New variations regulation: Regulatory and procedural guidance
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Practical questions and answers to support the implementation of the variations guidelines in the centralised procedure - superseded (PDF/143.83 KB)
First published: 18/05/2015
Last updated: 02/06/2016
EMA/427505/2013 Rev.3 -
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Practical questions and answers to support the implementation of the variations guidelines in the centralised procedure: document with track changes - superseded (PDF/150.06 KB)
First published: 25/07/2013
Last updated: 02/06/2016
EMA/427505/2013 Rev. 3 -
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Transitional provisions for implementation of Commission Regulation (EU) No 712/2012 amending Variations Regulation (EC) No 1234/2008 (PDF/71.98 KB)
First published: 25/10/2012
Last updated: 25/10/2012
EMA/626908/2012 -
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Questions and answers on variations to an existing pharmacovigilance system as described in the detailed description of the pharmacovigilance system (PDF/75.05 KB)
Adopted
First published: 02/03/2011
Last updated: 02/08/2013
EMA/456003/2013 -
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Annex B Word template (DOC/49 KB)
First published: 21/12/2009
Last updated: 06/04/2017 -
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Annex B PDF template (PDF/27.82 KB)
First published: 21/12/2009
Last updated: 02/08/2013 -
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Template letter of intent work sharing procedure (DOCX/117.15 KB)
First published: 17/12/2009
Last updated: 14/10/2020
EMA/293212/2017 -
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Template cover letter for worksharing procedures including centrally authorised products and nationally authorised products (DOC/50.5 KB)
First published: 18/06/2010
Last updated: 02/08/2013 -
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European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (PDF/2.48 MB)
First published: 01/07/2009
Last updated: 21/12/2022
EMEA-H-19984/03 Rev. 100
- 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
- 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
- Variations guidelines - Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV 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 and on the documentation to be submitted pursuant to those procedures
- Electronic variation application form
- Variation application form
- European Medicines Agency/CMDh explanatory notes on Variation Application Form
- eCTD Variation Q&A document