The AU Model Law on Medical Products Regulation: Domestication and Implementation — Course | CARSP
What the AU Model Law says, why it says it, and how a country turns it into national legislation and a functioning authority.
In January 2016 the Assembly of Heads of State and Government of the African Union endorsed the AU Model Law on Medical Products Regulation — a template developed under the African Medicines Regulatory Harmonisation initiative, with AUDA-NEPAD and the Pan-African Parliament, to give every Member State a sound, convergent legal basis for regulating medical products.This course reads the Model Law provision by provision — establishment and autonomy of the authority, scope, functions, powers, financing, governance, transparency, offences, appeals and regional cooperation — and then turns to the harder question: how a country domesticates it. You will work through legal gap analysis, drafting, consultation, parliamentary passage, subsidiary regulations and the transition to an operating authority, using experience from countries that have done it.Format: five modules, ten lessons with knowledge checks, one final assessment. Completion earns 5 CPD credits and a CARSP certificate. Learning outcomes: Explain the purpose, status and structure of the AU Model Law; Describe the key provisions on establishment, scope, functions, powers, financing and governance of a regulatory authority; Analyse a national legal framework against the Model Law to identify gaps; Plan the domestication process from gap analysis to commencement; Anticipate implementation challenges and the transition to a functioning authority
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