Variations for veterinary medicines

A variation is a change to the terms of a marketing authorisation. Guidance is available from the European Medicines Agency (EMA) for marketing authorisation holders for centrally authorised veterinary medicines on the regulatory requirements and procedures for the different types of variations. 


Guidance under the Veterinary Medicinal Products Regulation Regulation (EU) 2019/6

Guidance for marketing authorisation holders on variation procedures under Regulation (EU) 2019/6. This applies for procedures submitted on or after 28 January 2022.

Guidance under Regulation (EC) No 1234/2008 and Regulation (EU) No 712/2012

Guidance for marketing authorisation holders on variations procedures submitted on or before 27 January 2022 to be concluded in accordance with Regulation (EC) No 1234/2008 and Regulation (EU) No 712/2012.


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