Library / regulatory-reference
Slovenia: Agency for Medicinal Products and Medical Devices (JAZMP)
Audience: administrators-policy, researchers-scientists ยท Review state: published
The national authority
The Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, known by its Slovenian initials JAZMP, is the country's national regulatory authority for medicines and medical devices.
Slovenia's market sits inside the European single market, and the agency works within the European regulatory network while overseeing a market shaped by a major domestic generic-pharmaceutical industry.
How products enter the market
Medicines require marketing authorization through national or European procedures after evaluation of quality, safety and efficacy, and establishments are licensed and inspected by the agency.
Post-market work includes safety monitoring, laboratory control and recalls within the European alert network, with the agency's oversight of export-oriented manufacturers giving its inspection work international reach.
Regional and international role
The agency is an active member of the European regulatory network, contributing assessments and inspections to shared European work.
Its inspection of globally supplying generic manufacturers makes its certificates and inspection outcomes relevant to regulators worldwide.
Using this profile
The agency publishes regulations and announcements in Slovenian, with English material, 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: Slovenia illustrates the small member state with outsized inspection reach: domestic plants supply the world, so its oversight travels.
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.