Morocco

The primary regulatory authority for health products in Morocco 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 Pharmacy Code), complemented by a series of ministerial circulars and decrees that regulate the registration, importation, distribution, and post-market surveillance of pharmaceuticals, medical devices, in-vitro diagnostics, and increasingly, digital health solutions. All health products intended for the Moroccan market must obtain a Marketing Authorization (Autorisation de Mise sur le Marché, AMM) prior to commercialization, following a structured technical and administrative dossier review process conducted by the DMP and its advisory technical committees.

Applicants are required to appoint a local responsible pharmacist or an authorized representative established in Morocco to submit and maintain the registration dossier. Morocco accepts dossiers formatted according to the Common Technical Document (CTD) standard, and the DMP increasingly references international guidelines from the ICH, WHO, and European Medicines Agency (EMA) as benchmarks for scientific evaluation. Supporting documentation must generally include preclinical and clinical data, quality and manufacturing information, labeling compliant with Arabic and French requirements, and a Good Manufacturing Practice (GMP) certificate from the country of origin. Recent reforms include Morocco's engagement with the African Medicines Regulatory Harmonization (AMRH) initiative and efforts to streamline the AMM renewal process, as well as growing attention to frameworks for digital health and software as a medical device (SaMD) classification.

Public procurement of health products in Morocco is centrally coordinated through the Ministry of Health and Social Protection, which manages national-level tenders for pharmaceuticals, medical devices, and diagnostics destined for public hospitals, regional health directorates, and primary care facilities. The Direction de l'Approvisionnement et des Médicaments (within the Ministry) oversees the annual consolidated tender process, which is governed by Decree No. 2-22-431 on public procurement, ensuring competitive bidding, price transparency, and technical compliance. Regional health directorates may conduct supplementary local procurement for specific needs, but the majority of essential medicines and strategic health commodities are sourced through centralized national frameworks. Products must hold a valid AMM and appear on the national essential medicines list or approved formulary to be eligible for public tender participation.

The private sector represents a significant and growing channel, distributed through a network of licensed pharmaceutical wholesalers and private clinic and pharmacy chains concentrated in urban centers such as Casablanca, Rabat, and Marrakech. Morocco also benefits from donor-funded procurement channels, with the Global Fund supporting HIV, tuberculosis, and malaria commodities, and UNICEF and WHO providing technical and material support for immunization and maternal and child health programs. The government has articulated a strong policy preference for local manufacturing as part of its industrial acceleration strategy, offering incentives for companies that establish or partner with local production facilities. This localization agenda has accelerated following the COVID-19 pandemic, with Morocco positioning itself as a regional pharmaceutical manufacturing hub through initiatives such as the Mohammed VI Investment Fund and partnerships targeting API and vaccine production capacity on the African continent.