AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
a “managing director under trade law” ( gewer- berechtlicher Geschäftsführer ) who is appropri- ately qualified (as further defined in the GewO). The manufacturing licence will only be issued after a successful on-site inspection of the man- ufacturing premises by BASG, during which the authority checks compliance with the require- ments of the AMBO and ensures that the qual- ity of the medicinal products as required for the health and life of humans (or animals) is ensured on the basis of the provided facts. The statutory timeframe for issuing a manufacturing licence is 90 days from submitting a complete applica- tion. Any additional requests by the authority or missing information identified in the inspection will lead to a clock stop. The manufacturing authorisation is granted for a specific site, for specific manufacturing activi- ties and types of medicinal products as speci- fied in the application, and – in principle – for an unlimited period. However, the authorisation remains subject to regular GMP inspections by the BASG, and can be withdrawn in the case of any detected and non-remedied deficiencies. The manufacture of medical devices and IVD devices is not subject to a specific governmental authorisation. However, requirements as appli- cable to any manufacturing activity – for exam- ple, those under construction law and under trade law regarding operating plants – will apply. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices A wholesale dealer licence (WDL) (also called an “operating licence”) is required to carry out
wholesale distribution of medicinal products. Such a licence is required not only if the respec- tive entity actually carries out physical handling and storage of medicinal products but also for selling and supplying medicinal products – even though the actual logistics are outsourced to a third party (likewise requiring a WDL itself). The WDL is granted by the BASG upon applica- tion, in which the applicant must provide details of: • the nature, scope and location of the intend- ed distributing 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 responsible person ( fachkun- dige Person ) for wholesale distribution being appropriately qualified, experienced and reliable. Furthermore, a trade permit is also required for the wholesale of medicinal products (see 4.1 Requirement for Authorisation for Manufac- turing Plants of Pharmaceuticals and Medical Devices ). Such a permit requires the nomination of an appropriately qualified managing director under trade law. The WDL may only be issued after the BASG successfully inspects the wholesale distribu- tion site. The statutory timeframe for issuing a WDL is 90 days from the submission of a com- plete application. Any additional requests by the authority or missing information identified in the inspection will lead to a clock stop. The WDL is granted for a specific site and for specific distribution activities as specified in the application and is in principle for an unlim-
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