BASG and companies

News

Current issue of “RMS NEWS”

messages in brief | 30/04/2021

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”

messages in brief | 29/01/2021

This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.

BREXIT – End of transition period

messages in brief | 22/01/2021

The United Kingdom has left the European Union and the transition period ended on 31 December 2020. This article gives a short overview about the current applicable rules.

Accessible Patient Information leaflet

messages in brief | 17/12/2020

Due to current events, FAQ No. 2 on accessible information for use has been revised, to better reflect the current approach.

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.

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.

BREXIT

The transition period ended on 31.12.2020. Marketing authorisation holders are reminded to submit any outstanding amendments without delay.

Clinical Trials

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

Austrian Pharmacopoeia

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