Austrian Federal Office for Safety in Health Care
Recent updates
Here you can find new page content of the last 4 weeks.
Safety information on communicable diseases (e.g. WNV, dengue) can be found here.
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 process for combination studies Top-News
messages in brief
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02/06/2025
The regulatory processes for combined medicinal product and medical device studies are being simplified in Austria.
The new regulation for lead ethics committees harmonises the responsibilities of the ethics committees and enables a coordinated assessment. As a result, combination studies will start faster and more smoothly in future.
New process for combination studies
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Cryos International - Aarhus ApS, donor: BLICHER New
Safety warnings
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10/07/2025
The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank Cryos International - Aarhus ApS that the donor BLICHER has been diagnosed with ADHD. As there is a slightly increased risk (1-12%) of ADHD in donor conceived children, the donor gametes are blocked.
Cryos International - Aarhus ApS, donor: BLICHER
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Safety information on the medical device Disinfection system with 3% peroxide New
Safety warnings
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Medical devices
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09/07/2025
The Federal Office for Safety in Health Care (BASG) warns against the disinfection system with peroxide 3 % from the manufacturer DISOP S.A. Only certain batch numbers are affected.
Safety information on the medical device Disinfection system with 3% peroxide
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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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Current issue of “RMS NEWS” New
companies
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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”
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