Paragraph 14

This Part applies—

(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 F1or 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.

Annotations

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.