The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

38.  In regulation 50 (amendment of Schedule 8 (material to accompany an application for a UK marketing authorisation))—

(a) in paragraph (2)—

(i) in paragraph (a), after “in the United Kingdom” insert “or a member State”;

(ii) for paragraph (b) substitute—

“(b) for sub-paragraph (b) substitute—

“(b) the country (which must be either the United Kingdom or a member State) in which the appropriately qualified person resides and carries out his or her tasks;”;”;

(iii) for paragraph (c) substitute—

“(c) for paragraph (e) substitute—

“(e) a reference to the physical location where the pharmacovigilance system master file for the medicinal product can be accessed electronically, which must be in the United Kingdom.”.”;

(b) in paragraph (3), for the inserted paragraph 18, substitute—

“18.   Where—

(a) in the case of a UKMA(NI) or a UKMA(UK), an application for authorisation for the medicinal product to be placed on the market is under consideration in one or more member States—

(i) a list of the member State or States concerned, and

(ii) in relation to each such application, a copy of the summary of the product characteristics, and the package leaflet, proposed by the applicant;

(b) in the case of a medicinal product for sale or supply in Great Britain, an application for authorisation for the medicinal product to be placed on the market is under consideration in a country other than the United Kingdom, or by the EMA, notification of that fact.”;

(c) for paragraph (4) substitute—

“(4) In paragraph 19, for “a member State or by a third country” substitute “, in the case of a medicinal product for sale or supply in Northern Ireland, a member State or by a country other than an EEA State, or in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom or by the European Commission”.”;

(d) for paragraph (5) substitute—

“(5) In paragraph 20, after “Where” insert “, in the case of a medicinal product for sale or supply in Northern Ireland,”.”;

(e) for paragraph (6) substitute—

“(6) For paragraph 21 substitute—

“21.   Where an authorisation for the medicinal product to be placed on the market has been refused—

(a) in the case of a medicinal product for sale or supply in Northern Ireland, by a member State or by a country other than an EEA State, or

(b) in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom,

details of that decision and of the reasons for it.”.”;

(f) for paragraph (7) substitute—

“(7) In paragraph 22 for “A copy of any” substitute “In the case of a medicinal product for sale or supply in Northern Ireland, a copy of any”.”;

(g) for paragraph (8) substitute—

“(8) For paragraph 23 substitute—

“23.   For medicinal products included on the list referred to—

(a) in the case of a medicinal product for sale or supply in Northern Ireland, in Article 23 of Regulation (EC) No 726/2004, the symbol and statement “▼ This medicinal product is subject to additional monitoring”, or

(b) in the case of a medicinal product for sale or supply in Great Britain, in regulation 202A, the symbol and statement “▼ This medicinal product is subject to additional monitoring”.”.”;

(h) in paragraph (9), in the inserted paragraph 25A, after “advanced therapy medicinal product ” insert “for sale or supply in Great Britain”;

(i) in paragraph (10), in the inserted paragraph 36, after “advanced therapy medicinal product ” insert “for sale or supply in Great Britain”.