Mozambique

Mozambique's primary health regulatory authority is the Autoridade Reguladora de Medicamentos e Tecnologias de Saúde (AREMED), established under Decree No. 67/2020 to replace the former Departamento de Gestão de Medicamentos (DGM) within the Ministry of Health (Ministério da Saúde, MISAU). AREMED operates under the overarching framework of the National Medicines Policy and is responsible for the registration, licensing, and post-market surveillance of pharmaceuticals, medical devices, in vitro diagnostics, and related health technologies. All health products intended for the Mozambican market must obtain marketing authorization from AREMED prior to importation, distribution, or sale, with applications reviewed through a structured dossier evaluation process that includes technical, safety, and quality assessments.

Applicants are required to appoint a local registered representative or agent based in Mozambique, who assumes regulatory and legal responsibility for the product on the market. AREMED formally accepts dossiers submitted in the Common Technical Document (CTD) format, and applications supported by approvals from stringent regulatory authorities (SRAs) such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), or WHO-prequalified products may benefit from expedited or abridged review pathways. The African Medicines Regulatory Harmonization (AMRH) initiative and Mozambique's participation in the Southern African Development Community (SADC) regulatory harmonization framework are gradually shaping convergence toward regionally aligned standards. Recent reforms have focused on strengthening AREMED's institutional capacity, improving transparency in review timelines, and developing clearer regulatory pathways for diagnostics and digital health tools, though implementation capacity remains a work in progress.

Public procurement of health products in Mozambique is centrally coordinated through the Ministry of Health (MISAU), with the Central de Medicamentos e Artigos Médicos (CMAM) serving as the primary national supply chain and procurement agency responsible for warehousing, distribution, and quantification of medicines, vaccines, medical devices, and diagnostics for the public health system. Tenders and procurement processes are governed by the national public procurement law (Lei de Contratação Pública) and overseen by the Unidade Funcional de Supervisão das Aquisições (UFSA). Procurement is largely centralized at the national level, with CMAM managing distribution to provincial and district health facilities, though decentralization efforts are ongoing. Suppliers wishing to participate in public tenders must typically be registered with AREMED and comply with local procurement regulations, including demonstrated product registration or authorization.

Mozambique's public health system is heavily dependent on international donor funding, making donor-funded procurement channels critically important for market access. Major partners include the Global Fund to Fight AIDS, Tuberculosis and Malaria, PEPFAR and USAID (including procurement through USAID supply chain mechanisms such as GHSC-PSM), UNICEF, and Gavi, the Vaccine Alliance, which collectively finance a substantial proportion of essential medicines, diagnostics, vaccines, and health commodities procured in-country. These donors often procure through international competitive tendering or pre-approved supplier lists, frequently requiring WHO prequalification or SRA approval as eligibility criteria. The private health sector remains relatively small but is growing, concentrated primarily in Maputo and other urban centers, with procurement occurring through licensed private importers and distributors. Mozambique currently has limited domestic pharmaceutical manufacturing capacity, and while national policy expresses aspirations to promote local manufacturing under the broader African Union Pharmaceutical Manufacturing Plan for Africa (PMPA) framework, no strong local content preference or mandatory local manufacturing policies are currently enforced in procurement regulations.