Legal basis

Legal basis for the Austrian Federal Office for Safety in Health Care (BASG)

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)

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

Falsified medicines

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

Medical devices

Austrian legal basis

European legal basis

Guidances

 

Further relevant Regulations and Directives

Fees for medical devices

Email

Further inquiry note