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Guideline on Application for Registration of Unregistered Veterinary Medicines Already on the Zambian Market

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

These Guidelines provide information to applicants who intend to register veterinary medicinal products which are already on the Zambian Market. It is intended to provide guidance to applicants on how to complete each part of the application form and the procedure for submitting the application. 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. The Guideline further provide for completing the application form; details of applicant; details of the distributor; manufacturer(s), site(s) for the finished veterinary medicinal product; name of product and dosage form; description of the veterinary medicinal product; active pharmaceutical ingredient(s); therapeutic indications; directions for use; contraindications/ drug interactions; warnings/precautions/overdosage; side effects; withdrawal periods; storage conditions; container- closure system and administration devices; package sizes/ presentation; shelf life; method of sale/category of distribution; composition; any other information; and declaration by an applicant.

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