Austrian Federal Office for Safety in Health Care

Recent updates

Here you can find new page content of the last 4 weeks.

News

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
News

CHMP Meeting Highlights November 2024

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

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

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

Information

Shortages

Shortages

Based on reports from pharmaceutical companies, BASG informs about current shortages.

Shortages read more
Reporting to BASG

Reporting to BASG

The Federal Office relies on reports from consumers, health care professionals and companies for the continuous re-evaluation of the safety profile of medicinal products and medical devices.

Reporting to BASG read more
Online form for adverse reactions

Online form for adverse reactions

The reporting of suspected adverse reactions to vaccines and medicinal
products is possible using a patient-friendly online form.

Online form for adverse reactions read more
Austrian Medicinal Product Index

Austrian Medicinal Product Index

The medicinal products database contains all products authorised in Austria, including up-to-date product information leaflets and the summary of products characteristics.

Austrian Medicinal Product Index read more

For Consumers

This is the subpage with information from the BASG directed to consumers (patients, their relatives and owners of animals).

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For Health Care Professionals

This is the subpage with information from the BASG directed to health care professionals (physicians, dentists, veterinarians, midwives and pharmacists).

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For Companies

This is the subpage with information by the BASG directed to companies producing, controlling or distributing medicinal products or medical devices.

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Market Surveillance

This is the subpage with the official announcements and public databases provided by the BASG as well as procedures for reporting to BASG.

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