The Human Medicines Regulations 2012 No. 1916

SCHEDULES

SCHEDULE 11 Advice and representations

PART 2 Type II variation applications, complex variation applications and new excipient variation applications

Application of this Part

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(1); 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.

(1)

OJ No L 334, 12.12.2008, p.7.