Morocco

Morocco regulates pharmaceutical products through the Direction du Médicament et de la Pharmacie (DMP) within the Ministry of Health and Social Protection (Ministère de la Santé et de la Protection Sociale), under Law 17-04 (Code du Médicament et de la Pharmacie) and its implementing decrees. DMP handles registration (Autorisation de Mise sur le Marché — AMM), pricing approval, GMP inspection, pharmacovigilance, clinical trial authorisation and post-market surveillance. Marketing authorisation (AMM) is valid for 5 years and renewable. Morocco is transitioning to a more autonomous regulator: Law 03-22 (2023) establishes the Agence Marocaine du Médicament et des Produits de Santé (AMMPS) as a successor to DMP — operationalisation is in progress. Morocco is a WHO Member State, an observer to PIC/S and an active participant in the African Medicines Regulatory Harmonisation (AMRH) initiative and the African Medicines Agency (AMA) treaty. The dossier follows ICH CTD format with a Moroccan Module 1; French is the working language. Public-sector access runs through the Assurance Maladie Obligatoire (AMO) administered by CNSS (employees, since 2022 universal extension) and CNOPS (public sector), and the medical assistance scheme AMO-Tadamon (replacing the former RAMED). Pricing is regulated under Decree 2-13-852 (revised 2023) using international reference pricing across a defined basket of countries.