Austrian Federal Office for Safety in Health Care

Recent updates

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

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.

Kexxtone 32,4 g Intraruminales System mit kontinuierlicher Freigabe für Rinder. Monensin New

Recall | Veterinary Medicines | 31/05/2024

Recall due to possible lack of efficacy and unintentional ingestion in non-target species

BASG becomes WHO Listed Authority New

messages in brief | 20/05/2024

After a review process lasting almost a year, the WHO decided on 14.05.2024 to include the European network of EU and EEA medicines authorities, of which the Federal Office for Safety in Health Care is an essential and active part, as a recognized "regional entity" in the list of WHO Listed Authorities (WLA) for human medicines and vaccines.

Extreme White Lightening Cream

Enforcement | 14/05/2024

"Extreme White Lightening Cream" contained the declared glucocorticoid clobetasol propionate and is therefore to be classified as an illegal medicinal product.

Acetic acid 99% - excipient

Recall | Medicines | 08/05/2024

Recall due unknown impurity

CHMP Meeting Highlights April 2024

CHMP Monthly News | 06/05/2024

Up-to-date information from the 22.04.-25.04.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

West Nile Virus (WNV) - Spain

Safety warnings | Blood & Tissue | 30/04/2024

The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Center for Disease Prevention and Control) that a human WNV infection has been recorded in Seville, in the region of Andalusia.

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Information

Shortages

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

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.

Online form for adverse reactions

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

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.

For Consumers

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

For Health Care Professionals

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

For Companies

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

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.