AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
• If concerns arise regarding the medicinal product’s risks, the holder may face addi- tional requirements or conditions imposed by the BASG, such as the performance of post- authorisation safety studies. If findings on the disease or clinical methodology indicate that previous assessments of efficacy may need to be significantly corrected, an efficacy study must be imposed (Section 19a of the AMG). Medical Devices and IVD Devices For medical devices and IVD devices, the MDR/ IVDR require the manufacturer to plan, establish, document, implement, maintain and update a post-market surveillance system as part of the quality management system in a manner appro- priate for the risk class and type of the prod- uct (Article 83 of the MDR and Article 78 of the IVDR). To this end, a post-market surveillance plan must be established (Article 84 of the MDR and Article 79 of the IVDR) and post-market sur- veillance reports must be prepared and updat- ed (Article 85 of the MDR and Article 80 of the IVDR). Further obligations concern, for example, the preparation of PSUR (Article 86 of the MDR and Article 81 of the IVDR), the reporting and analysis of serious incidents and safety correc- tive measures (Articles 87 and 89 of the MDR and Articles 82 and 84 of the IVDR) and trend reports (Article 88 of the MDR and Article 83 of the IVDR). 3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices On an EU level, the EMA publishes a monthly list of medicinal products under current evalu- ation under the centralised procedure. A list of all medicinal products that have received marketing authorisation under the centralised procedure is provided in the “Union Register” published by the European Commission. This
register includes information on the name of a product, the registration number, name and address of the marketing authorisation holder, the active substance, the therapeutic indication, and relevant documents – as well as suspended, withdrawn or refused marketing authorisations. On a national level, the BASG keeps a pub- lic register of all medicinal products for which a national marketing authorisation has been obtained ( Arzneispezialitätenregister ). Any granting, variation, cancellation and transfer of a marketing authorisation must be entered into this register. Entries regarding the granting of a marketing authorisation include information on the authorisation number, the name of the prod- uct, the authorisation holder, prescription-only or narcotic status, and the composition of the medicinal product. Furthermore, the BASG operates an internet portal on medicinal products for public infor- mation purposes. In addition to information on the granting of marketing authorisation and the variation of a medicinal product, the BASG shall (inter alia) publish the technical informa- tion and approved directions for use, information on approved variations, and the conditions and constraints of marketing authorisations. Also, every expert opinion provided in the context of an application for marketing authorisation shall be published after all confidential informa- tion in the party’s commercial interest has been removed. Information on products authorised via a mutual recognition procedure can be found in the MRI Product Index. Information on medical devices and IVD devices (including summaries of safety and clinical performance) and their manufactur- ers and importers, as well as certificates, may be publicly accessed via the EUDAMED database.
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