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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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!
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NEWSTICKER 30.11.2024 New
messages in brief
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19/11/2024
The BASG reminds marketing authorization holders/registration holders that submissions by a third party (e.g. a consultant) are only valid with the appropriate authorization.
NEWSTICKER 30.11.2024
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Safety information on the ultrasound gel „AquaUltra“ of the manufacturer Ultragel Medical Kft. New
Safety warnings
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Medical devices
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19/11/2024
The Federal Office for Safety in Health Care (BASG) warns against a potential Contamination of non-sterile ultrasound gel „AquaUltra Clear“ of the manufacturer Ultragel Medical Kft. According to the manufacturer the affected LOT has been narrowed down to LOT-Number 2024-4 to 2024-10.
Safety information on the ultrasound gel „AquaUltra“ of the manufacturer Ultragel Medical Kft.
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Update: West Nile Virus (WNV) - Turkey New
Safety warnings
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Blood & Tissue
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18/11/2024
The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that confirmed human WNV infections have been recorded in Turkey in Antalya, Hatay, Kırklareli and Muğla, in addition to the regions already announced.
Update: West Nile Virus (WNV) - Turkey
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Update: West Nile Virus (WNV) - Spain New
Safety warnings
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Blood & Tissue
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18/11/2024
The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that in Spain, in addition to the regions already announced, confirmed human WNV infections have been recorded in Toledo.
Update: West Nile Virus (WNV) - Spain
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Update: West Nile Virus (WNV) - Germany New
Safety warnings
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Blood & Tissue
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18/11/2024
The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that in Germany, in addition to the regions already announced, confirmed human WNV infections have been recorded in Spree-Neiße.
Update: West Nile Virus (WNV) - Germany
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Romefen PR 10% New
Recall
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Veterinary Medicines
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15/11/2024
Recall due to delivery of an incorrect batch in Austria
Romefen PR 10%
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