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Guidelines on Application for Registration of a Veterinary Medicine

Country/Territory
Zambia
Document type
Miscellaneous
Date
2014
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Drugs Animal health Procedural matters Registration Packaging/labelling Internal trade Standards Data collection/reporting
Geographical area
Africa, Eastern Africa, Landlocked Developing Nations, Least Developed Countries
Abstract

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.

Full text
English
Website
www.zamra.co.zm