# The Human Medicines Regulations 2012, 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 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.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/11/paragraph/14 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-11/paragraph-14
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.