AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
put into service if they comply with the MDR/ IVDR. Specifically, they must meet the general safety and performance requirements, taking into account their intended purpose. Also, an assessment of the conformity of the device must be conducted, and a corresponding declaration of conformity must be issued. Depending on the risk classification of a medical device, a notified body must be involved in the process. The CE marking of the product indicates conformity with the applicable requirements. Transfers of CE markings are not provided for in the MDR/IVDR. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations Medicinal Products As far as medicinal products are subject to a marketing authorisation, such marketing authori- sation is a prerequisite for lawful placing on the market in Austria. For this reason, opportunities to supply such medicinal products to patients without marketing authorisation are limited. Nevertheless, there are a number of exceptions to this principle. The following are among the exceptions to the authorisation requirement. • Named Patient Use (Section 8, paragraph 1(2) of the AMG) – no marketing authorisation is needed if a physician or dentist authorised to practise independently in Austria certifies that: (a) a medicinal product is urgently needed to prevent a threat to life or serious damage to the health of a specific patient; and (b) this threat or damage cannot be pre- vented with an authorised and available medicinal product according to the state of the art. • Compassionate Use Programmes (Section 8a of the AMG and Article 83 of Regulation (EC) 726/2004) – marketing authorisation is
not needed within Compassionate Use Pro- grammes, which may be established (subject to prior approval by the BASG) for a defined group of patients suffering from a debilitating chronic or severe disease or whose disease is life-threatening and cannot be satisfacto- rily treated with an authorised and available medicinal product. • Clinical trials (Section 8, paragraph 1(1) of the AMG) – medicinal products intended for the use in non-clinical or clinical studies or clini- cal trials do not need a marketing authorisa- tion. • Hospital exemption (Section 7, paragraph 4 of the AMG and Article 28 of Regulation (EC) 1394/2007) – ATMP that are manufactured on a non-routine basis in Austria on the basis of an individual medical prescription specifi- cally for a particular patient, in order to be used on that patient in an Austrian hospital under the exclusive professional responsibility of a physician, are not subject to marketing authorisation. • Officinal and magisterial medicinal prepara- tions (Section 7, paragraphs 2 and 3 of the AMG) – certain medicinal products manufac- tured in pharmacies are not subject to mar- keting authorisation. Further exemptions are listed in Sections 7 et seq of the AMG. It should be noted that a marketing authorisa- tion is a prerequisite for placing medicinal prod- ucts on the market but not for their use. For this reason, medicinal products can, in principle, be used on patients beyond the scope of their marketing authorisation (off-label use). In this context, however, the physician has increased obligations to provide information to the patient.
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