To make sure that you are on the latest valid status, please visit the Austrian Legal Information System RIS.

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

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

New legislation on falsified medicines 2011/62/EU

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

• MEDDEV
• Harmonised Standards

• Ordinance on operation and use of medical devices 2007
• Ordinance on the Medical Devices Registry 2011
• Austrian Ministry of Health: Guideline on CJD 2016
• Ordinance on Implant Registry 2008

• Ordinance on disposal of magnetic field therapy machines 2003
• Ordinance on unconditional medical devices 2002

Ordinance on annual fee for medical devices

• Austrian Blood Safety Act 1999
• Austrian Tissue Safety Act 2008
• Ordinance on human tissue banks 2008
• Ordinance on human tissue procurement establishments 2008
• Ordinance on tissue vigilance 2008

Ordinance of the Federal Minister for Social Affairs, Health, Care and Consumer Protection concerning COVID-19 special regulations for medicinal products (COVID-19-ArzneimittelV)

Ordinance of the Federal Minister for Social Affairs, Health, Care and Consumer Protection concerning COVID-19 special regulations for medical devices (COVID-19-MedizinprodukteV)