Guidelines on Submission of Documentation for Registration of Veterinary Biological Products.

These guidelines apply only to veterinary biological products other than immunological products intended for marketing in Rwanda. They describe the data required to demonstrate that a veterinary biological product intended for marketing in Rwanda complies with the established requirements.
The Guidelines regulate the application procedure and the necessary requirements as well as the dossier assessment procedure.
The document is composed by 5 Modules on, respectively, administrative and product information, overviews and summaries on clinical and nonclinical studies, quality (from a chemical and manufacturing point of view), nonclinical trials and clinical studies.