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 different types of variation procedure. 

There are two types of variation under Regulation (EU) 2019/6:

Historical variation procedures

A number of historical variation procedures are no longer applicable because of changes in European law. They took place under Regulation (EC) No 1234/2008 and Regulation (EU) No 712/2012. 

The names of these historical procedures are listed below, for reference: 

The outcomes of a number of these historical variation procedures, and references to them, are available on this website.


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