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

Amendment of regulation 45O (requirements for registration as an importer, manufacturer or distributor of an active substance)

44.—(1) Regulation 45O(1) is amended as follows.

(2) In paragraph (1), for “the Commission has adopted principles and guidelines of good manufacturing practice under the third paragraph of Article 47 of the 2001 Directive which applies” substitute “principles and guidelines of good manufacturing practice have been published under, or apply by virtue of, regulation C17, which apply”.

(3) In paragraph (2), for “the Commission has adopted principles and guidelines of good distribution practice under the fourth paragraph of Article 47 of the 2001 Directive which applies” substitute “principles and guidelines of good distribution practice have been published under, or apply by virtue of, regulation C17, which apply”.

(4) In paragraph (3)—

(a) for “the Commission has adopted principles and guidelines of good manufacturing practice under the third paragraph of Article 47 of the 2001 Directive which applies” substitute “principles and guidelines of good manufacturing practice have been published under, or apply by virtue of, regulation C17, which apply”;

(b) for “imported from a third country” substitute “so imported”;

(c) in sub-paragraph (c)—

(i) omit “third” in both places it appears,

(ii) in paragraph (ii), for “Union” substitute “United Kingdom”, and

(iii) in paragraph (iii), for “Union” substitute “licensing authority”.

(5) In paragraph (4)—

(a) in sub-paragraph (a), for “Article 111b of the 2001 Directive” substitute “paragraph (6)”; and

(b) in sub-paragraph (b)(i), for “competent authority of a member State” substitute “licensing authority or an appropriate authority responsible for the licensing of medicinal products in a country included in a list under paragraph (6)”.

(6) At the end insert—

“(6) The licensing authority may publish a list of countries which it is satisfied have a regulatory framework applicable to active substances exported to the United Kingdom that is equivalent to the regulatory framework in the United Kingdom, in that the respective control and enforcement activities in those countries ensures an equivalent level of protection of public health.

(7) Before including a country in the list under paragraph (6), the licensing authority must assess the equivalence referred to in that paragraph by—

(a) reviewing relevant documentation; and

(b) unless the country is included in the approved country for batch testing list, carrying out—

(i) an on-site review of the country’s regulatory system, and

(ii) if the licensing authority considers it necessary, an inspection of one or more of that country’s manufacturing sites for active substances.

(8) In carrying out an assessment under paragraph (7) the licensing authority must in particular take account of the—

(a) country’s rules for good manufacturing practice;

(b) regularity of inspections to verify compliance with good manufacturing practice;

(c) effectiveness of enforcement of good manufacturing practice; and

(d) regularity and rapidity of information provided by that country relating to non-compliant producers of active substances.

(9) The licensing authority must—

(a) review the list under paragraph (6) to determine if a country included in it still satisfies the requirements for inclusion in the list, and if it is not so satisfied, remove that country; and

(b) undertake such a review at least every three years, beginning with the date on which a country is included in the list .”.

(1)

Regulation 45O was inserted by S.I. 2013/1855.