AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
4. Regulatory Reliance and Fast Track Registration Routes 4.1 Fast Track Registration Routes In case of an application for a centralised author- isation granted by EMA, applicants can ask for an “accelerated assessment”, which reduces the timeframe for the European Medicines Agen- cy’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to review a marketing- authorisation application (from up to 210 days to 150 days). In order to be eligible for such accel- erated assessment, applicants need to argue that the product is of major interest to public health and therapeutic innovation. The Austrian (national) regulatory landscape does not provide for a fast-track registration route. Regarding medical devices, the MDR and IVDR currently do not provide for accelerated proce- dures. 4.2 Regulatory Reliance Austria is a member of the European Union. An authorisation granted by the European Medi- cines Agency (EMA) through the so-called “cen- tralised procedure” is valid throughout the EU, and the respective medicinal product may be marketed in all member states. Further, where a national authorisation already exists in an EU member state, it may be extended to the territory of other member states through a mutual recognition procedure (Section 18a of the AMG). For medicinal products that cannot be authorised under the centralised procedure, marketing authorisation in different EU member states may be applied for through a decentral- ised procedure (Section 18a of the AMG). See also 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices. Medical devices that have successfully
undergone a conformity assessment in accord- ance with the MDR or IVDR, as applicable, and carry a CE mark can be marketed throughout the European Union. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices The manufacture of medicinal products (includ- ing packaging, labelling and final release of the finished product) may only be carried out based on a manufacturing authorisation (known as an “operating licence”) to be applied for in accord- ance with the AMG. The BASG grants the authorisation upon appli- cation, in which the applicant must provide details of: • the nature, scope and location of the intend- ed manufacturing activity; • the nature, size, equipment, dedication and location of the premises (as well as their fur- nishings and equipment); • the nature of the technical equipment; and • the appointed Qualified Person (QP) ( sachkundige Person ) who needs to be appro- priately qualified, experienced and reliable. Another prerequisite for the manufacturing licence is a trade permit for the manufacturing of medicinal products. This is issued, in accord- ance with the Trade Act ( Gewerbeordnung , or GewO), by the Trade Authority – ie, the compe- tent district administrative authority ( Bezirksver- waltungsbehörde ) at the intended manufacturing site. Such a permit requires the nomination of
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