Variations not requiring assessment (veterinary medicines)

Guidance is available from the European Medicines Agency (EMA) on variations for centrally authorised veterinary medicines not requiring assessment under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6). This includes information on the documents that marketing authorisation holders need to submit as part of the variation procedure.

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

For more information, including guidance on how to register, see:

Separate guidance is also available on Variations requiring assessment.

List of variations not requiring assessment

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