The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

Amendment of regulation 214 (sale or supply of prescription only medicines)

180.—(1) Regulation 214(1) is amended as follows.

(2) In paragraph (2)(a), for “EEA health professional” substitute “approved country health professional”.

(3) In paragraph (6), for “EEA health professional” substitute “approved country health professional”.

(4) After paragraph (6) insert—

“(6A) The licensing authority must publish a list of approved countries and professions for the purposes of the definition of “approved country health professional”.

(6B) In order to determine whether a country or profession should be included in the list published under paragraph (6A), the licensing authority may, in particular, take into account—

(a) the country’s standards of professional qualification;

(b) the country’s system for ensuring that qualified professionals have undergone training which meets the requirements that apply in that country;

(c) the effectiveness of enforcement of professional standards;

(d) the mechanisms the country has in place to assist members of the public in obtaining information in respect of a qualified professional who is established there; and

(e) the regularity and rapidity of information provided by that country relating to non-compliant professionals.

(6C) The licensing authority must—

(a) review a country or profession it has included in the list published under paragraph (6A) to determine if it is still satisfied that they should remain on the list, and if it is not so satisfied, remove it from that list; and

(b) undertake such a review at least every 3 years beginning with the date on which that country or profession was included in that list.”.

(1)

Regulation 214 was amended S.I. 2013/1855, 2014/490, 2016/186 and 2018/199.