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:

• 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.

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.

Guidance and application form to request a classicification

Procedural advice for requests for the classification of variations not already listed in Commission Implementing Regulation (EU) 2021/17 or EMA/CMDv guidance on the details of the classification of variations requiring assessment according to Article 62

Reference Number: EMA/CMDv/144284/2021 Rev.2

Request form - Request for a recommendation on the classification of a not already listed variation