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

These guidelines apply only to Immunological Veterinary Products intended for marketing in Rwanda. They describe data required to demonstrate that an Immunological Veterinary Product intended for marketing in Rwanda complies with the established requirements.
The guidelines describe the application procedure for registration of immunological veterinary products, for its renewal and variation.
The document contains 5 Modules bringing, respectively, administrative information, overviews and summaries on safety and efficacy data, quality information, safety and efficacy.