# The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994, Paragraph 4: Scope and application of the procedural provisions


This Schedule does not apply—
(a) if the licensing authority make a decision in relation to the application in accordance with Article 7.2 of the 1965 Directive (suspension of detailed examination of an application under active examination in another Member State); or
(b) the application or proposal relates to the renewal or variation of a marketing authorization which has been granted in accordance with the provisions of Chapter III of Council Directive 75/319 EEC or which has been granted by Member States in accordance with Article 4 of Council Directive 87/22/EEC before 1st January 1995; or
(c) to the variation of an authorization on the application of holder.

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Source: https://www.legislation.gov.uk/uksi/1994/3144/schedule/2/paragraph/4 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.