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Guidelines on Application for Registration of a Veterinary Medicine

País/Territorio
Zambia
Tipo de documento
Miscelanea
Fecha
2014
Fuente
FAO, FAOLEX
Materia
Ganado
Palabra clave
Medicamentos Sanidad animal Cuestiones de procedimiento Registro Envasado/etiquetado Comercio interior Normas Recopilación de datos/informes
Área geográphica
Africa, Africa Oriental, Naciones en desarrollo sin litoral, Países menos desarrollados
Resumen

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.

Texto completo
Inglés
Página web
www.zamra.co.zm