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 principal governing legislation includes Law No. 17-04 (Code of Medicines and Pharmacy) and its implementing decrees, which establish the legal framework for the registration, importation, distribution, and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and related health products. All health products intended for commercialization in Morocco must obtain a Marketing Authorization (Autorisation de Mise sur le Marché, AMM) prior to market entry. The DMP evaluates dossiers on the basis of quality, safety, and efficacy criteria, and applications are subject to review by technical advisory committees before a final decision is issued. Digital health solutions and in vitro diagnostics are subject to evolving sector-specific guidance, with the DMP increasingly coordinating with other bodies such as the Agence Nationale de l'Assurance Maladie (ANAM) for reimbursement considerations.

Applicants are required to appoint a local representative or a licensed Moroccan pharmaceutical company (exploitant) to submit and manage the registration dossier on behalf of the foreign manufacturer. Dossiers must generally conform to the Common Technical Document (CTD) format, and Morocco recognizes scientific assessments from stringent regulatory authorities (such as the EMA or FDA) as supportive references, which may facilitate accelerated review in certain cases. Local quality control testing is typically required as part of the approval process. Morocco has been undertaking regulatory modernization efforts aligned with African Union and WHO benchmarks, including participation in the African Medicines Regulatory Harmonization (AMRH) initiative. Recent reforms have sought to streamline timelines for priority products, introduce electronic submission mechanisms, and strengthen post-market surveillance frameworks. The country is also progressing toward alignment with the African Medicines Agency (AMA) treaty commitments.

Public procurement of health products in Morocco is centrally coordinated through the Ministère de la Santé et de la Protection Sociale, which consolidates demand planning and tendering at the national level via the Division de l'Approvisionnement et des Equipements. The Central Pharmacy (Pharmacie Centrale, PCM) plays a critical role as the primary public procurement and distribution entity for essential medicines, vaccines, medical devices, and diagnostics destined for the public health system. National tenders are conducted in accordance with Decree No. 2-12-349 governing public procurement, which mandates competitive bidding procedures, transparency requirements, and defined evaluation criteria. Certain strategic products, including vaccines and antiretrovirals, may be procured through direct or framework agreements. Regional health delegations may conduct limited local procurement for specific operational needs, but the overarching procurement authority remains centralized at the national level. Price controls and reference pricing mechanisms apply to reimbursable products, with pricing negotiations conducted in coordination between the DMP and relevant ministries.

The private sector constitutes a significant and growing channel for health product distribution in Morocco, served by licensed wholesale distributors and a dense network of private pharmacies across urban and peri-urban areas. Private hospitals and clinics procure independently through authorized distributors, and this channel is particularly important for higher-value medical devices, advanced diagnostics, and digital health solutions. Morocco also benefits from donor-funded procurement channels, notably through the Global Fund to Fight AIDS, Tuberculosis and Malaria, which supports procurement of HIV, TB, and malaria-related commodities, and through UNICEF supply mechanisms for maternal and child health products. USAID-funded programs have historically contributed to health commodity supply chains in Morocco, although at more modest levels compared to sub-Saharan African counterparts. The government has articulated a strategic priority for local pharmaceutical manufacturing as part of its industrial acceleration plan, offering fiscal incentives and preferential tender scoring for domestically produced health products, with ambitions to position Morocco as a regional manufacturing hub under the Africa Medicines Manufacturing initiative.