REGISTRATION OF DRUGS - REQUIREMENTS OF F ORM AND CONTENT IN THE REGISTRATION DOCUMENTATION OF VETERINARY MEDICINAL PRODUCTS IN HUNGARY

Registration of veterinary medicinal products has been regulated by th e Agricultural Ministerial Decree 24/1994 (V. 4.) st. FM in Hungary. T he authorities evaluate the medicinal products according to quality, i nnocuity and effectiveness in the procedure of registration. Requireme nts of applications for marketing authorization of veterinary medicina l products other than immunological veterinary medicinal products in H ungary are available for request in Hungarian or English language at t he State Institute for the Control of Veterinary Biologicals, Drugs an d Feeds. Registration documentation can be presented in Hungarian, Eng lish or German language. Three registration samples from different bat ches, furthermore samples of active ingredients, other costituents or excipients, analytical standards as well as quality control certificat es should be enclosed to the documentation. The documentation has four chapters: I. Summary of the documentation (including the experts' opi nions), II. Chemical and pharmaceutical documentation (composition, co ntrol and stability tests), III. Innocuity and residual matter documen tation, IV. Pre-clinical and clinical documentation. More frequent for mal defects of documentation are the lack of four experts' opinions on the adequate chapters of documentation and studies for the residues a re not available or appropriate for the preparations used in food anim als. To evaluate the documentation, the EEC norms of residues are cons idered by the Hungarian authorities.