A Guidance Document for Domestication of the African Union Model Law on Medical Products Regulation15 May 2022
This guidance document aims to assist countries as they navigate through the domestication process. It provides material on understanding key concepts, guidance on how to draft legislation and a chapter-by-chapter analysis of the AU Model Law, explaining the meaning of each provision and the reason for its inclusion. It also offers useful drafting suggestions. All of these features will enable countries to align their regulatory laws to the AU Model Law and will not only facilitate effective regulation in each country but will also advance the goal of the harmonization of regulatory systems.