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

Applications to be included in or make amendment to a pharmaceutical list E+W

15.—(1) A person may submit an application to a Local Health Board where that person—

(a) wishes to be included in a pharmaceutical list maintained by the Local Health Board,

(b) is already included in a pharmaceutical list maintained by the Local Health Board but wishes, within the Local Health Board’s area, to—

(i) open additional premises from which to provide the same or different pharmaceutical services,

(ii) relocate to different premises and at those premises to provide the same or different pharmaceutical services, or

(iii) provide from the listed premises pharmaceutical services that are of a different description to those pharmaceutical services already listed in relation to that person, or

(c) is already included in a pharmaceutical list maintained by a neighbouring Local Health Board but wishes to relocate to different premises in the area of the Local Health Board to which the application is made and, at those premises, to provide the same or different pharmaceutical services.

(2) 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 1 of Schedule 2.

(3) Subject to regulation 60 (home Local Health Board), a person making an application under paragraph (1)(a) must provide the information and undertakings specified in Part 2 of Schedule 2.

(4) If a Local Health Board considers that an application does not contain all of the information required under paragraphs (2) and (3)—

(a) it may request the missing relevant information or documentation from the applicant, and

(b) the applicant must, within the period reasonably specified by the Local Health Board in the request under sub-paragraph (a)—

(i) provide any information or documentation reasonably requested,

(ii) notify the Local Health Board that there is to be a delay in providing the requested information or documentation, for specified reasons, and specify a date by which the applicant undertakes to provide the information or documentation, or

(iii) if the applicant considers that any information or documentation has been unreasonably requested, notify the Local Health Board of that and seek a review by the Local Health Board of the reasonableness of the request.

(5) If an applicant refuses to comply with a request under paragraph (4)(a)—

(a) within the period—

(i) reasonably specified by the Local Health Board under paragraph (4)(b), or

(ii) ending on the date specified by the applicant in accordance with paragraph (4)(b)(ii), if the Local Health Board is satisfied that a delay beyond the period it specified, and the length of the delay, are for good cause,

unless sub-paragraph (b) applies, the application is to be treated as withdrawn;

(b) in circumstances where the applicant has, in accordance with paragraph (4)(b)(iii), sought a review by the Local Health Board of the reasonableness of the request, if the review determines that any or all of the information or documentation requested—

(i) must after all, be provided, the application is to be treated as withdrawn unless the information or documentation that must still be provided is provided within a new period reasonably specified by the Local Health Board for the provision of that information or documentation, or

(ii) need not be provided by the applicant, the request of the Local Health Board is to be treated as withdrawn to the extent that it relates to information or documentation that need not be provided.

(6) The Local Health Board may request information or documentation under this paragraph at any time after it receives an application and before its determination of that application.

(7) An application to be included in a pharmaceutical list by a person not already included must be refused if the applicant is an individual who qualified as a pharmacist in Switzerland or an EEA State other than the United Kingdom, unless that person satisfies the Local Health Board they have the level of knowledge of English which, in the interests of that individual and the persons making use of the pharmaceutical services to which the application relates, is necessary for the provision of those pharmaceutical services in the area of the Local Health Board.

(8) All applications made under regulation 15(1) will be determined in accordance with regulation 16 (determination of applications to be included in or to make amendment to a pharmaceutical list) except for applications to which—

(a) regulation 19 (applications involving relocation within a Local Health Board’s area),

(b) regulation 20 (applications involving relocation between neighbouring Local Health Board areas),

(c) regulation 21 (applications involving temporary relocation), or

(d) regulation 22 (applications involving a change of ownership),

applies and which are determined in accordance with those regulations.

(9) Parts 1 and 3 of Schedule 3 specify the procedures to be followed by a Local Health Board when determining applications made under this Part.

Commencement Information

I1 Reg. 15 in force at 1.10.2021, see reg. 1(3)