SCHEDULES

SCHEDULE 11 U.K.Advice and representations

PART 2 U.K.Type II variation applications, complex variation applications and new excipient variation applications

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.