Centralised Procedure

Centralised marketing authorisation procedures are coordinated by the European Medicines Agency (EMA) based in Amsterdam. For these marketing authorisation procedures, Regulation (EU ) 2019/6 applies. A centralised marketing authorisation is issued by the European Commission on the basis of an opinion from the EMA for all states of the European Union (EU) and is also recognised by three states of the European Free Trade Association (EFTA) of the European Economic Area (EEA). A centrally authorised veterinary medicinal product can thus be marketed throughout the entire EU and the EFTA states of Luxemburg, Liechtenstein and Norway.

The centralised procedure is mandatory for all veterinary medicinal products listed under Article 42 (2) of Regulation (EU) 2019/6. In addition, an application for a centralised authorisation can also be made for other veterinary medicinal products, if no other marketing authorisation has yet been granted for the relevant product within the Union.

The EMA is supported by the Committee for Veterinary Medicinal Products (CVMP) in the scientific assessment of the quality, safety, environmental compatibility and efficacy of a veterinary medicinal product. Each Member State appoints one member and one alternate member to the Committee, who may be assisted by further experts.

Due to its expertise, the Paul-Ehrlich-Institut (PEI) participates in the CVMP and its working groups. The Paul-Ehrlich-Institut takes part in the:

• preparation of scientific assessments within the scope of rapporteurships and co-rapporteurships,
• scientific advice for companies and
• preparation of guidelines and expert opinions on specific questions relating primarily to immunological veterinary medicinal products.

Extensive information on pharmaceutical legislation (for veterinary products) at a European level can be found on the websites of the Directorate-General for Health and Food Safety (DG SANTE) of the European Commission.

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