Official announcements
Safety warnings
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Blood & Tissue
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17/02/2025
The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that confirmed autochthonous cases of chikungunya have been recorded in the overseas department of La Réunion (Saint Denis).
Blood & Tissue
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14/02/2025
The Federal Office for Safety in Health Care was informed by the Danish authority that it had been informed by the Danish tissue bank European Sperm Bank (DK257572) that the sperm donor 9677 had been diagnosed with Graves' disease (Graves' disease).
The donor/gametes have been permanently blocked.
CHMP Monthly News
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12/02/2025
Up-to-date information from the 27.01.-30.01.2025 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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10/02/2025
The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish Born Donor Bank (DK261306) that an offspring of the sperm donor Peters was born with a congenital structural heart defect (muscular ventricular septal defect and atrial septal defect).
The donor/gametes were permanently blocked.
Safety warnings
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Blood & Tissue
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06/02/2025
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 European Sperm Bank (DK257572) that the sperm donor 8324/Iners is a carrier of carnitine palmitoyltransferase 2 (CPT2) deficiency due to a mutation in the CPT2 gene.
The donor/the donor gametes were permanently blocked.
Dengue - France New
Safety warnings
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Blood & Tissue
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03/02/2025
The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that 4 confirmed autochthonous dengue cases have been recorded in the overseas department of La Réunion.
messages in brief
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31/01/2025
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Recall
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Medicines
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24/01/2025
Recall due to unregistered serial numbers
Recall
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Medicines
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23/01/2025
Recall due to increased release of active ingredient
messages in brief
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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.