Morocco

The primary regulatory authority for health products in Morocco is the Direction du Médicament et de la Pharmacie (DMP), operating under the Ministère de la Santé et de la Protection Sociale. The overarching legal framework is governed by Law No. 17-04 (Code du Médicament et de la Pharmacie), which establishes the conditions for the authorization, manufacturing, importation, distribution, and marketing of medicinal products and health technologies. Medical devices are regulated under separate provisions and ministerial circulars, with the DMP increasingly taking a more structured role in their oversight. All health products intended for the Moroccan market require a Marketing Authorization (Autorisation de Mise sur le Marché, AMM) prior to commercialization, obtained through a formal dossier review process that includes technical, clinical, and quality evaluations. Diagnostics and digital health tools are subject to evolving regulatory guidance, with classification frameworks being progressively formalized.

Submission dossiers for pharmaceuticals are generally required in CTD (Common Technical Document) format, and Morocco recognizes data from reference regulatory agencies such as the EMA, FDA, and ICH member authorities, which can facilitate abridged or accelerated review pathways. A local registered representative or a Moroccan-licensed pharmaceutical establishment (exploitant) is mandatory for all foreign applicants seeking an AMM. Labeling must be in Arabic and French. Morocco has undertaken significant regulatory modernization efforts in recent years, including alignment with African Medicines Regulatory Harmonization (AMRH) initiatives and collaboration with the African Medicines Agency (AMA). The country is also advancing its pharmacovigilance and post-market surveillance frameworks, with increased requirements for periodic safety update reports (PSURs) and risk management plans for approved products.

Public procurement of health products in Morocco is primarily coordinated through the Ministère de la Santé et de la Protection Sociale, which manages centralized national tenders for essential medicines, vaccines, medical devices, and diagnostics. The Central Pharmacy (Pharmacie Centrale des Hôpitaux, PCH) plays a critical role as the central purchasing body responsible for the acquisition and distribution of health products to public hospitals and regional health facilities. Procurement procedures are governed by Decree No. 2-22-431 on public procurement, which mandates competitive tendering processes including open calls for bids (appels d'offres ouverts). Regional health delegations may conduct decentralized procurement for specific local needs, but strategic and high-volume purchases are typically managed at the national level. Price controls are enforced for reimbursable medicines, with maximum retail and wholesale prices set by the DMP.

The private sector represents a substantial and growing channel for health product distribution in Morocco, with a well-developed network of private pharmacies, clinics, and hospitals served by licensed wholesale distributors (répartiteurs). International donor and multilateral procurement channels also operate in Morocco, including UNICEF supply agreements for vaccines and maternal-child health commodities, and Global Fund-supported procurement for HIV, tuberculosis, and malaria programs. USAID-funded health initiatives have historically contributed to supply chain strengthening and specific commodity procurement. Morocco has articulated a strategic priority for local pharmaceutical manufacturing as part of its industrial acceleration plan and its ambition to become a regional pharmaceutical hub for Africa, with preferential consideration increasingly given to locally manufactured or regionally produced products in public tenders, aligned with the broader Africa Medicines Security agenda.