Guidelines on Application for Registration of a Veterinary Medicine Pays/Territoire Zambie Type du document Miscellaneous Date 2014 Source FAO, FAOLEX Sujet Bétail Mot clé Médicaments Santé des animaux Questions de procédures Enregistrement Emballage/étiquetage Commerce intérieur Normes Collecte de données/déclarations Aire géographique Afrique, Afrique Orientale, Nations en développement sans littoral, Pays les moins avances Résumé These Guidelines regulate the application for registration of veterinary medicines. They apply to all veterinary medicinal products (VMPs) except vaccines, biological products, traditional medicinal products, diagnostic aids, medical appliances and public health chemicals. A separate application is required for each product. Products differing in active ingredient(s), strength, dosage forms, package size (preparations for injection only) or manufactured at different sites are considered to be different products and hence require separate applications. However pharmaceutically equivalent products bearing the same proprietary name and manufactured at the same manufacturing site, but differing only in packaging material or pack sizes require only one application but stability study report is required for each package material of different technical specifications. Applications shall be made by submitting a dully filled in prescribed application form. The Guidelines also cover chemistry, manufacturing and quality control data; Preclinical pharmaco- toxicological data; efficacy data; therapeutic equivalence/interchangeability; labelling and package inserts; documentation for fixed dose combination products (FDC) appendices; anatomic therapeutic chemical classification system (ATC); guidelines to analytical method validation; and application form for registration of veterinary medicines. Texte intégral Anglais Site web www.zamra.co.zm