AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
dure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices ). According to Article 56 of the MDR, certificates of conformity issued by the notified bodies will be valid for the period they indicate, which must not exceed five years. Upon application by the manufacturer, the validity may be extended for further periods (of no more than five years), based on a re-assessment. The CE marking will be suspended, restricted or withdrawn if a noti- fied body finds that the manufacturer no longer meets the requirements of the MDR. 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices Marketing Authorisation for Medicinal Products There are, in practice, four different procedures for obtaining a marketing authorisation for medicinal products. • Marketing authorisation must be obtained via the centralised procedure for medicinal prod- ucts according to Annex I Regulation (EC) 726/2004 (eg, ATMP). Under certain condi- tions (see Article 3, paragraph 2), the cen- tralised procedure is also available for other medicinal products. A marketing authorisation obtained under the centralised procedure is issued by the European Commission and is valid in all EU member states. Applications must be submitted to the EMA. • For other medicinal products, marketing authorisation may be obtained under the national procedure according to Sections 7 et seq of the AMG via application to the BASG. The BASG is also the competent authority for issuing the national marketing authorisation, which is only valid on Austrian territory. • Where a national authorisation already exists in a 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 proce- dure, marketing authorisation in different EU member states may be applied for through a decentralised procedure (Section 18a of the AMG). Variations to marketing authorisations Variations to marketing authorisations are gov- erned by Regulation (EC) 1234/2008 for all types of authorisations. Depending on the degree of health risk and the impact on quality, safety and efficacy, either a simple notification procedure, a notification obligation with a prohibition reserva- tion or a prior authorisation procedure is required. In contrast, applications for authorisation exten- sions (eg, in the case of relevant changes to the active substance) must be evaluated according to the same procedure as the application for the original authorisation. Transfers of marketing authorisations Transfers of marketing authorisations obtained through the centralised procedure must be requested from the EMA in accordance with the guidelines established in Regulation (EC) 2141/96. If this process is not followed, then Section 25 of the AMG applies. According to this section, a waiver declaration of the authorisa- tion from the previous marketing authorisation holder and an acceptance declaration from the new holder (transferee) must be submitted to the BASG. Medical Device and IVD Device Compliance Placing medical devices and IVD devices on the market is not subject to obtaining a marketing authorisation; however, medical devices or IVD devices may only be placed on the market or
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