The Human Medicines Regulations 2012

Application of this Part U.K.

14.  This Part applies— U.K.

(a) to an application (a “Type II variation application”) to vary a UK marketing authorisation if the variation is a major variation of Type II within the meaning of Article 2(3) of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products M1 [F1 or paragraph 1 of Schedule 10A]; and

(b) to an application to vary a traditional herbal registration that is—

(i) a complex variation application, or

(ii) a new excipient variation application.

Textual Amendments

F1 Words in Sch. 11 para. 14(a) inserted (31.12.2020) by S.I. 2019/775, reg. 63(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(b))

Marginal Citations

M1 OJ No L 334, 12.12.2008, p.7.

15.—(1) In paragraph 14(b)(i) “ complex variation application” means an application by the holder of the registration to vary it so that one or more of the following changes can be made to the product to which it relates— U.K.

(a) a change in the product's active ingredients by the addition of an active ingredient from a new source;

(b) a change in the product's excipients by the addition of a TSE risk excipient from a new source; or

(c) a change by the addition of a vitamin or mineral from a new source, where no European Pharmacopoeia certificate of suitability for the vitamin or mineral is submitted with the application.

(2) For the purpose of sub-paragraph (1), an ingredient, vitamin or mineral is “from a new source” if its manufacturer as named in the application has not been named as its manufacturer in a [F2 UK] marketing authorisation or traditional herbal registration granted for a medicinal product including the ingredient, vitamin or mineral.

(3) For the purpose of sub-paragraph (1), an excipient is a “TSE risk excipient from a new source” if—

(a) it has been manufactured from raw materials of ruminant origin or such raw materials have been used in its manufacture; and

(b) its manufacturer as named in the application has not been named as its manufacturer in a [F3 UK] marketing authorisation or traditional herbal registration granted for a medicinal product that includes the excipient.

Textual Amendments

F2 Word in Sch. 11 para. 15(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(5); 2020 c. 1, Sch. 5 para. 1(1)

F3 Word in Sch. 11 para. 15(3)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(5); 2020 c. 1, Sch. 5 para. 1(1)

16.—(1) In paragraph 14(b)(ii) “ new excipient variation application” means an application (other than a complex variation application) by the holder of the registration to vary it so that the formulation of the medicinal product to which it relates can be changed by the addition of a new excipient. U.K.

(2) For the purpose of sub-paragraph (1) “new excipient” means, subject to paragraphs (3) and (4), an ingredient of a medicinal product that is not an active ingredient and that has not been included in a medicinal product—

(a) intended to be administered by the same route as the product to which the application relates; and

(b) for which a [F4 UK] marketing authorisation (other than a product licence of right) or traditional herbal registration has been granted.

(3) In the application of sub-paragraph (1) to a medicinal product intended to be administered orally, the reference to a new excipient does not include any ingredient specified in an enactment as an approved ingredient or additive in food or in a food product.

(4) In the application of sub-paragraph (1) to a medicinal product intended for external use only, the reference to a new excipient does not include any ingredient specified in an enactment as an approved ingredient or additive in a cosmetic product.

(5) In this paragraph “enactment” includes an enactment comprised in subordinate legislation F5 ....

Textual Amendments

F4 Word in Sch. 11 para. 16(2)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(6)(a); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Sch. 11 para. 16(5) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(6)(b); 2020 c. 1, Sch. 5 para. 1(1)

[F6 17.   In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.] U.K.

Textual Amendments

F6 Sch. 11 para. 17 substituted (31.12.2020) by S.I. 2019/775, reg. 63(7) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(c))