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
|
25/03/2024
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!
Read more
European Sperm Bank - Donor - 8558/Edward New
Safety warnings
|
Blood & Tissue
|
03/12/2024
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 8558/Edward has been diagnosed with type 2 diabetes (DM2).
The donor/gametes have been permanently blocked.
European Sperm Bank - Donor - 8558/Edward
Read more
European Sperm Bank - Donor - 28203/INGO New
Safety warnings
|
Blood & Tissue
|
29/11/2024
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 an offspring of the sperm donor 28203/INGO has been diagnosed with Joubert syndrome. The child shows a Dandy Walker malformation.
The donor/gametes have been permanently blocked.
European Sperm Bank - Donor - 28203/INGO
Read more
CHMP Meeting Highlights November 2024 New
CHMP Monthly News
|
26/11/2024
Up-to-date information from the 11.11.-14.11.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
CHMP Meeting Highlights November 2024
Read more
Update: West Nile Virus (WNV) - Germany New
Safety warnings
|
Blood & Tissue
|
25/11/2024
The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that, in addition to the regions already announced, confirmed human WNV infections have been recorded in Dahme-Spreewald in Germany.
Update: West Nile Virus (WNV) - Germany
Read more
Update: West Nile Virus (WNV) - Greece New
Safety warnings
|
Blood & Tissue
|
22/11/2024
The Federal Office for Safety in Health Care has been informed by the Greek authorities that in Greece, in addition to the regions already announced, a confirmed human WNV infection has been recorded in Zografos.
Update: West Nile Virus (WNV) - Greece
Read more
UPDATE: Safety information on possible contamination of the non-sterile ultrasound gels „AquaUltra Clear“, „AquaUltra Basic“, and “Sono plus Ultraschall gel” of the manufacturer Ultragel Medical Kft.
Safety warnings
|
Medical devices
|
22/11/2024
The Federal Office for Safety in Health Care (BASG) warns against a potential Contamination of non-sterile ultrasound gels „AquaUltra Clear“, „AquaUltra Basic“, “Sono plus Ultraschall gel“ of the manufacturer Ultragel Medical Kft. According to the manufacturer the affected LOT has been narrowed down to LOT-Number 2024-3 to 2024-10.
UPDATE: Safety information on possible contamination of the non-sterile ultrasound gels „AquaUltra Clear“, „AquaUltra Basic“, and “Sono plus Ultraschall gel” of the manufacturer Ultragel Medical Kft.
Read more
