Borderline medicinal products

Legal differentiation between medicinal products and other products

Formal inquiries


Legal and natural persons intending  to place a product on the Austrian market can apply for a statement of the Federal Office for Safety in Health Care (BASG) whether this product meets the legal definition of a medicinal product (§ 1 para 3b of the Austrian Medicinal Products Act - AMG).

 

The application fee is 1.000,00 EURO (pursuant to V.2. of the actual version of the fee regulation of the BASG).

 

The application including the duly completed form F_M65 (in German) and the required documents should be submitted via e-mail to abgrenzungagesat.  

 

The statement consists of an official notification as well as an expert report (in German).

The expert report may be prepared by the “Abgrenzungsbeirat” (see below).


Informal inquiries


Alternatively it is possible to submit an informal inquiry via e-mail to abgrenzungagesat.

This inquiry will be responded informally via e-mail without official notification or expert report.  

The fee depends on the actual processing time (150 EURO per hour, according to §7 (2) of the fee regulation of the BASG).


Advisory Board on Classification - "Abgrenzungsbeirat”

The Advisory Board on Classification (Abgrenzungsbeirat - AGBR) is a commission set up by the Federal Ministry of Health (BMG) according to § 49a AMG.

 

Acting only by order of the BMG or the BASG it prepares expert reports in connection with queries concerning the legal differentiation between medicinal products and other products.

 

Expert reports of the “Abgrenzungsbeirat” in German are to be published on the website of the BASG.

 

Link to Abgrenzungsbeirat



Advisory Board on Distribution of medicines - "Abgrenzungskommission"

Set up according to §60 AMG, the Abgrenzungskommission advises on distribution rights of medicines, which are only to be distributed in pharmacies, or in drugstores as well.

 

Link to Abgrenzungskommission

Created: 08.03.2009 | Page last modified: 17.08.2017

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