The National Health Service (Pharmaceutical Services) (Wales) Regulations 2013

Outline consent and premises approval

24.—(1) A doctor who is a provider of primary medical services or who is engaged or employed by a provider of primary medical services and who wishes to make an arrangement with a Local Health Board to provide pharmaceutical services to patients under regulation 20(1)(b) or (c) (arrangements for the provision of pharmaceutical services by doctors) must submit an application in writing to the Local Health Board for—

(a) consent specifying the area in which the doctor wishes to provide pharmaceutical services (“outline consent”); and

(b) approval of any practice premises from which the doctor wishes to dispense (“premises approval”) .

(2) A doctor who has outline consent which has taken effect under regulation 25 (taking effect of outline consent and premises approval) may submit an application for premises approval only in relation to—

(a) additional practice premises from which to provide pharmaceutical services; or

(b) practice premises to which the doctor wishes to relocate from listed premises.

(3) An application to a Local Health Board made under this regulation must be made in writing and must provide the information set out in Part 4 of Schedule 1.

(4) A Local Health Board must return an application if it does not contain all of the information required under paragraph (3).

(5) The Local Health Board—

(a) must refuse outline consent in relation to any part of the area specified in the application which is not in a controlled locality or which is within 1.6 kilometres of any pharmacy;

(b) must refuse premises approval in relation to any premises specified in the application which are within 1.6 kilometres of any pharmacy;

(c) must refuse an application where it is of the opinion that to grant it would prejudice the proper provision of primary medical services, dispensing services or pharmaceutical services in the controlled locality within which the premises specified in the application are situated (the “prejudice test”);

(d) subject to paragraph (7) and where an application has not been refused under the prejudice test, must refuse the application unless it is satisfied that it is necessary or expedient to grant the application in order to secure in the area in respect of which the doctor has applied for outline consent the adequate provision, by persons included in a list, of the services, or some of the services, specified in the application; and

(e) may, where the Local Health Board has considered two or more applications together and in relation to each other, refuse one or more of them (notwithstanding that it would, if determining the applications in isolation, grant them) where the number of applications is such that to grant all of them or more than one of them would prejudice the proper provision of primary medical services, dispensing services or pharmaceutical services in any controlled locality.

(6) Any refusal of an application outlined at subparagraphs (a) to (e) above may relate to all or any part of the area within the controlled locality, or, as the case may be, all or some of the premises for which approval is sought.

(7) Where in determining an earlier application made under this regulation that application was refused under paragraph (5)(d), the question under paragraph (5)(d) must not be considered again in relation to the same area as was specified in the earlier application—

(a) for three years, beginning on the date on which the earlier application was determined by the Local Health Board or, if that determination was appealed, the date of the decision on the appeal; unless

(b) the Local Health Board is satisfied that there has been a substantial change of circumstances in relation to the area in respect of which the doctor has applied for outline consent since the question under paragraph (5)(d) was last considered.

(8) Subject to any specific requirements that are contained within this Part, Parts 1 and 3 of Schedule 2 specify the procedures to be followed by a Local Health Board when determining applications under this Part.

(9) An application under this regulation is granted on the date which is the later of—

(a) 30 days after notice of the Local Health Board’s decision on the application was sent by the Local Health Board in accordance with paragraph 15 of Schedule 2; or

(b) where an appeal is made against the decision of the Local Health Board, the date on which the Welsh Ministers gave notice of their decision on the appeal under paragraph 8 of Schedule 3.