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

Notification of applications for outline consent and premises approval U.K.

52.—(1) Where [F1 NHS England] receives an application for outline consent or premises approval (including an application for premises approval to which regulation 54 or 55 applies, but not an application for temporary premises approval to which regulation 58 or 61 applies), as soon as is practicable, it must give notice of that application to—

(a) any Local Pharmaceutical Committee—

(i) whose area includes the medical practice premises or all or part of the area to which the application relates, or

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

(b) any Local Medical Committee—

(i) whose area includes the medical practice premises or all or part of the area to which the application relates, or

(ii) any part of whose area is within 2 kilometres of the medical practice premises 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) any provider of primary medical services, or 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 medical practice premises to which the application relates; and

(h) the relevant HWB and any other HWB (HWB2) any part of whose area—

(i) is within 2 kilometres of the medical practice premises to which the application relates, or

(ii) in the case of an application for outline consent, is part of the area specified in the application;

(2) [F1 NHS England] may also give notice of the 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 a HWB is notified under paragraph (1)(h), [F1 NHS England] must also give notice of the application to—

(a) 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;

(b) 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,

(c) 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

(d) any provider of primary medical services, or 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) A person (P) notified under paragraphs (1) to (3) may make representations in writing about the application that is the subject of the notification to [F1 NHS England], provided P does so within 45 days of the date on which notice of the application was given to them.

(5) If [F1 NHS England] is considering, as a consequence of an application for outline consent or premises approval, making (including revising) a determination as to whether or not an area is or is not to be part of controlled locality, it must give notice under paragraph (1) at the same time that it gives notice under regulation 38(1).

(6) A person (P) notified under paragraphs (1) to (3)—

(a) must be informed of P's right to make representations under paragraph (4); and

(b) need not be given the same information as other persons notified under paragraphs (1) to (3) but, subject to sub-paragraphs (7) to (9), 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.

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

(8) P must not be provided with any private addresses, private telephone numbers or dates of birth supplied by the applicant (A).

(9) 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.

(10) 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.

(11) If information is being withheld from P under paragraph (9), 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