BASG and companies

News

News

Current issue of "RMS NEWS"

messages in brief | 29/09/2020
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Current issue of "RMS NEWS" Read more
News

BREXIT – current challenges for Marketing Authorisation Holders

messages in brief | 29/09/2020
In the following cases Marketing Authorisation Holders/Holders of a Registration need to act, these tasks have to be finalised until 31.12.2020.
BREXIT – current challenges for Marketing Authorisation Holders Read more
News

Creating Accessible Documents

messages in brief | 29/09/2020
Please note that all package leaflets have to be published in an accessible format on Arzneispezialitätenregister at latest at 31.12.2020.
Creating Accessible Documents Read more
News

Creating Accessible Package Leaflets – FAQ Update

messages in brief | 10/09/2020
Since July, it has been possible request conversion to accessible product information texts, even for several products together, if this cannot be done within ongoing regulatory procedures. Based on previous experience, the corresponding FAQ No. 2 has now been updated and supplemented regarding this approach.
Creating Accessible Package Leaflets – FAQ Update Read more
News

Creating Accessible Package Leaflets

messages in brief | 27/07/2020
We have published updated versions for human accessible Package Leaflets and the QRD template!
Creating Accessible Package Leaflets 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
keyboard_arrow_up to top