Library / regulatory-reference
Serbia: Medicines and Medical Devices Agency (ALIMS)
Audience: administrators-policy, researchers-scientists ยท Review state: published
The national authority
The Medicines and Medical Devices Agency of Serbia, known by its Serbian initials ALIMS, is the country's national regulatory authority for medicines and medical devices.
Serbia combines imports with a domestic pharmaceutical industry with deep regional roots, and the agency's registration, licensing and inspection decisions cover both channels.
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, batch release for certain products, and recalls, with the agency publishing alerts to professionals and the public.
Regional and international role
Serbia's European-accession orientation drives progressive alignment of its medicines legislation with European frameworks, and the agency participates in European regulatory cooperation as a candidate-country authority.
Its domestic industry's export presence across the Balkans and beyond gives its oversight regional significance.
Using this profile
The agency publishes regulations, registers and alerts in Serbian 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: Serbia illustrates the accession-aligned agency: a full-function regulator converging on European norms while overseeing an export-active domestic industry.
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.