BASG and healthcare professionals
News
Accelerated procedure for mononational studies Top-News
messages in brief
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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.
Accelerated procedure for mononational studies
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New Export Option for Packaging Master Data in eService Marketing Authorisation and Lifecycle Management
messages in brief
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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
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Information on the ESMP for Marketing Authorisation Holders
messages in brief
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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.
Information on the ESMP for Marketing Authorisation Holders
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Current issue of “RMS NEWS”
messages in brief
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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”
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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”
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