Marketing authorization of veterinary medicinal products in Poland.

Opening of the European Agency for the Evaluation of Medicinal Products (EMEA) in London (February 1, 1995) has begun harmonization of international requirements in veterinary drug legislation in the European Union (EU). The main objective of this paper is to introduce the principal rules of veterinary drug registration in Poland, a candidate to membership in the EU. In Poland the basic guideline governing quality, production, marketing, and inspection of medicinal products is "The Pharmaceutical Products, Medical Materials, Pharmacies, Wholesaler Outlets, and Pharmacy Inspection Act, dated October 10, 1991." The detailed rules are given in directives of the Minister of Health or the Minister of Agriculture in case of veterinary medicinal products. Since 1993 licensing of drugs in Poland has become a universal procedure for both human and veterinary products. The common Committee of Drug and Medical Materials Registration, which is under control of the Minister of Health and Social Welfare, ensures that the quality, safety (e.g., maximum residue limits and current FAO/WHO and EEC regulations for products used in food-producing animals are accepted), and efficacy are the criteria for the registration process. During 1994-1996 almost 300 veterinary products (more than 200 from the EU) received marketing authorizations in Poland. All these products were evaluated and registered on a similar basis to those in the European Union.