Regulation of immunological veterinary medicinal products in the European Union.

Abstract

Since 1990, immunological veterinary medicinal products have been covered by the pharmaceutical legislation of the European Union (EU) and, as a consequence, these products are now subject to the relevant general provisions regarding manufacturing and marketing authorization. For new veterinary immunologicals, the legislation entered into force on 1 April 1993. For products already on the market, a transitional period of five years was granted, during which Member States must proceed with the review of these products. Member States are coordinating this review and have set a calendar for the various species-specific products. Despite the extensive harmonization of requirements and criteria, and the existence of procedures for marketing authorization involving the Committee for Veterinary Medicinal Products (CVMP), the actual decision whether to authorize a product was still taken by individual Member States, thus leading to divergences at the very last stage of the process. Therefore, in 1993, the European Council adopted a Regulation and Directives; this legislation modified the current system, introduced two new procedures for veterinary medicinal products and established the European Medicines Evaluation Agency. Under the new system, innovatory medicinal products obtained through biotechnology will be authorized centrally and marketed throughout the EU. Conventional medicinal products will be subject to mutual recognition of authorizations, with binding arbitration by the Agency in case of disagreements between Member States.