The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020

Premises approval: additional and new premises after outline consent has taken effect E+W

34.—(1) A doctor who has outline consent which has taken effect and who wishes to be granted premises approval for premises in addition to those premises in respect of which premises approval has been given (“additional premises”) may apply in writing providing the information set out in Part 4 of Schedule 2 to all of the appropriate Local Health Boards and the application will be determined by the relevant Local Health Board in accordance with paragraph (2).

(2) An application for additional premises must be determined by the relevant Local Health Board in accordance with regulation 30 (outline consent and premises approval) and regulation 31 (taking effect of outline consent and premises approval).

(3) For the purposes of this regulation—

(a) the “appropriate Local Health Boards” are those Local Health Boards that hold the dispensing doctor lists on which the doctor making the application is included, and

(b) the “relevant Local Health Board” is the Local Health Board in whose area the additional premises are situated.

(4) A doctor wishing to be granted premises approval in relation to premises (“new premises”) where they wish to dispense instead of listed premises may apply to all the appropriate Local Health Boards providing the information set out in Part 4 of Schedule 2 and the application will be determined by the relevant Local Health Board in accordance with paragraphs (5) and (6).

(5) In the case of an application for new premises, the relevant Local Health Board must give notice of the application in accordance with paragraph 9 of Schedule 3 and the content of the notification must comply with paragraph 10 of that Schedule.

(6) In the case of an application for new premises the relevant Local Health Board must—

(a) grant an application, where it is satisfied that—

(i) for the patients that are accustomed to accessing pharmaceutical services at the existing premises, the location of the new premises is not significantly less accessible, and

(ii) granting the application would not result in a significant change in the arrangements for the provision of pharmaceutical or dispensing services to any part of the controlled locality in which the new premises are located, or

(b) in any case, determine the application as if it were an application for premises approval made under regulation 30(1)(b).

(7) A Local Health Board must, unless it has good cause not to do so, refuse an application under paragraph (1) or (4) if an application made by the doctor has been granted under paragraph (6)(a) during the 12 months before the application was submitted under paragraph (1) or (4).

(8) The Local Health Board must notify its determination under paragraph (2) or paragraph (6)(b) to the persons to whom notice of the application is required to be given in accordance with regulation 30 and paragraph 8 of Schedule 3.

(9) The Local Health Board must notify its determination under paragraph (6)(a) to those persons to whom notification is required to be given in accordance with paragraph 15 of Schedule 3.

(10) A determination by the Local Health Board under paragraph (2), (6)(a) or (6)(b) may be appealed to the Welsh Ministers by the persons listed in paragraph 6(1) of Schedule 4.

(11) Subject to paragraph (12), the premises approval for the additional or new premises will take effect from the date of notification of the grant of premises approval, which is—

(a) where no appeal is made against the decision of the Local Health Board, the date after the expiry of 30 days beginning with the date on which notice of that decision is given under paragraph (8) or paragraph (9), or

(b) where such an appeal is made, the date on which the Welsh Ministers give notice of their decision on that appeal.

(12) Where—

(a) the premises approval is granted in relation to additional premises, and

(b) in relation to the premises for which the approval is granted there, at the date of the grant, outstanding pharmacy applications (as defined in regulation 31(11)),

the premises approval will take effect on the date which is the day after the end of a period of 1 year, or such further period (not exceeding 3 months) as the Local Health Board may for good cause allow, from the final resolution of any outstanding pharmacy application.

(13) The Local Health Board may grant temporary premises approval to a doctor who has outline consent and premises approval in relation to additional or new premises where the Local Health Board considers it would meet a need for pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant locality and which has been included in the relevant pharmaceutical needs assessment and in respect of which the doctor has applied for outline consent, and renew any such temporary approval granted, and where it does so it must—

(a) notify those persons to whom notice of the application under regulation 30 (outline consent and premises approval) was required to be given under paragraph 8 of Schedule 3 and the applicants in relation to the outstanding pharmacy applications,

(b) state the period during which the temporary premises approval is to apply, and

(c) include those premises in the dispensing doctor list in relation to that doctor.

(14) Temporary premises approval may be granted for a period not exceeding 12 months, and may be renewed for a further period not exceeding 3 months.

(15) The determination by the Local Health Board under paragraph (13) may be appealed by the applicant to the Welsh Ministers.

(16) If, in the circumstances outlined in paragraph (15), a notice of appeal is submitted to the Welsh Ministers, Part 1 of Schedule 4 and the following paragraphs of Schedule 4 will apply—

(a) 6(3)(b) and (c),

(b) 7(1) and (3), and

(c) 8,

as if the notice of appeal were submitted under paragraph 6(1) of Schedule 4.

Commencement Information

I1 Reg. 34 in force at 1.10.2021, see reg. 1(3)