* The national legal bases are only available in German

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.

Health and Food Safety Act (GESG)

Please note the current fee regulation and the submission regulation:

Fee Regulation of BASG

Electronic Submission Regulation 2011 of BASG (EEVO 2011)

• Medicinal Products Act (AMG)
• Regulation on Medicinal Products derived from Human Blood
• Operating Rules for Pharmaceutical Establishments 2009 (AMBO 2009)
• Regulation concerning the Austrian Medicinal Product Index 2013
• Medicinal Products Import Act 2010 (AWEG 2010)
• Herd-specific Vaccines - Company Regulation (BIBO)
• Regulation concerning Batch Testing Institutes
• Regulation on Product Information 2008
• Distance Sales Regulation
• Operating Rules for Medicated Feedingstuffs Establishments 2006 (FAMBO 2006)
• Package Leaflet Regulation 2008
• Hemovigilance Regulation 2007 (HäVO 2007)
• Contributions towards Security of Pharmaceutical Infrastructure Act (ISB) 2023
• Pharmaceutical Labelling Regulation 2008
• Regulation on Pharmacovigilance 2013 (PhVO 2013)
• Prescription Requirements Act (RezeptPG)
• Prescription Requirements Regulation
• Narcotics Act (SMG)
• Veterinary Medicinal Products Act (TAMG)
• Animal Diseases Act (TSG)
• Regulation on Good Laboratory Practice 2006
• Regulation on Security of the Supply of Medicinal Products

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

Directive 2011/62/EU on the prevention of the entry into the legal supply chain of falsified medicinal products.

Austrian legal basis

• Medical Devices Act (MPG 2021) *
• Medical Device Operator regulation (MPBV) - legacy devices & old devices *

European legal basis

• Regulation (EU) 2017/745 on medical devices („MDR“)
• Regulation (EU) 2017/746 on in vitro diagnostic medical devices („IVDR“)
• Regulation (EU) 2023/607 amending the transitional provisions
• Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices
   
• Directive 93/42/EEC concerning medical devices - legacy devices & old devices
• Directive 98/79/EC on in vitro diagnostic medical devices - legacy devices & old devices
• Directive 90/385/EEC on active implantable medical devices - legacy devices & old devices
   
• Regulation (EU) 2019/1020 on market surveillance and compliance of products

Guidances

• MDCG Guidance Documents
• Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending the transitional provisions
   
• Harmonised Standards - MDR
• Harmonised Standards - IVDR

Further relevant Regulations and Directives

• Regulation on Magnetic Field Therapy Devices (MFTGV) *
• Regulation on the Supply of HIV tests for Self-testing *

• Regulation (EU) No 722/2012 concerning Requirements with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin
• Regulation laying down accompanying measures to Regulation (EU) No 722/2012 (MPTG-VO)

• Directive on CJD of the Austrian Federal Ministry of Health *
   

Fees for medical devices

• Medical Device Levy Ordinance *

• Medicinal Products Act (AMG)
• Blood Safety Act 1999 (BSG 1999)
• Regulation concerning Medicinal Products derived from Human Blood
• Hemovigilance Regulation 2007 (HäVO 2007)
• Blood Donor Regulation (BSV)
• Regulation laying down more detailed Rules on the Operation and Quality System of Blood Establishments and Establishments that process, store or distribute Blood or Blood Components intended exclusively for Transfusion (QS-VO Blut)
• The Blood Guide
   
• Tissue Safety Act (GSG)
• Tissue Vigilance Regulation (GVVO)
• Tissue Bank Regulation (GBVO)
• Tissue Procurement Regulation (GEEVO)
• Regulation (EC) No 1394/2007 on advanced therapy medicinal products
• Regulation (EU) 2019/1020 on market surveillance and compliance of products