AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
• companies authorised to distribute pharma- ceutical products in a state within the EEA. The entitlement to apply for a parallel import authorisation is granted to the following entities, according to Section 9 of the AMG: • professionals authorised to manufacture or wholesale the medicinal product concerned; • operators of domestic public pharmacies; and • pharmaceutical companies established within the EEA that are authorised to place the medicinal product concerned on the market. Depending on their activities (eg, repackag- ing), importers may be subject to the operating licence requirement of Section 63 of the AMG (see also 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices and 6.1 Wholesale of Pharma- ceutical and Medical Devices ). The MDR and the IVDR do not provide for spe- cific legal requirements to act as the importer of record of medical devices or IVD devices. How- ever, they define the importer as “any natural or legal person established within the Union that places a device from a third country on the Union market”. Importers must register in accordance with Article 28 of the MDR/IVDR. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices Under the AWEG, pharmaceutical products imported from a state outside the EEA are subject to a prior importation permit issued by the BASG. Similarly, pharmaceutical products imported from a state within the EEA must be notified to the BASG in advance.
Section 11 of the AWEG, however, provides for extensive exceptions to these requirements, including exceptions for: • medicinal products for which a marketing authorisation or an authorisation for parallel import has been obtained; • medicinal products for Named Patient Use; • medicinal products for use in a Compassion- ate Use Programme; • medicinal products needed in the event of emergencies; or • medicinal products for personal use, in an amount corresponding to the usual personal needs of the traveller concerned. Parallel importation of medicinal products is subject to a prior authorisation by/notification to the BASG in accordance with Section 10c of the AMG (see also Article 57, paragraph 1(o) of Regulation (EC) 726/2004 for medicinal products authorised under the centralised procedure). The importation of medical devices and IVD devices does not require any specific authori- sation under the MDR/IVDR or the MPG. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports The products subject to restrictions under the AWEG are determined based on the classifica- tion of goods according to the tariff and statisti- cal nomenclature of the EU, as established by Regulation (EEC) 2658/87. Only those products that fall under the specific subheadings of the combined nomenclature listed in Section 2(1) of the AWEG – such as subheadings 3002 20, 3002 30, and 3004 – are considered “pharmaceutical products” within the context of the AWEG.
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