Validity of a marketing authorisation (veterinary medicines)
Guidance is available from the European Medicines Agency (EMA) on the validity of a marketing authorisation for centrally authorised veterinary medicines in the form of questions and answers (Q&As). The Q&As provide an overview of EMA's position on issues that are typically addressed in discussions or meetings with marketing authorisation holders in the post-authorisation phase. Revised topics are marked 'New' or 'Rev.' upon publication.
The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) changed rules on the authorisation of veterinary medicines in the EU when it became applicable on 28 January 2022. This includes changes to certain post-authorisation procedures.
Guidance for marketing authorisation holders whose marketing authorisation’s five-year validity period expires on or after 28 January 2022 is available in a notice published by the European Commission. This explains the practical steps they need to take to implement the relevant provisions of the Regulation.
Procedural guidance for centrally authorised veterinary medicinal products based on the European Commission notice is available below.
The Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) provides information to marketing authorisation holders for nationally authorised products: CMDv: Implementation of the VMP Regulation