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

Decisions on outline consent and premises approval applications and the taking effect of grants U.K.

53.—(1) Once [F1 NHS England] has determined an application for outline consent or premises approval, as soon as is practicable, it must give notice of that decision to—

(a) the applicant; and

(b) any person notified by it under regulation 52(1) to (3) in relation to the application.

(2) Each notification under paragraph (1) must include a statement of the reasons for the decision and, if the person notified is a person with rights of appeal in relation to the decision under regulation 63(1)(c) or (d), an explanation of how those rights may be exercised.

(3) When outline consent is granted, subject to paragraphs (11) and (13)(b), [F1 NHS England] must determine when the outline consent is to take effect.

(4) Subject to regulation 54, premises approval takes effect, if the application for it had a related outline consent application, when the related outline consent takes effect (but otherwise it does so in accordance with regulation 56).

(5) Outline consent takes effect on the day the proceedings relating to the grant of it have reached their final outcome, unless on the day before that day within 1.6 kilometres of the relevant practice premises there are premises which are the subject of an outstanding pharmacy application.

(6) For the purposes of this regulation, the “relevant practice premises” are the premises—

(a) which are the subject of a related premises approval application; or

(b) if there is no related premises approval application, that are the medical practice premises of the dispensing doctor from which the dispensing doctor wishes to dispense to patients in the area in relation to which outline consent is sought.

(7) In these Regulations, “outstanding pharmacy application” means—

(a) an application which has not yet reached its final outcome—

(i) for inclusion in a pharmaceutical list (not necessarily that of the relevant HWB), or

(ii) from a person included in a pharmaceutical list—

(aa) to relocate to different premises in the area of the relevant HWB, or

(bb) to open, within the area of that HWB, additional premises from which to provide pharmaceutical services,

where the applicant is seeking the listing of pharmacy premises other than distance selling premises; or

(b) circumstances where an application of the type mentioned in paragraph (a) has been granted, and—

(i) the provision of pharmaceutical services from the premises for which listing was sought has not yet commenced, and

(ii) the grant has not yet lapsed.

(8) In a case where outline consent is not to take effect on the date on which it is granted, [F1 NHS England] must give the dispensing doctor to whom outline consent was granted (D) written details of—

(a) the outstanding pharmacy application; and

(b) the earliest date (referred to in this Part as the “provisional date”) on which an application can be made by D for a determination of when the outline consent is to come into effect.

(9) That provisional date, subject to paragraph (10), is the day after the end of the period of one year beginning on the day of—

(a) the determination by [F1 NHS England] of D's application of outline consent; or

(b) where that determination is the subject of an appeal, the day on which the appeal reaches its final outcome.

(10) [F1 NHS England] may at any time before the provisional date determine that the provisional date be changed to a later date, but only to a date which is not more than 3 months after the date originally determined in accordance with paragraph (8).

(11) Outline consent lapses if, before the provisional date, pharmaceutical services are provided at the pharmacy premises to which the outstanding pharmacy application relates.

(12) On or as soon as is reasonably practicable after the provisional date, [F1 NHS England] must notify D that D may within 3 months of the provisional date request in writing that [F1 NHS England] determine whether the outline consent is to come into effect.

(13) Where [F1 NHS England] receives a request under paragraph (12), it must, as soon as is reasonably practicable determine—

(a) unless paragraph (b) applies, that the outline consent is to come into immediate effect; or

(b) that the outline consent has lapsed—

(i) where on the date of the determination (which must be a day from Monday to Friday, except Good Friday, Christmas Day or a bank holiday) primary medical services are not being provided at the relevant practice premises, or

(ii) by virtue of paragraph (11),

and it must inform D accordingly.

(14) [F1 NHS England] must notify the applicant for outline consent of its determination under paragraph (10) or (13) and must include with the notification of its determination an explanation of—

(a) the reasons for the determination; and

(b) the applicant's rights of appeal in relation to it under regulation 63(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