AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
Herbst Kinsky Rechtsanwälte GmbH Dr Karl Lueger Platz 5
Vienna A-1010 Austria Tel: +43 1 904 21 80 Fax: +43 1 904 21 80 210 Email: office@herbstkinsky.at Web: www.herbstkinsky.at
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices Austrian law regarding medicinal products is heavily influenced by European Union legisla- tion. The primary national legal framework for pharmaceuticals (referred to as “medicinal prod- ucts”) intended for human use is the Austrian Medicinal Products Act ( Arzneimittelgesetz , or AMG). This act incorporates the key provisions of EU legislation, particularly Directive 2001/83/ EC. As of 28 January 2022, medicinal products intended for veterinary use are regulated by the Regulation on Veterinary Medicinal Products (Regulation (EU) 2019/6). Starting in January 2024, the new Austrian Veterinary Medicinal Products Act ( Tierarzneimittelgesetz ) has sup- plementd this regulation in Austria. Specific provisions in relation to medicinal prod- ucts can also be found in other Austrian laws, such as the Austrian Pharmaceutical Products Import Act ( Arzneiwareneinfuhrgesetz , or AWEG)
or the Austrian Prescription Act ( Rezeptpfli - chtgesetz ). Furthermore, the manufacture and distribution of medicinal products is governed by several national ordinances ( Durchführungs- verordnungen ), which are based on the AMG, including the Medicinal Products Operations Ordinance ( Arzneimittelbetriebsordnung , or AMBO). Medicinal products law is also increasingly regu- lated by directly applicable EU regulations – for example, Regulation (EC) 726/2004 (see 3.4 Procedure for Obtaining a Marketing Authorisa- tion for Pharmaceutical and Medical Devices), Regulation (EU) 536/2014 (“Clinical Trials Regu- lation”, or CTR), and Regulation (EC) 1394/2007 (“Advanced Therapy Medicinal Products Regu- lation”, or ATMPR). As of 26 May 2021, medical devices have mainly been governed by the Regulation (EU) 2017/745 (“Medical Devices Regulation”, or MDR), which is complemented by the Austrian Medical Devic- es Act 2021 ( Medizinproduktegesetz , or MPG) providing for rules regarding the safety, function- ality and quality of medical devices with regard to their construction, operation, use and main-
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