Federal law establishing the Austrian Agency for Health and Food Safety and setting up the Federal Office for Food Safety and the Federal Office for Safety in Health Care (Gesundheits- und Ernährungssicherheitsgesetz - GESG)

Gesundheits- und Ernährungssicherheitsgesetz GESG 2002

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)

• Animal Diseases Act (TSG)
• Austrian Act on the Import of Medicinal Products - AWEG 2010
• Austrian Addictive Drug Act - SMG 1997
• Austrian Compulsory Prescription Act 1972
• Austrian Medicines Act - AMG 1983
• Austrian Ordinance on Good Manufacturing Practices - AMBO 2009
• Infrastruktursicherungsbeitrag (ISB) 2023
• Ordinance on the Austrian Medicinal Products Registry 2013
• Ordinance on reporting obligation for Non Interventional Studies - NIS 2010 - cancelled in 2022
• 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 200
• Ordinance on Compulsory Prescription 197
• 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

*only available in German

Austrian legal basis

• Austrian Medical Devices Act (MPG 2021) *
• Medical Device Operator regulation (legacy devices & old devices) *
• Electronic submission regulation *
• Medical Device Notification regulation *

European legal basis

• Regulation (EU) 2017/745 on Medical Devices
• Regulation (EU) 2017/746 on in vitro diagnostics medical devices
• Regulation (EU) 2023/607 Extension of the MDR transitional period
   
• Directive 93/42/EEC (legacy devices & old devices)
• Directive 98/79/EC (legacy devices & old devices)
• Directive 90/385/EEC (legacy devices & old devices)

Guidances

• MDCG Guidance Documents
   
• Harmonised Standards (MDR)
• Harmonised Standards (IVDR)

Further relevant regulations and directives

• Regulation on Magnetic Field Therapy Devices *
• Regulation on the supply of HIV tests for self-testing *
• Regulation on Implant Registry *
• Regulation on unconditional medical devices *
   
• Directive on CJD of the Federal Ministry of Health *
   

Fees for medical devices

• Regulation on the 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