1)

Consultations held from distance selling premises and some small pharmacy premises U.K.

28B.   An NHS pharmacist in respect of distance selling premises must ensure that there are arrangements in place at those premises which enable a person performing pharmaceutical services to communicate confidentially with a person accessing pharmaceutical services—

(a) by telephone or another live audio link; and

(b) via a live video link.]

Textual Amendments

F149 Sch. 4 paras. 28A, 28B inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 15(1)

[F150 Distance selling premises requirements in respect of websites and health promotion zones U.K.

28C.   An NHS pharmacist (P) in respect of distance selling premises must ensure that P has a website for use by the public for the purpose of accessing pharmaceutical services from those premises, on which there is an interactive page, clearly promoted to any user of the website when they first access it, which provides public access to a reasonable range of up to date materials that promote healthy lifestyles by addressing a reasonable range of health issues.]

Textual Amendments

F150 Sch. 4 para. 28C inserted (1.4.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(4), 15(2)

Professional Standards U.K.

29.  An NHS pharmacist must provide pharmaceutical services and exercise any professional judgement in connection with the provision of such services in conformity with the standards generally accepted in the pharmaceutical profession.

[F151 Accessing summary care records U.K.

29A.— [F152 (1) An NHS pharmacist (P) must have access to summary care records at P’s pharmacy premises, and must ensure that the access that P has to summary care records at those premises is constant and reliable during core and supplementary opening hours, in so far as that is within the control of P.

(2) P must access the summary information in a patient’s summary care record whenever P is providing pharmaceutical services to the patient, to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so.]

(3) In this paragraph, a “summary care record” and “summary information” mean a summary care record and summary information within the meanings given in—

(a) regulation 68 of the GMS Regulations (summary care records); and

(b) regulation 61 of the PMS Regulations (summary care records).]

Textual Amendments

F151 Sch. 4 para. 29A inserted (1.4.2016) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2016 (S.I. 2016/296), regs. 1(1)(a), 4(3)

F152 Sch. 4 para. 29A(1)(2) substituted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 16

[F153 Electronic Prescription Service access U.K.

29B.   An NHS pharmacist (P) must have access to the EPS at P’s pharmacy premises, and must ensure that the access that P has to the EPS at those premises is constant and reliable during core and supplementary opening hours, in so far as that is within the control of P.]

Textual Amendments

F153 Sch. 4 paras. 29B, 29C inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 17

[F153 Contact via NHSmail, pharmacy profiles and the Central Alerting System U.K.

29C.— (1) An NHS pharmacist (P) must ensure that pharmacy staff at pharmacy premises (including locums) have access to, and are able to send and receive NHSmail from, a premises specific NHSmail account.

(2) P must ensure that at least two members of the pharmacy staff have live, linked NHSmail accounts to the premises specific NHSmail account (unless fewer than two members of the pharmacy staff are engaged in the provision of NHS services).

(3) P must ensure that there is a comprehensive and accurate pharmacy profile in respect of P’s pharmacy premises in the [F154 NHS England directory of services], and P must verify and where necessary update the information contained in that profile at least once each quarter of the financial year.

(4) P must ensure that there is a comprehensive and accurate pharmacy profile in respect of P’s pharmacy premises on the NHS.uk website, and P must verify and where necessary update the information contained in that profile at least once each quarter of the financial year.

(5) As regards the Central Alerting System (CAS) operated by the Medicines and Healthcare products Regulatory Agency (MHRA)—

(a) P must register P’s premises specific NHSmail address with MHRA as an address at which P is content to accept notifications as part of the CAS (unless they are content with the address already in the system);

(b) if P changes P’s premises specific NHSmail address, P must immediately notify MHRA of P’s new premises specific NHSmail address, in accordance with paragraph (a); and

(c) P must monitor P’s premises specific NHSmail account with sufficient frequency to ensure the safe and effective supply of medicinal products at or from P’s pharmacy premises, and must act on the alerts P receives as part of the CAS, as appropriate.]

Textual Amendments

F153 Sch. 4 paras. 29B, 29C inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 17

F154 Words in Sch. 4 para. 29C(3) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 47(3)(b) (with reg. 3)

[F155 Business continuity plans to deal with temporary suspensions U.K.

29D.— (1) An NHS Pharmacist (P) must have at all times an up to date business continuity plan for P’s pharmacy premises, which is available at those premises, to deal with the temporary suspension because of illness or another reason beyond the control of P of the provision of pharmaceutical services at or from those premises that—

(a) is proportionate to the needs of the people who are anticipating or are accustomed to receiving pharmaceutical services from P; and

(b) includes the components set out in sub-paragraph (2).

(2) The components are—

(a) arrangements for notifying NHS England, in the approved manner—

(i) about the prospect of a temporary suspension, whenever such a suspension becomes likely, and

(ii) about a temporary suspension and its anticipated duration, wherever possible before the start of the suspension;

(b) arrangements for updating the pharmacy profile mentioned in paragraph 29C(3) about the suspension, including in due course about the resumption of the provision of pharmaceutical services at the pharmacy premises;

(c) if P provides directed services that provide people with urgent care services, arrangements for ensuring, to the extent practicable, that people are not referred to P’s pharmacy premises for those services during the temporary suspension;

(d) arrangements, where practicable and to an extent that is reasonable having regard to the needs of the people who are anticipating or are accustomed to receiving pharmaceutical services from P, for notifying other providers of pharmaceutical and local pharmaceutical services and providers of primary medical services about the suspension and its anticipated duration;

(e) arrangements for displaying information about the suspension and its anticipated duration—

(i) in the case of distance selling pharmacies, on the website for the distance selling pharmacy, clearly promoted to any user of the website when they first access it, or

(ii) in any other case, on a notice at P’s pharmacy premises visible from outside the premises, which also provides information, where appropriate in the approved manner and to an extent that is reasonable having regard to the needs of the people who are anticipating or are accustomed to receiving pharmaceutical services from P, about the availability of pharmaceutical or local pharmaceutical services at or from other pharmacy premises nearby; and

(f) arrangements, where practicable, for the continuity of care for the people who are anticipating or are accustomed to receiving pharmaceutical services from P, including for any people who—

(i) have booked appointments, or

(ii) attend the pharmacy premises regularly for the supervised administration of medicines.

(3) For the purposes of sub-paragraph (2), “approved” means approved by NHS England.

(4) In the event of the temporary suspension, or the likely temporary suspension, of pharmaceutical services provision at or from P’s pharmacy premises, P must use all reasonable endeavours to implement P’s business continuity plan, and in the case of a likely temporary suspension, in a manner proportionate to that likelihood.]

Textual Amendments

F155 Sch. 4 para. 29D inserted (31.7.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(3), 13

Inducements etc. U.K.

30.—(1) An NHS pharmacist (P) (including P's staff) must not give, promise or offer to any person any gift or reward (whether by way of a share of or dividend on the profits of P's business or by way of discount or rebate or otherwise) as an inducement to or in consideration of a person (X)—

(a) presenting an order for drugs or appliances on a prescription form or repeatable prescription, non-electronic prescription form or non-electronic repeatable prescription;

(b) nominating P as X's dispensing contractor (or one of them) in X's PDS patient details; or

(c) receiving from P any directed services.

(2) Promising, offering or providing an auxiliary aid in relation to the supply of drugs or a home delivery service is not a gift or reward for the purposes of sub-paragraph (1).

(3) Nothing in sub-paragraph (1) prohibits P from providing to a patient to whom P is providing any directed services any gift which—

(a) is supplied as part of the provision of any directed service to that patient;

(b) is directly related to that directed service;

(c) is supplied in order to encourage or promote health or well-being or the adoption by the patient or the patient's family of a healthy lifestyle; and

(d) in the case of a gift which—

(i) is not a medicine, has a monetary value not exceeding £10, or

(ii) is a medicine, is supplied as part of the provision of a minor ailments service.

(4) P (including P's staff) must not give, promise or offer to any relevant person any gift or reward (including by way of a share of, or dividend on, the profits of P's business, or by way of a discount or rebate) as an inducement to or in consideration of the relevant person recommending to any person that they—

(a) present to P an order for drugs or appliances on a prescription form or repeatable prescription;

(b) nominate P as their dispensing contractor (or one of them) in their entry in their PDS patient details; or

(c) ask P to provide them with any directed service.

(5) For the purpose of sub-paragraph (4), “relevant person” means any person who performs or provides NHS services, whether on their own behalf or on behalf of another, and includes—

(a) any NHS body or provider of primary medical services; and

(b) any person employed or engaged by any of the persons mentioned in paragraph (a).

(6) In the case of the provision of appliances, P (including P's staff) must not accept or receive any gift or reward in respect of only—

(a) providing contact details of alternative NHS pharmacists or NHS appliance contractors pursuant to paragraph 10(2)(b), 12(4) or 20(2)(b); or

(b) referring a prescription form or repeatable prescription to another NHS pharmacist or NHS appliance contractor pursuant to paragraph 10(2)(a) or 20(2)(a) and providing no additional service in connection with the item on that prescription.

Duty to provide information about fitness matters as they arise U.K.

31.—(1) An NHS pharmacist (P) and, where P is a body corporate, every director and superintendent of P must, within 7 days of its occurrence, inform [F1 NHS England] in writing if they—

(a) are convicted of any criminal offence in the United Kingdom;

(b) are bound over following a criminal conviction in the United Kingdom;

(c) accept a police caution in the United Kingdom;

(d) have, in summary proceedings in Scotland in respect of an offence, been the subject of an order discharging them absolutely (without proceeding to conviction);

(e) have accepted and agreed to pay either a procurator fiscal fine under section 302 of the Criminal Procedure (Scotland) Act 1995 M18 (fixed penalty: conditional offer by procurator fiscal) or a penalty under section 115A of the Social Security Administration Act 1992 M19 (penalty as alternative to prosecution);

(f) have been convicted of an offence elsewhere than in the United Kingdom where the originating events, if they took place in England, could lead to a criminal conviction in England;

(g) are charged in the United Kingdom with a criminal offence, or are charged elsewhere than in the United Kingdom with an offence where the originating events, if they took place in England, could lead to a criminal conviction in England;

(h) are notified by any licensing, regulatory or other body of the outcome of any investigation into their professional conduct, and there is a finding against them;

(i) become the subject of any investigation into their professional conduct by any licensing, regulatory or other body;

(j) become the subject of any investigation into their professional conduct in respect of any current or previous employment, or are notified of the outcome of any such investigation and any finding against them;

(k) become the subject of any investigation by the NHS BSA in relation to fraud;

(l) become the subject of any investigation by another primary care organisation which might lead to their removal from a relevant list; or

(m) are removed, contingently removed or suspended from, refused inclusion in or conditionally included in any relevant list for a reason relating to unsuitability, fraud or efficiency of service provision,

and must give details of any investigation or proceedings which were or are to be brought, including the nature of the investigation or proceedings, where and approximately when that investigation or those proceedings took place or are to take place, and any outcome.

(2) If a person to whom paragraph (1) applies (X) is, or was at the time of the originating events, a director or superintendent of a body corporate, X must in addition inform [F1 NHS England] within 7 days if any such body corporate—

(a) is convicted of any criminal offence in the United Kingdom;

(b) is convicted of an offence elsewhere than in the United Kingdom where the originating events, if they took place in England, could lead to a criminal conviction in England;

(c) is charged in the United Kingdom with a criminal offence, or is charged elsewhere than in the United Kingdom with an offence where the originating events, if they took place in England, could lead to a criminal conviction in England;

(d) is notified by any licensing, regulatory or other body of the outcome of any investigation into its provision of professional services, and there is a finding against the body corporate;

(e) becomes the subject of any investigation into its provision of professional services by any licensing, regulatory or other body;

(f) becomes the subject of any investigation by the NHS BSA in relation to any fraud or is notified of the outcome of such an investigation where it is adverse;

(g) becomes the subject of any investigation by another primary care organisation which might lead to its removal from any relevant list; or

(h) is removed, contingently removed or suspended from, refused inclusion in or conditionally included in any relevant list for a reason relating to unsuitability, fraud or efficiency of service provision,

and must give the name and registered office of the body corporate and details of any investigation or proceedings which were or are to be brought, including the nature of the investigation or proceedings, where and approximately when that investigation or those proceedings took place or are to take place, and any outcome.

(3) P or X must consent to a request being made by [F1 NHS England] to any employer or former employer or licensing or regulatory body in the United Kingdom or elsewhere, for information relating to a current investigation, or an investigation where the outcome was adverse.

Marginal Citations

M18 1995 c. 46. Section 302 has been amended by: the Communications Act 2003 (c. 21), Schedule 17, paragraph 133; the Wireless Telegraphy Act 2006 (c. 36), Schedule 7, paragraph 16; the Criminal Proceedings etc. (Reform) (Scotland) Act 2007 (asp 6), section 50(1); and the Criminal Justice and Licensing (Scotland) Act 2010 (asp 13), section 70(3).

M19 1992 c. 5. Section 115A was inserted by the Social Security Administration (Fraud) Act 1997 (c. 47), section 15, and amended by the Social Security Fraud Act 2001 (c. 11) (“the 2001 Act”), section 14. The amendments made by the 2001 Act are to be repealed by, and other amendments to section 115A are to be made by, the Welfare Reform Act 2012 (c. 5), sections 113 to 115, and Schedule 14, Part 1.

Other information to be supplied U.K.

32.—(1) An NHS pharmacist (P) must give notice to [F1 NHS England] within 30 days (or if this is impracticable, as soon as practicable thereafter) of—

(a) any occurrence requiring a change in the information recorded about P in the pharmaceutical list which P has not otherwise notified to [F1 NHS England] in accordance with these Regulations;

(b) if P is an individual, any change to P's private address;

(c) if P is a body corporate, any change to the name, registration number, registered office or telephone number relating to that office of the body corporate; and

(d) any occurrence requiring P's addition to or removal from an EPS list or a change in the information recorded about P in that list.

(2) P must give [F1 NHS England], if it so requests, the name of any pharmacist employed or engaged by P who is responsible for dispensing a particular prescription.

(3) If P is a body corporate, it must give notice to [F1 NHS England] within 30 days (or if this is impracticable, as soon as practicable thereafter) of any changes to—

(a) the names of its directors; and

(b) the name or address of its superintendent.

(4) If P is a body corporate and appoints a superintendent or director who was not listed on P's application for inclusion on a pharmaceutical list, P must, within 30 days of the person's appointment, supply to [F1 NHS England] the information mentioned in paragraph 3 and 4 of Schedule 2 about that person.

(5) If P or a director or superintendent of P (if P is a body corporate) is on, or is a director or superintendent of a body corporate which is on, a relevant list other than a pharmaceutical list held by [F1 NHS England], they must supply in writing to [F1 NHS England]—

(a) in the case of a director or superintendent of a body corporate, the name and registered office of the body corporate on the other relevant list; and

(b) particulars of the other relevant list.

(6) P or the director or superintendent of P (if P is a body corporate) must inform [F1 NHS England] if they, or a body corporate of which they are a director or superintendent, apply to be included in a relevant list of another primary care organisation, and of the outcome of any such application.

[F156 Facilitating remote access to pharmaceutical services U.K.

32A.— (1) An NHS pharmacist (P) must, to the extent reasonable—

(a) facilitate remote access to the pharmaceutical services provided at or from P’s pharmacy premises, where users wish to access those services under arrangements that make those services available using remote access; and

(b) establish, maintain and keep under review procedures to facilitate remote access to those services under arrangements that make those services available using remote access.]

Textual Amendments

F156 Sch. 4 para. 32A inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 18

Co-operation with [F157 NHS England] U.K.

33.  An NHS pharmacist must co-operate with [F157 NHS England] in the discharge by [F157 NHS England] of the duty under section 1F(1) of the 2006 Act M20 (duty as to education and training).

Textual Amendments

F157 Words in Sch. 4 para. 33 substituted (1.4.2023) by The Health Education England (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/368), reg. 1(2), Sch. 2 para. 14(3) (with reg. 7)

Marginal Citations

M20 Section 1F was inserted by the Health and Social Care Act 2012 (c. 7), section 7.

Complaints U.K.

34.—(1) An NHS pharmacist must have in place arrangements, which comply with the requirements of the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 M21 , for the handling and consideration of any complaints.

(2) In this paragraph, “complaint” means a complaint about a matter connected with the provision of pharmaceutical services by the NHS pharmacist.

Marginal Citations

M21 S.I. 2009/309; amended by S.I. 2009/1768.

Inspections and access to information U.K.

35.—(1) An NHS pharmacist (P) must allow persons authorised in writing by [F1 NHS England] to enter and inspect P's pharmacy premises at any reasonable time, for the purposes of—

(a) ascertaining whether or not P is complying with the requirements of this Schedule;

(b) auditing, monitoring and analysing—

(i) the provision made by P, in the course of providing pharmaceutical services, for patient care and treatment, including any arrangement made with a person in respect of provision of appliances, and

(ii) the management by P of the pharmaceutical services P provides,

where the conditions in sub-paragraph (2) are satisfied.

(2) The conditions are that—

(a) reasonable notice of the intended entry has been given;

(b) the Local Pharmaceutical Committee for the area where the pharmacy premises are situated have been invited to be present at the inspection, where this is requested by P;

(c) the person authorised in writing (X) carries written evidence of X's authorisation, which X produces on request; and

(d) X does not enter any part of the premises used solely as residential accommodation without the consent of the resident.

(3) P must, at the request of [F1 NHS England] or of X, allow it or X access to any information which it or X reasonably requires—

(a) for the purposes mentioned in sub-paragraph (1); or

(b) in the case of [F1 NHS England], in connection with its functions that relate to pharmaceutical services.

[F158 (4) P must, at the request of [F1 NHS England], send to [F1 NHS England] by means of an electronic communication of the type specified in the request any information to which a person authorised in writing by [F1 NHS England] would have access during an inspection of P’s pharmacy premises pursuant to sub-paragraph (1), if—

(a) P has that information in a form which means it may be sent by that form of electronic communication; or

(b) it is reasonable for [F1 NHS England] to request that P convert that information into a form which means that it may be sent by that form of electronic communication (and [F1 NHS England] does so request).

(5) P must, at the request of [F1 NHS England] or a person authorised in writing by [F1 NHS England] to make the request, send to [F1 NHS England] or that person by means of an electronic communication, a duly completed questionnaire, which is—

(a) in a format approved by [F1 NHS England]; and

(b) for the purpose of enabling [F1 NHS England], or a person authorised in writing by [F1 NHS England], to determine whether or when it is necessary or expedient for a person authorised in writing by [F1 NHS England] to undertake an inspection of P’s premises pursuant to sub-paragraph (1).

(6) Before information is requested pursuant to sub-paragraph (5), [F1 NHS England] must consult the person who is, for the time being, the person consulted under section 165(1)(a) of the 2006 Act, in respect of pharmaceutical remuneration of NHS pharmacists on the terms of the request.]

Textual Amendments

F158 Sch. 4 para. 35(4)-(6) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 19

Regulation 11(2)(a)(i)

SCHEDULE 5 U.K. Terms of service of NHS appliance contractors

Division of responsibilities between individuals and corporate bodies U.K.

1.—(1) To the extent that this Schedule imposes a requirement on an NHS appliance contractor in respect of an activity which could only, or would normally, be undertaken by a natural person—

(a) if the NHS appliance contractor is a natural person—

(i) that person must comply with that requirement, or

(ii) if the NHS appliance contractor employs or engages other natural persons in connection with the provision of pharmaceutical services, the NHS appliance contractor must either comply with that requirement or secure compliance with that requirement by the other natural persons whom the NHS appliance contractor employs or engages; or

(b) if the NHS appliance contractor is not a natural person, that NHS appliance contractor must secure compliance with that requirement by the natural persons whom the NHS appliance contractor employs or engages in connection with the provision of pharmaceutical services.

(2) Where in this Schedule reference is made to an NHS appliance contractor—

(a) being the subject of any activity, and it is an activity to which a natural person could only, or would normally, be subject; or

(b) forming a view,

that reference is to be construed, as referring, as appropriate to the NHS appliance contractor (if a natural person) or to the NHS appliance contractor's staff.

(3) References in this Schedule to an NHS appliance contractor are to be construed in accordance with sub-paragraphs (1) and (2).

Breaches by directors U.K.

2.  Where this Schedule imposes a requirement on the director of a body corporate that is included in a pharmaceutical list, a breach of that requirement is to be deemed to be a breach by the body corporate of its terms of service.

Dispensing services U.K.

3.  An NHS appliance contractor must, to the extent that paragraphs 4 to 8 require and in the manner described in those paragraphs, provide proper and sufficient appliances to persons presenting prescriptions for appliances ordered by health care professionals in pursuance of their functions in the health service, the Scottish health service or the Northern Ireland health service.

Dispensing of appliances U.K.

4.—(1) In this Part, “ signed” includes signature with a prescriber's advanced electronic signature.

(2) Subject to the following provisions of this Schedule, where—

(a) any person presents to an NHS appliance contractor (C) a non-electronic prescription form which contains—

(i) an order for an appliance, not being a restricted availability appliance, signed by a prescriber, or

(ii) an order for a restricted availability appliance, signed by a prescriber and including the reference “SLS”; F159 ...

(b) C receives [F160 as a nominated dispensing contractor] from the Electronic Prescription Service an electronic prescription form which contains an order of a kind specified in paragraph (a)(i) and (ii) and—

(i) any person requests the provision of an appliance in accordance with that prescription, or

(ii) C has previously arranged with the patient that C will dispense that prescription on receipt[F161 ; or]

[F162 (c) any person—

(i) presents C with an EPS token that relates to an order of a kind specified in paragraph (a)(i) or (ii), and

(ii) requests the provision of an appliance in accordance with the related electronic prescription form,]

C must, with reasonable promptness, provide the appliance so ordered if C supplies it in the normal course of business.

(3) Subject to the following provisions of this Schedule, where—

(a) any person presents to C a non-electronic repeatable prescription which contains—

(i) an order for appliances, not being restricted availability appliances, signed by a prescriber, or

(ii) an order for a restricted availability appliance, signed by a prescriber and including the reference “SLS”,

and also presents an associated batch issue; F163 ...

(b) C receives [F164 as a nominated dispensing contractor] from the Electronic Prescription Service an electronic repeatable prescription which contains an order of a kind specified in paragraph (a)(i) or (ii) and—

(i) any person requests the provision of appliances in accordance with that prescription, or

(ii) C has previously arranged with the patient that the supplier will dispense that prescription on receipt[F165 ; or]

[F166 (c) any person—

(i) presents C with an EPS token that relates to an order of a kind specified in paragraph (a)(i) or (ii), and

(ii) requests the provision of appliances in accordance with the related electronic repeatable prescription,]

C must, with reasonable promptness, provide such of the appliances so ordered as C supplies in the normal course of business.

(4) For the purposes of this paragraph, a non-electronic repeatable prescription for appliances shall be taken to be presented even if the person who wishes to obtain the appliances does not present that prescription, where—

(a) C has that prescription in the supplier's possession; and

(b) that person presents, or C has in C's possession, an associated batch issue.

Textual Amendments

F159 Word in Sch. 5 para. 4(2)(a) omitted (26.11.2018) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(2)(a)(i)

F160 Words in Sch. 5 para. 4(2)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(2)(a)(ii)

F161 Word in Sch. 5 para. 4(2)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(2)(a)(iii)

F162 Sch. 5 para. 4(2)(c) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(2)(a)(iv)

F163 Word in Sch. 5 para. 4(3)(a) omitted (26.11.2018) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(2)(b)(i)

F164 Words in Sch. 5 para. 4(3)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(2)(b)(ii)

F165 Word in Sch. 5 para. 4(3)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(2)(b)(iii)

F166 Sch. 5 para. 4(3)(c) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(2)(b)(iv)

[F167 Supply in accordance with a SSP U.K.

4A.— (1) This sub-paragraph applies where—

(a) any person requests an appliance from an NHS appliance contractor (C) in accordance with a prescription form or repeatable prescription; and

(b) a SSP has effect in respect of—

(i) the requested appliance, or

(ii) appliances of a specified description, and the requested appliance is of that description.

(2) Where sub-paragraph (1) applies, C must consider whether it is reasonable and appropriate to supply in accordance with the SSP instead of in accordance with the prescription form or repeatable prescription.

(3) Where sub-paragraph (1) applies, C may provide a different product or quantity of product to the product or quantity of product ordered on the prescription form or repeatable prescription, where—

(a) C is able to do so with reasonable promptness;

(b) to do so is in accordance with the SSP; and

(c) C is of the opinion that supplying a different product or quantity of product to that ordered by the prescriber is reasonable and appropriate.

(4) Where C, in accordance with sub-paragraph (3), provides a different product or quantity of product to that ordered by the prescriber—

(a) C must endorse the prescription or the associated batch issue accordingly (if the manner for making the endorsement is provided for in the Drug Tariff, in the manner provided for in the Drug Tariff), and the prescription or associated batch issue as thus endorsed is treated as being the prescription for product reimbursement purposes (even though the supply is not in pursuance of that prescription); and

(b) if—

(i) the patient to or for whom the product is provided is on a patient list, and

(ii) the supply is of a type in relation to which the Secretary of State and the person who is, for the time being, the person consulted under section 165(1)(a) of the 2006 Act in respect of pharmaceutical remuneration of NHS appliance contractors, acting jointly, have issued and publicised in such manner as they see fit a recommendation to the effect that, for clinical reasons, in the case of supplies of that type, providers of primary medical services should be notified of a supply to a patient on its patient list that is in accordance with a SSP instead of in accordance with a prescription form or repeatable prescription,

C must notify the provider of primary medical services on whose patient list the patient is of the supply in accordance with a SSP instead of in accordance with a prescription form or repeatable prescription.

(5) Where—

(a) sub-paragraph (1) applies;

(b) C is of the opinion that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate; and

(c) C is able to supply the product or quantity of product ordered by the prescriber within a reasonable timescale but not with reasonable promptness,

the requirements to act with reasonable promptness in paragraph 4(2) and (3) are to be read as requirements to act within a reasonable timescale.]

Textual Amendments

F167 Sch. 5 para. 4A inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 5(2)

Urgent supply without a prescription U.K.

5.—(1) This paragraph applies where, in a case of urgency, a prescriber requests an NHS appliance contractor (C) to provide an appliance.

(2) C may provide the appliance requested before receiving a prescription form or repeatable prescription in respect of that appliance, provided that the prescriber undertakes to—

(a) give C a non-electronic prescription form or non-electronic repeatable prescription in respect of the appliance within 72 hours of the request being made; or

(b) transmit an electronic prescription to the Electronic Prescription Service within 72 hours of the request being made.

Preliminary matters before providing appliances U.K.

6.—(1) If a person specified in sub-paragraph (2) asks an NHS appliance contractor (C) to do so—

(a) C must give an estimate of the time when the appliance will be ready; and

(b) if it is not ready by then, P must give a revised estimate of the time when it will be ready (until it is ready).

(2) A person specified in this sub-paragraph is a person—

(a) presenting a non-electronic prescription form or non-electronic repeatable prescription; or

(b) requesting the provision of appliances in accordance with an electronic prescription form or an electronic repeatable prescription.

(3) Before providing an appliance in accordance with a prescription form or repeatable prescription—

(a) C must ask any person who makes [F168 or duly completes a declaration as or on behalf of the person named on the prescription form or repeatable prescription] that the person named on the prescription form or repeatable prescription does not have to pay the charges specified in regulation 3(1) [F169 or (2)] of the Charges Regulations M22 (supply of drugs and appliances by chemists) by virtue of either—

(i) entitlement to exemption under [F170 regulation 10(1)] of the Charges Regulations M23 (exemptions), or

(ii) entitlement to remission of charges under regulation 5 of the Remission of Charges Regulations M24 (entitlement to full remission and payment),

to produce satisfactory evidence of such entitlement, unless the declaration is in respect of entitlement to exemption by virtue of sub-paragraph (a), (c), (d), (e), (f) or (g) of [F170 regulation 10(1)] of the Charges Regulations or in respect of entitlement to remission by virtue of regulation 5(1)(e) or (2) of the Remission of Charges Regulations, and at the time of the declaration C already has such evidence available to C;

(b) if, in the case of a non-electronic prescription form or non-electronic repeatable prescription, no satisfactory evidence, as required by paragraph (a), is produced to C, C must endorse the form on which the declaration is made to that effect; and

(c) in the case of an electronic prescription form or an electronic repeatable prescription, C must [F171 ensure that the following information is duly entered into the records managed by [F172 NHS England] that are accessible as part of the Electronic Prescription Service (if either it is not already recorded in those records or a check, known as real time exemption check, has not produced satisfactory evidence as mentioned in sub-paragraph (a))]—

(i) in a case where exemption from or remission of charges is claimed, a record of—

(aa) the exemption category specified in [F170 regulation 10(1)] of the Charges Regulations or the ground for remission under regulation 5 of the Remission of Charges Regulations which it is claimed applies to the case; and

(bb) whether or not satisfactory evidence was produced to C as required by sub-paragraph (a), and

(ii) in any case where a charge is due, confirmation that the relevant charge was paid.

[F173 (3A) For the purposes of sub-paragraph (3), satisfactory evidence includes evidence derived from a check, known as a real time exemption check, of electronic records that are managed by the NHS BSA for the purposes (amongst other purposes) of providing advice, assistance and support to patients or their representatives in respect of whether a charge is payable under the Charges Regulations.]

[F174 (3B) Sub-paragraphs (3) and (3A) apply to the provision of an appliance in accordance with a SSP as they apply to the provision of an appliance in accordance with a prescription form or a repeatable prescription (or an associated batch issue), and for these purposes the prescription for product reimbursement purposes, as mentioned in paragraph 4A(4)(a), is treated as being the prescription in accordance with which the appliance is provided (even though the supply is not in pursuance of that prescription).]

Textual Amendments

F168 Words in Sch. 5 para. 6(3)(a) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(3)(a)

F169 Words in Sch. 5 para. 6(3) substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(5)(a)

F170 Words in Sch. 5 para. 6 substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(5)(b)

F171 Words in Sch. 5 para. 6(3)(c) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(3)(b)

F172 Words in Sch. 5 para. 6(3)(c) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 47(4) (with reg. 3)

F173 Sch. 5 para. 6(3A) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(3)(c)

F174 Sch. 5 para. 6(3B) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 5(3)

Marginal Citations

M22 Regulation 3 has been amended by S.I. 2002/2352, 2003/1084, 2004/865, 2005/578, 2008/571, 2009/411, 2010/1727, 2011/518 and 2012/470.

M23 Regulation 7 has been amended by S.I. 2000/3189, 2002/2352, 2004/696, 2005/578 and 2009/29.

M24 Regulation 5 has been amended by S.I. 2004/663 and 936, 2006/562, 2008/1697 and 2009/411.

Providing appliances U.K.

7.—(1) Where an NHS appliance contractor (C) is presented with, or receives from the Electronic Prescription Service, a prescription form or a repeatable prescription, C must only provide the appliances so ordered—

(a) if the prescription form or repeatable prescription is duly signed and completed as described in paragraph 4; and

(b) in accordance with the order on the prescription form or repeatable prescription,

subject to any regulations in force under the Weights and Measures Act 1985 M25 and the following provisions of this Schedule.

(2) If the order is for[F175 , or a product to be provided in accordance with a SSP is,] an appliance of a type requiring measuring and fitting (for example a truss), C must make all necessary arrangements for—

(a) measuring the person named on the prescription form for the appliance; and

(b) fitting the appliance.

(3) If the order is for[F176 , or a product to be provided in accordance with a SSP is,] an appliance included in the Drug Tariff, the British National Formulary (including any Appendix published as part of that Formulary), the Dental Practitioner's Formulary, the European Pharmacopoeia or the British Pharmaceutical Codex, the appliance provided must comply with the standard or formula specified therein.

[F177 (4) Where C provides an appliance under paragraph 4A, C must include with it in a written note, for the patient’s benefit, information to the effect that the product is being supplied in accordance with a SSP, identifying the particular SSP.]

Textual Amendments

F175 Words in Sch. 5 para. 7(2) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 5(4)(a)

F176 Words in Sch. 5 para. 7(3) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 5(4)(b)

F177 Sch. 5 para. 7(4) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 5(4)(c)

Marginal Citations

M25 1985 c. 72.

Refusal to provide appliances ordered U.K.

8.—(1) An NHS appliance contractor (C) may refuse to provide an appliance ordered on a prescription form or repeatable prescription where—

(a) C reasonably believes that it is not a genuine order for the person named on the prescription form or repeatable prescription (for example because C reasonably believes it has been stolen or forged);

(b) it appears to C that there is an error on the prescription form or on the repeatable prescription or, in the case of a non-electronic repeatable prescription, its associated batch issue (including a clinical error made by the prescriber) or that, in the circumstances, providing the appliance would be contrary to C's clinical judgement;

(c) C or other persons on the premises are subjected to or threatened with violence by the person presenting the prescription form or repeatable prescription or requesting the provision of appliances in accordance with an electronic prescription form or repeatable prescription, or by any person accompanying that person

(d) the person presenting the prescription form or requesting the provision of appliances in accordance with an electronic prescription form or repeatable prescription, or any other person accompanying that person, commits or threatens to commit a criminal offence; or

(e) the prescription form or repeatable prescription is incomplete because it does not include information relating to the identification of the prescriber that [F1 NHS England] (or a person exercising its functions) requires in order to perform its functions relating to—

(i) the remuneration of persons providing pharmaceutical services, and

(ii) any apportionment of, or any arrangements for recharging in respect of, that remuneration,

unless C (or the person who employs or engages C) is to receive no pharmaceutical remuneration of any kind in respect of the appliances.

[F178 (1A) C may refuse to provide an appliance ordered on an electronic prescription if the access that C has to the Electronic Prescription Service is not such as to enable C to dispense that prescription promptly (or at all).]

[F179 (1B) C must refuse to provide an appliance ordered on a prescription form or a repeatable prescription where—

(a) a SSP has effect in respect of—

(i) the requested appliance; or

(ii) appliances of a specified description, and the requested appliance is of that description; and

(b) alternative provision has already taken place in accordance with the SSP.

(1C) C may refuse to provide an appliance ordered on a prescription form or a repeatable prescription where—

(a) a SSP has effect in respect of—

(i) the requested appliance, or

(ii) appliances of a specified description, and the requested appliance is of that description;

(b) C is of the opinion that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate; and

(c) C is unable to provide the appliance within a reasonable timescale,

but if C does refuse to do so, C must provide the patient or the person requesting the appliance on behalf of a patient with appropriate advice, as necessary, about reverting to the prescriber for the prescriber to review the patient’s treatment.]

(2) C must refuse to provide appliances ordered on a repeatable prescription where—

(a) C has no record of that prescription (other than on the first occasion on which the prescription is presented);

(b) C does not, in the case of a non-electronic repeatable prescription, have any associated batch issue and it is not presented to the supplier;

(c) it is not signed by a prescriber;

(d) to do so would not be in accordance with any intervals specified in the prescription;

(e) it would be the first time an appliance had been provided pursuant to the prescription and the prescription was signed (whether electronically or otherwise) more than 6 months previously;

(f) the repeatable prescription was signed (whether electronically or otherwise) more than one year previously;

(g) the expiry date on the repeatable prescription has passed; or

(h) C has been informed by the prescriber that the prescription is no longer required.

(3) Where a patient requests the supply of appliances ordered on a repeatable prescription (other than on the first occasion that the request is made), C must only provide the appliance ordered if C is satisfied that—

(a) the patient to whom the prescription relates—

(i) is using and is likely to continue to use the appliance appropriately, and

(ii) is not suffering from any side effects of the treatment which indicate the need or desirability of reviewing the patient's treatment;

(b) the manner of utilisation of the appliance by the patient to whom the prescription relates has not altered in a way which indicates the need or desirability of reviewing the patient's treatment; and

(c) there have been no changes to the health of the patient to whom the prescription relates which indicate the need or desirability of reviewing the patient's treatment.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F178 Sch. 5 para. 8(1A) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(4)

F179 Sch. 5 para. 8(1B)(1C) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 5(5)

Further activities to be carried out in connection with the provision of dispensing services U.K.

9.—(1) In connection with the services provided under paragraph 3, an NHS appliance contractor (C) must—

(a) ensure that appropriate advice is given to patients about any appliances provided to them—

(i) to enable them to utilise the appliances appropriately, and

(ii) to meet the patient's reasonable needs for general information about the appliances;

(b) provide appropriate advice to patients to whom they provide appliances on the safe keeping of the appliances;

(c) when providing appliances to patients in accordance with a prescription form or repeatable prescription—

(i) provide appropriate advice in particular on the importance of only requesting those items which they actually need, and

(ii) for those purposes, have regard to the details contained in the records maintained under paragraph (f) in respect of the provision of appliances and prescribing pattern relating to the patient in question;

(d) provide a patient with a written note of any appliance which is owed, and inform the patient when it is expected that the appliance will become available;

(e) provide a patient with a written note of C's name, address and telephone number;

(f) keep and maintain records—

(i) of appliances provided, in order to facilitate the continued care of the patient,

(ii) in appropriate cases, of advice given and any interventions or referrals made (including clinically significant interventions in cases involving repeatable prescription), and

(iii) of notes provided under paragraph (d);

(g) undertake appropriate training in respect of repeat dispensing having regard to any recommendations in respect of such training set out in the Drug Tariff;

(h) if C takes possession of a non-electronic repeatable prescription or an associated batch issue, securely store that repeatable prescription or associated batch issue;

(i) if C provides an appliance under an electronic prescription, provide the patient, if the patient so requests, with a written record of the appliances ordered on that prescription and, in the case of an electronic repeatable prescription, of the number of occasions on which it can be dispensed;

(j) maintain records of repeatable prescriptions in such a form as to provide a clear audit trail of supplies under the repeatable prescription (including dates and quantities supplied);

(k) destroy any surplus batch issues relating to appliances—

(i) which are not required, or

(ii) where a patient is refused an appliance pursuant to paragraph 8;

(l) ensure that where a person is refused appliances pursuant to paragraph 8(1)(b), (2) or (3), the patient is referred back to the prescriber for further advice;

(m) where a patient is provided with appliances under a repeatable prescription, notify the prescriber of any clinically significant issues arising in connection with the prescription and keep a record of that notification;

(n) notify the prescriber of any refusal to provide appliances pursuant to paragraph 8(4); and

(o) when providing specified appliances, comply with the additional requirements set out in paragraph 11.

(2) Where, on presentation of a prescription form or repeatable prescription in connection with the dispensing of appliances under paragraph 4, C is unable to provide an appliance, or stoma appliance customisation is required and C is unable to provide that, C must—

(a) if the patient consents, refer the prescription form or repeatable prescription to another NHS appliance contractor or to an NHS pharmacist; or

(b) if the patient does not consent to a referral, provide the patient with contact details of at least 2 people who are NHS pharmacists or NHS appliance contractors who are able to provide the appliance or stoma appliance customisation (as the case may be), if these details are known to C.

Additional requirements in relation to electronic prescribing U.K.

10.—(1) An NHS appliance contractor (C) must, if requested to do so by any person—

(a) explain to that person the Electronic Prescription Service, whether or not it is a service which is available through C's appliance contractor premises; and

(b) where the Electronic Prescription Service is not available through C's appliance contractor premises, provide that person with the names of at least 2 NHS appliance contractors through whom the Electronic Prescription Service is available, if these details are known to C.

(2) Where the Electronic Prescription Service is available through C's appliance contractor premises, C must, if requested to do so by any person, enter in that person's PDS patient details—

(a) where the person does not have a nominated dispensing contractor, [F180 a nominated dispensing contractor]; or

(b) where the person does have a nominated dispensing contractor—

(i) a replacement dispensing contractor, or

(ii) a further dispensing contractor,

chosen by that person.

(3) Sub-paragraph (2)(b)(ii) does not apply if the number of nominated dispensing contractors would thereby exceed the maximum number permitted by the Electronic Prescription Service.

(4) Regulation 116(a) to (c) applies to a request under this paragraph as it applies to an application to an NHS chemist for pharmaceutical services.

(5) If C is a nominated dispensing contractor for a person (X) but the nomination was made before C became the person listed in a pharmaceutical list in relation to the appliance contractor premises nominated in X's PDS patient details, C must within 6 months of C becoming the person so listed—

(a) explain to X that the ownership of the appliance contractor premises has changed; and

(b) ask X whether X wishes to maintain the nomination in respect of those appliance contractor premises.

[F181 (6) If C dispenses an electronic prescription or makes an urgent supply without a prescription, C must send the form duly completed by or on behalf of the patient, if one is required under regulation 3(3)(b), (5C) or (5E) of the Charges Regulations in respect of that prescription (which may be the associated EPS token), to the NHS BSA.]

Textual Amendments

F180 Words in Sch. 5 para. 10(2)(a) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(5)(a)

F181 Sch. 5 para. 10(6) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(5)(b)

Additional requirements in relation to specified appliances U.K.

11.—(1) This paragraph sets out the additional requirements referred to in paragraph 9(1)(o) relating to the provision of specified appliances.

(2) An NHS appliance contractor (C) who dispenses specified appliances in the normal course of business must provide a home delivery service in respect of those appliances and, as part of that service—

(a) C must offer to deliver the specified appliance to the patient's home;

(b) if the patient accepts that offer, the delivery must be made with reasonable promptness and at such time as is agreed with the patient;

(c) the specified appliance must be delivered in a package which displays no writing or other markings which could indicate its content; and

(d) the manner of delivery of the package and any supplementary items required by sub-paragraph (3) must not convey the type of appliance being delivered.

(3) In any case where a specified appliance is provided (whether by home delivery or otherwise), C must provide a reasonable supply of appropriate supplementary items (such as disposable wipes and disposal bags) and—

(a) must ensure that the patient may, if the patient wishes, consult a person to obtain expert clinical advice regarding the appliance; or

(b) if C believes it is appropriate to do so, must—

(i) refer the patient to a prescriber; or

(ii) offer the patient an appliance use review service.

(4) If C is unable to provide an appliance use review service in accordance with sub-paragraph (3)(b)(ii), C must give the patient the contact details of at least 2 people who are NHS pharmacists or NHS appliance contractors who are able to arrange for the service to be provided, if these details are known to C.

(5) Where C provides a telephone care line in respect of the dispensing of any specified appliance, C must ensure that during out of hours periods—

(a) advice is made available to patients through that telephone care line; or

(b) [F182 telephone or website contact details for providers of NHS services that may be consulted for advice regarding specified appliances during those periods], are made available to patients through the telephone care line.

(6) For the purposes of this paragraph—

“expert clinical advice”, in relation to a specified appliance, means advice which is given by a person who is suitably trained and who has relevant experience in respect of the appliance;

“out of hours periods”, in relation to the appliance contractor premises, means the periods outside the core opening hours and any supplementary opening hours of the premises.

Textual Amendments

F182 Words in Sch. 5 para. 11(5)(b) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 19

Signposting U.K.

12.—(1) Where, on presentation of a prescription form or repeatable prescription, an NHS appliance contractor (C) is unable to provide an appliance or stoma appliance customisation because the provision of the appliance or customisation is not within C's normal course of business, C must—

(a) if the patient consents, refer the prescription form or repeatable prescription to another NHS appliance contractor or to an NHS pharmacist; and

(b) if the patient does not consent to a referral, provide the patient with contact details of at least 2 people who are NHS pharmacists or NHS appliance contractors who are able to provide the appliance or stoma appliance customisation (as the case may be), if these details are known to C.

(2) C must, in appropriate cases, keep and maintain a record of any information given or referral made under sub-paragraph (1) and that record must be in a form that facilitates—

(a) auditing of the provision of pharmaceutical services by C; and

(b) follow-up care for the person who has been given the information or in respect of whom the referral has been made.

Opening hours: general U.K.

13.—(1) An NHS appliance contractor (C) must ensure that pharmaceutical services are provided at C's appliance contractor premises—

(a) for not less than 30 hours each week;

(b) for not less than 100 hours per week, in the case of which a 100 hours condition (originally imposed under the 2005 Regulations) applies;

(c) if [F1 NHS England] or a Primary Care Trust, or on appeal the Secretary of State, has directed that pharmaceutical services are to be provided at the premises for fewer than 30 hours per week, provided that the person listed in relation to them provides those services at set times and on set days, at the times and on the days so set;

(d) if a Primary Care Trust, or on appeal the Secretary of State, has (under previous Regulations) directed that pharmaceutical services are to be provided at the premises for more than 30 hours per week, and at set times and on set days, at the times and on the days so set; or

(e) if [F1 NHS England] or a Primary Care Trust, or on appeal the Secretary of State, has directed that pharmaceutical services are to be provided at the premises for more than 30 hours each week, but only on set times and on set days as regards the additional opening hours—

(i) for the total number of hours each week required by virtue of that direction, and

(ii) as regards the additional opening hours for which the person listed in relation to the premises is required to provide pharmaceutical services by virtue of that direction, at the days on which and times at which that person is required to provide pharmaceutical services during those additional opening hours, as set out in that direction,

but [F1 NHS England] may, in appropriate circumstances, agree a temporary suspension of services for a set period, where it has received 3 months notice of the proposed suspension.

(2) The hours during which appliance contractor premises must be open by virtue of sub-paragraph (1) are referred to in these Regulations as “core opening hours”.

(3) C must exhibit a notice specifying the days on which and times at which the appliance contractor premises are open for the provision of appliances.

(4) C must, on request, submit a return to [F1 NHS England] setting out—

(a) the days on which and times at which pharmaceutical services are provided at C's appliance contractor premises (including times at which C is providing pharmaceutical services when C is not obliged to do so by virtue of sub-paragraph (1), which are referred to in these Regulations as “supplementary opening hours”); and

(b) the pharmaceutical services which C ordinarily provides at those premises.

(5) Where C changes—

(a) the supplementary opening hours of C's appliance contractor premises; or

(b) the pharmaceutical services which C is ordinarily to provide at those premises,

C must supply [F1 NHS England] with a return informing it of the change.

(6) Where C has notified to [F1 NHS England] (or, before the appointed day, a Primary Care Trust) the days on which and the times at which pharmaceutical services are to be provided at C's appliance contractor premises (for example, in a return under sub-paragraph (4) or (5) or in an application for inclusion in a pharmaceutical list)—

(a) C must ensure that pharmaceutical services are provided at the premises to which the notification relates on the days and at the time set out in that notification (unless the notification has been superseded by a return, or further return, under sub-paragraph (5)); and

(b) C must not change—

(i) the days on which or the times at which pharmaceutical services are to be provided at those premises during core opening hours that are neither additional opening hours nor in total less than 30 (but if those core opening hours are additional opening hours, or are in total less than 30, regulation 65(5) to (7) and paragraphs 15 and 16 apply,

(ii) the total number of any supplementary opening hours (regulation 65(5) to (7) and paragraphs 15 and 16 apply to changes to the total number of core opening hours),

(iii) the days on which or the times at which pharmaceutical services are to be provided at those premises during supplementary opening hours, or

(iv) the pharmaceutical services which P is ordinarily to provide at those premises,

for a period of at least 3 months after that notification was received by [F1 NHS England] (or, before the appointed day, a Primary Care Trust), unless [F1 NHS England] agrees otherwise.

(7) Subject to sub-paragraph (8), where C is prevented by illness or other reasonable cause from complying with C's obligations under sub-paragraph (1), C must, where practicable, make arrangements with one or more NHS appliance contractors, NHS pharmacists or LPS chemists whose premises are situated in the same area for the provision of pharmaceutical services or local pharmaceutical services during that time.

(8) C may only make an arrangement with an LPS chemist under sub-paragraph (7) where that LPS chemist provides local pharmaceutical services which are of a similar description as, and a similar extent to, the pharmaceutical services which C ordinarily provides.

(9) Where there is a temporary suspension in the provision of pharmaceutical services by C for a reason beyond the control of C, C is not in breach of sub-paragraphs (1) and (6), provided that—

(a) C notifies [F1 NHS England] of that suspension as soon as practical; and

(b) C uses all reasonable endeavours to resume provision of pharmaceutical services as soon as is practicable.

(10) Planned refurbishment of appliance contractor premises is neither a “reasonable cause” for the purposes of sub-paragraph (7) nor a “reason beyond the control of C” for the purposes of sub-paragraph (9).

(11) For the purposes of calculating the number of hours that premises are open during a week that includes Christmas Day, Good Friday, Easter Sunday or a bank holiday, it is to be deemed that the premises were open on that day at the times at which they would ordinarily have been open on that day of the week.

(12) In this Schedule, the “additional opening hours”, when they are required, are those hours during which C would not be providing pharmaceutical services, were C subject to the condition set out in sub-paragraph (1)(a) and not the condition set out in sub-paragraph (1)(e).

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Matters to be considered when issuing directions in respect of core opening hours U.K.

14.—(1) Where [F1 NHS England] issues a direction setting any days or times under this Schedule, it must in doing so seek to ensure that the hours at which premises are open for the provision of pharmaceutical services are such as to ensure that pharmaceutical services are provided on such days and at such times as are necessary to meet the needs of people in its area, or other likely users of the premises, for pharmaceutical services.

(2) In considering the matters mentioned in sub-paragraph (1), [F1 NHS England]—

(a) must treat any local pharmaceutical services being provided in its area at the days and times in question as if they were pharmaceutical services being so provided; and

(b) may have regard to any pharmaceutical services that are being provided in its area in circumstances where the person providing the services is not obliged to provide those services.

(3) [F1 NHS England] may only direct that an NHS appliance contractor (C) may provide pharmaceutical services at appliance contractor premises for less than 30 hours in any week if it is satisfied that the arrangements for the supply of appliances in its area are likely to be adequate to meet the need for such services at times when C is not providing pharmaceutical services.

(4) Except in the case of premises that have (at any time) been subject to a direction under regulation 65 or regulation 65 of the 2012 Regulations (core opening hours conditions), [F1 NHS England] may only direct that C must provide pharmaceutical services at premises for more than 30 hours in any week if it is satisfied that C is to receive reasonable remuneration in respect of the additional opening hours for which C is required to provide pharmaceutical services (and any additional remuneration payable in accordance with a determination made as mentioned in regulation 91(6) in respect of those hours is “reasonable remuneration” for these purposes).

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Determination of core opening hours instigated by [F1 NHS England] U.K.

15.—(1) Where it appears to [F1 NHS England], after consultation with or having considered the matter at the request of the Local Pharmaceutical Committee for the area in which the premises are situated, that the days on which or times at which appliance contractor premises are or are to be open for the provision of pharmaceutical services will not, or no longer, meet the needs of—

(a) people in its area; or

(b) other likely users of the appliance contractor premises,

for the pharmaceutical services available at or from those premises, it must carry out an assessment as to whether to issue a direction requiring the NHS appliance contractor (C) to provide pharmaceutical services at the premises at set times and on set days (which may include Christmas Day, Good Friday and bank holidays).

(2) Before concluding the assessment under sub-paragraph (1) [F1 NHS England] must—

(a) give notice to C of any proposed changes to the days on which or times at which the appliance contractor premises are to be open; and

(b) allow C 30 days within which to make written representations to [F1 NHS England] about the proposed changes.

(3) After considering any representations made in accordance with sub-paragraph (2)(b), [F1 NHS England] must—

(a) issue a direction (which replaces any existing direction) which meets the requirements of sub-paragraphs (4) and (5);

(b) confirm any existing direction in respect of the times at which C must provide pharmaceutical services at the appliance contractor premises, provided that the existing direction (whether issued under regulation 65, this Schedule, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations) would meet the requirements of sub-paragraphs (4) and (5);

(c) either—

(i) revoke (without replacing it) any existing direction in respect of the times at which C must provide pharmaceutical services at the premises (whether issued under regulation 65, this Schedule, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations), or

(ii) in a case where there is no existing direction, issue no direction,

in which case, by virtue of whichever of paragraph 13(1)(a) or (b) applies, the appliance contractor premises will need to be open for not less than 30 hours each week or not less than 100 hours each week.

(4) Where [F1 NHS England] issues a direction under sub-paragraph (3) in respect of appliance contractor premises that are to be required to be open—

(a) for more than 30 hours each week, it must set out in that direction—

(i) the total number of hours each week for which C must provide pharmaceutical services at the premises, and

(ii) as regards the additional opening hours for which C is to provide pharmaceutical services, the days on which and the times at which C is required to provide those services during those additional opening hours,

but it must not set out in that direction the days on which or times at which C is to provide pharmaceutical services during hours which are not additional opening hours; or

(b) for less than 30 hours each week, it must set out in that direction the days on which and times at which pharmaceutical services are to be provided at those premises.

(5) [F1 NHS England] must not issue a direction under sub-paragraph (3) that has the effect simply of requiring premises to be open for 30 hours each week on set days and at set times (that is, the direction must have the effect of requiring premises to be open for either more or less than 30 hours each week).

(6) [F1 NHS England] must notify C in writing of any direction issued or any other action taken under sub-paragraph (3), and where it sets new days on which or times at which the NHS appliance contractor is to provide pharmaceutical services at the premises, it must include with the notification a statement of—

(a) the reasons for the change; and

(b) C's right of appeal under paragraph (7).

(7) C may, within 30 days of receiving notification under sub-paragraph (6), appeal in writing to the Secretary of State against any direction issued or any other action taken under sub-paragraph (3) which sets new days on which or times at which C is to provide pharmaceutical services.

(8) The Secretary of State may, when determining an appeal, either confirm the action taken by [F1 NHS England] or take any action that [F1 NHS England] could have taken under paragraph (3).

(9) The Secretary of State must notify C of the determination and must in every case include with the notification a statement of the reasons for the determination.

(10) If the days on which or times at which C is to provide pharmaceutical services at appliance contractor premises have been changed in accordance with this paragraph, C must introduce the changes—

(a) if C has not appealed under sub-paragraph (7), not later than 8 weeks after the date on which C receives notification under sub-paragraph (6); or

(b) if C has appealed under sub-paragraph (7), not later than 8 weeks after the date on which C receives notification under sub-paragraph (9).

(11) This paragraph does not apply where regulation 65(5) to (7) applies.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Determination of core opening hours instigated by the NHS appliance contractor U.K.

16.—(1) An NHS appliance contractor (C) may apply to [F1 NHS England] for it to change the days on which or times at which C is obliged to provide pharmaceutical services at C's premises, in a way that—

(a) reduces the total number of hours for which C is obliged to provide pharmaceutical services each week (but not any of those required under a 100 hours condition); or

(b) keeps that total number of hours the same.

(2) Where C makes an application under sub-paragraph (1), as part of that application C must provide [F1 NHS England] with such information as [F1 NHS England] may reasonably request in respect of any changes to the needs of the people in its area, or other likely users of the premises, for pharmaceutical services that are material to the application.

(3) [F1 NHS England] must determine an application under sub-paragraph (1) within 60 days of receiving it (including any information required of C in accordance with sub-paragraph (2)).

(4) In determining the application, [F1 NHS England] must—

(a) issue a direction (which replaces any existing direction) which meets the requirements of sub-paragraphs (5) and (6) and which has the effect of either granting the application under this paragraph or granting it only in part;

(b) confirm any existing direction in respect of the times at which C must provide pharmaceutical services at the premises, provided that the existing direction (whether issued under regulation 65, this Schedule, the 2005 Regulations or the 1992 Regulations) would meet the requirements of sub-paragraphs (5) and (6); or

(c) either—

(i) revoke (without replacing it) any existing direction in respect of the times at which C must provide pharmaceutical services at the premises (whether issued under regulation 65, this Schedule, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations), where this has the effect of granting the application under this paragraph or granting it only in part, or

(ii) in a case where there is no existing direction, issue no direction,

in which case, by virtue of whichever of paragraph 13(1)(a) or (b) applies, the appliance contractor premises will need to be open for not less than 30 hours each week or not less than 100 hours each week.

(5) Where [F1 NHS England] issues a direction under sub-paragraph (4) in respect of appliance contractor premises that are to be required to be open—

(a) for more than 30 hours each week, it must set out in that direction—

(i) the total number of hours each week for which C must provide pharmaceutical services at the premises, and

(ii) as regards the additional opening hours for which C is to provide pharmaceutical services, the days on which and the times at which C is required to provide those services during those additional opening hours,

but it must not set out in that direction the days on which or times at which C is to provide pharmaceutical services during hours which are not additional opening hours; or

(b) for less than 30 hours each week, it must set out in that direction the days on which and times at which pharmaceutical services are to be provided at those premises.

(6) [F1 NHS England] must not issue a direction under sub-paragraph (4) that has the effect simply of requiring appliance contractor premises to be open for 30 hours each week on set days and at set times (that is, the direction must have the effect of requiring appliance contractor premises to be open for either more or less than 30 hours each week).

(7) Where [F1 NHS England] is considering taking action under sub-paragraph (4)(a) or (c)(i), it must consult the Local Pharmaceutical Committee for the area where the premises are situated before determining the application.

(8) [F1 NHS England] must notify C of any direction issued or any other action taken under sub-paragraph (4), and where this has the effect of refusing an application under this paragraph or granting it in part, it must send C a statement setting out—

(a) the reasons for the refusal or, as the case may be, for granting the application only in part; and

(b) C's right of appeal under sub-paragraph (9).

(9) C may, within 30 days of receiving a notification pursuant to sub-paragraph (8), appeal in writing to the Secretary of State against any action under sub-paragraph (4) which has the effect of refusing an application under this paragraph or granting it only in part.

(10) The Secretary of State may, when determining an appeal, either confirm the action taken by [F1 NHS England] or take any action that [F1 NHS England] could have taken under sub-paragraph (4).

(11) The Secretary of State must notify C of the determination and must in every case include with the notification a statement of the reasons for the determination.

(12) If the days on which or times at which C is to provide pharmaceutical services at appliance contractor premises have been changed in accordance with this paragraph, C must introduce the changes—

(a) if C has not appealed under sub-paragraph (9), not earlier than 30 days after the date on which C receives notification under sub-paragraph (4); or

(b) if C has appealed under sub-paragraph (9), not earlier than 30 days after the date on which C receives notification under sub-paragraph (11).

(13) This paragraph does not apply where regulation 65(5) to (7) applies.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Temporary open hours and closures during an emergency requiring the flexible provision of pharmaceutical services U.K.

17.—(1) Notwithstanding the provisions of paragraphs 13 to 16, during an emergency requiring the flexible provision of pharmaceutical services, [F1 NHS England] may, on application from an NHS appliance contractor (C), permit C a temporary change to the days on which or times at which C is obliged to provide pharmaceutical services at appliance contractor premises, or permit temporary closure of those premises, if—

(a) C gives at least 24 hours notice of the change or closure; and

(b) the reasons given by C for the request are, in the opinion of [F1 NHS England], adequate reasons.

(2) [F1 NHS England] need not approve the request in advance of the change or closure, but if it does not do so and decides subsequently that C's reasons are not, in its opinion, adequate reasons, then the days on which or times at which C is obliged to provide pharmaceutical services at the premises are to revert to the overridden days and times, from the day after the date on which that decision is given to C.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Clinical governance U.K.

18.—(1) An NHS appliance contractor (C) must, in connection with the pharmaceutical services provided by C, participate, in the manner reasonably required by [F1 NHS England], in an acceptable system of clinical governance.

(2) For these purposes a system of clinical governance is “acceptable” if it is considered acceptable by [F1 NHS England] and comprises the following components—

(a) a patient and public involvement programme, which includes—

(i) a requirement that C produces in an approved manner a practice leaflet containing approved particulars in respect of each of the premises from which the supplier provides pharmaceutical services,

(ii) a requirement that C publicises the NHS services that are available at or from C's appliance contractor premises,

(iii) a requirement that C undertakes an approved patient satisfaction survey annually, in an approved manner,

(iv) C's monitoring arrangements in respect of appliances owed to patients but which are out of stock,

(v) an approved complaints system (which meets the requirements of paragraph 24),

(vi) a requirement that C co-operates appropriately with visits by an authorised representative of any relevant Local Healthwatch organisation and takes appropriate action following the outcome of such visits,

(vii) a requirement that C co-operates appropriately with any reasonable inspection or review that [F1 NHS England] or any relevant statutory authority wishes to undertake, and

(viii) C's monitoring arrangements in respect of C's compliance with the Equality Act 2010 M26 ;

(b) a clinical audit programme (normally of 5 days) twice in each financial year;

(c) a risk management programme, which includes—

(i) arrangements for ensuring that all stock is procured and handled in an appropriate way,

(ii) arrangements for ensuring that all equipment used in the provision of pharmaceutical services is maintained appropriately,

(iii) an approved incident reporting system, together with arrangements for analysing and responding to critical incidents,

(iv) appropriate standard operating procedures, including standard operating procedures in respect of dispensing appliances, repeatable prescriptions and providing advice and support to people caring for themselves or their families,

(v) appropriate waste disposal arrangements for clinical and confidential waste,

(vi) identifying a clinical governance lead person in respect of each of C's appliance contractor premises,

(vii) C's monitoring arrangements of C's compliance with the Health and Safety at Work etc. Act 1974 M27 ;

(d) a clinical effectiveness programme, which includes arrangements for ensuring that appropriate advice is given by C—

(i) in respect of the provision of appliances in accordance with a prescription form or repeatable prescription, or

(ii) to people caring for themselves or their families,

and arrangements for ensuring that C, when giving advice to any patient on a matter mentioned in paragraph (d)(i), has regard to the details contained in the records maintained under paragraph 9(1)(f) in respect of the provision of appliances and prescribing pattern relating to the patient in question;

(e) a staffing and staff management programme, which includes—

(i) arrangements for appropriate induction for staff (including locums),

(ii) appropriate training for all staff in respect of any role they are asked to perform,

(iii) arrangements for the checking of qualifications and references of all staff engaged in the provision of NHS services,

(iv) arrangements for identifying and supporting the development needs of all staff engaged in the provision of NHS services, including continuing professional development for registered pharmacists, registered nurses and registered pharmacy technicians and any necessary accreditation in respect of the provision of directed services, and

(v) arrangements for addressing poor performance (in conjunction with [F1 NHS England] as appropriate); and

(f) an information governance programme, which provides for—

(i) compliance with approved procedures for information management and security, and

(ii) submission of an annual self assessment of compliance (to an approved level) with those procedures via approved data submission arrangements which allow [F1 NHS England] to access that assessment.

(3) For the purposes of sub-paragraph (2), “approved” means approved by [F1 NHS England].

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Marginal Citations

M26 2010 c. 15.

M27 1974 c. 37.

Professional Standards U.K.

19.  An NHS appliance contractor must provide pharmaceutical services and exercise any professional judgment in connection with the provision of such services in conformity with the standards generally accepted in the pharmaceutical profession.

Inducements etc. U.K.

20.—(1) An NHS appliance contractor (C) (including C's staff) must not give, promise or offer to any person any gift or reward (whether by way of a share of or dividend on the profits of the business or by way of discount or rebate or otherwise) as an inducement to or in consideration of a person (X)—

(a) presenting an order for appliances on a prescription form or repeatable prescription; or

(b) nominating C as X's dispensing contractor (or one of them) in X's PDS patient details.

(2) Promising, offering or providing a home delivery service is not a gift or reward for the purposes of sub-paragraph (1).

(3) C (including C's staff) must not accept or receive any gift or reward in respect of only—

(a) providing contact details of alternative NHS pharmacists or NHS appliance contractors pursuant to paragraph 9(2)(b), 11(4) or 12(1)(b); or

(b) referring a prescription form or repeatable prescription to another NHS appliance contractor or NHS pharmacist pursuant to paragraph 9(2)(a) or 12(1)(a) and providing no additional service in connection with the item on that prescription.

Duty to provide information about fitness matters as they arise U.K.

21.—(1) An NHS appliance contractor (C) and, where C is a body corporate every director of C must, within 7 days of its occurrence, inform [F1 NHS England] in writing if they—

(a) are convicted of any criminal offence in the United Kingdom;

(b) are bound over following a criminal conviction in the United Kingdom;

(c) accept a police caution in the United Kingdom;

(d) have, in summary proceedings in Scotland in respect of an offence, been the subject of an order discharging them absolutely (without proceeding to conviction);

(e) have accepted and agreed to pay either a procurator fiscal fine under section 302 of the Criminal Procedure (Scotland) Act 1995 M28 (fixed penalty: conditional offer by procurator fiscal) or a penalty under section 115A of the Social Security Administration Act 1992 M29 (penalty as alternative to prosecution);

(f) have been convicted of an offence elsewhere than in the United Kingdom where the originating events, if they took place in England, could lead to a criminal conviction in England;

(g) are charged in the United Kingdom with a criminal offence, or are charged elsewhere than in the United Kingdom with an offence where the originating events, if they took place in England, could lead to a criminal conviction in England;

(h) are notified by any licensing, regulatory or other body of the outcome of any investigation into their professional conduct, and there is a finding against them;

(i) become the subject of any investigation into their professional conduct by any licensing, regulatory or other body;

(j) become subject to an investigation into their professional conduct in respect of any current or previous employment, or are notified of the outcome of any such investigation and any finding against them;

(k) become the subject of any investigation by NHS BSA in relation to fraud;

(l) become the subject of any investigation by another primary care organisation, which might lead to their removal from a relevant list; or

(m) are removed, contingently removed or suspended from, refused inclusion in or conditionally included in any relevant list for a reason relating to unsuitability, fraud or efficiency of service provision,

and must give details of any investigation or proceedings which were or are to be brought, including the nature of the investigation or proceedings, where and approximately when that investigation or those proceedings took place or are to take place, and any outcome.

(2) If a person to whom paragraph (1) applies (X) is, or was at the time of the originating events, a director of a body corporate, X must in addition inform [F1 NHS England] within 7 days if any such body corporate—

(a) is convicted of any criminal offence in the United Kingdom;

(b) is convicted of an offence elsewhere than in the United Kingdom where the originating events, if they took place in England, could lead to a criminal conviction in England;

(c) is charged in the United Kingdom with a criminal offence, or is charged elsewhere than in the United Kingdom with an offence where the originating events, if they took place in England, could lead to a criminal conviction in England;

(d) is notified by any licensing, regulatory or other body of the outcome of any investigation into its provision of professional services, and there is a finding against the body corporate;

(e) becomes the subject of any investigation into its provision of professional services by any licensing, regulatory or other body;

(f) becomes the subject of any investigation by the NHS BSA in relation to any fraud or is notified of the outcome of such an investigation where it is adverse;

(g) becomes the subject of any investigation by another primary care organisation which might lead to its removal from any relevant list; or

(h) is removed, contingently removed or suspended from, refused inclusion in or conditionally included in any relevant list for a reason relating to unsuitability, fraud or efficiency of service provision,

and X must give the name and registered office of the body corporate and details of any investigation or proceedings which were or are to be brought, including the nature of the investigation or proceedings, where and approximately when that investigation or those proceedings took place or are to take place, and any outcome.

(3) C or X must consent to a request being made by [F1 NHS England] to any employer or former employer or licensing or regulatory body in the United Kingdom or elsewhere, for information relating to a current investigation, or an investigation where the outcome was adverse.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Marginal Citations

M28 1995 c. 46. Section 302 has been amended by: the Communications Act 2003 (c. 21), Schedule 17, paragraph 133; the Wireless Telegraphy Act 2006 (c. 36), Schedule 7, paragraph 16; the Criminal Proceedings etc. (Reform) (Scotland) Act 2007 (asp 6), section 50(1); and the Criminal Justice and Licensing (Scotland) Act 2010 (asp 13), section 70(3).

M29 1992 c. 5. Section 115A was inserted by the Social Security Administration (Fraud) Act 1997 (c. 47), section 15, and amended by the Social Security Fraud Act 2001 (c. 11) (“the 2001 Act”), section 14. The amendments made by the 2001 Act are to be repealed by, and other amendments to section 115A are to be made by, the Welfare Reform Act 2012 (c. 5), sections 113 to 115, and Schedule 14, Part 1.

Other information to be supplied U.K.

22.—(1) An NHS appliance contractor (C) must give notice to [F1 NHS England] within 30 days (or if this is impracticable, as soon as practicable thereafter) of—

(a) any occurrence requiring a change in the information recorded about C in the pharmaceutical list which C has not otherwise notified to [F1 NHS England] in accordance with these Regulations;

(b) if C is an individual, any change of C's private address;

(c) if C is a body corporate, any change to the name, registered number, registered office, telephone number relating to that office of the body corporate; and

(d) any occurrence requiring C's addition to or removal from the EPS list or a change in the information recorded about C in that list.

(2) C must give [F1 NHS England], if it so requests, the name of any pharmacist employed or engaged by C who is responsible for dispensing a particular prescription.

(3) If C is a body corporate, it must give notice to [F1 NHS England] within 30 days (or if this in impracticable, as soon as practicable thereafter) of any changes to the names and addresses of each of its directors.

(4) If C is a body corporate and appoints a director who was not listed on C's application for inclusion on a pharmaceutical list, C must, within 30 days of the person's appointment, supply to [F1 NHS England] the information mentioned in paragraphs 3 and 4 of Schedule 2 about that person.

(5) If C or a director of C (if C is a body corporate) is on, or is a director of a body corporate which is on, a relevant list other than a pharmaceutical list held by [F1 NHS England], they must supply in writing to [F1 NHS England]—

(a) in the case of a director of a body corporate, the name and registered office of the body corporate on the other relevant list; and

(b) particulars of the other relevant list.

(6) C or a director C (if C is a body corporate) must inform [F1 NHS England] if they, or a body corporate of which they are a director, apply to be included in a relevant list other than a pharmaceutical list held by [F1 NHS England], and of the outcome of any such application.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Co-operation with [F183 NHS England] U.K.

23.  An NHS appliance contractor must co-operate with [F183 NHS England] in the discharge by [F183 NHS England] of the duty under section 1F(1) of the 2006 Act M30 (duty as to education and training).

Textual Amendments

F183 Words in Sch. 5 para. 23 substituted (1.4.2023) by The Health Education England (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/368), reg. 1(2), Sch. 2 para. 14(4) (with reg. 7)

Marginal Citations

M30 Section 1F was inserted by the Health and Social Care Act 2012 (c. 7), section 7.

Complaints U.K.

24.—(1) An NHS appliance contractor must have in place arrangements, which comply with the requirements of the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 M31 , for the handling and consideration of any complaints.

(2) In this paragraph, “complaint” means a complaint about a matter connected with the provision of pharmaceutical services by the NHS appliance contractor.

Marginal Citations

M31 S.I. 2009/309; amended by S.I. 2009/1768.

Inspections and access to information U.K.

25.—(1) An NHS appliance contractor (C) must allow persons authorised in writing by [F1 NHS England] to enter and inspect any premises C uses for the provision of pharmaceutical services at any reasonable time, for the purposes of—

(a) ascertaining whether or not C is complying with the requirements of this Schedule;

(b) auditing, monitoring and analysing—

(i) the provision made by C, in the course of providing pharmaceutical services, for patient care and treatment, including any arrangement made with a person in respect of provision of appliances, and

(ii) the management by C of the pharmaceutical services C provides,

where the conditions in sub-paragraph (2) are satisfied.

(2) The conditions are that—

(a) reasonable notice of the intended entry has been given;

(b) the Local Pharmaceutical Committee for the area where the premises are situated have been invited to be present at the inspection, where this is requested by C;

(c) the person authorised in writing (X) carries written evidence of X's authorisation, which X produces on request; and

(d) X does not enter any part of the premises used solely as residential accommodation without the consent of the resident.

(3) C must, at the request of [F1 NHS England] or of X, allow it or X access to any information which it or X reasonably requires—

(a) for the purposes mentioned in sub-paragraph (1); or

(b) in the case of [F1 NHS England], in connection with its functions that relate to pharmaceutical services.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Regulation 47(1)(a)(i)

SCHEDULE 6 U.K. Terms of service of dispensing doctors

Persons duly authorised to dispense on behalf of dispensing doctors U.K.

1.—(1) Where this Schedule imposes a requirement on a dispensing doctor in respect of an activity which the dispensing doctor has duly authorised another person to undertake, if that other person undertakes that activity instead of the dispensing doctor—

(a) that other person must comply with that requirement; and

(b) the dispensing doctor must secure compliance with that requirement by that other person.

(2) Where reference is made in this Schedule to a dispensing doctor—

(a) being the subject of an activity, and in fact a person duly authorised by the dispensing doctor is the subject of that activity; or

(b) forming a view, and in fact a person duly authorised by the dispensing doctor is to form that view,

that reference is to be construed as referring, as appropriate, to that duly authorised person.

(3) References in this Schedule to a dispensing doctor are to be construed in accordance with sub-paragraphs (1) and (2).

Dispensing of drugs and appliances ordered by another prescriber U.K.

2.—(1) In this paragraph, “ signed” includes signature with a prescriber's advanced electronic signature.

(2) Subject to the following provisions of this Schedule, where—

(a) any person presents to a dispensing doctor (D) a non-electronic prescription form which contains—

(i) an order for drugs, not being Scheduled drugs, or for appliances, not being restricted availability appliances, signed by a prescriber other than D,

(ii) an order for drugs specified in Schedule 2 to the Prescription of Drugs Regulations M32 (drugs, medicines and other substances that may be ordered only in certain circumstances), signed by a prescriber other than D, and including the reference “SLS”, or

(iii) an order for restricted availability appliances, signed by a prescriber other than D and including the reference “SLS”; F184 ...

(b) subject to sub-paragraph (4), D receives [F185 as a nominated dispensing contractor] from the Electronic Prescription Service an electronic prescription form which contains an order of a kind specified in paragraph (a)(i) to (iii) and—

(i) any person requests the provision of drugs or appliances in accordance with that prescription, or

(ii) D has previously arranged with the patient that D will dispense that prescription on receipt[F186 ; or]

[F187 (c) any person—

(i) presents D with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iii), and

(ii) requests the provision of drugs or appliances in accordance with the related electronic prescription form,]

and D is authorised or required by virtue of Part 8 to provide the drugs or appliances so ordered, D must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as D supplies in the normal course of business.

(3) Subject to the following provisions of this Schedule, where—

(a) any person presents to D a non-electronic repeatable prescription which contains—

(i) an order for drugs, not being Scheduled drugs or controlled drugs within the meaning of the Misuse of Drugs Act 1971 M33 , other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 M34 (which relate to controlled drugs excepted from certain prohibitions under the Regulations), signed by a prescriber other than D,

(ii) an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations, not being a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001, signed by a prescriber other than D and including the reference “SLS”,

(iii) an order for appliances, not being restricted availability appliances, signed by a prescriber other than D, or

(iv) an order for a restricted availability appliance, signed by a prescriber other than D, and including the reference “SLS”,

and also presents an associated batch issue; F188 ...

(b) D receives [F189 as a nominated dispensing contractor] an electronic repeatable prescription from the Electronic Prescription Service which contains an order of a kind specified in paragraph (a)(i) to (iv) and—

(i) any person requests the provision of drugs or appliances in accordance with that repeatable prescription, or

(ii) D has previously arranged with the patient that D will dispense that repeatable prescription on receipt[F190 ; or]

[F191 (c) any person—

(i) presents D with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iv), and

(ii) requests the provision of drugs or appliances in accordance with the related electronic repeatable prescription,]

and D is authorised or required by virtue of Part 8 to provide the drugs or appliances so ordered, D must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as D supplies in the normal course of business.

(4) D must not provide under an electronic prescription form a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in [F192 Schedules 2 to 5] to the Misuse of Drugs Regulations 2001.

(5) For the purposes of this paragraph, a non-electronic repeatable prescription for drugs or appliances shall be taken to be presented even if the person who wishes to obtain the drugs or appliances does not present that prescription, where—

(a) D has that prescription in D's possession; and

(b) that person presents, or D has in D's possession, an associated batch issue.

(6) Drugs and appliances provided under this paragraph must be provided in a suitable container.

Textual Amendments

F184 Word in Sch. 6 para. 2(2)(a) omitted (26.11.2018) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(2)(a)(i)

F185 Words in Sch. 6 para. 2(2)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(2)(a)(ii)

F186 Word in Sch. 6 para. 2(2)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(2)(a)(iii)

F187 Sch. 6 para. 2(2)(c) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(2)(a)(iv)

F188 Word in Sch. 6 para. 2(3)(a) omitted (26.11.2018) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(2)(b)(i)

F189 Words in Sch. 6 para. 2(3)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(2)(b)(ii)

F190 Word in Sch. 6 para. 2(3)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(2)(b)(iii)

F191 Sch. 6 para. 2(3)(c) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(2)(b)(iv)

F192 Words in Sch. 6 para. 2(4) substituted (1.7.2015) by The National Health Service (Amendments to Primary Care Terms of Service relating to the Electronic Prescription Service) Regulations 2015 (S.I. 2015/915), regs. 1, 4(3)

Marginal Citations

M32 Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680 and 1043.

M33 1971 c.38; see section 2(1)(a) of that Act, which defines “controlled drug” for the purposes of that Act.

M34 S.I. 2001/3998. Schedule 4 has been amended by S.I. 2003/1432, 2005/3372, 2007/2154, 2009/3136 and 2012/973, and Schedule 5 has been amended by S.I. 2005/2864.

Dispensing of drugs and appliances ordered by the dispensing doctor U.K.

3.  In circumstances where paragraph 2 does not apply and subject to the following provisions of this Schedule, where a dispensing doctor (D) is authorised or required by virtue of Part 8 to provide a drug or appliance to a person—

(a) D must record any order for the provision of any drugs or appliances which are needed for the treatment of the patient, before the drugs or appliances are dispensed (unless it is personally administered)—

(i) on a prescription form completed in accordance with the term of the contract under which primary medical services are provided to the patient which gives effect to paragraph 39 of Schedule 6 to the GMS Regulations M35 (other contractual terms – prescribing) or an equivalent provision applying in relation to that contract,

(ii) if paragraph 39A of Schedule 6 to the GMS Regulations M36 (other contractual terms – electronic prescriptions) or an equivalent provision applies in relation to the contract under which primary medical services are provided to the patient, on an electronic prescription form, or

(iii) in the case of a personally administered vaccine in respect of which the NHS BSA does not require an individual prescription form in order to process payment, on the form provided by the NHS BSA for the purposes of claiming payments for administering that vaccine (as well, potentially, as claiming other payments), and in the manner required by the NHS BSA (which may be as part of an aggregate total);

(b) D must provide those drugs or appliances in a suitable container (unless it is personally administered);

(c) D must provide for the patient a drug specified in Schedule 2 to the Prescription of Drugs Regulations M37 (drugs, medicines and other substances that may be ordered only in certain circumstances) only where the conditions in paragraph 42(2) of Schedule 6 to the GMS Regulations M38 (other contractual terms – a restrictions on prescribing by medical practitioners) are satisfied; and

(d) D must provide for the patient a restricted availability appliance only if the patient is a person, or it is for a purpose, specified in the Drug Tariff.

Marginal Citations

M35 Paragraph 39 has been amended by S.I. 2005/893, 2007/3491 and 2009/2230.

M36 Paragraph 39A was inserted by S.I. 2005/893 and has been amended by S.I. 2007/3491.

M37 Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680 and 1043.

M38 Paragraph 42 has been amended by S.I. 2005/893 and 2009/2230.

[F193 Supply in accordance with a SSP U.K.

3A.— (1) This sub-paragraph applies where, in relation to an order for a drug or an appliance on a prescription form or a repeatable prescription—

(a) a SSP has effect in respect of—

(i) the requested drug or appliance, or

(ii) drugs or appliances of a specified description, and the requested drug appliance is of that description.

(2) Where sub-paragraph (1) applies and D provides a different product or quantity of product to the product or quantity of product ordered on the prescription form or repeatable prescription, in accordance with the SSP—

(a) D must endorse the prescription or the associated batch issue accordingly (if the manner for making the endorsement is provided for in the Drug Tariff, in the manner provided for in the Drug Tariff); and

(b) the prescription or associated batch issue as thus endorsed is treated as being the prescription for product reimbursement purposes (even though the supply is not in pursuance of that prescription).

(3) Where D provides a drug or appliance under this paragraph, D must include in the dispensing label on the packaging of the product, for the patient’s benefit, information to the effect that the product is being supplied in accordance with a SSP, identifying the particular SSP.]

Textual Amendments

F193 Sch. 6 para. 3A inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 6(2)

[F194 Supply in accordance with a PTP [F195 or a PTPGD] U.K.

3B.— (1) Subject to the following provisions of [F196 this Schedule,] where—

(a) a dispensing doctor (D) receives, via a secure service approved by [F1 NHS England] for this purpose, an electronic message that amounts to an order for the supply of a drug in accordance with a PTP [F197 or a PTPGD]; and

(b) a person who is entitled to be supplied with that drug [F198 by D (Part 8 and this Schedule having that effect)] in pursuance of that order requests the provision of the drug in accordance with that order,

D must, with reasonable promptness, provide the drug so ordered.

[F199 (1A) Where D considers—

(a) on the basis of a request for the supply of a drug in accordance with a PTP or a PTPGD that has been approved by [F1 NHS England] as a basis for supply as part of pharmaceutical services;

(b) having made the appropriate checks; and

(c) having regard to what is reasonable and appropriate,

that a person is entitled to be supplied with the drug [F200 by D (Part 8 and this Schedule having that effect)] in accordance with the PTP or PTPGD as part of pharmaceutical services, D must, with reasonable promptness, provide the drug requested.]

(2) If a person requesting the provision of the drug asks D to do so—

(a) D must give an estimate of the time when the drug will be ready; and

(b) if they are not ready by then, D must give a revised estimate of the time when they will be ready (until they are ready).

(3) Where D provides a drug under sub-paragraph (1) [F201 or (1A)], D must include a dispensing label on the packaging of the product and include in the label (in addition to the particulars required or permitted by Part 1 of Schedule 26 to the Human Medicines Regulations 2012), for the patient’s benefit, information to the effect that the product is being supplied in accordance with a PTP [F202 or a PTPGD], identifying the particular PTP [F203 or PTPGD].

[F204 (4) Sub-paragraph (1) does not apply where arrangements are in place for the provision of the drug ordered pursuant to the PTP or PTPGD as part of a directed service which includes arrangements for the provision of such a drug ordered in accordance with such a PTP or PTPGD.

(5) Sub-paragraph (1A) does not apply where arrangements are in place for the provision of the drug requested in accordance with the PTP or PTPGD as part of a directed service which includes arrangements for the provision of such a drug requested in accordance with such a PTP or PTPGD.]]

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F194 Sch. 6 para. 3B inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 21

F195 Words in Sch. 6 para. 3B heading inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(2)(c)(iii)

F196 Words in Sch. 6 para. 3B(1) substituted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 9(2)(a)

F197 Words in Sch. 6 para. 3B(1)(a) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(2)(a)

F198 Words in Sch. 6 para. 3B(1)(b) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 9(2)(b)

F199 Sch. 6 para. 3B(1A) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(2)(b)

F200 Words in Sch. 6 para. 3B(1A) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 9(2)(c)

F201 Words in Sch. 6 para. 3B(3) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(2)(c)(i)

F202 Words in Sch. 6 para. 3B(3) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(2)(c)(ii)

F203 Words in Sch. 6 para. 3B(3) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(2)(c)(iii)

F204 Sch. 6 para. 3B(4)(5) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 9(2)(d)

[F205 Supply in accordance with a LPIV U.K.

3C.— (1) Subject to the following provisions of this Schedule, where—

(a) a dispensing doctor (D) receives a LPIV; and

(b) a person who is entitled to be supplied by D (Part 8 and this Schedule having that effect) with a prescription item ordered on the LPIV requests the provision of the item in accordance with that LPIV,

D must, with reasonable promptness, provide the prescription item so ordered.

(2) If a person who is entitled as mentioned in sub-paragraph (1)(b) asks D to do so—

(a) D must give an estimate of the time when the prescription item will be ready; and

(b) if they are not ready by then, D must give a revised estimate of the time when the item will be ready (until it is ready).

(3) Sub-paragraph (1) does not apply where arrangements are in place for the provision of the item ordered on the LPIV as part of a directed service which includes arrangements for the provision of such an item ordered on such a LPIV.]

Textual Amendments

F205 Sch. 6 para. 3C inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 9(3)

Preliminary matters before providing ordered drugs or appliances U.K.

4.  Before providing any drugs or appliances in accordance with paragraph 3 [F206 or 3A], or in the circumstances set out in paragraph 5—

(a) a dispensing doctor (D) must ask any person who makes [F207 or duly completes a declaration as or on behalf of the person named on the prescription form or repeatable prescription] that the patient does not have to pay the charges specified in regulation 4(1) of the Charges Regulations M39 (supply of drugs and appliances by doctors) by virtue of either—

(i) entitlement to exemption under [F208 regulation 10(1)] of the Charges Regulations M40 (exemptions), or

(ii) entitlement to remission of charges under regulation 5 of the Remission of Charges Regulations M41 (entitlement to full remission and payment),

to produce satisfactory evidence of such entitlement, unless the declaration is in respect of entitlement to exemption by virtue of [F208 regulation 10] of the Charges Regulations or in respect of entitlement to remission by virtue of regulation 5 of the Remission of Charges Regulations, and at the time of the declaration D has such evidence available to D;

(b) if, in the case of a non-electronic prescription form or non-electronic repeatable prescription, no satisfactory evidence, as required by sub-paragraph (a), is produced to D, D must endorse the form on which the declaration is made to that effect; and

(c) in the case of an electronic prescription, D must [F209 ensure that the following information is duly entered into the records managed by [F210 NHS England] that are accessible as part of the Electronic Prescription Service (if either it is not already recorded in those records or a check, known as a real time exemption check, has not produced satisfactory evidence as mentioned in sub-paragraph (a))]—

(i) in a case where exemption from or remission of charges is claimed for all or some of the items included in the prescription, a record of—

(aa) the exemption category specified in [F211 regulation 10(1)] of the Charges Regulations or the ground for remission under regulation 5 of the Remission of Charges Regulations which it is claimed applies to the case, and

(bb) whether or not satisfactory evidence was produced to D as required by sub-paragraph (a),

(ii) in any case where a charge is due, confirmation that the relevant charge was paid, and

(iii) in a case of a prescription for or including contraceptive substances, confirmation that no charge was payable in respect of those substances.

Textual Amendments

F206 Words in Sch. 6 para. 4 inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 6(3)

F207 Words in Sch. 6 para. 4(a) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(3)(a)

F208 Words in Sch. 6 para. 4(a) substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(6)(a)

F209 Words in Sch. 6 para. 4(c) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(3)(b)

F210 Words in Sch. 6 para. 4(c) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 47(5) (with reg. 3)

F211 Words in Sch. 6 para. 4(c)(i)(aa) substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(6)(b)

Marginal Citations

M39 Regulation 4 has been amended by S.I. 2000/2393, 2001/2887, 2002/548 and 2352, 2005/578, 2008/571, 2009/411, 2010/1727 and 2011/518.

M40 Regulation 7 has been amended by S.I. 2000/3189, 2002/2352, 2004/696, 2005/578 and 2009/29.

M41 Regulation 5 has been amended by S.I. 2004/663 and 936, 2006/562, 2008/1697 and 2009/411.

[F212 Charge exemption and remission of charges: declarations and checks U.K.

4A.— (1) For the purposes of paragraph 4, satisfactory evidence includes evidence derived from a check, known as a real time exemption check, of electronic records that are managed by the NHS BSA for the purposes (amongst other purposes) of providing advice, assistance and support to patients or their representatives in respect of whether a charge is payable under the Charges Regulations.

(2) If D dispenses an electronic prescription, D must send the form duly completed by or on behalf of the patient, if one is required under regulation 4(2)(b) or (3A) of the Charges Regulations in respect of that electronic prescription (which may be the associated EPS token), to the NHS BSA.]

Textual Amendments

F212 Sch. 6 para. 4A inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(4)

[F213 Checks and records in the case of supply in accordance with a SSP U.K.

4B.   In a case involving providing drugs or appliances in accordance with paragraph 3A, the references in paragraph 4 to a prescription form or repeatable prescription are to be construed as references to the prescription for product reimbursement purposes, as mentioned in paragraph 3A(2)(b).]

Textual Amendments

F213 Sch. 6 para. 4B inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 6(4)

Provision of Scheduled drugs U.K.

5.—(1) A dispensing doctor (D) must only provide for a patient any Scheduled drug if—

(a) it is ordered as specified in sub-paragraph (2) or (4); or

(b) in the case of a drug specified in Schedule 2 to the Prescription of Drugs Regulations M42 (drugs, medicines and other substances that may be ordered only in certain circumstances), it is ordered in the circumstances prescribed in that Schedule.

(2) A Scheduled drug that is a drug with an appropriate non-proprietary name may be provided in response to an order on a prescription form or repeatable prescription for a drug (“the prescribed drug”) that is not a Scheduled drug but which has the same non-proprietary name as the Scheduled drug if—

(a) the prescribed drug is ordered by that non-proprietary name or by its formula; and

(b) the prescribed drug has the same specification as the Scheduled drug (so the Scheduled drug may be dispensed generically).

(3) If a Scheduled drug is a combination of more than one drug, it can only be ordered as specified in sub-paragraph (2) if the combination has an appropriate non-proprietary name, whether or not the drugs in the combination each have such names.

(4) Nothing in this Schedule prevents D providing, otherwise than under pharmaceutical services, a Scheduled drug or a restricted availability appliance for a patient.

Marginal Citations

M42 Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680 and 1043.

Refusal to provide drugs or appliances ordered U.K.

6.—(1) A dispensing doctor (D) may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription where—

(a) D reasonably believes that it is not a genuine order for the person named on the prescription form or the repeatable prescription (for example because D reasonably believes it has been stolen or forged);

(b) it appears to D that there is an error on the prescription form or on the repeatable prescription or, in the case of a non-electronic repeatable prescription, its associated batch issue (including a clinical error made by the prescriber) or that, in the circumstances, providing the drugs or appliances would be contrary to D's clinical judgement; or

(c) where the prescription form or repeatable prescription is incomplete because it does not include the information relating to the identification of the prescriber that [F1 NHS England] (or a person exercising its functions) requires in order to perform its functions relating to—

(i) the remuneration of persons providing pharmaceutical services, and

(ii) any apportionment of, or any arrangements for recharging in respect of, that remuneration,

unless D (or the person who employs or engages D) is to receive no pharmaceutical remuneration of any kind in respect of the drug or appliance.

[F214 (1A) D may refuse to provide a drug or appliance ordered on an electronic prescription if the access that D has to the Electronic Prescription Service is not such as to enable D to dispense that prescription promptly (or at all).]

(2) D must refuse to provide drugs or appliances ordered on a repeatable prescription where—

(a) D has no record of that prescription;

(b) D does not, in the case of a non-electronic repeatable prescription, have any associated batch issue and it is not presented to D;

(c) it is not signed by a prescriber;

(d) to do so would not be in accordance with any intervals specified in the prescription;

(e) it would be the first time a drug or appliance had been provided pursuant to the prescription and the prescription was signed (whether electronically or otherwise) more than 6 months previously;

(f) if the repeatable prescription was signed (whether electronically or otherwise) more than one year previously;

(g) the expiry date on the repeatable prescription has passed; or

(h) D has been informed by the prescriber that the prescription is no longer required.

(3) Where a patient requests the supply of drugs or appliances ordered on a repeatable prescription (other than on the first occasion that the patient makes such a request), D must only provide the drugs or appliances ordered if D is satisfied—

(a) that the patient to whom the prescription relates—

(i) is taking or using, and is likely to continue to take or use, the drug or appliance appropriately, and

(ii) is not suffering from any side effects of the treatment which indicates the need or desirability of reviewing the patient's treatment;

(b) that the medication regimen of the patient to whom the prescription relates has not altered in a way which indicates the need or desirability of reviewing the patient's treatment; and

(c) there have been no changes to the health of the patient to whom the prescription relates which indicate the need or desirability of reviewing the patient's treatment.

[F215 (4) D must refuse to provide a drug or appliance ordered on a prescription form or a repeatable prescription where—

(a) a SSP has effect in respect of—

(i) the requested drug or appliance; or

(ii) drugs or appliances of a specified description, and the requested drug or appliance is of that description; and

(b) alternative provision has already taken place in accordance with the SSP.]

[F216 (5) D may refuse to [F217 fulfil an order or a request] for a drug that is or is purportedly in accordance with [F218 a LPIV,] a PTP [F219 or a PTPGD] where—

(a) D reasonably believes it is not a genuine order [F220 or valid request] for the person who requests, or on whose behalf is requested, the provision of the drug;

(b) providing it would be contrary to D’s clinical judgement;

(c) D or other persons are subjected to or threatened with violence by the person who requests the provision of the drug, or by any person accompanying that person; or

(d) the person who requests the provision of the drug, or any person accompanying that person, commits or threatens to commit a criminal offence.

(6) D must refuse to provide, pursuant to [F221 a LPIV,] a PTP [F222 or a PTPGD], an order [F223 or a request] for a drug that is or is purportedly in accordance with [F224 the LPIV,] the PTP [F225 or PTPGD] where D is not satisfied that it is in accordance with [F224 the LPIV,] the PTP [F225 or PTPGD].]

[F226 (7) D may refuse to provide a prescription item ordered on a prescription form or repeatable prescription where—

(a) more than one prescription item has been ordered on the prescription form or repeatable prescription;

(b) at least one of those prescription items is a listed HRT prescription item and at least one of those prescription items is not; and

(c) the person named on the prescription form or repeatable prescription is claiming entitlement to exemption under regulation 10(1)(j) of the Charges Regulations (exemptions) in respect of any of those prescription items which is a listed HRT prescription item.]

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F214 Sch. 6 para. 6(1A) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(5)

F215 Sch. 6 para. 6(4) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 6(5)

F216 Sch. 6 para. 6(5)(6) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 22

F217 Words in Sch. 6 para. 6(5) substituted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(3)(a)(i)

F218 Words in Sch. 6 para. 6(5) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 9(4)(a)

F219 Words in Sch. 6 para. 6(5) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(3)(a)(ii)

F220 Words in Sch. 6 para. 6(5)(a) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(3)(a)(iii)

F221 Words in Sch. 6 para. 6(6) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 9(4)(b)(i)

F222 Words in Sch. 6 para. 6(6) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(3)(b)(i)

F223 Words in Sch. 6 para. 6(6) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(3)(b)(ii)

F224 Words in Sch. 6 para. 6(6) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 9(4)(b)(ii)

F225 Words in Sch. 6 para. 6(6) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(3)(b)(iii)

F226 Sch. 6 para. 6(7) inserted (1.4.2023) by The National Health Service (Amendments Relating to Pre-Payment Certificates, Hormone Replacement Therapy Treatments and Medicines Shortages) Regulations 2023 (S.I. 2023/171), regs. 1(1), 4

Dispensing doctors issuing prescription forms which may be presented to an NHS chemist U.K.

7.  Notwithstanding the existence of arrangements under which a dispensing doctor (D) is to provide pharmaceutical services to a patient (P), if D determines that P requires a drug or appliance that is available on prescription from an NHS chemist—

(a) D may with the agreement of P issue; or

(b) if P so requests, D must not unreasonably refrain from issuing,

a prescription form that P may present to any NHS chemist instead of D supplying that drug or appliance to P.

[F227 Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc. U.K.

7A.— (1) Before dispensing any item on a prescription form or supplying it in accordance with a serious shortage protocol, a dispensing doctor (D) must provide a home delivery option to eligible patients in respect of the item where, as a consequence of a disease being or in anticipation of a disease being imminently—

(a) pandemic; and

(b) a serious risk or potentially a serious risk to human health,

[F1 NHS England] with the agreement of the Secretary of State has made an announcement to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, eligible patients are advised to stay away from listed dispensing premises in the area specified, in the circumstances specified and for the duration of the period specified in the announcement.

(2) If D’s listed dispensing premises are in the area specified in the announcement, during the period when, in the circumstances specified in the announcement, eligible patients need to stay away from D’s premises, D must ascertain from—

(a) an eligible patient—

(i) who has contacted D about the home delivery of prescription items, or

(ii) who is a person whom D considered, on the basis of the nature of an item on a prescription form, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; or

(b) a person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted D about the home delivery of prescription items,

whether or not the item could be supplied by a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which D must provide.

(3) Where paragraph (2) does not apply, if D’s listed dispensing premises are in the area specified in the announcement, during the period when, in the circumstances specified in the announcement, eligible patients need to stay away from D’s premises, the home delivery option that P must provide must comprise—

(a) D delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);

(b) D arranging for an item dispensed by D to be delivered by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; or

(c) if D is unable to deliver the item or arrange for its delivery by another dispensing doctor, or by an NHS pharmacist or by an LPS contractor, D arranging for the dispensing or supply of the item by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, who would be able to deliver the dispensed item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.

(4) Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at D’s listed dispensing premises for the purposes of receiving dispensing services.

(5) Notwithstanding the foregoing provisions of this Schedule, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, D may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale.]

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F227 Sch. 6 para. 7A inserted (27.3.2020) by The National Health Service (Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/351), regs. 1(2), 10

[F228 Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc. U.K.

7AA.— (1) Before dispensing a notified item on a prescription form or supplying it in accordance with a serious shortage protocol, a PTP or a PTPGD, a dispensing doctor (D) must provide a home delivery option to eligible patients in respect of that item.

(2) For the purposes of this paragraph, a “notified item” is an item that, as a consequence of a disease being or in anticipation of a disease being imminently—

(a) pandemic; and

(b) a serious risk or potentially a serious risk to human health,

is the subject of an announcement made by [F1 NHS England], with the agreement of the Secretary of State, to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, eligible patients are entitled to be provided with a home delivery option in respect of that item, if it is supplied to them as part of pharmaceutical services.

(3) Where D is to, or may be required to, dispense a notified item on a prescription form or supply it in accordance with a serious shortage protocol, a PTP or a PTPGD, D must ascertain from—

(a) an eligible patient—

(i) who has contacted D about the home delivery of a notified item, or

(ii) who is a person whom D considered, on the basis of an order or request for a notifiable item, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; or

(b) a person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted D about the home delivery of a notified item,

whether or not the item could be supplied via a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which D must provide.

(4) Where paragraph (3) does not apply, the home delivery option that D must provide must comprise—

(a) D delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);

(b) D arranging for an item dispensed by D to be delivered by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; or

(c) if D is unable to deliver the item or arrange for its delivery by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, D arranging for the dispensing or supply of the item by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, who would be able to deliver the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.

(5) Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at D’s listed dispensing premises for the purposes of being supplied with the notifiable item.

(6) Notwithstanding the foregoing provisions of this Schedule, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, D may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale.]

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F228 Sch. 6 para. 7AA inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(4)

Complaints procedures U.K.

8.  Where a dispensing doctor is a provider of primary medical services, or is employed or engaged by such a provider, the complaints procedure established by—

(a) the provider or practice; or

(b) the provider or practice that employs or engages the dispensing doctor,

to deal with complaints in relation to the provision of primary medical services is also to apply in relation to a complaint about any matter reasonably connected with the provision of pharmaceutical services by that provider, practice or individual.

Inspections and access to information U.K.

9.—(1) A dispensing doctor (D) must allow persons authorised in writing by [F1 NHS England] to enter and inspect any premises D uses for the provision of pharmaceutical services at any reasonable time, for the purposes of—

(a) ascertaining whether or not D is complying with the requirements of this Schedule;

(b) auditing, monitoring and analysing—

(i) the provision made by D, in the course of providing pharmaceutical services, for patient care and treatment, and

(ii) the management by D of the pharmaceutical services D provides,

where the conditions in sub-paragraph (2) are satisfied.

(2) The conditions are that—

(a) reasonable notice of the intended entry has been given;

(b) the Local Medical Committee for the area where the premises are situated have been invited to be present at the inspection, where this is requested by D;

(c) the person authorised in writing (X) carries written evidence of X's authorisation, which X produces on request; and

(d) X does not enter any part of the premises used solely as residential accommodation without the consent of the resident.

(3) D must, at the request of [F1 NHS England] or of X, allow it or X access to any information which it or X reasonably requires—

(a) for the purposes mentioned in sub-paragraph (1); or

(b) in the case of [F1 NHS England], in connection with its functions that relate to pharmaceutical services.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Voluntary closure of premises U.K.

10.—(1) Where a dispensing doctor (D) wishes—

(a) to withdraw from a dispensing doctor list, or

(b) except in the circumstances described in paragraph (2), for particular listed dispensing premises no longer to be listed in relation to D,

D must notify [F1 NHS England] of D's wish at least 3 months in advance of the date on which pharmaceutical services are no longer to be provided, unless it is impracticable for D to do so, in which case D must notify [F1 NHS England] as soon as it is practicable for D to do so.

(2) If particular listed dispensing premises no longer need to be listed in relation to D as a consequence of a relocation application under regulation 55, before the date on which D commences the provision of pharmaceutical services at the new premises, D must give notice to [F1 NHS England] of when, before that date, D is to cease to provide pharmaceutical services at the existing premises.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Regulation 102(3)

SCHEDULE 7 U.K. Mandatory terms for LPS schemes

General provisions U.K.

1.—(1) The LPS contractor must comply with all relevant legislation, including—

(a) the relevant provisions of Part 13 of these Regulations; and

(b) relevant provisions that are—

(i) included in regulations under section 225 of the 2007 Act M43 (duties of services-providers to allow entry by Local Healthwatch organisations or contractors), and

(ii) made for the purpose of imposing on a services-provider (within the meaning of that section) a duty to allow authorised representatives (within the meaning of that section) to enter and view, and observe the carrying-on of activities on, premises owned or controlled by the services-provider.

(2) The LPS contractor must comply with the relevant provisions of the Drug Tariff.

(3) The LPS contractor must have regard to all relevant guidance issued by—

(a) [F1 NHS England]; or

(b) the Secretary of State.

(4) To the extent that the provisions of the terms required by this Schedule impose a requirement on the LPS contractor (C) in respect of an activity which could only, or would normally, be undertaken by a natural person—

(a) if C is a registered pharmacist—

(i) C must comply with the requirement, or

(ii) if C employs or engages a registered pharmacist in connection with the provision of local pharmaceutical services under C's LPS scheme, C must either comply with that requirement or secure compliance with that requirement by the registered pharmacist C employs or engages; or

(b) if C is not a natural person, C must secure compliance with that requirement by the registered pharmacists C employs or engages, and references in this Schedule to an LPS contractor are to be construed accordingly.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Marginal Citations

M43 Section 225 has been amended by the Health and Social Care Act 2012 (c. 7), section 186(6) to (10), Schedule 14, paragraphs 103 and 106, and Schedule 5, paragraphs 148 and 151.

Restrictions in an LPS scheme on supply U.K.

2.—(1) Where an LPS scheme is limited to the provision of specified drugs or appliances, the LPS contractor must not provide other drugs or appliances at or from the scheme premises.

(2) An LPS scheme must contain the following terms, where applicable—

(a) where the local pharmaceutical services to be provided include the supply of appliances—

(i) the only appliances which may be supplied are appliances listed in Parts IXA, IXB, IXC or X of the Drug Tariff, and

(ii) those appliances must be supplied in accordance with the provisions of the Notes, and the List of Technical Specifications, which appear at the beginning of Part IX of the Drug Tariff, which apply at the time of supply; and

(b) where the local pharmaceutical services to be provided include the supply of chemical reagents, the only chemical reagents which may be supplied are those listed from time to time in Part IXR of the Drug Tariff.

(3) Where an LPS scheme is limited to the provision of services—

(a) to a specified class of persons (for example persons who require the provision of local pharmaceutical services for the treatment of a specified disease or condition); or

(b) to persons residing in a particular place (for example persons in a specified residential home),

the LPS contractor must not provide local pharmaceutical services to persons other than those so specified.

Dispensing U.K.

3.—(1) Subject to any provisions of an LPS scheme included pursuant to paragraph 2 and the following provisions of this Schedule, where—

(a) any person presents to the LPS contractor (C) a non-electronic prescription form which contains—

(i) an order for a drug, not being a Scheduled drug, or for an appliance, not being a restricted availability appliance, signed by a prescriber,

(ii) an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations M44 (drugs, medicines and other substances that may be ordered only in certain circumstances), signed by a prescriber and including the reference “SLS”, or

(iii) an order for a restricted availability appliance, signed by a prescriber and including the reference “SLS”; F229 ...

(b) C receives [F230 as a nominated dispensing contractor] from the Electronic Prescription Service an electronic prescription form which contains an order of a kind specified in paragraph (a)(i) to (iii), and—

(i) any person requests the provision of a drug [F231 or appliance] in accordance with that prescription, or

(ii) C has previously arranged with the patient that it will dispense that prescription on receipt[F232 ; or]

[F233 (c) any person—

(i) presents C with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iii), and

(ii) requests the provision of a drug or appliance in accordance with the related electronic prescription form,]

C must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as C supplies in the normal course of business.

(2) Where an LPS scheme includes the provision of repeat dispensing services, subject to any provisions of the LPS scheme included pursuant to paragraph 2 and the following provisions of this Schedule, where—

(a) any person presents to C a non-electronic repeatable prescription which contains—

(i) an order for a drug, not being a Scheduled drug or a controlled drug within the meaning of the Misuse of Drugs Act 1971 M45 , other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 M46 (which relate to controlled drugs excepted from certain prohibitions under the Regulations), signed by a prescriber,

(ii) an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations, not being a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001, signed by a prescriber and including the reference “SLS”,

(iii) an order for an appliance, not being a restricted availability appliance, signed by a prescriber, or

(iv) an order for a restricted availability appliance, signed by a prescriber, and including the reference “SLS”,

and also presents an associated batch issue; F234 ...

(b) C receives [F235 as a nominated dispensing contractor] from the Electronic Prescription Service an electronic repeatable prescription which contains an order of a kind specified in sub-paragraph (a)(i) to (iv) and—

(i) any person requests the provision of a drug or an appliance in accordance with that repeatable prescription, or

(ii) C has previously arranged with the patient that it will dispense that repeatable prescription on receipt[F236 ; or]

[F237 (c) any person—

(i) presents C with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iv), and

(ii) requests the provision of a drug or appliance in accordance with the related electronic repeatable prescription,]

C must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as C supplies in the normal course of business.

(3) C must not provide under an electronic prescription form a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in [F238 Schedules 2 to 5] to the Misuse of Drugs Regulations 2001.

(4) For the purposes of this paragraph, a non-electronic repeatable prescription for drugs or appliances must be taken to be presented even if the person who wishes to obtain the drug or appliance does not present that prescription, where—

(a) C has that prescription in C's possession; and

(b) that person presents, or C has in C's possession, an associated batch issue.

Textual Amendments

F229 Word in Sch. 7 para. 3(1)(a) omitted (26.11.2018) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(2)(a)(i)

F230 Words in Sch. 7 para. 3(1)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(2)(a)(ii)

F231 Words in Sch. 7 para. 3(1)(b)(i) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(2)(a)(iii)

F232 Word in Sch. 7 para. 3(1)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(2)(a)(iv)

F233 Sch. 7 para. 3(1)(c) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(2)(a)(v)

F234 Word in Sch. 7 para. 3(2)(a) omitted (26.11.2018) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(2)(b)(i)

F235 Words in Sch. 7 para. 3(2)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(2)(b)(ii)

F236 Word in Sch. 7 para. 3(2)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(2)(b)(iii)

F237 Sch. 7 para. 3(2)(c) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(2)(b)(iv)

F238 Words in Sch. 7 para. 3(3) substituted (1.7.2015) by The National Health Service (Amendments to Primary Care Terms of Service relating to the Electronic Prescription Service) Regulations 2015 (S.I. 2015/915), regs. 1, 4(4)

Marginal Citations

M44 Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680 and 1043.

M45 1971 c.38; see section 2(1)(a) of that Act, which defines “controlled drug” for the purposes of that Act.

M46 S.I. 2001/3998. Schedule 4 has been amended by S.I. 2003/1432, 2005/3372, 2007/2154, 2009/3136 and 2012/973, and Schedule 5 has been amended by S.I. 2005/2864.

[F239 Supply in accordance with a SSP U.K.

3A.— (1) This sub-paragraph applies where—

(a) any person requests a drug or appliance from an LPS contractor (C) in accordance with a prescription form or repeatable prescription; and

(b) a SSP has effect in respect of—

(i) the requested drug or appliance, or

(ii) drugs or appliances of a specified description, and the requested drug or appliance is of that description.

(2) Where sub-paragraph (1) applies, C must consider whether it is reasonable and appropriate to supply in accordance with the SSP instead of in accordance with the prescription form or repeatable prescription.

(3) Where sub-paragraph (1) applies, C may provide a different product or quantity of product to the product or quantity of product ordered on the prescription form or repeatable prescription, where—

(a) C is able to do so with reasonable promptness;

(b) to do so is in accordance with the SSP; and

(c) the supply of a different product or quantity of product to that ordered by the prescriber is by or under the direct supervision of a registered pharmacist who is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is reasonable and appropriate.

(4) Where C, in accordance with sub-paragraph (3), provides a different product or quantity of product to that ordered by the prescriber—

(a) the registered pharmacist mentioned in sub-paragraph (3)(c) must endorse the prescription or the associated batch issue accordingly (if the manner for making the endorsement is provided for in the Drug Tariff, in the manner provided for in the Drug Tariff), and the prescription or associated batch issue as thus endorsed is treated as being the prescription for product reimbursement purposes (even though the supply is not in pursuance of that prescription); and

(b) if the patient to or for whom the product is provided is on a patient list, and the supply—

(i) by virtue of regulation 226A(5)(c)(iii) of the Human Medicines Regulations 2012 (sale etc. by a pharmacist in accordance with a serious shortage protocol), is of a prescription only medicine that is different to but has a similar therapeutic effect to the product ordered by the prescriber, or

(ii) is of any other type, and the Secretary of State and the person who is, for the time being, the person consulted under section 165(1)(a) of the 2006 Act in respect of pharmaceutical remuneration of LPS chemists, acting jointly, have issued and publicised in such manner as they see fit a recommendation to the effect that, for clinical reasons, in the case of supplies of that type, providers of primary medical services should be notified of a supply to a patient on its patient list that is in accordance with a SSP instead of in accordance with a prescription form or repeatable prescription,

C must notify the provider of primary medical services on whose patient list the patient is of the supply in accordance with a SSP instead of in accordance with a prescription form or repeatable prescription.

(5) Where—

(a) sub-paragraph (1) applies;

(b) a registered pharmacist is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate; and

(c) C is able to supply the product or quantity of product ordered by the prescriber within a reasonable timescale but not with reasonable promptness,

the requirements to act with reasonable promptness in paragraph 3(1) and (2) are to be read as requirements to act within a reasonable timescale.]

Textual Amendments

F239 Sch. 7 para. 3A inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 7(2)

[F240 Supply in accordance with a LPIV U.K.

3B.— (1) Subject to the following provisions of this Schedule, where—

(a) a LPS Contractor (C) receives a LPIV; and

(b) a person who is entitled to be supplied by C with a prescription item ordered on the LPIV requests the provision of the item in accordance with that LPIV,

C must, with reasonable promptness, provide the prescription item so ordered.

(2) If a person who is entitled as mentioned in sub-paragraph (1)(b) asks C to do so—

(a) C must give an estimate of the time when the prescription item will be ready; and

(b) if they are not ready by then, C must give a revised estimate of the time when the item will be ready (until it is ready).

(3) Sub-paragraph (1) does not apply where arrangements are in place for the provision of the item ordered on the LPIV as part of a directed service which includes arrangements for the provision of such an item ordered on such a LPIV.]

Textual Amendments

F240 Sch. 7 para. 3B inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 10(2)

Urgent supply without a prescription U.K.

4.  Where, in case of urgency, a prescriber personally known to the LPS contractor (C) requests C to provide a drug, C may provide that drug (where it would otherwise be able to provide that drug in accordance with the LPS scheme) before receiving a prescription form or repeatable prescription, provided that—

(a) the drug is not a Scheduled drug;

(b) the drug is not a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain prohibitions under the Regulations); and

(c) the prescriber undertakes to—

(i) give C a non-electronic prescription form or non-electronic repeatable prescription in respect of the drug within 72 hours of the request being made, or

(ii) transmit to the Electronic Prescription Service within 72 hours of the request being made an electronic prescription.

Preliminary matters before providing ordered drugs or appliances U.K.

5.—(1) If a person specified in paragraph (2) asks the LPS contractor (C) to do so—

(a) C must give an estimate of the time when the drugs or appliances will be ready; and

(b) if they are not ready by then, C must give a revised estimate of the time when they will be ready (until they are ready).

(2) A person specified in paragraph (1) is a person—

(a) presenting a non-electronic prescription form or non-electronic repeatable prescription; or

(b) requesting the provision of drugs or appliances in accordance with an electronic prescription form or a repeatable prescription.

(3) Before providing any drugs or appliances in accordance with a prescription form or a repeatable prescription, C must ask any person who makes [F241 or duly completes a declaration as or on behalf of the person named on the prescription form or repeatable prescription] that the person named on the prescription form or the repeatable prescription does not have to pay the charges specified in regulation 3(1) [F242 or (2)] of the Charges Regulations M47 (supply of drugs and appliances by chemists) by virtue of either—

(a) entitlement to exemption under [F243 regulation 10(1)] of the Charges Regulations M48 (exemptions); or

(b) entitlement to remission of charges under regulation 5 of the Remission of Charges Regulations M49 (entitlement to full remission and payment),

to produce satisfactory evidence of such entitlement, unless the declaration is in respect of entitlement to exemption by virtue of sub-paragraph (a), (c), (d), (e), (f) or (g) of [F243 regulation 10(1)] of the Charges Regulations or in respect of entitlement to remission by virtue of regulation (5)(1)(e) or (2) of the Remission of Charges Regulations, and at the time of the declaration C already has such evidence available to C.

[F244 (3ZA) For the purposes of sub-paragraph (3), satisfactory evidence includes evidence derived from a check, known as a real time exemption check, of electronic records that are managed by the NHS BSA for the purposes (amongst other purposes) of providing advice, assistance and support to patients or their representatives in respect of whether a charge is payable under the Charges Regulations.]

[F245 (3A) In any case where no satisfactory evidence, as required by sub-paragraph (3), is produced to C, C must ensure before the drugs or appliances are provided that the person who was asked to produce that evidence is advised, in appropriate terms, that checks are routinely undertaken to ascertain entitlement to—

(a) exemption under the Charges Regulations; or

(b) remission of charges under the Remission of Charges Regulations,

where such entitlement has been claimed, as part of the arrangements for preventing or detecting fraud or error in relation to such claims.]

(4) If, in the case of a non-electronic prescription form or non-electronic repeatable prescription, no satisfactory evidence, as required by sub-paragraph (3), is produced, C must endorse the form on which the declaration is made to that effect.

(5) In the case of an electronic prescription, C must [F246 ensure that the following information is duly entered into the records managed by [F247 NHS England] that are accessible as part of the Electronic Prescription Service (if either it is not already recorded in those records or a check, known as a real time exemption check, has not produced satisfactory evidence as mentioned in sub-paragraph (3))]—

(a) in a case where exemption from or remission of charges is claimed for all or some of the items included in the prescription, a record of—

(i) the exemption category specified in [F243 regulation 10(1)] of the Charges Regulations or the ground for remission under regulation 5 of the Remission of Charges Regulations which is claimed applies to the case, and

(ii) whether or not satisfactory evidence was produced to C as required by sub-paragraph (3);

(b) in any case where a charge is due, confirmation that the relevant charge was paid; and

(c) in a case of a prescription for or including contraceptive substances, confirmation that no charge was payable in respect of those substances.

[F248 (6) Sub-paragraphs (3) to (5) apply to the provision of a drug or appliance in accordance with a SSP as they apply to the provision of a drug or appliance in accordance with a prescription form or a repeatable prescription (or an associated batch issue), and for these purposes the prescription for product reimbursement purposes, as mentioned in paragraph 3A(4)(a), is treated as being the prescription in accordance with which the drug or appliance is provided (even though the supply is not in pursuance of that prescription).]

Textual Amendments

F241 Words in Sch. 7 para. 5(3) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(3)(a)

F242 Words in Sch. 7 para. 5(3) substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(7)(a)(i)

F243 Words in Sch. 7 para. 5 substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(7)(a)(ii)

F244 Sch. 7 para. 5(3ZA) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(3)(b)

F245 Sch. 7 para. 5(3A) inserted (E.) (1.7.2016) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2016 (S.I. 2016/296), regs. 1(1)(b), 5(2)

F246 Words in Sch. 7 para. 5(5) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(3)(c)

F247 Words in Sch. 7 para. 5(5) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 47(6) (with reg. 3)

F248 Sch. 7 para. 5(6) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 7(3)

Marginal Citations

M47 Regulation 3 has been amended by S.I. 2002/2352, 2003/1084, 2004/865, 2005/578, 2008/571, 2009/411, 2010/1727, 2011/518 and 2012/470.

M48 Regulation 7 has been amended by S.I. 2000/3189, 2002/2352, 2004/696, 2005/578 and 2009/29.

M49 Regulation 5 has been amended by S.I. 2004/663 and 936, 2006/562, 2008/1697 and 2009/411.

Providing ordered drugs or appliances U.K.

6.—(1) Where the LPS contractor (C) is presented with, or receives from the Electronic Prescription Service, a prescription form or a repeatable prescription, C must only provide the drugs or appliances so ordered—

(a) if the prescription form or repeatable prescription is duly signed and completed as described in paragraph 3(1) or (2); and

(b) in accordance with the order on the prescription form or repeatable prescription,

subject to any regulations in force under the Weights and Measures Act 1985 M50 and the following provisions of this Schedule.

(2) If the order is for [F249 , or a product to be provided in accordance with a SSP is,] an appliance of a type requiring measuring and fitting by C (for example a truss), C shall make all necessary arrangements for—

(a) measuring the person named on the prescription form or repeatable prescription for the appliance; and

(b) fitting the appliance.

(3) If the order is for [F250 , or a product to be provided in accordance with a SSP is,] a drug or appliance included in the Drug Tariff, the British National Formulary (including any Appendix published as part of that Formulary), the Dental Practitioner's Formulary, the European Pharmacopoeia or the British Pharmaceutical Codex, the drug or appliance provided must comply with the relevant standard or formula specified therein.

(4) If the order—

(a) is an order for a drug; but

(b) is not an order for a controlled drug within the meaning of the Misuse of Drugs Act 1971 M51 , other than a drug which is for the time being specified in Schedule 4 or 5 of the Misuse of Drugs Regulations 2001 M52 (which relate to controlled drugs excepted from certain prohibitions under the Regulations),

and does not prescribe its quality, strength or dosage, C (in practice, a registered pharmacist) may provide the drug in such strength and dosage as in the exercise of C's professional skill, knowledge and care C considers to be appropriate and, subject to sub-paragraph (5), in such quantity as C considers to be appropriate for a course of treatment for a period not exceeding 5 days.

(5) Where an order to which sub-paragraph (4) applies is for—

(a) an oral contraceptive substance;

(b) a drug, which is available for supply as part of local pharmaceutical services only together with one or more other drugs; or

(c) an antibiotic in a liquid form for oral administration in respect of which pharmaceutical considerations require its provision in an unopened package,

which is not available for provision as part of local pharmaceutical services except in such packages that the minimum size available contains a quantity appropriate to a course of treatment for a period of more than 5 days, C may provide the minimum size available package.

(6) Where any drug to which this sub-paragraph applies (that is, a drug that is not one to which the Misuse of Drugs Act 1971 applies, unless it is a drug for the time being specified in Schedule 5 to the Misuse of Drugs Regulations 2001), ordered by a prescriber on a prescription form or repeatable prescription, is available for provision by C in a pack in a quantity which is different to the quantity which has been so ordered, and that drug is—

(a) sterile;

(b) effervescent or hygroscopic;

(c) a liquid preparation for addition to bath water;

(d) a coal tar preparation;

(e) a viscous preparation; or

(f) packed at the time of its manufacture in a special container,

C must provide the drug in the pack whose quantity is nearest to the quantity which has been so ordered.

(7) In this paragraph, “special container” means any container with an integral means of application or from which it is not practicable to dispense an exact quantity.

(8) Subject to sub-paragraph (9), where a drug is ordered by a prescriber on a prescription form or repeatable prescription[F251 , or is to be provided in accordance with a SSP,] in a quantity that is, or is a multiple of a quantity that is, readily available in a pack size manufactured for a holder of a [F252 UK] marketing authorisation for the drug, C must provide the drug in an original pack (or in original packs) of that size which has been assembled by a manufacturer of the drug for such a holder of a [F252 UK] marketing authorisation, unless—

(a) it is not possible for C to obtain such a pack (or packs) with reasonable promptness in the normal course of business; or

(b) it is not practicable for C to provide such a pack (or packs) in response to the order (for example, because of patient needs or the method of administration of the drug).

(9) In the case of oral liquid methadone, C (in practice, a registered pharmacist) must decide whether it would be most appropriate to provide—

(a) each dose in a separate container;

(b) an original pack (or original packs); or

(c) the oral liquid methadone in some other way,

and C must then provide it in packaging that accords with that decision.

(10) C must only provide a Scheduled drug in response to an order by name, formula or other description on a prescription form or repeatable prescription if—

(a) it is ordered as specified in sub-paragraph (11); or

(b) in the case of a drug specified in Schedule 2 to the Prescription of Drugs Regulations M53 (drugs, medicines and other substances that may be ordered only in certain circumstances), it is ordered in the circumstances prescribed in that Schedule.

(11) A Scheduled drug that is a drug with an appropriate non-proprietary name may be provided in response to an order on a prescription form or repeatable prescription for a drug (“the prescribed drug”) that is not a Scheduled drug but which has the same non-proprietary name as the Scheduled drug if—

(a) the prescribed drug is ordered by that non-proprietary name or by its formula;

(b) the prescribed drug has the same specification as the Scheduled drug (so the Scheduled drug may be dispensed generically); and

(c) the Scheduled drug is not in a pack which consists of a drug in more than one strength, and providing it would involve the supply of part only of the pack.

(12) If a Scheduled drug is a combination of more than one drug, it can only be ordered as specified in sub-paragraph (11) if the combination has an appropriate non-proprietary name, whether or not the drugs in the combination each have such names.

(13) C must provide any drug which it is required to provide under paragraph 3 [F253 or 3B] [F254 , or provides under paragraph 3A,] in a suitable container.

[F255 (14) Where C provides a drug or appliance under paragraph 3A, C must include in the dispensing label on the packaging of the product, for the patient’s benefit, information to the effect that the product is being supplied in accordance with a SSP, identifying the particular SSP.]

[F256 (15) Sub-paragraphs (3) to (8) apply to the provision of a drug in accordance with a LPIV as they apply to the provision of a drug in accordance with a prescription form or a repeatable prescription (or an associated batch issue).]

Textual Amendments

F249 Words in Sch. 7 para. 6(2) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 7(4)(a)

F250 Words in Sch. 7 para. 6(3) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 7(4)(b)

F251 Words in Sch. 7 para. 6(8) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 7(4)(c)

F252 Word in Sch. 7 para. 6(8) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 11(3); 2020 c. 1, Sch. 5 para. 1(1)

F253 Words in Sch. 7 para. 6(13) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 10(3)(a)

F254 Words in Sch. 7 para. 6(13) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 7(4)(d)

F255 Sch. 7 para. 6(14) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 7(4)(e)

F256 Sch. 7 para. 6(15) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 10(3)(b)

Marginal Citations

M50 1985 c. 72.

M51 1971 c.38; see section 2(1)(a) of that Act, which defines “controlled drug” for the purposes of that Act.

M52 S.I. 2001/3998. Schedule 4 has been amended by S.I. 2003/1432, 2005/3372, 2007/2154 and 2009/3136, and Schedule 5 has been amended by S.I. 2005/2864.

M53 Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680 and

1043.

Refusal to provide drugs or appliances ordered U.K.

7.—(1) The LPS contractor (C) may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription where—

(a) C reasonably believes that it is not a genuine order for the person named on the prescription form or the repeatable prescription (for example because C reasonably believes it has been stolen or forged);

(b) it appears to C that—

(i) there is an error on the prescription form or on the repeatable prescription, or in the case of a non-electronic repeatable prescription, its associated batch issue (including a clinical error made by the prescriber), or

(ii) in the circumstances, providing the drugs or appliances would be contrary to the C's (in practice, a registered pharmacist's) clinical judgement;

(c) C or other persons on the premises are subjected to or threatened with violence by the person presenting the prescription form or repeatable prescription or requesting the provision of drugs or appliances in accordance with an electronic prescription form or a repeatable prescription, or by any person accompanying that person;

(d) the person presenting the prescription form or repeatable prescription or requesting the provision of drugs or appliances in accordance with an electronic prescription form or a repeatable prescription, or any person accompanying that person, commits or threatens to commit a criminal offence; or

(e) the prescription form or repeatable prescription is incomplete because it does not include the information relating to the identification of the prescriber that [F1 NHS England] (or a person exercising its functions) requires in order to perform its functions relating to—

(i) the remuneration of persons providing local pharmaceutical services, and

(ii) any apportionment of, or any arrangements for recharging in respect of, that remuneration,

unless C is to receive no pharmaceutical remuneration of any kind in respect of the drug or appliance.

(2) C must refuse to provide a drug ordered on a prescription form or repeatable prescription where the order is for a prescription only medicine which the prescriber was not entitled to prescribe.

[F257 (2A) C may refuse to provide a drug or appliance ordered on an electronic prescription if the access that C has to the Electronic Prescription Service is not such as to enable C to dispense that prescription promptly (or at all) [F258 , but where C does so, C must take all reasonable steps to ensure that the product ordered by the prescriber is supplied within a reasonable timescale, which may include (depending on what steps or combination of steps the circumstances require)—

(a) providing details of other LPS chemists or NHS pharmacists whose premises are situated in the same area and who may be able to provide the product ordered by the prescriber;

(b) urgent supply without a prescription in accordance with paragraph 4;

(c) arranging for the urgent provision of a non-electronic prescription form by the prescriber.]]

[F259 (2B) C must refuse to provide a drug or appliance ordered on a prescription form or a repeatable prescription where—

(a) a SSP has effect in respect of—

(i) the requested drug or appliance, or

(ii) drugs or appliances of a specified description, and the requested drug or appliance is of that description; and

(b) alternative provision has already taken place in accordance with the SSP.

(2C) C may refuse to provide a drug or appliance ordered on a prescription form or a repeatable prescription where—

(a) a SSP has effect in respect of—

(i) the requested drug or appliance, or

(ii) drugs or appliances of a specified description, and the requested drug or appliance is of that description;

(b) a registered pharmacist is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate; and

(c) C is unable to provide the drug or appliance within a reasonable timescale,

but if C does refuse to do so, C must provide the patient or the person requesting the drug or appliance on behalf of a patient with appropriate advice, as necessary, about reverting to the prescriber for the prescriber to review the patient’s treatment.]

(3) C must refuse to provide drugs or appliances ordered on a repeatable prescription where—

(a) C has no record of that prescription;

(b) C does not, in the case of a non-electronic repeatable prescription, have any associated batch issue and it is not presented to C;

(c) it is not signed by a prescriber;

(d) to do so would not be in accordance with any intervals specified in the prescription;

(e) it would be the first time a drug or appliance had been provided pursuant to the prescription and the prescription was signed (whether electronically or otherwise) more than 6 months previously;

(f) the repeatable prescription was signed (whether electronically or otherwise) more than one year previously;

(g) the expiry date on the repeatable prescription has passed; or

(h) C has been informed by the prescriber that the prescription is no longer required.

(4) Where a patient requests the supply of drugs or appliances ordered on a repeatable prescription (other than on the first occasion that he makes such a request), C must only provide the drugs or appliances ordered if C is satisfied—

(a) that the patient to whom the prescription relates—

(i) is taking or using, and is likely to continue to take or use, the drug or appliance appropriately, and

(ii) is not suffering from any side effects of the treatment which indicates the need or desirability of reviewing the patient's treatment;

(b) that the medication regimen of the patient to whom the prescription relates has not altered in a way which indicates the need or desirability of reviewing the patient's treatment; and

(c) that there have been no changes to the health of the patient to whom the prescription relates which indicate the need or desirability of reviewing the patient's treatment.

[F260 (5) C may refuse to provide a prescription item that is or is purportedly ordered on a LPIV where—

(a) C reasonably believes it is not a genuine order for the person who requests, or on whose behalf is requested, the provision of the prescription item;

(b) providing it would be contrary to C’s clinical judgement;

(c) C or other persons are subjected to or threatened with violence by the person who requests the provision of the prescription item, or by any person accompanying that person; or

(d) the person who requests the provision of the prescription item, or any person accompanying that person, commits or threatens to commit a criminal offence.

(6) C must refuse to provide a prescription item that is or is purportedly ordered on a LPIV where C is satisfied that C is not entitled to provide it or the prescriber was not entitled to prescribe it.]

[F261 (7) C may refuse to provide a prescription item ordered on a prescription form or repeatable prescription where—

(a) more than one prescription item has been ordered on the prescription form or repeatable prescription;

(b) at least one of those prescription items is a listed HRT prescription item and at least one of those prescription items is not; and

(c) the person named on the prescription form or repeatable prescription is claiming entitlement to exemption under regulation 10(1)(j) of the Charges Regulations (exemptions) in respect of any of those prescription items which is a listed HRT prescription item.]

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F257 Sch. 7 para. 7(2A) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(4)

F258 Words in Sch. 7 para. 7(2A) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 24

F259 Sch. 7 para. 7(2B)(2C) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 7(5)

F260 Sch. 7 para. 7(5)(6) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 10(4)

F261 Sch. 7 para. 7(7) inserted (1.4.2023) by The National Health Service (Amendments Relating to Pre-Payment Certificates, Hormone Replacement Therapy Treatments and Medicines Shortages) Regulations 2023 (S.I. 2023/171), regs. 1(1), 5

Further activities to be carried out in connection with the provision of dispensing services U.K.

8.  In connection with the services provided under paragraphs 3 to 7, the LPS contractor (C) must—

(a) ensure that appropriate advice is given to patients about any drugs or appliances provided to them—

(i) to enable them to utilise the drugs or appliances appropriately, and

(ii) to meet the patient's reasonable needs for general information about the drugs or appliances;

(b) provide appropriate advice to patients to whom they provide drugs or appliances on—

(i) the safe keeping of the drugs or appliances, and

(ii) returning unwanted drugs or appliances to the scheme premises for safe destruction;

(c) provide a patient with a written note [F262 (which may be in an electronic form)] of any drug or appliance which is owed, and inform the patient when it is expected that the drug or appliance will become available;

(d) keep and maintain records—

(i) of drugs and appliances provided, in order to facilitate the continued care of the patient,

(ii) in appropriate cases, of advice given and any interventions or referrals made (including clinically significant interventions in cases involving repeatable prescriptions), and

(iii) of notes provided under sub-paragraph (c);

(e) if C provides a drug or appliance under an electronic prescription, provide the patient, if the patient so requests, with a written record of the drugs or appliances ordered on that prescription and, in the case of an electronic repeatable prescription, of the number of occasions on which it can be dispensed; and

(f) ensure that where a person is refused drugs or appliances pursuant to paragraph 7(1)(b), (2), (3) or (4), the patient is referred back to the prescriber for further advice.

Textual Amendments

F262 Words in Sch. 7 para. 8(c) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 25

Additional requirements in relation to electronic prescribing U.K.

9.—(1) The LPS contractor (C) must, if requested to do so by any person—

F263 (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) where the Electronic Prescription Service is [F264 temporarily unavailable] through C's scheme premises, provide that person with contact details of at least two pharmacies in the area through which the service is available, if these details are known to C.

(2) F265 ... C must, if requested to do so by any person, enter in that person's PDS patient details—

(a) where the person does not have a nominated dispensing contractor, [F266 a nominated dispensing contractor]; or

(b) where the person does have a nominated dispensing contractor—

(i) a replacement dispensing contractor, or

(ii) a further dispensing contractor,

chosen by that person.

(3) Sub-paragraph (2)(b)(ii) does not apply if the number of nominated dispensing contractors for that person would thereby exceed the maximum number permitted by the Electronic Prescription Service.

(4) If C is a nominated dispensing contractor for a person (X) but the nomination was made before C became the person specified in an LPS scheme in relation to the scheme premises nominated in X's PDS patient details, C must within 6 months of C becoming the person so specified—

(a) explain to X that the ownership of the scheme premises has changed; and

(b) ask X whether X wishes to maintain the nomination in respect of those scheme premises.

[F267 (5) If C dispenses an electronic prescription or makes an urgent supply without a prescription, C must send the form duly completed by or on behalf of the patient, if one is required under regulation 3(3)(b) or (c), (5C) or (5E) of the Charges Regulations in respect of that prescription (which may be the associated EPS token), to the NHS BSA.]

Textual Amendments

F263 Sch. 7 para. 9(1)(a) omitted (9.11.2020) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 26(a)(i)

F264 Words in Sch. 7 para. 9(1)(b) substituted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 26(a)(ii)

F265 Words in Sch. 7 para. 9(2) omitted (9.11.2020) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 26(b)

F266 Words in Sch. 7 para. 9(2)(a) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(5)(a)

F267 Sch. 7 para. 9(5) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(5)(b)

Further activities in connection with repeat dispensing U.K.

10.  In connection with the services provided under paragraphs 3 to 7, the LPS contractor (C) must—

(a) provide appropriate advice to patients to whom C provides drugs or appliances in accordance with a repeatable prescription, in particular on the importance of only requesting those items which they actually need;

(b) undertake appropriate training in respect of repeat dispensing, having regard to any recommendations in respect of such training set out in the Drug Tariff;

(c) if C takes possession of a non-electronic repeatable prescription or an associated batch issue, securely store that repeatable prescription or associated batch issue;

(d) maintain records of repeatable prescriptions in such a form as to provide a clear audit trail of supplies under the repeatable prescription (including dates and quantities supplied);

(e) destroy any surplus batch issues relating to drugs or appliances—

(i) which are not required, or

(ii) where a patient is refused the drugs or appliances pursuant to paragraph 7;

(f) where a patient is provided with drugs or appliances under a repeatable prescription, notify the prescriber of any clinically significant issues arising in connection with the prescription and keep a record of that notification; and

(g) notify the prescriber of any refusal to provide drugs or appliances pursuant to paragraph 7(4).

[F268 Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc. U.K.

10A.— (1) Before dispensing any item on a prescription form or supplying it in accordance with a serious shortage protocol, an LPS contractor (C) must provide a home delivery option to eligible patients in respect of the item where, as a consequence of a disease being or in anticipation of a disease being imminently—

(a) pandemic; and

(b) a serious risk or potentially a serious risk to human health,

[F1 NHS England] with the agreement of the Secretary of State has made an announcement to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, eligible patients are advised to stay away from listed chemist premises in the area specified, in the circumstances specified and for the duration of the period specified in the announcement.

(2) If C’s listed chemist premises are in the area specified in the announcement, during the period when, in the circumstances specified in the announcement, eligible patients need to stay away from C’s premises, C must ascertain from—

(a) an eligible patient—

(i) who has contacted C about the home delivery of prescription items, or

(ii) who is a person whom C considered, on the basis of the nature of an item on a prescription form, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; or

(b) a person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted C about the home delivery of prescription items,

whether or not the item could be supplied by a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which C must provide.

(3) Where paragraph (2) does not apply, if C’s listed chemist premises are in the area specified in the announcement, during the period when, in the circumstances specified in the announcement, eligible patients need to stay away from C’s premises, the home delivery option that C must provide must comprise—

(a) C delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);

(b) C arranging for an item dispensed by C to be delivered by another LPS contractor or by an NHS pharmacist to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; or

(c) if C is unable to deliver the item or arrange for its delivery by another LPS contractor or by an NHS pharmacist, C arranging for the dispensing or supply of the item by another LPS contractor or by an NHS pharmacist who would be able to deliver the dispensed item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.

(4) Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at C’s [F269 chemist] premises for the purposes of receiving dispensing services.

(5) Notwithstanding the foregoing provisions of this Schedule, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, C may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale.]

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F268 Sch. 7 para. 10A inserted (27.3.2020) by The National Health Service (Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/351), regs. 1(2), 11

F269 Word in Sch. 7 para. 10A(4) substituted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 5(2)

[F270 Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc. U.K.

10AA.— (1) Before dispensing a notified item on a prescription form or supplying it in accordance with a serious shortage protocol, an LPS contractor (C) must provide a home delivery option to eligible patients in respect of that item.

(2) For the purposes of this paragraph, a “notified item” is an item that, as a consequence of a disease being or in anticipation of a disease being imminently—

(a) pandemic; and

(b) a serious risk or potentially a serious risk to human health,

is the subject of an announcement made by [F1 NHS England], with the agreement of the Secretary of State, to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, eligible patients are entitled to be provided with a home delivery option in respect of that item, if it is supplied to them as part of local pharmaceutical services.

(3) Where C is to, or may be required to, dispense a notified item on a prescription form or supply it in accordance with a serious shortage protocol, C must ascertain from—

(a) an eligible patient—

(i) who has contacted C about the home delivery of a notified item, or

(ii) who is a person whom C considered, on the basis of an order or request for a notifiable item, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; or

(b) a person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted C about the home delivery of a notified item,

whether or not the item could be supplied via a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which C must provide.

(4) Where paragraph (3) does not apply, the home delivery option that C must provide must comprise—

(a) C delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);

(b) C arranging for an item dispensed by C to be delivered by another LPS contractor or by an NHS pharmacist to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; or

(c) if C is unable to deliver the item or arrange for its delivery by another LPS contractor or by an NHS pharmacist, C arranging for the dispensing or supply of the item by another LPS contractor or by an NHS pharmacist who would be able to deliver the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.

(5) Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at C’s chemist premises for the purposes of being supplied with the notifiable item.

(6) Notwithstanding the foregoing provisions of this Schedule, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, C may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale.]

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F270 Sch. 7 para. 10AA inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 5(3)

Information to be provided for [F1 NHS England’s] lists U.K.

11.—(1) The LPS contractor (C) must ensure that C provides to [F1 NHS England], on request, an up to date record of—

(a) the services that C provides; and

(b) the days on which and times at which those services are provided.

(2) Sub-paragraph (1) is without prejudice to the need for a variation of the LPS scheme if C wishes to change—

(a) the services that C provides; and

(b) the days on which and times at which those services are provided.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Clinical governance U.K.

12.—(1) The LPS contractor must participate, in the manner reasonably required by [F1 NHS England] in an acceptable system of clinical governance.

(2) In this paragraph, “system of clinical governance” means a framework through which an LPS contractor endeavours to improve continuously the quality of the LPS contractor's services and safeguards high standards of care by creating an environment in which clinical excellence can flourish.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Professional Standards U.K.

13.  The LPS contractor must provide local pharmaceutical services and exercise any professional judgement in connection with the provision of such services in conformity with the standards generally accepted in the pharmaceutical profession.

[F271 Accessing summary care records U.K.

13A.— [F272 (1) An LPS chemist (C) must have access to summary care records at C’s scheme premises, and must ensure that the access that C has to summary care records at those premises is constant and reliable during the hours when the scheme premises are open to the public, in so far as that is within the control of C.

(2) C must access the summary information in a patient’s summary care record whenever C is providing local pharmaceutical services to the patient, to the extent that C, in the exercise of C’s clinical judgement, considers it appropriate to do so.]

(3) In this paragraph, a “summary care record” and “summary information” mean a summary care record and summary information within the meanings given in—

(a) regulation 68 of the GMS Regulations (summary care records); and

(b) regulation 61 of the PMS Regulations (summary care records).]

Textual Amendments

F271 Sch. 7 para. 13A inserted (1.4.2016) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2016 (S.I. 2016/296), regs. 1(1)(a), 5(3)

F272 Sch. 7 para. 13A(1)(2) substituted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 27

[F273 Electronic Prescription Service access U.K.

13B.   An LPS chemist (C) must have access to the EPS at C’s scheme premises, and must ensure that the access that C has to the EPS at those premises is constant and reliable during the hours when the scheme premises are open to the public, in so far as that is within the control of C.]

Textual Amendments

F273 Sch. 7 paras. 13B, 13C inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 28

[F273 Contact via NHSmail and the Central Alerting System U.K.

13C.— (1) An LPS chemist (C) must ensure that pharmacy staff at listed premises (including locums) have access to, and are able to send and receive NHSmail from, a premises specific NHSmail account.

(2) C must ensure that at least two members of the pharmacy staff have live, linked NHSmail accounts to the premises specific NHSmail account (unless fewer than two members of the pharmacy staff are engaged in the provision of NHS services).

(3) As regards the Central Alerting System (CAS) operated by the Medicines and Healthcare products Regulatory Agency (MHRA)—

(a) C must register C’s premises specific NHSmail address with MHRA as an address at which C is content to accept notifications as part of the CAS (unless they are content with the address already in the system);

(b) if C changes C’s premises specific NHSmail address, P must immediately notify MHRA of C’s new premises specific NHSmail address, in accordance with paragraph (a); and

(c) C must monitor C’s premises specific NHSmail account with sufficient frequency to ensure the safe and effective supply of medicinal products at or from C’s pharmacy premises, and must act on the alerts C receives as part of the CAS, as appropriate.]

Textual Amendments

F273 Sch. 7 paras. 13B, 13C inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 28

Inducements etc U.K.

14.—(1) The LPS contractor (C) (including C's staff) must not give, promise or offer to any person any gift or reward (whether by way of a share of or dividend on the profits of C's business or by way of discount or rebate or otherwise) as an inducement to or in consideration of a person (X)—

(a) presenting an order for drugs or appliances on a non-electronic prescription form or non-electronic repeatable prescription;

(b) nominating C as X's dispensing contractor (or one of them) in X's PDS patient details; or

(c) being provided with any LP service by C.

(2) Promising, offering or providing an auxiliary aid in relation to the supply of drugs or a home delivery service is not a gift or reward for the purposes of sub-paragraph (1).

(3) C (including C's staff) must not give, promise or offer to any relevant person any gift or reward (including by way of a share of, or dividend on, the profits of C's business, or by way of a discount or rebate) as an inducement to or in consideration of the relevant person recommending to any person that they—

(a) present to C an order for drugs or appliances on a prescription form or repeatable prescription;

(b) nominate C as their dispensing contractor (or one of them) on their PDS patient details; or

(c) are provided with any LP service by C.

(4) For the purpose of sub-paragraph (3), “relevant person” means any person who performs or provides NHS services, whether on their own behalf or on behalf of another, and includes—

(a) any NHS body or provider of primary medical services; and

(b) any person employed or engaged by any of the persons mentioned in paragraph (a).

Duty to provide information about fitness to practise matters as they arise U.K.

15.—(1) The LPS contractor (C) must within 7 days of its occurrence supply in writing information to [F1 NHS England] as to whether a person (P) who is a relevant person in relation to C—

(a) has been convicted of any criminal offence in the United Kingdom;

(b) has been convicted elsewhere of an offence which would constitute a criminal offence if committed in England and Wales;

(c) has been charged with an offence and is currently the subject of any proceedings which might lead to a conviction, which have not yet been notified to [F1 NHS England];

(d) has accepted a police caution in the United Kingdom;

(e) has become subject to an order under section 246(2) or (3) of the Criminal Procedure (Scotland) Act 1995 M54 (admonition and absolute discharge) discharging R absolutely;

(f) has accepted a conditional offer under section 302 of the Criminal Procedure (Scotland) Act 1995 M55 (fixed penalty: conditional offer by procurator fiscal);

(g) has agreed to pay a penalty under section 115A of the Social Security Administration Act 1992 M56 (penalty as alternative to prosecution);

(h) has, to P's knowledge, become subject to any investigation into P's professional conduct by any licensing body or is notified of the outcome of such an investigation where it is adverse;

(i) has, to P's knowledge, become subject to an investigation into P's professional conduct in respect of any current or previous employment or is notified of the outcome of such an investigation where it is adverse;

(j) has, to P's knowledge, become subject to any investigation by the NHS BSA in relation to fraud or is notified of the outcome of such an investigation where it is adverse;

(k) has, to P's knowledge, become the subject of any investigation by another primary care organisation, which might lead to P's removal from any relevant list; or

(l) either—

(i) has been removed or contingently removed from, refused admission to, or conditionally included in, any relevant list of another primary care organisation,

(ii) has been suspended from such a list, on fitness to practise grounds, and if so, why and the name of that other primary care organisation, or

(iii) has become the subject of a national disqualification,

and if so, C must give details of any investigation or proceedings which are being or were undertaken or brought, including the nature of that investigation or proceedings, where and approximately when that investigation or those proceedings commenced, and any outcome.

(2) P is a “relevant person” in relation to C for these purposes, in the case of a contractor that is—

(a) an individual, if P is C;

(b) a partnership, if P is a partner in C;

(c) a body corporate, if P is a director, the chief executive, the company secretary or the superintendent pharmacist of C.

(3) C or any relevant person must consent to a request being made by [F1 NHS England] to any employer or former employer or licensing body in the United Kingdom or elsewhere, for information relating to a current investigation, or an investigation where the outcome was adverse.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Marginal Citations

M54 1995 c. 46; section 246(2) and (3) have been amended by the Criminal Justice and Licensing (Scotland) Act 2010 (asp 13), Schedule 2, paragraph 26.

M55 1995 c. 46. Section 302 has been amended by: the Communications Act 2003 (c. 21), Schedule 17, paragraph 133; the Wireless Telegraphy Act 2006 (c. 36), Schedule 7, paragraph 16; the Criminal Proceedings etc. (Reform) (Scotland) Act 2007 (asp 6), section 50(1); and the Criminal Justice and Licensing (Scotland) Act 2010 (asp 13), section 70(3).

M56 1992 c. 5. Section 115A was inserted by the Social Security Administration (Fraud) Act 1997 (c. 47), section 15, and amended by the Social Security Fraud Act 2001 (c. 11) (“the 2001 Act”), section 14. The amendments made by the 2001 Act are to be repealed by, and other amendments to section 115A are to be made by, the Welfare Reform Act 2012 (c. 5), sections 113 to 115, and Schedule 14, Part 1.

Co-operation with [F274 NHS England] U.K.

16.  The LPS contractor must co-operate with [F274 NHS England] in the discharge by [F274 NHS England] of the duty under section 1F(1) of the 2006 Act M57 (duty as to education and training).

Textual Amendments

F274 Words in Sch. 7 para. 16 substituted (1.4.2023) by The Health Education England (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/368), reg. 1(2), Sch. 2 para. 14(5) (with reg. 7)

Marginal Citations

M57 Section 1F was inserted by the Health and Social Care Act 2012 (c. 7), section 7.

Charges for drugs, appliances and containers, and ownership of containers U.K.

17.—(1) Subject to regulations made under Part 9 of the 2006 Act (charging), all drugs, containers and appliances provided under these terms of service must be provided free of charge.

(2) Where the LPS contractor supplies a container in response to an order for drugs signed by a prescriber, other than equipment specified in the Drug Tariff as not returnable to the contractor, the container and equipment must remain the property of the LPS contractor.

Refunds of prescription charges U.K.

18.—(1) Where any person who is entitled to a repayment of any charge paid under the Charges Regulations presents the LPS contractor with a valid claim for the repayment within three months of the date on which the charge was paid, the LPS contractor must make the repayment.

(2) For the purposes of sub-paragraph (1), a claim for repayment is only valid if duly made—

(a) in such form and manner as the Secretary of State has determined for an application for such a repayment under [F275 regulation 18(2)(b)] of the Charges Regulations M58 (repayment of charges); or

(b) on the equivalent form issued in Scotland, Wales or Northern Ireland.

Textual Amendments

F275 Words in Sch. 7 para. 18(2)(a) substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(7)(b)

Marginal Citations

M58 Regulation 10 has been amended by S.I. 2000/3189, 2002/2352 and 2004/696.

Remuneration, overpayments etc U.K.

19.—(1)  [F1 NHS England] must ensure that the LPS scheme requires it to remunerate the LPS contractor (C) promptly, in accordance with the remuneration arrangements provided for in the scheme, but subject to the arrangements for reductions of and deductions from payments provided for in the scheme.

(2) [F1 NHS England] must ensure that the LPS scheme requires that payment of any item of remuneration which would, if it were payable to an NHS pharmacist in connection with providing pharmaceutical services, be pharmaceutical reimbursement, is to be paid in accordance with the Drug Tariff.

(3) For these purposes, “pharmaceutical reimbursement” means pharmaceutical remuneration of the type which may be payable to NHS chemists in accordance with determinations by (only) the Secretary of State under section 164 of the 2006 Act M59 (remuneration for persons providing pharmaceutical services).

(4) Where an LPS scheme requires a fee, allowance or other item of remuneration to be made in accordance with the Drug Tariff and the Drug Tariff provides that the fee, allowance or other item of remuneration is to be determined by [F1 NHS England], that fee, allowance or other item of remuneration must be determined by [F1 NHS England].

(5) [F1 NHS England] must ensure that the LPS scheme—

(a) allows it to recover any payment made to C which should not have been made;

(b) provides that any such recovery of an overpayment is without prejudice to any investigation of any alleged breach of the scheme; and

(c) provides that the remuneration arrangements under the scheme, referred to in sub-paragraphs (1) to (4), are subject to any right [F1 NHS England] may have to set off against any amount payable to C, any amount—

(i) owed by C to it, or

(ii) which it is entitled to withhold under the terms of the scheme (including terms of the Drug Tariff applied by the scheme).

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Marginal Citations

M59 Section 164 has been amended by: the Health and Social Care Act 2008 (c. 14), section 141, and Schedule 15, Part 4; and by the Health and Social Care Act 2012 (c. 7), Schedule 4, paragraph 89.

Local resolution of disputes U.K.

20.  In the case of any dispute arising out of, or in connection with, the LPS scheme, the LPS contractor and [F1 NHS England] must made every reasonable effort to communicate and co-operate with each other with a view to resolving the dispute, before referring the dispute for determination in accordance with the NHS dispute resolution procedure (or, where applicable, before commencing court proceedings).

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Dispute resolution: non-NHS contracts U.K.

21.— [F276 (1) In the case of an LPS scheme that is not an NHS contract, any dispute arising out of or in connection with the scheme, except matters dealt with under the complaints procedure pursuant to paragraph 25, may be referred for consideration and determination to the Secretary of State—

(a) if it relates to a period when the contractor was treated as a health service body, by the contractor or by [F1 NHS England]; or

(b) in any other case, by the contractor or, if the contractor agrees in writing, by [F1 NHS England].]

(2) In the case of a dispute referred to the Secretary of State under sub-paragraph (1)—

(a) the procedure to be followed is the NHS dispute resolution procedure; and

(b) the parties must agree to be bound by any determination made by the adjudicator.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F276 Sch. 7 para. 21(1) substituted (1.3.2015) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015 (S.I. 2015/58), regs. 1(1), 9 (with reg. 10)

NHS dispute resolution procedure U.K.

22.—(1) The procedure specified in this paragraph and paragraph 23 applies in the case of any dispute arising out of or in connection with an LPS scheme which is referred to the Secretary of State—

(a) in accordance with section 9(6) of the 2006 Act (NHS contracts), where the scheme is an NHS contract; or

(b) in accordance with paragraph 21(1), where the scheme is not an NHS contract.

(2) Any party wishing to refer a dispute as mentioned in sub-paragraph (1) must send to the Secretary of State a written request for dispute resolution which must include or be accompanied by—

(a) the names and addresses of the parties to the dispute;

(b) a copy of the LPS scheme; and

(c) a brief statement describing the nature and circumstances of the dispute.

(3) Any party wishing to refer a dispute as mentioned in sub-paragraph (1) must send the request under sub-paragraph (2) within a period of 3 years beginning with the date on which the matter giving rise to the dispute happened or should reasonably have come to the attention of the party wishing to refer the dispute.

(4) Where the dispute relates to an LPS scheme which is not an NHS contract, the Secretary of State may determine the matter himself or, if the Secretary of State considers it appropriate, appoint a person or persons to consider and determine it.

(5) Before reaching a decision as to who should determine the dispute, either under sub-paragraph (4) or under section 9(8) of the 2006 Act, the Secretary of State must, within the period of 7 days beginning with the date on which a matter was referred to the Secretary of State, send a written request to the parties to make in writing, within a specified period, any representations which they may wish to make about the matter.

(6) The Secretary of State must give, with the notice given under sub-paragraph (5) to the party other than the one which referred the matter to dispute resolution a copy of any document by which the matter was referred to dispute resolution.

(7) The Secretary of State must give a copy of any representations received from a party to the other party and must in each case request (in writing) a party to whom a copy of the representations is given to make within a specified period any written observations which it wishes to make on those representations.

(8) Following receipt of any representations from the parties or, if earlier, at the end of the period for making such representations specified in the request sent under sub-paragraph (5) or (7), the Secretary of State must, if the Secretary of State decides to appoint a person or persons to hear the dispute—

(a) inform the parties in writing of the name of the person or persons whom the Secretary of State has appointed; and

(b) pass to the person or persons so appointed any documents received from the parties pursuant to sub-paragraph (2), (5) or (7).

(9) For the purpose of assisting them in their consideration of the matter, the adjudicator may—

(a) invite representatives of the parties to appear before the adjudicator to make oral representations either together or, with the agreement of the parties, separately, and may in advance provide the parties with a list of matters or questions to which the adjudicator wishes them to give special consideration; or

(b) consult other persons whose expertise the adjudicator considers will assist the adjudicator's consideration of the matter.

(10) Where the adjudicator consults another person under sub-paragraph (9)(b), the adjudicator must notify the parties accordingly and, where the adjudicator considers that the interests of any party might be substantially affected by the result of the consultation, the adjudicator must give to the parties such opportunity as the adjudicator considers reasonable in the circumstances to make observations on those results.

(11) In considering the matter, the adjudicator must consider—

(a) any written representations made in response to a request under sub-paragraph (5), but only if they are made within the specified period;

(b) any written observations made in response to a request under sub-paragraph (7), but only if they are made within a specified period;

(c) any oral representations made in response to an invitation under sub-paragraph (9)(a);

(d) the results of any consultation under sub-paragraph (9)(b); and

(e) any observations made in accordance with an opportunity given under sub-paragraph (10).

(12) In this paragraph, “specified period” means such period as the Secretary of State must specify in the request, being not less than 2, nor more than 4 weeks beginning with the date on which the notice referred to is given, but the Secretary of State may, if the Secretary of State considers that there is good reason for doing so, extend any such period (even after it has expired) and, where the Secretary of State does so, a reference in this paragraph to the specified period is to the period as so extended.

(13) Subject to the other provisions of this paragraph and paragraph 23, the adjudicator is to have wide discretion in determining the procedure of the dispute resolution to ensure the just, expeditious, economical and final determination of the dispute.

Determination of dispute U.K.

23.—(1) The adjudicator must record the adjudicator's determination, and the reasons for it, in writing and must give notice of the determination (including a record of the reasons) to the parties.

(2) In the case of a scheme referred for determination in accordance with paragraph 21(1), section 9(11) of the 2006 Act must apply as that subsection applies in the case of an LPS scheme referred for determination in accordance with section 9(6) of that Act.

Disputes: supplemental U.K.

24.—(1) In this Schedule, where reference is made to any dispute arising out of, or in connection with, an LPS scheme, that includes any dispute arising out of, or in connection with, the termination of the scheme.

(2) Any term of the LPS scheme that makes provision in respect of the requirements in paragraphs 20 to 23 must survive even where the scheme has terminated.

Complaints U.K.

25.—(1) The LPS contractor must have in place arrangements which comply with the requirements of the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 M60 , for the handling and consideration of any complaints.

(2) In this paragraph, “complaint” means a complaint about a matter connected with the provision of local pharmaceutical services by the LPS contractor.

Marginal Citations

M60 S.I. 2009/309; amended by S.I. 2009/1768.

Variation of LPS schemes U.K.

26.—(1) Subject to sub-paragraphs (2) to (4), no amendment or variation to the LPS scheme is to have effect unless it is in writing and signed by or on behalf of [F1 NHS England] and the (relevant) LPS contractor (C).

(2) [F1 NHS England] may vary an LPS scheme without C's consent where it—

(a) is reasonably satisfied that it is necessary to vary the scheme so as to comply with the 2006 Act, any regulations made under that Act, or any direction given by the Secretary of State under that Act; and

(b) notifies C in writing of the wording of the proposed variation and the date upon which that variation is to take effect,

and, where it is reasonably practicable to do so, the date that the proposed variation is to take effect must be not less than 14 days after the date on which the notice under paragraph (b) is served on C.

(3) During an emergency requiring the flexible provision of pharmaceutical services, [F1 NHS England] may, on application from C—

(a) permit C a temporary change to the days on which or times at which C is obliged to provide local pharmaceutical services at the scheme premises, or permit temporary closure of those premises, if—

(i) C gives at least 24 hours notice of the change or closure, and

(ii) the reasons given by C for the request are, in the opinion of [F1 NHS England] adequate reasons; or

(b) permit C any other temporary variation to C's LPS scheme that, in the opinion of [F1 NHS England], will facilitate continuity of the provision of services of a kind that may be provided under section 126, or by virtue of section 127, of the 2006 Act M61 (arrangements for pharmaceutical services and additional pharmaceutical services) during the emergency.

(4) [F1 NHS England] need not approve the request referred to in sub-paragraph (3)(a)(ii) in advance of the change or closure, but if it does not do so and decides subsequently that C's reasons are not, in its opinion, adequate reasons, then the days on which or times at which C is obliged to provide local pharmaceutical services at the scheme premises are to revert to the overridden days and times, from the day after the date on which that decision is given to C.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Marginal Citations

M61 Section 126 has been amended by the Health and Social Care Act 2012 (c. 7) (“the 2012 Act”), sections 220(7) and 213(7)(k), and Schedule 4, paragraph 63. Section 127 has been amended by the 2012 Act, Schedule 4, paragraph 64.

Termination by agreement U.K.

27.   [F1 NHS England] and the LPS contractor may agree in writing to terminate the LPS scheme (or end the LPS contractor's participation in it, in the case of more than one LPS contractor being party to the scheme), and if the parties so agree, they must agree the date upon which that termination should take effect and any further terms upon which the scheme should be terminated.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Termination by serving notice U.K.

28.—(1) Either the LPS contractor or [F1 NHS England] may terminate the LPS scheme (or end the LPS contractor's participation in it, in the case of more than one LPS contractor being party to the scheme), at any time by serving notice of not less than 6 months in writing to the other party.

(2) Where a notice is served pursuant to sub-paragraph (1), the LPS scheme must terminate on the expiry of the notice period.

(3) This paragraph is without prejudice to any other rights to terminate the agreement which the LPS contractor and [F1 NHS England] may have.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Termination of arrangements by [F1 NHS England] on grounds of suitability etc U.K.

29.—(1)  [F1 NHS England] may serve notice in writing on the LPS contractor terminating the LPS scheme (or ending the LPS contractor's participation in it, in the case of more than one LPS contractor being party to the scheme) with immediate effect, or from such date as may be specified in the notice, if, in the case of an LPS scheme (or an agreement that is part of an LPS scheme) entered into—

(a) with an individual as a party, that individual;

(b) with more than one individual (whether or not practising in partnership), any of those individuals; or

(c) with a body corporate—

(i) the body corporate, or

(ii) any director, chief executive, superintendent or company secretary of the body corporate,

falls within sub-paragraph (2) during the existence of the scheme (or the agreement).

(2) A person (X) falls within this sub-paragraph if—

(a) X is the subject of a national disqualification;

(b) subject to sub-paragraph (3), X is disqualified or suspended (other than by an interim suspension order or direction pending an investigation) from practising by any licensing body anywhere in the world;

(c) X is removed from, or refused admission to, a relevant list by reason that amounts to inefficiency, fraud or unsuitability (as understood by reference to the conditions in section 151(2) to (4) of the 2006 Act (disqualification of practitioners)), unless X has subsequently been included in such a list;

(d) X has been convicted in the United Kingdom of murder or a criminal offence other than murder—

(i) which was committed on or after 1st April 2006, and

(ii) for which X has been sentenced to a term of imprisonment of over six months;

(e) subject to sub-paragraph (4), X has been convicted outside the United Kingdom of an offence which, if committed in England and Wales—

(i) would constitute murder, or

(ii) would constitute an offence, and—

(aa) which was committed on or after 1st April 2006, and

(bb) for which X has been sentenced to a term of imprisonment of over six months;

(f) X has been convicted of an offence referred to in—

(i) Schedule 1 to the Children and Young Persons Act 1933 M62 (offences against children and young persons with respect to which special provisions of this Act apply), or

(ii) Schedule 1 to the Criminal Procedure (Scotland) Act 1995 M63 (offences against children under the age of 17 years to which special provisions apply),

which was committed on or after 1st April 2006;

(g) X—

(i) has been [F277 made] bankrupt, or sequestration of X's estate has been ordered, unless X has been discharged from the bankruptcy or the order has been annulled,

(ii) has become a person in relation to whom a moratorium period under a debt relief order (under Part 7A of the Insolvency Act 1986 M64 (debt relief orders)) applies,

(iii) has been made the subject of a bankruptcy restrictions order, an interim bankruptcy restrictions order, a debt relief restrictions order or an interim debt relief restrictions order under Schedule 4A or 4ZB to the Insolvency Act 1986 M65 or Schedule 2A of the Insolvency (Northern Ireland) Order 1989 M66 (which relate to bankruptcy and debt relief restrictions orders and undertakings), which has not been annulled,

(iv) if X is a body corporate, has been wound up under Part 4 of the Insolvency Act 1986;

(v) has made a composition or arrangement with, or granted a trust deed for, X's creditors and X has not been discharged in respect of it;

(h) in respect of X there is—

(i) an administrator, administrative receiver or receiver appointed, or

(ii) an administration order made under Schedule B1 to the Insolvency Act 1986 M67 (administration);

(i) X has been removed—

(i) from the office of charity trustee or trustee for a charity by an order made by the Charity Commissioners, the Charity Commission, the Charity Commission for Northern Ireland or the High Court on the grounds of any misconduct or mismanagement in the administration of the charity—

(aa) for which the person was responsible or to which the person was privy, or

(bb) which the person by their conduct contributed to or facilitated, or

(ii) under—

(aa) section 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990 M68 (powers of Court of Session to deal with management of charities), or

(bb) section 34(5)(e) or (ea) of the Charities and Trustee Investment (Scotland) Act 2005 M69 (powers of the Court of Session),

from being concerned with the management or control of any body;

(j) X has been subject to—

(i) a disqualification order or disqualification undertaking under the Company Directors Disqualification Act 1986 M70 or the Company Directors Disqualification (Northern Ireland) Order 2002 M71 , or

(ii) an order made under section 429(2) of the Insolvency Act 1986 M72 (disabilities on revocation of a county court administration order);

(k) X (in the case of an individual) has refused to comply with a request by [F1 NHS England] for X to be medically examined on the grounds that it is concerned that X is incapable of adequately providing services under the scheme; or

(l) it comes to the attention of [F1 NHS England] that information provided to it pursuant to—

(i) regulation 12 or 17 of the 2006 Regulations,

(ii) a term of the scheme required by paragraph 16 of Schedule 2 to the 2006 Regulations,

(iii) regulation 106, or

(iv) paragraph 15,

was, when given, untrue or inaccurate in a material respect.

(3) [F1 NHS England] is not to terminate the LPS scheme (or end an LPS contractor's participation in it) pursuant to sub-paragraph (2)(b) where it is satisfied that the disqualification or suspension imposed by a licensing body outside the United Kingdom does not make X unsuitable to be—

(a) an LPS contractor; or

(b) in the case of an LPS scheme (or agreement) with a body corporate, a director, chief executive, superintendent or company secretary of a contractor.

(4) [F1 NHS England] is not to terminate the scheme pursuant to sub-paragraph (2)(e) where it is satisfied that the conviction does not make X unsuitable to be—

(a) an LPS contractor; or

(b) in the case of an LPS scheme (or agreement) with a body corporate, a director, chief executive, superintendent or company secretary of an LPS contractor.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F277 Word in Sch. 7 para. 29(2)(g) substituted (6.4.2016) by The Enterprise and Regulatory Reform Act 2013 (Consequential Amendments) (Bankruptcy) and the Small Business, Enterprise and Employment Act 2015 (Consequential Amendments) Regulations 2016 (S.I. 2016/481), reg. 1, Sch. 2 para. 13

Marginal Citations

M62 1933 c. 12. Schedule 1 has been amended by: the Sexual Offences Act 1956 (c. 69), Schedule 4; the Criminal Justice Act 1988 (c. 33), Schedule 15, paragraph 8, and Schedule 16; the Sexual Offences Act 2003 (c. 42), Schedule 6, paragraph 7; the Domestic Violence, Crime and Victims Act 2004 (c. 28), Schedule 10, paragraph 2; the Coroners and Justice Act 2009 (c. 25), Schedule 21, paragraph 53; and the Protection of Freedoms Act 2012 (c. 9), Schedule 9, paragraph 136.

M63 1995 c. 46.

M64 1986 c. 45. Part 7A was inserted by the Tribunals, Courts and Enforcement Act 2007 (c. 15), Schedule 17.

M65 Schedule 4A was inserted by Schedule 20 to the Enterprise Act 2002 (c.40). Schedule 4ZB was inserted by the Tribunals, Courts and Enforcement Act 2007 (c. 15), Schedule 19.

M66 S.I. 1989/2405 (N.I. 19); Schedule 2A was inserted by S.I. 2005/1455 (N.I. 10).

M67 Schedule B1 was inserted by the Enterprise Act 2002 (c. 40), Schedule 16.

M68 1990 c.40; section 7 was repealed by the Charities and Trustee Investment (Scotland) Act 2005 (asp 10), Schedule 4, paragraph 7(b).

M69 2005 asp 10; section 34(5) has been amended by the section the Public Services Reform (Scotland) Act 2010 (asp 8), section 122.

M70 1986 c.46.

M71 S.I. 2002/3150 (N.I. 4); relevant amendments were made by S.I. 2005/1454 (N.I. 9).

M72 Section 429(2) was amended by the Enterprise Act 2002 (c.40), Schedule 23, paragraph 15.

Termination by [F1 NHS England]: patient safety and material financial loss U.K.

30.   [F1 NHS England] may serve notice in writing on the LPS contractor (C) terminating the LPS scheme (or ending the LPS contractor's participation in it, in the case of more than one LPS contractor being party to the scheme) with immediate effect or with effect from such date as may be specified in the notice if—

(a) C has breached the scheme and as a result of that breach, the safety of C's patients is at serious risk if the scheme is not terminated (or C's participation in it is not ended, in the case of more than one LPS contractor being party to the scheme); or

(b) C's financial situation is such that [F1 NHS England] considers that [F1 NHS England] is at risk of material financial loss.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Termination and the NHS dispute resolution procedure U.K.

31.—(1) Where [F1 NHS England] is entitled to serve written notice on the LPS contractor (C) terminating the LPS scheme (or ending C's participation in it) pursuant to paragraph 29 or 30, it must, in the notice served on C pursuant to those provisions, specify a date on which the scheme terminates (or C's participation in it is to end) that is not less than 28 days after the date on which [F1 NHS England] has served that notice on C, unless sub-paragraph (2) applies.

(2) This sub-paragraph applies if [F1 NHS England] is satisfied that a period less than 28 days, or termination with immediate effect, is necessary in order to—

(a) protect the safety of the C's patients; or

(b) protect itself from material financial loss.

(3) In a case falling within sub-paragraph (1), where—

(a) the exceptions in sub-paragraph (2) do not apply;

(b) C invokes the NHS dispute resolution procedure before the end of the period of notice referred to in sub-paragraph (1); and

(c) C notifies [F1 NHS England] in writing that it has done so,

subject to paragraph (5), the LPS scheme (or C's participation in it) is not to terminate at the end of the notice period but instead is only to terminate in the circumstances specified in sub-paragraph (4).

(4) Subject to paragraph (5), the LPS scheme (or C's participation in it) is only to terminate if and when—

(a) there has been a determination of the dispute pursuant to paragraph 23 and that determination permits [F1 NHS England] to terminate the scheme; or

(b) C ceases to pursue the NHS dispute resolution procedure,

whichever is the sooner.

(5) If [F1 NHS England] is satisfied that it is necessary to terminate the scheme before the NHS dispute resolution procedure is concluded in order to—

(a) protect the safety of the C's patients; or

(b) protect itself from material financial loss,

sub-paragraphs (3) and (4) shall not apply and [F1 NHS England] is entitled to confirm, by written notice to be served on C, that the LPS scheme (or C's participation in it) will nevertheless terminate at the end of the period of the notice it served pursuant to paragraph 29(1) or 30.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Third party rights U.K.

32.  The LPS scheme shall not create any right enforceable by any person not a party to it.

Regulation 91(1)(a)

SCHEDULE 8 U.K. Service remuneration determined by [F1 NHS England]

1.—(1) Any fees and allowances payable to NHS pharmacists for professional services provided as part of the provision of pharmaceutical services. U.K.

(2) Without prejudice to the generality of sub-paragraph (1), those fees and allowances may include—

(a) fees in connection with the dispensing of drugs and appliances, including any additional fees relating to the dispensing of particular types of drug or appliance;

(b) payments made to NHS pharmacists in respect of their providing particular types of advice or assistance to patients or in respect of their participation in particular activities or schemes; and

(c) payments made to NHS pharmacists that are a contribution to the overall cost of professional services provision (which may be calculated by reference to particular levels of activity).

(3) For the purposes of sub-paragraph (1), “professional services” does not include providing pre-registration training experience for pharmacy graduates or undergraduates.

2.—(1) Any fees and allowances payable to NHS appliance contractors for professional services provided as part of the provision of pharmaceutical services. U.K.

(2) Without prejudice to the generality of sub-paragraph (1), those fees and allowances may include—

(a) fees in connection with the dispensing of appliances, including any additional fees relating to the dispensing of particular types of appliance;

(b) payments made to NHS appliance contractors in respect of their providing particular types of advice or assistance to patients or in respect of their participation in particular activities or schemes; and

(c) payments made to NHS appliance contractors that are a contribution to the overall cost of professional services provision (which may be calculated by reference to particular levels of activity).

Regulation 119

SCHEDULE 9 U.K. Transitional provisions

The continuity principles U.K.

1.—(1) Where by virtue of this Schedule—

(a) a matter is to be dealt with in accordance with the 2006 Regulations or the 2012 Regulations; or

(b) a matter (by virtue of having been dealt with in accordance with Schedule 7 to the 2012 Regulations (transitional provisions)), is to be dealt with in accordance with the 2005 Regulations or the SCAT Regulations,

if that matter under those Regulations would fall to be dealt with by a Primary Care Trust, unless the context requires otherwise, that matter is to be dealt with instead by [F1 NHS England].

(2) Any matter that is ongoing under the 2006 Regulations or the 2012 Regulations (including, by virtue of Schedule 7 of those Regulations, under the 2005 Regulations or the SCAT Regulations) immediately before the appointed day, unless the context requires otherwise—

(a) is to be treated as ongoing under these Regulations on the appointed day (and where appropriate after that); and

(b) where that matter becomes the responsibility of [F1 NHS England] on the appointed day, anything done in relation to that matter by or with regard to a Primary Care Trust before the appointed day is to be treated as having been done (for the purposes of the ongoing treatment of the matter) by or with regard to [F1 NHS England].

(3) Where a period of time specified in a provision of the 2006 Regulations or the 2012 Regulations is current on the appointed day, and a period of time is also specified in a corresponding provision of these Regulations, unless the context requires otherwise, these Regulations have effect as if the corresponding provision of these Regulations had been in force when that period began to run.

(4) Where—

(a) consideration of a matter under a provision of these Regulations in respect of a specified period of time requires consideration of a period of time before the appointed day; and

(b) a corresponding provision of the 2006 Regulations or the 2012 Regulations also required consideration of that matter in respect of a specified period of time,

unless the context requires otherwise, the provision of these Regulations has effect as if it had been in force when the period of time specified in it began to run.

(5) Subject to sub-paragraphs (6) and (7), where on or after the appointed day—

(a) a matter is to be dealt with in accordance with the SCAT Regulations, the 2005 Regulations, the 2006 Regulations or the 2012 Regulations; or

(b) a matter that relates to circumstances that arose, or first arose, before the appointed day is to be dealt with in accordance with these Regulations or the Drug Tariff,

in dealing with that matter [F1 NHS England] (or where appropriate, on appeal, the Secretary of State or the First-tier Tribunal) is to apply those Regulations, the Drug Tariff and related provisions of the 2006 Act subject to such modifications as it (or where appropriate, on appeal, the Secretary of State or the First-tier Tribunal) considers necessary or expedient.

(6) Modifications pursuant to paragraph (5) must—

(a) be for a purpose related to—

(i) dealing with the matter justly, or

(ii) effecting an orderly transition from the scheme established by the Regulations mentioned in sub-paragraph (5)(a), read with the 2006 Act as in force before the appointed day, to the scheme established by these Regulations, read with the 2006 Act,

or for purposes related to both; and

(b) take account, as appropriate, of the manner in which—

(i) provisions in the 2005 Regulations were carried forward into the 2012 Regulations,

(ii) provisions in the 2006 Regulations and the 2012 Regulations were carried forward into these Regulations, and

(iii) the 2006 Act was amended by the Health and Social Care Act 2012 M73 .

(7) Modifications pursuant to paragraph (5) may—

(a) be for the purpose of seeking to ensure that a matter is dealt with expeditiously;

(b) be for the purpose of seeking to ensure that a matter is dealt with proportionately, having regard to (as relevant)—

(i) the importance of protecting the safety of persons to whom pharmaceutical and local pharmaceutical services are provided,

(ii) the need for fairness,

(iii) the complexity of the issues,

(iv) the importance of protecting [F1 NHS England] from material financial loss, and

(v) the importance of saving expense; or

(c) (without prejudice to the generality of the power to make modifications) have the effect of—

(i) adding to, modifying or removing functions that would have been performed by a Primary Care Trust under the SCAT Regulations, the 2005 Regulations, the 2006 Regulations, the 2012 Regulations or the 2006 Act as in force before the appointed day, or

(ii) adding to, modifying or removing functions that are to be performed by [F1 NHS England] or a HWB under these Regulations or the 2006 Act.

(8) In this Schedule, “the continuity principles” means the provisions of sub-paragraphs (1) to (7).

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Marginal Citations

M73 2012 c. 7.

Listing applications under the 2005 Regulations: NHS chemists U.K.

2.—(1) An application made to a Primary Care Trust under regulation 5(1), 40(1) or 54(2) of the 2005 Regulations (which relate to applications for inclusion in a pharmaceutical list, preliminary consent applications and temporary provision during a period of suspension) which—

(a) has not been determined before the appointed day; and

(b) by virtue of Schedule 7 to the 2012 Regulations (transitional provisions), was to be determined in accordance with the 2005 Regulations and if relevant the 2006 Regulations,

is to be dealt with by [F1 NHS England] in accordance with the 2005 Regulations.

(2) Where an application made under the 2005 Regulations for preliminary consent has been finally granted under those Regulations—

(a) an application under regulation 5(1) of the 2005 Regulations that is in accordance with regulation 41(1) of those Regulations (effect of preliminary consent) may be made in relation to that consent (within the 6 months period referred to in regulation 40(4) of the 2005 Regulations); and

(b) any such application is to be dealt with by [F1 NHS England] in accordance with the 2005 Regulations.

(3) Where on or after the appointed day, by virtue of this paragraph, an application is to be determined by [F1 NHS England] having regard to regulation 13(1)(a) of the 2005 Regulations (exemptions from the necessary or expedient test), for the purposes of that application an area is an approved retail area if on 31st August 2012 it was a retail area that was for the time being approved by the Secretary of State under regulation 15 of those Regulations (approved retail areas).

(4) Where an application under regulation 5(1), 40(1) or 54(2) of the 2005 Regulations has been determined in accordance with the 2005 Regulations, whether before the appointed day or by virtue of this paragraph—

(a) the arrangements for bringing an appeal in relation to that application; and

(b) the determination of any appeal validly brought,

are to be in accordance with the 2005 Regulations.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Listing applications under the 2012 Regulations: NHS chemists U.K.

3.—(1) Where a routine application has been made to a Primary Care Trust before the appointed day under the 2012 Regulations, subject to paragraph (2)—

(a) if that application has not been notified under Part 3 of Schedule 2 to the 2012 Regulations (applications in respect of pharmaceutical lists and the procedures to be followed – notification of certain applications) before the appointed day, it is to be dealt with by [F1 NHS England] in accordance with these Regulations; and

(b) if that application has been notified under Part 3 of Schedule 2 to the 2012 Regulations before the appointed day, it is to be dealt by [F1 NHS England] in accordance with the 2012 Regulations and the 2006 Act as in force immediately before the appointed day.

(2) Where—

(a) a routine application has been made to a Primary Care Trust before the appointed day under the 2012 Regulations; and

(b) determination of that application requires determination of whether granting it, or granting it in respect of some only of the services specified in it, would meet a current or future need for pharmaceutical services, or pharmaceutical services of a specified type, which have been included in a pharmaceutical needs assessment,

it is to be dealt with by [F1 NHS England] in accordance with the 2012 Regulations and the 2006 Act as in force immediately before the appointed day, whether or not it has been notified under Part 3 of Schedule 2 to the 2012 Regulations before the appointed day.

(3) Where an excepted application has been made to a Primary Care Trust before the appointed day under the 2012 Regulations—

(a) if that application—

(i) is not a notifiable application, and

(ii) has not been determined by the Primary Care Trust before the appointed day,

it is to be dealt with by [F1 NHS England] in accordance with these Regulations;

(b) if that application—

(i) is a notifiable application, and

(ii) has not been notified under Part 3 of Schedule 2 to the 2012 Regulations before the appointed day,

it is to be dealt with in accordance with these Regulations; and

(c) if that application—

(i) is a notifiable application, and

(ii) has been notified under Part 3 of Schedule 2 to the 2012 Regulations before the appointed day,

it is to be dealt with in accordance with the 2012 Regulations and the 2006 Act as in force immediately before the appointed day.

(4) Where an application under the 2012 Regulations is determined in accordance with the 2012 Regulations, whether before the appointed day or by virtue of this paragraph—

(a) the arrangements for bringing an appeal in relation to that application; and

(b) the determination of any appeal validly brought,

are to be in accordance with the 2012 Regulations.

(5) In applying the continuity principles in relation to decisions which are to be made under the 2012 Regulations by virtue of this paragraph, [F1 NHS England] must ensure that LPS chemists that would, by virtue of paragraph 32(5)(b)(ii) of Schedule 2 to these Regulations, have rights of appeal against particular types of decision under these Regulations, have the same rights of appeal against equivalent decisions under the 2012 Regulations, notwithstanding that those rights of appeal were not provided for in the 2012 Regulations.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Listing applications under the 2005 Regulations: dispensing doctors U.K.

4.—(1) An application made to a Primary Care Trust under Part 5 of the 2005 Regulations (provision of pharmaceutical services by doctors) for outline consent or premises approval (including temporary premises approval) which—

(a) has not been determined before the appointed day; and

(b) by virtue of Schedule 7 to the 2012 Regulations (transitional provisions) was to be determined in accordance with the 2005 Regulations,

is to be dealt with by [F1 NHS England] in accordance with the 2005 Regulations.

(2) Where an application under Part 5 of the 2005 Regulations has been determined in accordance with those Regulations, whether before the appointed day or by virtue of sub-paragraph (1)—

(a) the arrangements for bringing an appeal in relation to that application; and

(b) the determination of any appeal validly brought,

are to be in accordance with the 2005 Regulations.

(3) If, before the appointed day—

(a) a Primary Care Trust has required a doctor to provide pharmaceutical services under regulation 60(4)(a) of the 2005 Regulations M74 (arrangements for provision of pharmaceutical services by doctors); and

(b) the doctor has appealed against that decision,

the arrangements for bringing that appeal, and the determination of any appeal validly brought, are to be in accordance with the 2005 Regulations.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Marginal Citations

M74 Prior to its revocation, regulation 60(4) was amended by S.I. 2005/1015 and 2006/3373.

Listing applications under the 2012 Regulations: dispensing doctors U.K.

5.—(1) Where an application has been made to a Primary Care Trust before the appointed day under Part 8 of the 2012 Regulations (dispensing doctors) for outline consent or premises approval, other than an application for temporary premises approval to which regulation 58 or 61 of those Regulations (which relate to temporary provision in cases where premises approval has not taken effect or during an emergency requiring the flexible provision of pharmaceutical services) applies—

(a) if that application has not been notified under regulation 52 of the 2012 Regulations (notification of applications for outline consent and premises approval), it is to be dealt with by [F1 NHS England] in accordance with these Regulations; and

(b) if that application has been notified under regulation 52 of the 2012 Regulations, it is to be dealt with by [F1 NHS England] in accordance with the 2012 Regulations.

(2) Where—

(a) an application has been made to a Primary Care Trust before the appointed day under regulation 58 or 61 of the 2012 Regulations for temporary premises approval; and

(b) that application has not been determined before the appointed day,

it is to be dealt with by [F1 NHS England] in accordance with these Regulations.

(3) Where an application under that Part 8 of the 2012 Regulations has been determined in accordance with the 2012 Regulations, whether before the appointed day or by virtue of this paragraph—

(a) the arrangements for bringing an appeal in relation to that application; and

(b) the determination of any appeal validly brought,

are to be in accordance with the 2012 Regulations.

(4) If, before the appointed day, a Primary Care Trust has required a doctor to provide pharmaceutical services under regulation 48(5)(b) of the 2012 Regulations (arrangements for provision of pharmaceutical services by doctors: applications by patients), and—

(a) the doctor has appealed against that decision before the appointed day; or

(b) the time limit for bringing an appeal against the decision in regulation 63(1) of the 2012 Regulations (appeals against decisions under Part 8) has not elapsed before the appointed day,

the arrangements for bringing an appeal in relation to that decision, and the determination of any appeal validly brought, are to be in accordance with the 2012 Regulations.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Outstanding cases relating to dispensing contractor lists U.K.

6.—(1) If, before the appointed day the Primary Care Trust was engaged in a process which could have led to the inclusion or removal of a contractor or premises from a dispensing contractor list, that process and the action to be taken following its outcome (including relating to any appeal) are to be dealt with by [F1 NHS England] in accordance with paragraph 10 of Schedule 7 to the 2012 Regulations (transitional provisions – dispensing contractor lists).

(2) Where—

(a) [F1 NHS England] grants an application for premises approval by virtue of this paragraph; and

(b) [F1 NHS England] is as a consequence required to consider any postponement of the making of arrangements to provide dispensing services, arising out of that grant,

that consideration, [F1 NHS England’s] decision on any postponement, the arrangements for bringing an appeal against its decision, and the determination of any appeal validly brought, are to be in accordance with paragraph 10 of Schedule 7 to the 2012 Regulations.

(3) Conditions relating to postponement of the making of arrangements to provide dispensing services which are imposed by virtue of this paragraph, or which continued to have effect by virtue of paragraph 10 of Schedule 7 to the 2012 Regulations, continue to have effect as if imposed under these Regulations in relation to the provision of pharmaceutical services.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Controlled localities U.K.

7.—(1)  [F1 NHS England] must—

(a) in respect of an area which on the appointed day continues to be, or to be part of, a controlled locality by virtue of regulation 36(1), delineate precisely the boundary of the controlled locality on a map (which may be part of a series of maps which relate to HWB areas);

(b) publish that map; and

(c) make that map available as soon as is practicable to any HWB that has all or part of that controlled locality in its area.

(2) Where—

(a) before the appointed day, a Primary Care Trust was considering whether or not an area is either a controlled locality or part of a controlled locality; or

(b) [F1 NHS England] is required, by virtue of paragraphs 2 to 5, to determine an application and in connection with determining that application, it also needs to determine whether or not an area is or is not a controlled locality, or part of a controlled locality,

paragraph (3) applies.

(3) Where—

(a) consideration by a Primary Care Trust mentioned in sub-paragraph (2)(a) was, or (by virtue of paragraph 2 or 4) an application referred to in sub-paragraph (2)(b) is, to be dealt with under the 2005 Regulations—

(i) the consideration of whether or not a locality is either a controlled locality or part of a controlled locality is to be dealt with by [F1 NHS England] in accordance with the 2005 Regulations, and

(ii) the arrangements for bringing an appeal in relation to the decision of [F1 NHS England], and the determination of any appeal validly brought, are to be in accordance with the 2005 Regulations;

(b) consideration by a Primary Care Trust mentioned in sub-paragraph (2)(a) was under the 2012 Regulations (unless it was in connection with an application which by virtue of paragraph 3 or 5 is to be determined in accordance with these Regulations)—

(i) the consideration of whether or not a locality is either a controlled locality or part of a controlled locality is to be dealt with by [F1 NHS England] in accordance with the 2012 Regulations, and

(ii) the arrangements for bringing an appeal in relation to the decision of [F1 NHS England], and the determination of any appeal validly brought, are to be in accordance with the 2012 Regulations,

but if that consideration was in connection with an application which by virtue of paragraph 3 or 5 is to be determined in accordance with these Regulations, the consideration of whether or not a locality is either a controlled locality or part of a controlled locality is also to be dealt with by [F1 NHS England] in accordance with these Regulations;

(c) an application referred to in sub-paragraph (2)(b) is to be dealt with under the 2012 Regulations (by virtue of paragraphs 3 or 5)—

(i) the related consideration of whether or not a locality is either a controlled locality or part of a controlled locality is to be dealt with by [F1 NHS England] in accordance with the 2012 Regulations, and

(ii) the arrangements for bringing an appeal in relation to the decision of [F1 NHS England], and the determination of any appeal validly brought, are to be in accordance with the 2012 Regulations;

(d) an application referred to in sub-paragraph (2)(b) is to be dealt with under these Regulations, the related consideration of whether or not a locality is either a controlled locality or part of a controlled locality is to be dealt with by [F1 NHS England] in accordance with these Regulations.

(4) Where, by virtue of sub-paragraph (3), it is determined (whether by [F1 NHS England] or on appeal by the Secretary of State) that an area is or is not, or is or is not part of, a controlled locality, [F1 NHS England] must—

(a) delineate precisely the boundary of any resulting controlled locality on a map;

(b) publish that map; and

(c) make that map available as soon as is practicable to any HWB that has all or part of any resulting controlled locality in its area,

and any area that becomes, or becomes part of, a controlled locality as a consequence of that determination is then a controlled locality, or part of a controlled locality, for the purposes of these Regulations (unless or until it is determined under these Regulations that it is no longer, or no longer part of, a controlled locality).

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Reserved locations U.K.

8.—(1) Where—

(a) an application has been received which is to be determined under the 2005 Regulations—

(i) in accordance with paragraph 2, and

(ii) having regard to regulation 12 or 13 of the 2005 Regulations (which relate to the necessary or expedient test and exemptions from it); and

(b) the premises or relevant location at or from which the applicant wishes to provide pharmaceutical services is or may be a reserved location,

pending the final determination of that application, the classification of any area in relation to those premises or that relevant location as, or as not, a reserved location is to be determined in accordance with the 2005 Regulations (if a further reserved location determination is required after the application is finally determined, it is to be in accordance with these Regulations).

(2) Where a determination of whether or not an area is a reserved location is made under the 2005 Regulations by virtue of—

(a) sub-paragraph (1); or

(b) before the appointed day, paragraph 6 of Schedule 7 to the 2012 Regulations (transitional provisions – reserved locations),

the arrangements for bringing an appeal against the decision, and the determination of any appeal validly brought, are to be in accordance with the 2005 Regulations.

(3) Where—

(a) a routine application was received by a Primary Care Trust which [F1 NHS England] is required to determine under the 2012 Regulations in accordance with paragraph 3; and

(b) the premises or relevant location at or from which the applicant wishes to provide pharmaceutical services is or may be a reserved location,

pending the final determination of that application, the classification of any area in relation to those premises or that relevant location as, or as not, a reserved location is to be determined in accordance with the 2012 Regulations (if a further reserved location determination is required after the application is finally determined, it is to be in accordance with these Regulations).

(4) Where before the appointed day—

(a) a Primary Care Trust received a request for a determination under regulation 42 of the 2012 Regulations (second and subsequent determinations of reserved location status), but there is no related routine application which is (still) to be finally determined under the 2012 Regulations in accordance with paragraph 2; and

(b) the request was notified under regulation 42(2)(a) of the 2012 Regulations,

the classification of any area as, or as not, a reserved location pursuant to that request is to be determined in accordance with the 2012 Regulations (if a further reserved location determination is required after that determination, it is to be in accordance with these Regulations).

(5) Where a determination of whether or not an area is a reserved location is made under the 2012 Regulations by virtue of sub-paragraph (3) or (4), the arrangements for bringing an appeal against the decision, and the determination of any appeal validly brought, are to be in accordance with the 2012 Regulations.

(6) Where before the appointed day, a request is made to a Primary Care Trust for a reserved location determination, but the determination is not to be made under the 2005 Regulations or the 2012 Regulations by virtue of sub-paragraphs (1) to (5), it is to be made by [F1 NHS England] (or on appeal the Secretary of State) under these Regulations.

(7) Where, by virtue of sub-paragraphs (1) to (5), it is determined (whether by [F1 NHS England] or on appeal by the Secretary of State) that an area is a reserved location, if following the determination a reserved location thereafter takes effect (because the pharmacy premises to which it relates are included in a pharmaceutical list), [F1 NHS England] must—

(a) delineate precisely the boundary of the reserved location on a map;

(b) publish that map; and

(c) make that map available as soon as is practicable to any HWB that has all or part of that reserved location in its area.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Gradual discontinuation of the provision of pharmaceutical services by doctors U.K.

9.—(1) Where, when granting an application which by virtue of paragraph 2 is finally determined in accordance with the 2005 Regulations, [F1 NHS England] is required to consider under regulation 20(2) of the 2005 Regulations (imposition of conditions)—

(a) any termination of arrangements with any person on its dispensing doctor list; and

(b) any postponement of any such termination,

arising out of that grant (but not for a reason set out in regulation 50(1)(a) to (c), (e) or (f) of these Regulations), that consideration and its decision are to be in accordance with the 2005 Regulations.

(2) Where before the appointed day a Primary Care Trust was considering under the 2005 Regulations, in any case in which it could postpone the termination of arrangements with a dispensing doctor—

(a) the termination of arrangements with a dispensing doctor; or

(b) the postponement of the termination of arrangements with a dispensing doctor,

that matter is to be dealt with by [F1 NHS England], in accordance with the 2005 Regulations.

(3) Where, under the 2005 Regulations—

(a) a decision relating to termination of arrangements, or the postponement of the termination of arrangements, with a dispensing doctor is made by virtue of sub-paragraph (1) or (2); or

(b) before the appointed day, a decision relating to termination of arrangements, or the postponement of the termination of arrangements, with a dispensing doctor was made by a Primary Care Trust under the 2005 Regulations, and—

(i) that decision has been appealed before the appointed day, or

(ii) the time limit for bringing an appeal against that decision has not elapsed before the appointed day,

the arrangements for bringing an appeal in relation to that decision, and the determination of any appeal validly brought, are to be in accordance with the 2005 Regulations.

(4) Where, when granting an application which by virtue of paragraph 3 is finally determined in accordance with the 2012 Regulations, [F1 NHS England] is required to consider under regulation 50(1) or (3) of the 2012 Regulations (discontinuation of arrangements for the provision of pharmaceutical services by doctors)—

(a) any termination of arrangements with any person on its dispensing doctor list; and

(b) any postponement of any such termination,

arising out of that grant, that consideration and its decision are to be in accordance with the 2012 Regulations.

(5) Where before the appointed day a Primary Care Trust was considering under regulation 50(1) to (6) of the 2012 Regulations, in any case in which it could postpone the termination of arrangements with a dispensing doctor—

(a) the termination of arrangements with a dispensing doctor; or

(b) the postponement of the termination of arrangements with a dispensing doctor,

that matter is to be dealt with by [F1 NHS England], in accordance with the 2012 Regulations.

(6) Where, under the 2012 Regulations—

(a) a decision relating to termination of arrangements, or the postponement of the termination of arrangements, with a dispensing doctor is made by virtue of sub-paragraph (4) or (5); or

(b) before the appointed day, a decision relating to termination of arrangements, or the postponement of the termination of arrangements, with a dispensing doctor was made by a Primary Care Trust pursuant to the 2012 Regulations, and—

(i) that decision has been appealed before the appointed day, or

(ii) the time limit for bringing an appeal against that decision has not elapsed before the appointed day,

the arrangements for bringing an appeal in relation to that decision, and the determination of any appeal validly brought, are to be in accordance with the 2012 Regulations.

(7) Regulation 50(1)(f) applies to a determination under the 2005 Regulations or the 2012 Regulations (either before the appointed day or by virtue of paragraph 8) that a location ceases to be or be part of a reserved location as it does to a determination referred to in regulation 42 as D2.

(8) Conditions imposed by virtue of—

(a) regulation 20(2) or 35(6)(b) (pharmaceutical services in reserved locations) of the 2005 Regulations; or

(b) regulation 50(2), (5) or (6) of the 2012 Regulations,

relating to the postponement of termination of arrangements with a dispensing doctor, whether or not imposed by virtue of this paragraph, continue to have effect as if imposed under these Regulations.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Gradual introduction of the provision of pharmaceutical services by doctors U.K.

10.—(1) Where, when granting an application which by virtue of paragraph 4 is finally determined in accordance with the 2005 Regulations, [F1 NHS England] is required to consider under regulation 20(2) of the 2005 Regulations (imposition of conditions) any postponement of the making of arrangements with a dispensing doctor arising out of that grant, that consideration and its decision are to be in accordance with the 2005 Regulations.

(2) Where before the appointed day a Primary Care Trust is considering under regulation 20(2) of the 2005 Regulations the postponement of the making of arrangements with a dispensing doctor, that matter is to be dealt with by [F1 NHS England], in accordance with the 2005 Regulations.

(3) Where, under the 2005 Regulations—

(a) a decision relating to postponement of the making of arrangements with a dispensing doctor is made by virtue of sub-paragraph (1) or (2); or

(b) before the appointed day, a decision relating to postponement of the making of arrangements with a dispensing doctor was made by a Primary Care Trust under the 2005 Regulations, and—

(i) that decision has been appealed before the appointed day, or

(ii) the time limit for bringing an appeal against that decision has not elapsed before the appointed day,

the arrangements for bringing an appeal in relation to that decision, and the determination of any appeal validly brought, are to be in accordance with the 2005 Regulations.

(4) Where, when granting an application which by virtue of paragraph 5 is finally determined in accordance with the 2012 Regulations, [F1 NHS England] is required to consider under regulation 57(1) of the 2012 Regulations (gradual introduction of premises approval)—

(a) any postponement of the making of arrangements with a dispensing doctor arising out of that grant; or

(b) any limitation on the patients to whom a dispensing doctor is able to provide pharmaceutical services,

that consideration and its decision are to be in accordance with the 2012 Regulations.

(5) Where before the appointed day a Primary Care Trust is considering under regulation 57(1) of the 2012 Regulations—

(a) the postponement of the making of arrangements with a dispensing doctor; or

(b) any limitation on the patients to whom a dispensing doctor is able to provide pharmaceutical services,

that matter is to be dealt with by [F1 NHS England], in accordance with the 2012 Regulations.

(6) Where, under the 2012 Regulations—

(a) a decision relating to—

(i) postponement of the making of arrangements with a dispensing doctor, or

(ii) limiting the patients to whom a dispensing doctor is able to provide pharmaceutical services,

is made by virtue of sub-paragraph (1) or (2); or

(b) before the appointed day, a decision relating to postponement of the making of arrangements with a dispensing doctor, or to limiting the patients the patients to whom a dispensing doctor is able to provide pharmaceutical services, was made by a Primary Care Trust pursuant to the 2012 Regulations, and—

(i) that decision has been appealed before the appointed day, or

(ii) the time limit for bringing an appeal against that decision has not elapsed before the appointed day,

the arrangements for bringing an appeal in relation to that decision, and the determination of any appeal validly brought, are to be in accordance with the 2012 Regulations.

(7) Conditions imposed by virtue of—

(a) regulation 20(2) of the 2005 Regulations relating to postponement of the making of arrangements with a dispensing doctor; or

(b) regulation 57(1) of the 2012 Regulations relating to—

(i) the postponement of the making of arrangements with a dispensing doctor, or

(ii) limiting the patients to whom a dispensing doctor is able to provide pharmaceutical services,

whether or not imposed by virtue of this paragraph, continue to have effect as if imposed under these Regulations.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Giving effect to listing decisions: pharmaceutical lists and dispensing doctor lists U.K.

11.—(1) Where, before the appointed day or as a consequence of paragraphs 2 or 4, a person is entitled on the basis of a decision (whether by a Primary Care Trust or [F1 NHS England], or on appeal)—

(a) to be included [F278 in a pharmaceutical] list but has not been included in that list;

(b) to have listed in relation to their entry in a pharmaceutical list premises that have not been listed in relation to them;

(c) to be included in a dispensing doctor list but has not been included in that list;

(d) to have listed in relation to their entry in a dispensing doctor list premises that have not been listed in relation to them; or

(e) to have listed in relation to their entry in a dispensing doctor list an area that has not been listed in relation to them,

the arrangements for the listing of that person, those premises or that area, and the circumstances in which that decision lapses, are as set out in the 2005 Regulations.

(2) Where, before the appointed day or as a consequence of paragraphs 3 or 5, a person is entitled on the basis of a decision (whether by a Primary Care Trust or [F1 NHS England], or on appeal)—

(a) to be included [F279 in a pharmaceutical] list but has not been included in that list;

(b) to have listed in relation to their entry in a pharmaceutical list premises that have not been listed in relation to them;

(c) to be included in a dispensing doctor list but has not been included in that list;

(d) to have listed in relation to their entry in a dispensing doctor list premises that have not been listed in relation to them; or

(e) to have listed in relation to their entry in a dispensing doctor list an area that has not been listed in relation to them,

the arrangements for the listing of that person, those premises or that area, and the circumstances in which that decision lapses, are as set out in the 2012 Regulations.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F278 Words in Sch. 9 para. 11(1)(a) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 20(a)

F279 Words in Sch. 9 para. 11(2)(a) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 20(b)

Pharmaceutical lists, EPS lists and dispensing doctor lists: continuity of entries and decisions U.K.

12.—(1) Subject to sub-paragraph (2), the entries in pharmaceutical lists, EPS lists or dispensing doctor lists of Primary Care Trusts that are current immediately before the appointed day are to be current entries in the pharmaceutical lists, EPS lists and dispensing doctor lists maintained by [F1 NHS England] on the appointed day under regulations 10 and 46 (albeit that the lists may be maintained by reference to different geographical areas).

(2) Where immediately before the appointed day a Primary Care Trust was required or entitled to give effect to a decision reached before the appointed day to change, remove or include an entry in a pharmaceutical list, EPS list or dispensing doctor list but had not done so, [F1 NHS England] is required or entitled (unless the context requires otherwise) to give effect to that decision on or after the appointed day.

(3) If, as regards a decision to which paragraph (2) applies, before the appointed day—

(a) removal of an entry in a pharmaceutical list, EPS list or dispensing doctor list—

(i) would have resulted in removal of a person from a pharmaceutical list, EPS list or dispensing doctor list but no longer does so, or

(ii) would not have resulted in removal of a person from a pharmaceutical list, EPS list or dispensing doctor list but on or after the appointed day does so; or

(b) inclusion of an entry in a pharmaceutical list, EPS list or dispensing doctor list—

(i) would have required the new inclusion of a person in a pharmaceutical list, EPS list or dispensing doctor list but no longer does so, or

(ii) would not have required the new inclusion of a person in a pharmaceutical list, EPS list or dispensing doctor list but on or after the appointed day does so,

[F1 NHS England] is nevertheless required or entitled (unless the context requires otherwise) to give effect to that decision, and in a manner that reflects the new arrangements for maintaining pharmaceutical lists, EPS lists and dispensing doctor lists, regardless of whether or not a different procedure would have been followed before the appointed day, had the nature of the listing change been as it is on or after the appointed day.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Service provision issues: NHS chemists U.K.

13.—(1) Subject to sub-paragraph (3), where by virtue of a transfer scheme or paragraph 12, [F1 NHS England] becomes engaged in any matter—

(a) arising under the 2005 Regulations before the appointed day; and

(b) relating to compliance with the terms of service of a chemist (whether compliance by the chemist or a Primary Care Trust),

that matter is to be resolved in accordance with the 2005 Regulations, and where applicable the SCAT Regulations and the Drug Tariff, and the continuity principles are to be applied accordingly.

(2) Subject to sub-paragraph (3), as regards the resolution of any matter—

(a) arising under the 2005 Regulations before the appointed day; and

(b) relating to changing or removing any entry in a pharmaceutical list by virtue the 2005 Regulations other than pursuant to an application under regulation 5(1), 40(1) or 54(2) of those Regulations (which relate to applications for inclusion in a pharmaceutical list, preliminary consent applications and temporary provision during a period of suspension) (paragraph 2 applies in those cases),

that matter is to be resolved in accordance with the 2005 Regulations, and where applicable the SCAT Regulations and the Drug Tariff, and the continuity principles are to be applied accordingly.

(3) Sub-paragraphs (1) and (2) are without prejudice to the ability of [F1 NHS England] to commence proceedings under Chapter 6 of Part 7 of the 2006 Act (pharmaceutical services and local pharmaceutical services – disqualification) on or after the appointed day that relate to matters arising before 1st September 2012 (potentially together with matters arising between 1st September 2012 and the appointed day, or on or after the appointed day), but any decisions in such proceedings are be reached in accordance with the relevant provisions of these Regulations (and that Chapter 6).

(4) Subject to sub-paragraph (6), where by virtue of a transfer scheme or paragraph 12, [F1 NHS England] becomes engaged in any matter—

(a) arising under the 2012 Regulations before the appointed day; and

(b) relating to compliance with the terms of service of an NHS chemist (whether compliance by the NHS chemist or a Primary Care Trust),

that matter is to be resolved in accordance with the 2012 Regulations and where applicable the Drug Tariff, and the continuity principles are to be applied accordingly.

(5) Subject to sub-paragraph (6), as regards the resolution of any matter—

(a) arising under the 2012 Regulations before the appointed day; and

(b) relating to changing or removing any entry in a pharmaceutical list by virtue the 2012 Regulations other than pursuant to a routine or excepted application (paragraph 3 applies in those cases),

that matter is to be resolved in accordance with the 2012 Regulations and where applicable the Drug Tariff, and the continuity principles are to be applied accordingly.

(6) Sub-paragraphs (4) and (5) are without prejudice to the ability of [F1 NHS England]—

(a) to commence proceedings under Chapter 6 of Part 7 of the 2006 Act on or after the appointed day that relate to matters arising before the appointed day (potentially together with matters arising on or after the appointed day), but any decisions in such proceedings are be reached in accordance with the relevant provisions of these Regulations (and that Chapter 6);

(b) to issue breach or remedial notices under Part 10 on or after the appointed day that relate to matters arising before the appointed day (potentially together with matters arising on or after the appointed day); or

(c) to take action under regulation 73 based on breach or remedial notices issued by a Primary Care Trust under Part 10 of the 2012 Regulations (performance related sanctions and market exit).

(7) Decisions and reviews of decisions in any proceedings commenced under Chapter 6 of Part 7 of the 2006 Act before the appointed day—

(a) which by virtue of paragraph 10 of Schedule 7 to the 2012 Regulations (transitional provisions – other continuing matters: NHS chemists) were being determined in accordance with the 2005 Regulations and that Chapter 6 are to continue to be so determined; or

(b) were being determined in accordance with Part 11 of the 2012 Regulations (enforcement, reviews and appeals relating to fitness matters) and that Chapter 6 are to continue to be so determined,

except in the case of a review of a decision where the request by the practitioner for a review is made on or after the appointed day (such a review is to be in accordance with the relevant provisions of these Regulations and that Chapter 6).

(8) Where a person was suspended from a pharmaceutical list by virtue of Chapter 6 of Part 7 of the 2006 Act before the appointed day—

(a) decisions on payments in respect of any part of the period of suspension that preceded 1st September 2012, and any appeals relating to those decisions, are to be in accordance with the 2005 Regulations and with the determinations under regulation 58 of the 2005 Regulations M75 (payments to suspended chemists) that were in force immediately before 1st September 2012; and

(b) decisions on payments in respect of any part of the period of suspension between 1st September 2012 and 31st March 2013 inclusive, and any appeals relating to those decisions, are to be in accordance with the 2012 Regulations and with the determinations under regulation 98 of the 2012 Regulations (payments to suspended chemists) that were in force immediately before the appointed day.

(9) Any direction or approval under, or that continues in effect under, a provision of Schedule 4 or 5 of the 2012 Regulations (terms of service of NHS pharmacists and terms of service of NHS appliance contractors) is to continue in effect as a direction or approval under the corresponding provision of Schedule 4 or 5 to these Regulations, unless or until it is amended or revoked by virtue of that corresponding provision or as a consequence of a decision under this paragraph.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Marginal Citations

M75 Prior to its revocation, regulation 58 was amended by S.I. 2006/3373.

Service provision issues: dispensing doctors U.K.

14.—(1) Where, by virtue of a transfer scheme or paragraph 12, [F1 NHS England] becomes engaged in any matter—

(a) arising under the 2005 Regulations before the appointed day; and

(b) relating to compliance with the terms of service of a dispensing doctor (whether compliance by the dispensing doctor or a Primary Care Trust),

that matter is to be resolved in accordance with the 2005 Regulations, and where applicable the SCAT Regulations and directions under section 87 of the 2006 Act (GMS contracts: payments), and the continuity principles are to be applied accordingly.

(2) Where, by virtue of a transfer scheme or paragraph 12, [F1 NHS England] becomes engaged in any matter arising under the 2012 Regulations before the appointed day and relating to compliance with the terms of service mentioned in regulation 47(2) of the 2012 Regulations (terms of service of dispensing doctors: general), the arrangements mentioned in regulation 47(2)(a) of those Regulations must provide for the matter to be resolved—

(a) justly;

(b) in a manner that effects an orderly transition from the scheme established by the 2012 Regulations to the scheme established by these Regulations; and

(c) if necessary or expedient in a manner that is inconsistent with these Regulations, or with regulations or directions under the 2006 Act that were in force immediately before the appointed day,

and the continuity principles are to be applied, and that matter is to be acted upon, accordingly.

(3) As regards the resolution of any matter—

(a) arising under the 2012 Regulations before the appointed day; and

(b) relating to changing or removing any entry in a dispensing doctor list by virtue the 2012 Regulations other than pursuant to an application under Part 8 of those Regulations (dispensing doctors) for premises approval or outline consent (paragraph 5 applies in those cases),

the matter is to be resolved in accordance with the 2012 Regulations, and the continuity principles are to be applied accordingly.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

LPS schemes: replacement of Primary Care Trusts with [F1 NHS England] and service provision issues U.K.

15.—(1) For the purposes of this paragraph, “ the relevant transitional provisions” means—

(a) in the case of an LPS pilot scheme, paragraph 92(8) of Schedule 4 to the Health and Social Care Act 2012 M76 (amendments of the National Health Service Act 2006); or

(b) in the case of LPS schemes that are not LPS pilot schemes, paragraph 93(6) of Schedule 4 to the Health and Social Care Act 2012.

(2) The changes to LPS schemes by virtue of the relevant transitional provisions take effect on the appointed day without the need for notices—

(a) in the case of LPS pilot schemes, under any terms of those schemes; or

(b) in the case of LPS schemes that are not LPS pilot schemes, under the terms of the schemes that give effect to paragraph 26 of Schedule 7.

(3) Where, by virtue of a transfer scheme or the relevant transitional provisions, [F1 NHS England] becomes engaged in any matter arising under an LPS scheme before the appointed day and relating to compliance with the terms of the LPS scheme (whether compliance by the LPS chemist or a Primary Care Trust)—

(a) that matter is to be resolved in accordance with the relevant provisions of the LPS scheme, and any applicable provisions of 2006 Regulations and the Drug Tariff; and

(b) [F1 NHS England] may vary those terms, if necessary or expedient in a manner that is inconsistent with—

(i) the 2006 Regulations,

(ii) these Regulations, or

(iii) any directions under Chapter 2 of Part 7 of, and Schedule 11 to, the 2006 Act (which relate to local pharmaceutical services pilot schemes) that were in force immediately before the appointed day,

in order to provide for the matter to be resolved justly and in a manner that effects an orderly transition from the regulatory schemes for local pharmaceutical services established by the 2006 Regulations and directions under the 2006 Act to the regulatory schemes for local pharmaceutical services established by these Regulations and directions under the 2006 Act,

and the continuity principles are to be applied, and the matter is to be acted upon, accordingly.

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

Marginal Citations

M76 2012 c. 7.

Notification of LPS designations and completion of reviews U.K.

16.—(1) The making, varying or cancellation of a designation by a Primary Care Trust under Part 2 of the 2006 Regulations (designation) before the appointed day that was not, before the appointed day, notified in accordance with that Part is to be notified by [F1 NHS England] as if it were made, varied or notified under Part 13 of these Regulations.

(2) Any review of a designation which was being undertaken by a Primary Care Trust before the appointed day but which was not completed before the appointed day is to be completed by [F1 NHS England].

Textual Amendments

F1 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

The application of Group 12 of Schedule 8 to the Value Added Tax Act 1994 U.K.

17.  Pending amendment of Group 12 of Schedule 8 to the Value Added Tax Act 1994 M77 (zero rating: drugs, medicines, aids for the handicapped, etc.) to take account of the coming into force of these Regulations, the definition of “relevant provision” in Note (2D) shall apply in relation to supplies on or after the appointed day as if for paragraph (j) there were substituted—

“(j) Part 8 of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013.”.

Marginal Citations

M77 1994 c.23; relevant amendments have been made to Group 12 by S.I. 2009/2972.

Regulation 120

SCHEDULE 10 U.K. Amendments and revocations

Amendment of the National Health Service (Charges for Drugs and Appliances) Regulations 2000 U.K.

F280 1.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F280 Sch. 10 para. 1 revoked (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 3

Revocation of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) Regulations 2002 U.K.

2.  The National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) Regulations 2002 M78 are revoked.

Marginal Citations

M78 S.I. 2002/888.

Revocation of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) (No. 2) Regulations 2002 U.K.

3.  The National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) (No. 2) Regulations 2002 M79 are revoked.

Marginal Citations

M79 S.I. 2002/2016.

Revocation of the National Health Service (Pharmaceutical Services) Amendment Regulations 2005 U.K.

4.  The National Health Service (Pharmaceutical Services) Amendment Regulations 2005 M80 are revoked.

Marginal Citations

M80 S.I. 2005/1015.

Revocation of the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 and amendments to those Regulations U.K.

5.—(1) The National Health Service (Local Pharmaceutical Services etc.) Regulations M81 are revoked.

(2) The following provisions are revoked—

(a) regulation 4 of the National Health Service (Miscellaneous Amendments Relating to Independent Prescribing) Regulations 2006 M82 ;

(b) regulation 8 of the National Health Service (Pharmaceutical Services) (Remuneration for Persons Providing Pharmaceutical Services) (Amendment) Regulations 2007 M83 ;

(c) Part 2 of the National Health Service (Miscellaneous Amendments Relating to Community Pharmaceutical Services and Optometrist Prescribing) Regulations 2009 M84 ;

(d) paragraphs 134 to 136 of Schedule 3 to the Transfer of Tribunal Functions Order 2010 M85 ; and

(e) paragraph 53 of Schedule 4 to the Pharmacy Order 2010 M86 .

Marginal Citations

M81 S.I. 2006/552.

M82 S.I. 2006/913.

M83 S.I. 2007/674.

M84 S.I. 2009/2205.

M85 S.I. 2010/22.

M86 S.I. 2010/231.

Revocation of the National Health Service (Pharmaceutical Services) (Amendment) Regulations 2006 U.K.

6.  The National Health Service (Pharmaceutical Services) (Amendment) Regulations 2006 M87 are revoked.

Marginal Citations

M87 S.I. 2006/3373.

Amendments to the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 U.K.

7.  In the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 M88 —

(a) in the definition of “relevant complaints procedure” in regulation 2 (interpretation), for paragraphs (i) to (iii) of sub-paragraph (a) substitute the following paragraphs—

“(i) paragraph 34 of Schedule 4 to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013;

(ia) paragraph 24 of Schedule 5 to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013;

(ii) paragraph 8 of Schedule 6 to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013; or

(iii) paragraph 25 of Schedule 7 to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013; or”; and

(b) paragraph 2 of the Schedule is revoked.

Marginal Citations

M88 S.I. 2009/309.

Revocation of the National Health Service (Pharmaceutical Services and Local Pharmaceutical Services) Amendment Regulations 2009 U.K.

8.  The National Health Service (Pharmaceutical Services and Local Pharmaceutical Services) Amendment Regulations 2009 M89 are revoked.

Marginal Citations

M89 S.I. 2009/599.

Revocation of the National Health Service (Pharmaceutical Services and Local Pharmaceutical Services) (Amendment) Regulations 2010 U.K.

9.  The National Health Service (Pharmaceutical Services and Local Pharmaceutical Services) (Amendment) Regulations 2010 M90 are revoked.

Marginal Citations

M90 S.I. 2010/914.

Revocation of the National Health Service (Local Pharmaceutical Services) Amendment Regulations 2012 U.K.

10.  The National Health Service (Local Pharmaceutical Services) Amendment Regulations 2012 M91 are revoked.

Marginal Citations

M91 S.I. 2012/1467.

Revocation of the National Health Service (Pharmaceutical Services) Regulations 2012 and of amendments to those Regulations U.K.

11.—(1) The following Regulations are revoked—

(a) the National Health Service (Pharmaceutical Services) Regulations 2012 M92 ; and

(b) National Health Service (Pharmaceutical Services) Regulations 2012 (Amendment) Regulations 2012 M93 .

Marginal Citations

M92 S.I. 2012/1909.

M93 S.I. 2012/2371.

Amendment of the Local Authorities (Partnership Arrangements, Care Trusts, Public Health and Local Healthwatch Arrangements etc.) Regulations 2012 U.K.

12.  In regulation 12(3)(d) of the Local Authorities (Partnership Arrangements, Care Trusts, Public Health and Local Healthwatch Arrangements etc.) Regulations 2012 M94 (National Health Service payments by local authorities to specified NHS bodies in respect of prescribed functions) for “National Health Service (Pharmaceutical Services) Regulations 2012” substitute “ National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 ”.

Marginal Citations

M94 S.I. 2012/3094.