Messages in brief

News

Accelerated procedure for mononational studies Top-News

messages in brief | 03/06/2025
Austria is sending a clear signal in favour of research-friendly framework conditions. For clinical trials in accordance with Regulation (EU) No. 536/20214 that are conducted exclusively in Austria, EU-wide coordination is no longer required. The new procedure significantly shortens the authorisation period.
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News

New Export Option for Packaging Master Data in eService Marketing Authorisation and Lifecycle Management

messages in brief | 02/07/2025
Starting in July 2025, BASG/AGES MEA will provide an Excel export of the packages available in our database for each human medicinal product. This is also intended to support data entries in SPOR-PMS and XEVMPD (Article 57). Detailed information can be found in the following guide (L_Z34).
New Export Option for Packaging Master Data in eService Marketing Authorisation and Lifecycle Management Read more
News

Current issue of “RMS NEWS” New

companies | 30/06/2025
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

Information on the ESMP for Marketing Authorisation Holders

messages in brief | 17/06/2025
To better monitor and, if necessary, counteract supply shortages of medicinal products at EU level, the European Shortages Monitoring Platform (ESMP) was established by the EMA in accordance with the Regulation (EU) 2022/123. The full version of the platform was launched in January 2025.
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News

Current issue of “RMS NEWS”

messages in brief | 31/03/2025
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

Current issue of “RMS NEWS”

messages in brief | 31/01/2025
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

Transition of clinical trials of medicinal products - the countdown is on!

messages in brief | 21/01/2025
All ongoing clinical trials need to be converted to Clinical Trials Information System ("CTIS") in accordance with Regulation (EU) 536/2014 ("CTR") by January 31, 2025. This date marks the end of a three-year transition period that began when the CTR came into force in the EU. Clinical trials that are not converted by the sponsor in time lose their legal basis and will have to be terminated by the National authority.
Transition of clinical trials of medicinal products - the countdown is on! Read more
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BASG "All-in-One Register" provides compact medication information in a new design

messages in brief | 21/01/2025
The pilot phase for the new medicines information system of the Federal Office for Safety in Health Care (BASG) begins on 21 January 2025.
BASG "All-in-One Register" provides compact medication information in a new design Read more
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NEWSTICKER 30.11.2024

messages in brief | 19/11/2024
The BASG reminds marketing authorization holders/registration holders that submissions by a third party (e.g. a consultant) are only valid with the appropriate authorization.
NEWSTICKER 30.11.2024 Read more
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