Austrian Federal Office for Safety in Health Care
News
Transition of clinical trials of medicinal products - the countdown is on! Top-News
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.
Transition of clinical trials of medicinal products - the countdown is on!
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BASG "All-in-One Register" provides compact medication information in a new design Top-News
messages in brief
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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
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European Sperm Bank - Donor: 9677 New
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.
European Sperm Bank - Donor: 9677
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CHMP Meeting Highlights January 2025 New
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.
CHMP Meeting Highlights January 2025
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Update: Chikungunya - France New
Safety warnings
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Blood & Tissue
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10/02/2025
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 Benoit).
Update: Chikungunya - France
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Born Donor Bank - Donor: Peters New
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.
Born Donor Bank - Donor: Peters
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European Sperm Bank - Donor - 8324/Iners New
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.
European Sperm Bank - Donor - 8324/Iners
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