Library / regulatory-reference
Austria: Federal Office for Safety in Health Care (BASG)
Audience: administrators-policy, researchers-scientists ยท Review state: published
The national authority
The Federal Office for Safety in Health Care, known by its German initials BASG, is Austria's national regulatory authority for medicines and medical devices.
Austria's market sits inside the European single market, and the office works within the European regulatory network while overseeing a market that combines imports with a significant research-based industry presence.
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 office.
Post-market work includes safety monitoring within the European alert network, batch release for certain products through official control laboratories, and recalls.
Regional and international role
The office is a senior member of the European regulatory network, contributing assessments and expertise to shared European work.
Its official control-laboratory work for biological products is used beyond Austria's borders.
Using this profile
The office publishes regulations, registers and alerts in German, 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: Austria illustrates the full-service member state: authorization, inspection and official batch-control laboratories in one federal office.
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.