Legal basis
Legal basis for the Austrian Federal Office for Safety in Health Care (BASG)
To make sure that you are on the latest valid status, please visit the Austrian Legal Information System RIS.
Laws and regulations
Current laws and ordinances in force, as available in German from the Austrian Legal Information System (RIS)
- Austrian Medicines Act - AMG 1983
- Austrian Ordinance on Good Manufacturing Practices - AMBO 2009
- Ordinance on the Austrian Medicinal Products Registry 2013
- Austrian Act on the Import of Medicinal Products - AWEG 2010
- Ordinance on reporting obligation for Non Interventional Studies - NIS 2010
- Ordinance on herd-specific veterinary vaccines 2010
- Ordinance on labelling of medicinal products 2008
- Ordinance on package leaflet of medicinal products 2008
- Ordinance of the Summary of Product Characteristics 2008
- Austrian Compulsory Prescription Act 1972
- Ordinance on Compulsory Prescription 1973
- Austrian Addictive Drug Act - SMG 1997
- Ordinance on Pharmacovigilance 2013
- Ordinance on Ensuring the Medicines Supply 2020
Eudralex
The body of European Union legislation in the pharmaceutical sector is compiled in Volume 1 and Volume 5 of the publication "The rules governing medicinal products in the European Union" - Eudralex
Medical devices
Austrian legal basis
- Austrian Medical Devices Act 2021
- Medical Device Operator Ordinance
- Medical Device Notification Ordinance
- Ordinance for Magnetic Field Therapy Devices
- Ordinance for the supply of HIV tests for self-testing
European Directives
- Regulation (EU) 2017/745 on Medical Devices
- Regulation (EU) 2017/746 on in vitro diagnostics medical devices
- Directive 93/42/EEC
- Directive 98/79/EC
- Directive 90/385/EEC
Guidances to the directives
Further inquiry note
Page last modified:
02/03/2022