AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
ited period. However, the authorisation remains subject to regular Good Distribution Practice inspections by the BASG and can be withdrawn in the case of any detected and unremedied deficiencies. No licence comparable to the WDL is necessary for the distribution of medical devices. However, a trade licence and an appropriately qualified managing director under trade law are neces- sary. Finally, according to Section 67 of the MPG, registration in the publicly accessible Medical Devices Register is mandatory for all persons or entities responsible for placing medical devices on the market for the first time in the European Economic Area (EEA) and domiciled in Austria. 6.2 Different Classifications Applicable to Pharmaceuticals See 1.3 Different Categories of Pharmaceuti - cals and Medical Devices . 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies The importation and transfer of “pharmaceutical products” ( Arzneiwaren ) is regulated under the AWEG. In this context, it should be noted that the term “pharmaceutical products” is not identi- cal to the term “medicinal product” as defined in the AMG or Directive 2001/83/EC – rather, it is based on the customs tariff regulations of Regu- lation (EEC) 2658/87. The AWEG, therefore, does not apply to all medicinal products. Also, medi-
cal devices are explicitly excluded from its scope (Section 1, paragraph 2 of the AWEG). Provisions for parallel imports of medicinal prod- ucts are regulated in the AMG (in particular, Sec- tion 10c). Products that have been authorised for parallel import are exempt from the notifica- tion obligation under the AWEG. Furthermore, obligations for importers and exporters are pro- vided by the AMBO (see, for example, Section 4a). Specific provisions for the importation of investigational medicinal products are regulat- ed in the CTR (Articles 61 and 63). The transfer of investigational medicinal products within the EEA (and Switzerland) is exempt from the noti- fication obligation under the AWEG (Section 6, paragraph 2 of the AWEG). The BASG is competent in issuing import certifi- cates, receiving notifications under the AWEG, and supervising compliance with the AMG, the AWEG, and the CTR. In addition, certain powers are granted to the customs administration under the AWEG. General and specific obligations regarding the importation of medical devices and IVD devices are laid down in the MDR/IVDR (see, in particu- lar, Articles 13 and 60 of the MDR and Articles 13 and 55 of the IVDR) and enforced by the BASG Pharmaceuticals and Medical Devices According to Section 4 of the AWEG, the follow- ing entities are entitled to apply for an import permit or carry out an importation notification for pharmaceutical products: • public pharmacies; • hospital pharmacies; and as the competent authority. 7.2 Importer of Record of
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