Morocco

In Morocco, the primary regulatory authority for health products is the Direction du Médicament et de la Pharmacie (DMP), operating under the Ministry of Health and Social Protection. The overarching legal framework is governed by Law No. 17-04 (the Code of Medicinal Products and Pharmacy), along with a series of decrees and ministerial circulars that extend requirements to medical devices, in vitro diagnostics, and digital health solutions. All health products intended for the Moroccan market must obtain a Marketing Authorization (Autorisation de Mise sur le Marché, AMM) before commercialization. The DMP evaluates applications on the basis of quality, safety, and efficacy, and coordinates with technical committees and external experts as needed. Medical devices and diagnostics are subject to a separate conformity and registration process, increasingly aligned with international standards, while digital health products are subject to emerging frameworks under national eHealth and data protection legislation.

Applicants are required to appoint a locally registered legal representative or pharmaceutical establishment responsible for regulatory submissions and post-market obligations. Dossiers must be submitted in accordance with the Common Technical Document (CTD) format, and the DMP increasingly accepts international reference dossiers from recognized regulatory authorities such as the EMA, FDA, or WHO Prequalification Programme to support accelerated review pathways for priority products. Labeling and product information must be provided in Arabic and French. Morocco has undertaken significant regulatory modernization efforts in recent years, including harmonization initiatives within the African Medicines Regulatory Harmonization (AMRH) framework, closer alignment with the African Union's continental regulatory agenda, and the implementation of pharmacovigilance obligations for post-market surveillance. Fee structures and procedural guidelines have also been updated to improve transparency and predictability for applicants.

Public procurement of health products in Morocco is centrally coordinated through the Ministry of Health and Social Protection, which sets national health priorities, defines essential medicines and device lists, and manages the bulk of public sector purchasing. The Direction de l'Approvisionnement (Procurement Directorate) within the Ministry oversees national tenders and framework agreements for pharmaceuticals, medical devices, and diagnostics. Procurement is governed by Decree No. 2-22-431 on public procurement, which mandates competitive tendering processes, price transparency, and supplier qualification criteria. The Centre Hospitalier Universitaire (CHU) networks and regional health directorates may also conduct decentralized procurement for specific needs, but national-level tenders typically dominate volume purchasing. The Caisse Nationale des Organismes de Prévoyance Sociale (CNOPS) and the Caisse Nationale de Sécurité Sociale (CNSS), the two main social health insurance bodies, influence reimbursement eligibility and indirectly shape procurement decisions for covered products.

The private sector represents a significant and growing channel for health product commercialization in Morocco, operating through a network of private hospitals, clinics, and retail pharmacies that source products via licensed importers and distributors. Morocco also benefits from donor-funded procurement programs, particularly for communicable diseases and maternal and child health: the Global Fund to Fight AIDS, Tuberculosis and Malaria supports procurement of antiretrovirals, antituberculars, and malaria commodities, while UNICEF and WHO engage on immunization supply chains and essential medicines access. USAID has historically supported health system strengthening initiatives with procurement components. Morocco has articulated a strategic ambition to develop local pharmaceutical manufacturing capacity, reflected in industrial policy incentives and a preference, where applicable, for locally manufactured or regionally sourced products in public tenders, consistent with broader import substitution goals under the national industrial acceleration plan.