Delineation between medicinal products and other products
Pursuant to Section 1 (3b) of the Austrian Medicines Act (AMG), persons wishing to place a product on the market may submit an application to the Federal Office for Safety in Health Care (BASG) to determine whether this product falls within the definition of a medicinal product. This is a chargeable entry in accordance with the Fees Ordinance of the Federal Office as amended. Within the framework of this determination, an expert opinion is drawn up together with an official decision.
The application must be sent preferably by e-mail using the completed form F_M65 and the necessary documents.
Within the scope of this procedure, the BASG may obtain an expert opinion of the Delineation Commission pursuant to § 49a AMG pursuant to § 1 para 3b AMG.
Alternatively, persons wishing to place a product on the market can submit an informal enquiry to BASG by e-mail, which is answered by e-mail without a formal expert opinion and without notification. A fee will be charged for the processing time in accordance with §8 (2) Fees Ordinance of the Federal Office .
Form for the delineation of medicinal products
Delineation Advisory Board
The Delineation Advisory Board (AGBR) is an organ established at the Federal Ministry of Health (BMG) (§ 49a AMG). Its task is the preparation of expert opinions on the delineation of medicinal products from other products, on behalf of the BMG or the BASG.
According to the "Verordnung der Bundesministerin für Gesundheit und Frauen, mit der Geschäftsordnung des Abgrenzungsbeirats erlassen wird", BGBl. II Nr. 354/2006 (Ordinance of the Federal Minister of Health and Women on the Rules of Procedure of the Delineation Advisory Board), expert opinions of the Delineation Advisory Board together with the reasons for the decision are to be published on the Internet on the website of the BASG.
Delineation and classification of medical devices
The Federal Office for Safety in Health Care carries out delineations of medical devices exclusively based on § 5a of the Austrian Medical Devices Act (BGBl. 657/1996 as amended, MPG). We would like to point out that a fee-based application for delineation can only be made by a manufacturer or authorised representative domiciled in Austria.
The applicable fee can be found under Fees Ordinance of the Federal Office (section XI).
EU assistance with delineation
The European Commission provides its own internet site with guidance (not legally binding) on the delineation and classification of medical devices, which also provides assistance in the delineation of medicinal products, biocides and cosmetics.