Library / regulatory-reference
Mozambique: National Medicines Regulatory Authority (ANARME)
Audience: administrators-policy, researchers-scientists ยท Review state: published
The national authority
The National Medicines Regulatory Authority, known by its Portuguese initials ANARME, is Mozambique's national regulator for medicines, vaccines, biological products and other health products.
Mozambique's medicine supply is heavily import-based, with a large public-sector and donor-supported flow, so the authority's marketing-authorization and licensing decisions shape national availability.
How products enter the market
Medicines require a marketing authorization granted after evaluation of quality, safety and efficacy, which the authority can issue through full registration, notification routes, or special and emergency import provisions.
The authority licenses entities that manufacture, import, export, distribute or retail medicines, as well as pharmaceutical professionals, and supervises the market after authorization.
Regional and international role
The authority participates in Southern African regulatory work-sharing, including the ZAZIBONA joint-assessment initiative, and hosts regional regulatory forums.
Its emergency and special-import provisions are frequently used to keep donor-supported treatment programs supplied, making its procedures relevant well beyond the domestic commercial market.
Using this profile
The authority publishes guidance, licensing information and announcements in Portuguese through its official portal, which is the primary source for current rules and listed in this profile's internal reference record.
For cross-country comparison: ANARME illustrates the program-critical regulator: a national authority whose special-import and work-sharing routes carry a large public-health supply burden.
Limitations
Educational profile of a national regulatory system, current as of drafting. It simplifies routes and classes and is not legal, regulatory, or clinical advice. Filing and compliance decisions must be confirmed against the authority's current published rules and, where needed, professional regulatory counsel.