Library / regulatory-reference
Kosovo: Agency for Medicinal Products and Medical Devices (AKPPM)
Audience: administrators-policy, researchers-scientists ยท Review state: published
The national authority
The Kosovo Agency for Medicinal Products and Medical Devices, known by its Albanian initials AKPPM, is Kosovo's national regulatory authority for medicines and medical devices.
Kosovo imports nearly all of its medicines, and the agency's registration and licensing decisions govern a small market closely linked to regional supply routes.
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 reliance on trusted authorities' decisions important for a young regulatory institution.
Regional and international role
Kosovo's European-integration orientation shapes the agency's development, with technical requirements modeled on European frameworks.
As one of Europe's youngest medicines agencies, its institution-building path is watched by other small systems.
Using this profile
The agency publishes regulations and announcements in Albanian and 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: Kosovo illustrates the institution-building regulator: a young agency standing up full functions in a small import market.
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.