Regulatory framework and requirements for managing risks associated with veterinary biological products in Africa:...

Veterinary vaccines are considered to be medicinal products. As such, they are subject to assessment for managing risks associated with their marketing and use. The current risk assessment procedures used in Africa are based on the quality testing methods standardised by the Pan-African Veterinary Vaccine Centre (PANVAC). The authors examine the risk assessment procedures related to the importation of products and to the release of live products into the environment. The lack of infrastructures, specialised personnel and financial resources prevents each individual country from establishing its own system for managing the risks associated with the importation of veterinary vaccines. Regional co-operation between African countries is therefore recommended, and must be based on the existing PANVAC network for the quality testing of priority vaccines. This is justified by the results obtained by PANVAC in the standardisation of production technologies for vaccines against rinderpest and contagious bovine pleuropneumonia, and in other areas. The authors recommend that PANVAC be used to aid regional co-operation in Africa in the management of risks associated with the marketing and use of veterinary vaccines.