Classification of changes for veterinary medicines


This guidance only applies to procedures initiated under Regulation (EC) No 1234/2008 and Regulation (EU) No 712/2012. before 28 January 2022.

The European Medicines Agency (EMA) provides guidance in the form of questions and answers (Q&As) to marketing authorisation holders of centrally authorised veterinary medicines about classification of changes to the marketing authorisation post-authorisation and certain variation classification categories.

EMA updates the Q&As regularly. Revised topics are marked 'New' or 'Rev.' on publication.

These Q&As are for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 6, notice to applicants, the European Commission 'Variations Guidelines' 2013/C 223/01 and the Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008 published on the website of oordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which covers CMDh/v and EMA human/vet.

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