Library / regulatory-reference
Bosnia and Herzegovina: Agency for Medicines and Medical Devices (ALMBIH)
Audience: administrators-policy, researchers-scientists ยท Review state: published
The national authority
The Agency for Medicines and Medical Devices of Bosnia and Herzegovina, known by its local initials ALMBIH, is the state-level national regulatory authority for medicines and medical devices.
Bosnia and Herzegovina's complex constitutional structure makes a state-level agency significant: it gives the country's fragmented health system a single regulatory front door for medicines.
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, coordinated across the country's administrative levels.
Regional and international role
Bosnia and Herzegovina's European-integration orientation shapes the agency's alignment work, and it cooperates with neighboring Balkan agencies that share language and market ties.
Its experience shows how a single medicines authority can function inside a highly decentralized state.
Using this profile
The agency publishes regulations and announcements in the country's official languages 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: Bosnia and Herzegovina illustrates the unified agency in a decentralized state: one regulator serving several health-system administrations.
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.