BASG and companies

News

News

BREXIT Transition period New

messages in brief | 09/07/2020
The EC has published a useful summary of applicable EU rules after the end of the transition period. You can find the link here on the website of the BASG.
BREXIT Transition period Read more
News

Creating Accessible Package Leaflets New

messages in brief | 01/07/2020
In an arbitration process, the Federal Office for Safety in Health Care (BASG) was obliged according to § 14 of the Federal Disability Equality Act (BGStG) to request Holders of a Marketing authorization/Registration/Parallel import license to provide their Package Leaflets (PL) in an accessible format corresponding to the standard PDF-UA until 31.12.2020.
Creating Accessible Package Leaflets Read more
News

Save the Date: BASG-dialogue “Meet the Case Manager”

messages in brief | 30/06/2020
In 2017, we have received a lot of positive feedback for our first BASG-dialogue “Meet the Case Manager”. Therefore, we are very happy to announce your next chance to meet with us in person!
Save the Date: BASG-dialogue “Meet the Case Manager” Read more
News

The „RMS NEWS“ are back!

messages in brief | 30/06/2020
Also in the future, we want to continue to inform our applicants of marketing authorisation procedures with Austria as RMS with relevant news from the committees or exciting innovations such as the slot application via our eServices!
The „RMS NEWS“ are back! Read more
News

COVID-19: Regulatory flexibility

messages in brief | 22/04/2020
Recent information about regulatory flexibility during the corona pandemic can be found here on the website of the BASG.
COVID-19: Regulatory flexibility Read more

Information

BREXIT

BREXIT

Marketing authorisation holders are reminded to be prepared for the possibility of a "hard" Brexit"!

BREXIT read more
Reporting to BASG

Reporting to BASG

The Federal Office relies on reports from consumers, health care professionals and companies for the continuous re-evaluation of the safety profile of medicinal products and medical devices.

Reporting to BASG read more
Clinical Trials

Clinical Trials

The BASG authorises and monitors the conduct of clinical trials with medicinal products and medical devices.

Clinical Trials read more
Austrian Pharmacopoeia

Austrian Pharmacopoeia

The Austrian Pharmacopoeia (ÖAB) is a national addendum to the European Pharmacopoeia and is currently being revised by the ÖAB Commission.

Austrian Pharmacopoeia read more
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