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

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PART 4U.K.Other terms of service

Clinical governance [F1and 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 [F2NHS England], in an acceptable system of clinical governance [F3and for the promotion of healthy living].

(2) For these purposes a system of clinical governance [F4and for the promotion of healthy living] is “acceptable” if it is considered acceptable by [F2NHS 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[F5, 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,

F6(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 [F2NHS England] or any relevant statutory authority wishes to undertake, F7...

(vii)P's monitoring arrangements in respect of P's compliance with the Equality Act 2010; [F8and]

[F9(viii)undertaking at least once in each financial year an approved community engagement exercise in relation to the promotion of healthy living.]

[F10(b)an audit programme, which in each financial year includes at least one clinical audit specified by P, and whichever of the following that [F2NHS England] specifies—

(i)a clinical audit carried out in a manner which is compatible with [F2NHS 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 [F2NHS England]) carried out in a manner which is compatible with [F2NHS 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 M1 and [F2NHS England],

(v)appropriate standard operating procedures, including standard operating procedures in respect of [F11the 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 M2;

[F12(ca)at the request of [F2NHS 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), [F2NHS 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,

[F13(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 [F14, certification or declarations of competence in respect of any role they are asked to perform],

(v)arrangements for addressing poor performance (in conjunction with [F2NHS 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 M3 (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 [F2NHS 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 [F2NHS 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 [F15and for the promotion of healthy living],

and for the purposes of this sub-paragraph, “approved” means approved by [F2NHS England].

Textual Amendments

Marginal Citations

M1The 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.

M31996 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).

[F16Premises requirements in respect of consultation roomsU.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 [F2NHS 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 [F2NHS 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 [F2NHS 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

Consultations held from distance selling premises and some small pharmacy premisesU.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

[F17Distance selling premises requirements in respect of websites and health promotion zonesU.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

Professional StandardsU.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.

[F18Accessing summary care recordsU.K.

29A.—[F19(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

[F20Electronic Prescription Service accessU.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

[F20Contact via NHSmail, pharmacy profiles and the Central Alerting SystemU.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 [F21NHS 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

[F22Business continuity plans to deal with temporary suspensionsU.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

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 ariseU.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 [F2NHS 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 M4 (fixed penalty: conditional offer by procurator fiscal) or a penalty under section 115A of the Social Security Administration Act 1992 M5 (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 [F2NHS 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 [F2NHS 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

M51992 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 suppliedU.K.

32.—(1) An NHS pharmacist (P) must give notice to [F2NHS 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 [F2NHS 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 [F2NHS 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 [F2NHS 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 [F2NHS 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 [F2NHS England], they must supply in writing to [F2NHS 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 [F2NHS 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.

[F23Facilitating remote access to pharmaceutical servicesU.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

Co-operation with [F24NHS England] U.K.

33.  An NHS pharmacist must co-operate with [F24NHS England] in the discharge by [F24NHS England] of the duty under section 1F(1) of the 2006 Act M6 (duty as to education and training).

Textual Amendments

Marginal Citations

M6Section 1F was inserted by the Health and Social Care Act 2012 (c. 7), section 7.

ComplaintsU.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 M7, 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

Inspections and access to informationU.K.

35.—(1) An NHS pharmacist (P) must allow persons authorised in writing by [F2NHS 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 [F2NHS 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 [F2NHS England], in connection with its functions that relate to pharmaceutical services.

[F25(4) P must, at the request of [F2NHS England], send to [F2NHS England] by means of an electronic communication of the type specified in the request any information to which a person authorised in writing by [F2NHS 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 [F2NHS 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 [F2NHS England] does so request).

(5) P must, at the request of [F2NHS England] or a person authorised in writing by [F2NHS England] to make the request, send to [F2NHS England] or that person by means of an electronic communication, a duly completed questionnaire, which is—

(a)in a format approved by [F2NHS England]; and

(b)for the purpose of enabling [F2NHS England], or a person authorised in writing by [F2NHS England], to determine whether or when it is necessary or expedient for a person authorised in writing by [F2NHS England] to undertake an inspection of P’s premises pursuant to sub-paragraph (1).

(6) Before information is requested pursuant to sub-paragraph (5), [F2NHS 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

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