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The Human Medicines Regulations 2012

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PART 3U.K.Obligations of qualified person

12.—[F1(1)] [F2In Great Britain, the qualified person] is responsible for securing—

(a)that each batch of medicinal products manufactured in [F3Great Britain] has been manufactured and checked in accordance with these Regulations and the requirements of the [F4UK marketing authorisation], certificate of registration or traditional herbal registration [F5, or an equivalent authorisation,] relating to those products; F6... [F7and]

(b)in the case of [F8medicinal 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], 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 [F9UK marketing authorisation], certificate of registration or traditional herbal registration [F10, or an equivalent authorisation,] relating to those products; [F11and]

F12(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F13(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.]

Textual Amendments

F6Word in Sch. 7 para. 12(a) omitted (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 17(a) and word in Sch. 7 para. 12(a) omitted (N.I.) (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 17(a)

F11Sch. 7 para. 12(c) and preceding word inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 17(b) and Sch. 7 para. 12(c) and preceding word inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 17(b)

[F1412A.—(1) In Northern Ireland, the qualified person is responsible for securing—U.K.

(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[F15.]

F16(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F17(2) This paragraph does not apply in relation to listed NIMAR products in Northern Ireland.]]

Textual Amendments

13.—(1) This paragraph applies [F18in Northern Ireland] where—U.K.

(a)a medicinal product which has undergone the controls referred to in [F19paragraph 12A in a member State is imported to Northern Ireland]; and

(b)each batch of the product is accompanied by control reports signed by another qualified person in respect of the medicinal product.

(2) Where this paragraph applies, the qualified person is not responsible for carrying out the controls referred to in paragraph [F2012A].

Textual Amendments

14.—(1) This paragraph applies where—U.K.

(a)medicinal products are imported [F21into Great Britain from a country other than an approved country for import or into Northern Ireland] from a country other than an EEA State; and

[F22(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.]

(2) Where this paragraph applies, the qualified person is not responsible for carrying out the controls referred to in paragraph 12 [F23or 12A].

[F24(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

15.—(1) The qualified person is responsible for ensuring, in relation to a medicinal product, that documentary evidence is produced that each batch of the product satisfies the requirements of paragraph 12.U.K.

(2) The documentary evidence referred to in sub-paragraph (1) must be kept up to date and must be available for inspection by the licensing authority for a period of at least five years.

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