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:
- variations not requiring assessment, which have minimal or no impact on the quality, safety or efficacy of the medicine, as listed in Commission Implementing Regulation (EU) 2021/17;
- variations requiring assessment.
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: