Variations not already listed (veterinary medicines)
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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.
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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 (PDF/347.67 KB)
First published: 04/10/2021
Last updated: 29/09/2022
EMA/CMDv/144284/2021 Rev.1 -
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Request form - Request for a recommendation on the classification of a not already listed variation (DOC/62 KB)
First published: 04/10/2021