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

Amendment of Schedule 7 (qualified persons)

32.—(1) Schedule 7(1) is amended as follows.

(2) In Part 1—

(a) in paragraph 3, for “the member State in which it is studied” substitute “the licensing authority”;

(b) in paragraph 6, for “the member State in which the courses take place” substitute “the licensing authority”.

(3) In Part 3 (obligations of qualified person)—

(a) in paragraph 12—

(i) the existing text becomes sub-paragraph (1),

(ii) in paragraph (a) of that sub-paragraph—

(aa) for “marketing authorisation, Article 126a authorisation” substitute “UK marketing authorisation”,

(bb) after “herbal registration” insert “, or an equivalent authorisation,”, and

(cc) insert “and” at the end,

(iii) in paragraph (b) of that sub-paragraph—

(aa) for “medicinal products imported from a non-EEA State, irrespective of whether the products have been manufactured in an EEA State” substitute “medicinal products imported from a country other than approved country for import, irrespective of whether the products have been manufactured in the United Kingdom or an approved country for import”, and

(bb) in paragraph (iii), for “marketing authorisation, Article 126a authorisation” substitute “UK marketing authorisation”, and

(cc) after “herbal registration” insert “, or an equivalent authorisation,”,

(iv) omit paragraph (c) of that sub-paragraph, and

(v) after that sub-paragraph insert—

“(2) In this paragraph “equivalent authorisation” means, in respect of a medicinal product that does not have a UK marketing authorisation, certificate of registration or traditional herbal registration, such equivalent authorisation or registration granted by an appropriate authority for the licensing of medicinal products in an approved country for import.”.

(b) omit paragraph 13;

(c) in paragraph 14—

(i) in sub-paragraph (1)(a) for “country other than an EEA State” substitute “country other than approved country for import”,

(ii) in sub-paragraph (1)(b)—

(aa) for “European Union” substitute “licensing authority”,

(bb) for “that country” substitute “the country from which those products are imported”, and

(cc) in sub-paragraph (i), for “laid down by the European Union” substitute “in the Good Manufacturing Practice Directive, as supplemented by the guidelines and principles which apply under, or by virtue of, regulation C17”,

(iii) at the end insert—

“(3) The licensing authority must publish a list of the countries with whom it has made appropriate arrangements under sub-paragraph (1)(b) (“approved country for batch testing list”).

(4) A country may be included in the approved country for batch testing list subject to any condition or restriction that the licensing authority considers appropriate, including as to categories of medicinal product, and any such condition or restriction must be included in the list.

(5) In order to satisfy itself of the matters specified in sub-paragraph (1)(b)(i) and (ii), the licensing authority may, in particular, take into account—

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

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

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

(d) the regularity and rapidity of information provided by that country relating to non-compliant manufacturers;

(e) any on-site review of that country’s regulatory system undertaken by the licensing authority;

(f) any on-site inspection of a manufacturing site in that country observed by the licensing authority;

(g) any other relevant documentation available to the licensing authority.

(6) The licensing authority must—

(a) review any appropriate arrangements it has made under sub-paragraph (1)(b) to determine if that country still satisfies the requirements of sub-paragraph (1)(b)(i) and (ii), and whether any condition or restriction in those arrangements remains appropriate;

(b) if it is not so satisfied, remove that country from the approved country for batch testing list or, as the case may be, amend or remove that condition or restriction; and

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

(1)

Schedule 7 was amended by S.I. 2019/62.