Variations not already listed (veterinary medicines)

Guidance is available from the European Medicines Agency (EMA) on how to classify a variation for a centrally authorised veterinary medicine that is not already listed in existing guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6).

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

When the variation marketing authorisation holders would like to make cannot be classified into either of these variation types, they can request a classification of the variation

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


How useful was this page?

Add your rating