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

Peritrast - Lösung zur parenteralen Anwendung New

Recall | Medicines | 12/07/2024
Recall due to particles in solution
Peritrast - Lösung zur parenteralen Anwendung Read more

Update: West Nile Virus (WNV) - Italy New

Safety warnings | Blood & Tissue | 12/07/2024
The Federal Office for Safety in Health Care (BASG) has been informed by the Italian authorities that in Italy, in addition to the provinces already announced, ID WNV NAT testing for donations of blood and blood components has been introduced in Rovigo (Veneto region).
Update: West Nile Virus (WNV) - Italy Read more

West Nile Virus (WNV) - Greece New

Safety warnings | Blood & Tissue | 08/07/2024
The Federal Office for Safety in Health Care has been informed by the ECDC (European Center for Disease Prevention and Control) that a confirmed human WNV infection has been recorded in Greece, in the Larissa region.
West Nile Virus (WNV) - Greece Read more

Inzolen

Recall | Medicines | 01/07/2024
Recall due to quality issues
Inzolen Read more
News

Current issue of “RMS NEWS”

messages in brief | 30/06/2024
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Current issue of “RMS NEWS” 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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