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

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