Variations: guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)

Guidance is available from the European Medicines Agency (EMA) on variation procedures under the Veterinary Medicinal Products Regulation.

The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) applies from 28 January 2022.

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

Separate guidance is available for 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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