Mozambique

Health product regulation in Mozambique is overseen by the Autoridade Reguladora de Medicamentos e Tecnologias de Saúde (ARMEDTS), established under Decree No. 36/2020 as the successor to the former Departamento de Medicamentos e Equipamentos de Saude (DMES) within the Ministry of Health (MISAU). ARMEDTS is mandated to regulate the quality, safety, and efficacy of medicines, medical devices, diagnostics, and related health technologies. The principal legislative framework is grounded in the National Medicines Policy and supporting regulations, including the Medicines Law and associated ministerial diplomas governing import, licensing, and post-market surveillance. All health products must undergo a formal registration process before they can be legally marketed or distributed in Mozambique, requiring applicants to submit a registration dossier for technical evaluation, followed by issuance of a marketing authorization.

Submission dossiers are generally expected to conform to the Common Technical Document (CTD) format, with ARMEDTS increasingly aligning its requirements with regional harmonization initiatives led by the African Medicines Regulatory Harmonization (AMRH) programme and the African Union Development Agency (AUDA-NEPAD). Applicants are required to appoint a local authorized representative or registered importer based in Mozambique to act as the responsible entity for regulatory correspondence and post-market obligations. Reliance pathways referencing approvals from stringent regulatory authorities (SRAs) such as the EMA, US FDA, or WHO-prequalified products are recognized in practice and can expedite review timelines, particularly for essential medicines and diagnostics. Recent reforms have focused on strengthening ARMEDTS institutional capacity, improving transparency of review procedures, and advancing digital submission systems, though implementation remains incremental and applicants should anticipate variable timelines depending on product category and dossier completeness.

Public procurement of health products in Mozambique is centrally coordinated through the Ministry of Health (MISAU) with technical and logistical support from the Central de Medicamentos e Artigos Medicos (CMAM), the national central medical stores responsible for quantification, procurement, warehousing, and distribution of medicines, medical devices, and diagnostics to public health facilities nationwide. Procurement processes are governed by the national public procurement law (Decree No. 5/2016 and subsequent amendments), which requires competitive tendering for contracts above defined thresholds, managed in coordination with the national procurement oversight bodies. CMAM publishes periodic tender notices and framework agreements and serves as the primary entry point for suppliers wishing to access the public sector market. Provincial health directorates may conduct supplementary local procurement for specific needs, but the majority of strategic health commodity procurement is centralized through CMAM.

Mozambique's public health system is heavily dependent on donor-funded procurement channels, which account for a significant share of health commodity supply. Key partners include the Global Fund to Fight AIDS, Tuberculosis and Malaria (which funds substantial volumes of HIV, TB, and malaria commodities), USAID through its implementing mechanisms such as PEPFAR and PMI, UNICEF for essential medicines and nutrition products, and Gavi, the Vaccine Alliance for immunization supplies. These donors often procure through international mechanisms such as the UNICEF Supply Division, IDA Foundation, or directly through CMAM-managed systems with technical assistance from Supply Chain Management System (SCMS) or similar partners. The private sector, composed of licensed pharmacies, private clinics, and hospitals, sources products through registered importers and distributors operating under ARMEDTS authorization. Local manufacturing capacity in Mozambique remains limited, and no strong formal local manufacturing preference policy is currently enforced in procurement regulations, though national strategies encourage investment in local production capacity as a long-term goal aligned with the African Union's Pharmaceutical Manufacturing Plan for Africa (PMPA).