# The Human Medicines Regulations 2012, Paragraph 36


This Schedule does not apply if the application or proposal relates to the renewal, revocation, suspension or variation of a UK marketing authorisation that—
(a) was granted in accordance with the provisions of Chapter 4 of Title III to the 2001 Directive (mutual recognition procedure and decentralised procedure);
(b) was granted before 1st January 1995 by member States in accordance with Article 4 of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology ; or
(c) was subject to the procedure laid down in Articles 32 to 34 of the 2001 Directive following a referral under Article 30 or 31 of that Directive, unless the procedure was limited to certain specific parts of the authorisation.

---
Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/11/paragraph/36 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-11/paragraph-36
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.