AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations Medicinal Products Holders of a marketing authorisation for a medic- inal product must operate a pharmacovigilance system (Section 75i et seq of the AMG). Within the framework of this system, the holder must, among other things: • appoint a pharmacovigilance officer; • keep a pharmacovigilance master file; • operate a risk management system; • monitor the results of risk minimisation meas - ures; • monitor pharmacovigilance data; and • subject the pharmacovigilance system to regular audits. The applicable law also provides for reporting obligations (Section 75j of the AMG, Article 28 of Regulation (EC) 726/2004 and Article 107 of Directive 2001/83/EC) and information obliga- tions of the holder (Section 75m of the AMG). In addition, holders are obliged to regularly prepare periodic safety update reports (PSUR) and trans- mit them electronically to an archive maintained by the EMA. Other obligations of the holder include the fol- lowing, as outlined below. • The holder must inform the BASG about the date of actual placing on the market of a medicinal product, as well as a temporary or permanent removal from the market (Section 21 of the AMG). • The holder must ensure that complete documentation of all activities related to the marketing authorisation or the medicinal product is available at all times (Section 24b of the AMG).
Medical Devices and IVD Devices With regard to medical devices and IVD devic- es, the MDR/IVDR provides exemptions from the obligation of CE marking for custom-made devices, investigational devices, and devices for performance studies (Article 20 of the MDR and Article 18 of the IVDR). Furthermore, the plac- ing on the market and putting into service of a medical device for which no conformity assess- ment has been carried out may be authorised by the BASG in specific cases upon request for reasons of public health or patient health and safety (Article 59 of the MDR, Article 54 of the IVDR and Section 12 of the MPG). As per the above-mentioned definition of Named Patient Use, if a physician or dentist authorised to practise independently in Austria confirms that a medical device is required for a specific patient in order to avert a danger to life or a seri- ous impairment of health – and that the treat- ment cannot be expected to be successful with a medical device for which conformity assess- ment procedures have already been carried out – then such authorisation is not necessary. The same applies to medical devices used in con- nection with certain deployments of the Federal Armed Forces (Section 12, paragraphs 2 and 3 of the MPG). Finally, under certain conditions, there are far- reaching exemptions from the MDR/IVDR obli- gations for in-house products manufactured and used only in healthcare facilities (Article 5, paragraph 5 of the MDR/IVDR and Section 9 of the MPG).
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