AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
1.3 Different Categories of Pharmaceuticals and Medical Devices In Austrian medicinal products law, various cri- teria exist based on which medicinal products are categorised and regulated differently. By way of an example, the AMG distinguishes between medicinal products available for the patient only upon prescription and over-the-counter (OTC) medicinal products available without prescrip- tion. Medicinal products requiring prescription may not be advertised to the general public (“laymen”) but, rather, only to healthcare pro- fessionals under the preconditions laid down in the AMG. The AMG makes another relevant distinction between medicinal products that are, in princi- ple, subject to marketing authorisation – known as “medicinal specialities” ( Arzneispezialitäten ) – and medicinal products not subject to such authorisation. Furthermore, the AMG differenti- ates on the basis of the material composition of a medicinal product (eg, biological medicinal products, herbal medicinal products, radioactive medicinal products, or homoeopathic medicinal products). Likewise, the Ministry of Health may qualify medical devices as requiring a prescription or as only available through certain specialised dealers. Prescription-only medical devices may not be advertised to the general public, either. However, in practice, the vast majority of medi- cal devices are freely available and not qualified as prescription-only or are exclusively available in specialist stores. There is an important distinction between in-vit- ro diagnostic (IVD) devices, which are governed by the In Vitro Diagnostic Regulation (IVDR), and other medical devices, which fall under the Medical Device Regulation (MDR). Additionally,
tenance. Since 26 May 2022, in vitro diagnostic (IVD) devices have been governed by Regulation (EU) 2017/746 (“In Vitro Diagnostics Regulation”, or IVDR), which is likewise complemented by the MPG. The MPG came into force on 1 July 2021 for medical devices and on 26 May 2022 for IVD devices. The competent national authority for medicinal products, medical devices and IVD devices is the Austrian Federal Office for Safety in Healthcare ( Bundesamt für Sicherheit im Gesundheitswes- en , or BASG). The BASG is responsible for the approval and control of medicinal products in Austria and the control and approval of clinical trials (see 2.2 Procedure for Securing Authori- sation to Undertake a Clinical Trial ). Together with the competent European agencies, the BASG further monitors at the national level the medicinal products, medical devices, and IVD devices already on the market in terms of their efficacy, safety, production, transport, and stor- age. 1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation Decisions by regulatory bodies qualify as spe- cific administrative acts ( Bescheide ), which can be challenged by the addressee – or by a (third) party having a legal interest, if applicable – by lodging an appeal with the regulatory body that issued the administrative act. The decision on the appeal is made by the competent adminis- trative court. Appeals against administrative acts must be made in writing and – unless the respective regulation provides otherwise – filed within four weeks of the date of the decision to be chal- lenged. The appellant is not legally obligated to be represented by an attorney.
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