Guidelines for Submission of Documents for Registration of Veterinary Vaccines in Zimbabwe

These Guidelines have been drafted for applicants interested in having their veterinary vaccines evaluated for registration in Zimbabwe. Applicants should submit a product dossier reflecting the data and information requested in this guideline. The current version of any guideline or pharmacopoeia referred to in this guideline shall be applicable in all instances. Any deviations must be highlighted, justified and require approval by the MCAZ. The present guidelines have been prepared taking into consideration the need for worldwide harmonization, which will assist the medicine manufacturers in the preparation of a well-structured dossier to be submitted for the registration of veterinary vaccines in order to facilitate their screening and subsequent review. This guideline provides details about the type of Quality information concerning the Manufacture and Control of veterinary vaccines that the applicant should present in the registration dossier. It also describes the data required to support the Safety and Efficacy of the product. In addition to these sections on Quality, Safety and Efficacy the applicant must include the documents described under Part 1 of the Dossier Structure document.