Committee on Veterinary Medicinal Products

Development and Validation of a Proposed Regulatory Method, EMEA/CVMP/573100, Vol. 8, Veterinary Medicinal Products Establishment of Maximum Residue Limits (MRLs) for Residues of Veterinary Products in Foodstuffs of Animal Origin, Committee for Veterinary Medicinal Products, London (2001). Also available on the World Wide Web http //www.emea.eu.int/pdfs/vet/swp/057300en.pdf. 

European Union (2004), Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMEA/410/01 Rev. 2—October 2003) adopted by the Committee for Proprietary Medicinal Products (CPMP) and by the Committee for Veterinary Medicinal Products (CVMP), Off. J. Europ. Union, C24/26-C24/19. 

European Agency for the Evaluation of Medicinal Products (EMEA), in Difloxacin, Opinion of the Committee for Veterinary Medicinal Products on the Estabhshment of MRLs, EMEA/CVMP/164/96, London, UK (1996). 

The EC Committee for Veterinary Medicinal Products (CVMP) -working group on the safety of residues of veterinary medicines... 

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 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. 

The draft decision is then sent to the Standing Committee on Medicinal Products or the Standing Committee on Veterinary Products for their opinions. Should there be detailed opposition from a member state to the draft decision, the standing committee can refer it back to the CPMP if the opposition is scientific. If the matter is nonscientific, the council decision is made on the basis of a qualified majority, where each member state has a different number of votes depending on its size and importance and the majority of votes must be in favor. If within a further 30 days there is no opposition, the draft decision is forwarded to the Commission secretariat-general for adoption, enabling the Commissioner for enterprise and the information society to issue the final decision which is published in the Official Journal of the European Communities. 

The European Union (EU) ageneies responsible for the scientific evaluation of the safety of feed additives and veterinary medicinal products are, respectively, the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA). The EFSA is advised on scientific aspects of feed additives, including the safety of target species, consumers, users and the environment, by the Panel on Additives and Products or Substances Used in Animal Feed (FEEDAP). Some of the older evaluations of feed additive uses of coccidiostats under Directive 70/524/EEC were performed by the Scientific Committee on Animal Nutrition (SCAN), which reported to the European Commission prior to the establishment of EFSA. The Committee for Medicinal Products for Veterinary Use (CVMP) advises the EMA on scientific aspects of veterinary medicines. The distinction between medicinal and feed additive uses is not always clear, as some uses to prevent coccidiosis are considered to be medicinal e.g. use of lasalocid in poultry). 

A variety of substances are used for the treatment and prevention of coccidiosis. In the EU, these may be regulated as feed-additives and/or as veterinary medicinal products under different legislation and with different expert committees providing opinions on consumer and user safety. 

The relevant advisory committees with a remit for medicines for human use established under the Medicines Act 1968 were the Committee on Safety of Medicines (CSM), set up in June 1970 (SI 1970/1257) under the Chairmanship of Professor EF Scowen and the British Pharmacopoeia Commission (BPC), also set up in June 1970 (SI 1970/1256) under the Chairmanship of Dr F Hartley (later Sir Frank Hartley). The Veterinary Products Committee (VPC), chaired by Professor CSG Grunsell (with a remit for... 

Committee for Medicinal Products for Veterinary Use (CVMP), Reflection Paper on the New Approach Developed by JECFAfor Exposure and MRL Assessment of Residues of VMP, European Medicines Agency, London, 2008. 

EMEA/CVMP/520190/2007—consultation. Reflection Paper on Injection Site Residues Considerations for Risk Assessment and Residue Surveillance, European Medicines Authority, Committee for Medicinal Products for Veterinary Use, 2008 (available at http //www.ema.europa.eu/ docs/en GB/document library/Scientific guide line/2009/10/WC500004430.pdf) accessed 12/06/10). 

The Licensing Authority is advised by expert committees, appointed by ministers, as advised by the Medicines Commission under Section 4 of the Medicines Act. These advisory committees consist of independent experts, such as hospital clinicians, general practitioners, pharmacists and clinical pharmacologists, not the staff of the DoH, and are appointed by ministers on the advice of the Medicines Commission. The relevant advisory committees since 1971 have been the Committee on Safety of Medicines (CSM), the Committee on Review of Medicines (CRM), the Committee on Dental and Surgical Materials (CDSM), the British Pharmacopoeia Commission (BPC) and the Veterinary Products Committee, which is administered through the Ministry of Agriculture, Food and Fisheries (MAFF). 

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