The Rules Governing Medicinal Products in the European Union
Auteur : European Commission
Date de publication : 1998
Éditeur : Office for Official Publications of the European Communities
Nombre de pages : 538
Résumé du livre
Directive 81/852/EEC describes the requirements for the demonstration of the quality, safety and efficacy of veterinary medicinal products. The conduct of tests and studies for such demonstration has been harmonised, both within the European Union and internationally. Volume 7 of "The Rules Governing Medicinal Products in the European Union" incorporates testing guidelines prepared within the European Union. This document is intended to provide general guidance on the type of data which should be included in applications for marketing authorisations. The guidelines are intended to supplement Directive 81/852/EEC, as amended by Directive 92/18/EEC and must be read in conjunction with that Directive.