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

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[F1 , 26(2) or 26A],

and [F2 NHS England] has not decided to dispense with the notification pursuant to paragraphs 15 to 17.

Textual Amendments

F1 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

F2 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 procedure for notifiable applications U.K.

19.—(1) As soon as is practicable (having regard to its functions under Part 2), [F2 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 [F2 NHS England], be significantly affected if the application were granted;

(d) any LPS chemist—

(i) with whom [F2 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 [F2 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 [F2 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 [F2 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) [F2 NHS England] may also give notice of the notifiable application to any other person who, in the opinion of [F2 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, [F2 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 [F2 NHS England], be significantly affected if the application were granted;

(d) any LPS chemist—

(i) with whom [F2 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 [F2 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 [F2 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 [F2 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 [F2 NHS England], provided they do so within 45 days of the date on which notice of the application was given to them [F3 , or within 30 days in the case of applications pursuant to regulation 26A].

[F4 (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

F2 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 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)

F4 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 [F2 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, [F2 NHS England] is required, by virtue of regulation 41 to determine whether or not an area is a reserved location, [F2 NHS England] must consider giving notice under this Part at the same time that it gives notice under regulation 41(4).

Textual Amendments

F2 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 [F2 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 [F2 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,

[F2 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

F2 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