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Intensifying co-operation within the EU for the authorisation of veterinary drugs

An exchange on current scientific developments, the consistent implementation of EU-legislation on the authorisation of veterinary drugs, and questions to do with health were the basis for a meeting of the members of the Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMEA) and the Coordination Group for Mutual Recognition and Decentralised Procedures for veterinary drugs (CMD(v)) on 3 and 4 May 2007 in Berlin. The German Federal Office of Consumer Protection and Food Safety (BVL) and the Paul-Ehrlich-Institute hosted the convention within the framework of the German presidency of the Council of the European Union. The aim is in particular to reduce the amount of bureaucratic hurdles in order to facilitate the work of the veterinary-pharmaceutical industry and the competent authorities.

The focus of the CMD(v) meeting was the exchange of experience, and proposals for improving the decentralised authorisation procedure. In this procedure, applications for the authorisation of veterinary drugs are submitted simultaneously in several EU Member States, although one state takes on the leadership and the role of the reference Member State. Experts saw this procedure as being the way for the future to authorise veterinary drugs, a procedure which is used more and more frequently by applicants.

Another topic was the increasing number of applications for authorisation for copies of existing veterinary drugs, containing the same active substances (generic products). The CVMP discussions were focussed on criteria for the risk/benefit analysis of veterinary drugs in the context of the decision on authorisation, organisational and procedural measures for improving work in the Committee and the role of the CVMP in the context of supranational negotiations to align requirements for authorisation.

The CVMP and CMD(v) discussed together the implementation of the new legal requirements for the evaluation of environmental compatibility, the problem of the divergent decisions made by the Member States concerned, and the involvement of the CVMP as well as recommendations from the heads of the competent authorities to improve the availability of veterinary drugs in Europe.

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