Library / regulatory-reference
North Macedonia: Agency for Medicines and Medical Devices (MALMED)
Audience: administrators-policy, researchers-scientists ยท Review state: published
The national authority
The Agency for Medicines and Medical Devices, known by its Macedonian initials MALMED, is North Macedonia's national regulatory authority for medicines and medical devices.
North Macedonia imports most of its medicines, and the agency's registration and licensing decisions govern the market.
How products enter the market
Medicines require marketing authorization after evaluation of quality, safety and efficacy documentation, and establishments across the supply chain are licensed and inspected by the agency.
Post-market work includes safety monitoring and recalls, with the agency active in professional and public communication on regulatory topics.
Regional and international role
North Macedonia's European-accession orientation shapes its regulatory alignment, and the agency participates in European cooperation as a candidate-country authority.
Its work on faster access to innovative therapies reflects a wider regional agenda among small European markets.
Using this profile
The agency publishes regulations and announcements in Macedonian 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: North Macedonia illustrates the small accession-market agency: alignment-driven modernization with an access-speed agenda.
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.