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

Amendment of Schedule 7 (qualified persons) U.K.

32.—(1) Schedule 7 M1 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),

[F1 (ia) for “The qualified person” substitute “In Great Britain, the qualified person”;]

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

[F2 (zaa) for “the United Kingdom” substitute “Great Britain”;]

(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 [F3 a country other than Northern Ireland or] 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.”.

[F4 (aa) after paragraph 12 insert—

“12A.— (1) In Northern Ireland, the qualified person is responsible for securing—

(a) that each batch of medicinal products manufactured in Northern Ireland has been manufactured and checked in accordance with these Regulations and the requirements of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to those products; and

(b) in the case of medicinal products imported from a country other than an EEA State, irrespective of whether the products have been manufactured in Northern Ireland or an EEA State, that each batch has undergone—

(i) a full qualitative analysis,

(ii) a quantitative analysis of all the active substances, and

(iii) all other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to those products; and

(c) in the case of medicinal products, other than radiopharmaceuticals, that are required to bear safety features pursuant to Article 54a of the 2001 Directive and not intended to be exported to a country other than an EEA State, that the features specified in paragraph 18A of Schedule 24 have been affixed on the packaging.”.]

[F5 (b) in paragraph 13—

(i) in sub-paragraph (1) after “This paragraph applies” insert “in Northern Ireland”;

(ii) in sub-paragraph (1)(a) for “paragraph 12 in another member State is imported to the United Kingdom” substitute “paragraph 12A in a member State is imported to Northern Ireland”;

(iii) in sub-paragraph (2) for “12” substitute “12A”;]

(c) in paragraph 14—

[F6 (i) in sub-paragraph (1)(a) after “are imported” insert “into Great Britain from a country other than an approved country for import or into Northern Ireland;]

[F7 (ii) for sub-paragraph (1)(b) substitute—

“(b) appropriate arrangements have been made, in the case of import into Great Britain by the licensing authority with the country from which those products are imported and, in the case of a product for import into Northern Ireland by the European Union with that country, to ensure that—

(i) the manufacturer of the medicinal products applies standards of good manufacturing practice at least equivalent to those laid down—

(aa) in the case of a product for sale or supply in Great Britain, in the Good Manufacturing Practice Directive, as supplemented by the guidelines and principles which apply under, or by virtue of, regulation C17, and

(bb) in the case of a product for sale or supply in Northern Ireland, by the European Union;

(ii) the controls referred to in paragraph 12(b) or 12A(b) (as appropriate) have been carried out in that country.”.]

[F8 (iia) in paragraph (2) after “paragraph 12” insert “or 12A”.]

(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.”.

Textual Amendments

F1 Reg. 32(3)(ia) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(a)

F2 Reg. 32(3)(a)(ii)(zaa) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(b)

F3 Words in reg. 32(3)(a)(iii)(aa) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(c)

F4 Reg. 32(3)(aa) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(d)

F5 Reg. 32(3)(b) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(e)

F6 Reg. 32(3)(c)(i) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(f)(i)

F7 Reg. 32(3)(c)(ii) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(f)(ii)

F8 Reg. 32(3)(c)(iia) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(f)(iii)

Commencement Information

I1 Reg. 32 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M1 Schedule 7 was amended by S.I. 2019/62.