Medicines

Marketing Authorisation of medicinal products

Each medicine must receive its marketing authorisation before it can be market in Austria. Authorised medicines are approved by the Federal Office in the Safety of Health Care (BASG). During the procedure the experts of BASG assesse medicines on the basis of the Austrian Medicines Act.

BASG determines whether the advantages of the medicine have been proven to outweigh the risks (efficacy-safety balance). If the advantages outweigh possible disadvantages the medicinal product receives the marketing authorisation. BASG carefully examines the efficacy, risks and quality of each medicinal product.

At the end of 2009 about 10,961 proprietary medicinal products were approved in Austria. Of those, 90 % are intended for human and 10 % for veterinary use. In addition, there are 8,162 medicinal products registered in Austria.