Drug database
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.
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Variations of a marketing authorisation – Variations Regulation
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Information for marketing authorisation holders
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Data overview for national marketing authorisations variations
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EC guidance on variations to marketing authorisations and variations classification from 4.8.2013
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Overview of the issue dates for variations to national marketing authorisations
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Useful links