Protecting Livestock. Improving Human Lives

Review of requirements and processes for registration of veterinary products in selected African and Asian countries


Year: 2016

About this Publication:

The present document provides a summarised overview of requirements and processes for the registration of veterinary products in a limited number of African and Asian countries. A number of salient points can be made: Although the majority of African countries have registration systems or related legislation in place, many of them do not effectively regulate the use of veterinary products in the country. Registration systems and procedures are constantly being put into place and/or evolving in African countries (and many other countries). The information provided here is thought to be accurate as of late 2015 but changes will certainly take place over the next few years. Precise details on the numbers of copies of dossiers, samples, documents such as Free Sales Certificates, etc. need to be checked with the relevant authorities when a submission is made. Sadly, centralised systems such as the one for UEMOA (the West African Economic and Monetary Union) are not operating effectively, and on the contrary are encouraging the introduction of unregulated products. UEMOA’s system is operating for the registration of products, but it is slow, with very rigorous requirements similar to those for registration in the European Union. It is hoped that it will evolve toward greater effectiveness1. Regional approaches could constitute a good basis for improving the situation in Africa. The information required in a dossier varies from country to country. Some countries will accept a basic dossier that contains mainly summary information, while others require a dossier containing extensive information and details similar to those required for a registration in the EU. All countries require additional documents to the dossier, e.g.: > Good Manufacturing Practice (GMP) Certificate > Certificate of Free Sale > Certificate of Pharmaceutical Product (CPP) > Certificate of Analysis > Information about the Qualified Person > Power of Attorney > Copies of Marketing Authorisations from other countries where the product is registered In addition, these documents may need to be notarised and/or certified in the country of origin. Countries increasingly have specific packaging requirements, such as: > Batch number > Date of manufacture > Expiry date > Local registration number > Manufacturer’s address

Grant: PLSHL2

Subject Areas: Policy and Advocacy


Vaccines, good manufacturing practice, vaccine certification, vaccine registration, vaccine registration procedures,


Bangladesh, Benin, Burkina Faso, Burundi, Cameroon, Comoros, Congo, Democratic Republic Of, Cote D'Ivoire, Ethiopia, Ghana, Guinea-Bissau, India, Kenya, Malawi, Mali, Morocco, Nepal, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, South Africa, Sudan, Tanzania, United Republic Of, Togo, Uganda, Viet Nam, Zambia, Zimbabwe

Download Publication (PDF)