Veterinary working parties

A central EEC registration authority (European Agency for the Evaluation of Medicinal Products) will be established and "shall take up its responsibilities on 1 January 1995 (Council Directive 2309/93 of 22 July 1993). The Committee on Proprietary Medicinal Products, CPMP, which consists of members of the Commission and from the states authorities, plays a central role in the existing and future system. It is assisted by different working parties for specific areas. The CPMP coordinates the procedures, assesses applications and provides "opinion reports" and acts as arbitrator in the case of national discrepancies. However, the opinion reports and decisions of the CPMP are not (yet) binding to the member states. For veterinary products identical rules apply here a CVMP acts as the central body. 

The CPMP working parties are concerned with biotechnology, efficacy, safety, and pharmacovigilance. The CVMP working parties are concerned with safety of residues, immunological veterinary products, veterinary pharmacovigilance, and efficacy. 

These working parties produce position papers, points to consider, notes for guidance, and joint CPMP/CVMP/International Conference on Harmonization (ICH) Guidelines that provide up-to-date scientific opinions on matters of current interest to all member states and pharmaceutical and veterinary manufacturers. 

Similarly to the CPMP Working Parties, the Efficacy, Safety of Residues, Immunologicals, and Pharma-covigilance Working Parties develop guidelines for the testing and reporting requirements of studies for products for veterinary use. 

Until 1998, the Medicines Commission consisted of an executive board, a chairman, four working parties and outside experts and consultants. Except for one general practitioner, all members are professors at different Belgian universities and are experts in either toxicopharmacology, clinical medicine, drug analysis and galenical pharmaceutics or veterinary medicine. The Secretariat of the Commission falls under the responsibility of the Inspector General, who is a pharmacist. In 1994 the inspectorate consisted in total of 28 civil servants (in 1982 the number was 37). 

The Committee for Human Medicinal Products (CHMP), Committee for Veterinary Medicinal Products (CVMP) and Committee for Orphan Medicinal Products (COMP) are the major committees run by this agency to ensure the above objectives. Additional support comes from more than 90 Working Parties (e.g., on efficacy, safety, quality, biotechnology, pharmacovigilance, blood and plasma, etc.) as well as ad-hoc Expert Groups (on subjects like pediatric use, bioterrorism, oncology, anti-HIV drugs, etc.) and also approximately 2500 European experts from competent national authorities. 

Anon. Anabolic, Anthelmintic and Antimicrobial Agents. The twenty-second report of the Steering Group on Food Surveillance. The Working Party on Veterinary Residues in Animal Products. Food Surveillance Paper No 22. Her Majesty s Stationery Office London, 1987, pp 19-20. 

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