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Variations to national marketing authorisations

The Commission Regulation (EU) no. 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products became effective on 4 August, 2013.

Variations of a marketing authorisation – Variations Regulation

Information for marketing authorisation holders

Data overview for national marketing authorisations variations

EC guidance on variations to marketing authorisations and variations classification from 4.8.2013

Overview of the issue dates for variations to national marketing authorisations

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