AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
In Austria, manufacturers of products (or their representatives) may initiate a procedure with the BASG, whereby questions concerning the product classification – including the demar- cation between the medicinal product and the medical device status of the product – will be clarified (Section 10 of the MPG and Section 49a of the AMG). 3.2 Granting a Marketing Authorisation for Biologic Medicinal Products Within the meaning of the AMG, the term “bio- logical medicinal products” comprises: • certain immunological medicinal products; • certain medicinal products manufactured by using human blood or blood plasma as a starting material; and • medicinal products listed in Annex I (1) and (1a) Regulation (EC) 726/2004, such as: (a) medicinal products developed by means of recombinant DNA technology, con- trolled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes (including transformed mammalian cells), or hybridoma and monoclonal antibody methods; and (b) ATMP. Austrian law does not provide for a marketing authorisation procedure specific to biological medicinal products. However, for medicinal products listed in Annex 1(1) and (1a) Regulation (EC) 726/2004, a central marketing authorisation according to said regulation is mandatory. In addition, differences with regard to the required application documents may arise for different types of biological medicinal products. Furthermore, the AMG contains specific pro- visions for certain immunological medicinal products, as well as medicinal products manu-
factured by the use of human blood or blood plasma. According to Section 7, paragraph 8 of the AMG, for example, blood and blood compo- nents intended for direct transfusion are exempt from the obligation to obtain a marketing author- isation. Also, a batch release may be required as a prerequisite for supplying certain biological medicinal products in national Austrian law (see Section 26 of the AMG). Lastly, specific provi- sions for so-called biosimilars can be found in Section 10, paragraph 6 of the AMG. 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices The BASG generally grants a national market- ing authorisation of a medicinal product for a period of five years (Section 20, paragraph 1 of the AMG). An extension of the marketing authori- sation (at the request of the marketing authori- sation holder) is valid without a time limit unless the BASG again sets a time limit of five years for reasons of pharmacovigilance. If an authorised medicinal product has not actu- ally been placed on the domestic market within three years of the marketing authorisation being granted or has not been on the market for three consecutive years, the marketing authorisation may expire in accordance with Section 22 of the AMG (the so-called sunset clause). In cer- tain cases, the marketing authorisation must also be revoked. Similar rules apply according to Regulation (EC) 726/2004 with regard to the period of validity of marketing authorisations for medicinal products authorised under the cen- tralised procedure. The placing on the market of medical devices is not subject to a marketing authorisation; however, the manufacturer must perform a con- formity assessment procedure (see 3.4 Proce-
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