This section has no associated Explanatory Memorandum
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.