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

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.