Official announcements
Recall
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Medicines
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02/06/2025
Recall due to visible particles in solution
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.
Recall
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Medicines
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15/05/2025
Recall due to possible metal particles in tablets
CHMP Monthly News
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14/05/2025
Up-to-date information from the 22.04.-25.04.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
Safety warnings
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Blood & Tissue
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08/05/2025
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 KRISS is a carrier of haemochromatosis type 1.
The donor/gametes have been permanently blocked.
Safety warnings
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Medical devices
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14/04/2025
The Federal Office for Safety in Health Care (BASG) has been informed that the manufacturer SEBBIN, which went bankrupt in March 2025, has no legal successor who continues to fulfil the manufacturer obligations arising from the Regulation (EU) 2017/745 on medical devices („MDR“), as amended.
CHMP Monthly News
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10/04/2025
Up-to-date information from the 24.03.-27.03.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
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.
CHMP Monthly News
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14/03/2025
Up-to-date information from the 24.02.-27.02.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
Recall
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Medicines
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06/03/2025
Recall due to possible contamination with glass splinters