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

West Nile Virus (WNV) - Italy New

Safety warnings | Blood & Tissue | 22/03/2024
The Federal Office for Safety in Health Care has been informed by the Italian authorities that ID WNV NAT testing for donations of blood and blood components has been introduced in the province of Cosenza (Calabria region) due to a horse testing positive for WNV NAT. Throughout Italy, donors who have spent at least one night in the specified region are excluded from donating for 28 days.
West Nile Virus (WNV) - Italy Read more
News

Medicinal products containing estragole New

messages in brief | 15/03/2024
The committee on herbal medicinal products (HMPC) of the European Medicines Agency (EMA) published the revised Public Statement on the use of herbal medicinal products1 containing estragole.
Medicinal products containing estragole Read more

European Sperm Bank - Donor-8212 WITTE New

Safety warnings | Blood & Tissue | 14/03/2024
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 one offspring of donor 8212 WITTE has been diagnosed with autosomal recessive hearing loss 77 (DFNB77).
European Sperm Bank - Donor-8212 WITTE Read more

Soolantra 10 mg/g Creme

Recall | Medicines | 08/03/2024
Recall due to exceeding the limit value of the parameter "known impurities"
Soolantra 10 mg/g Creme Read more

Information

Shortages

Shortages

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

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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.

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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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