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

Update: West Nile Virus (WNV) - Romania New

Safety warnings | Blood & Tissue | 21/10/2024
The Federal Office for Safety in Health Care has been informed by the Romanian authorities that, in addition to the regions already announced, confirmed human WNV infections have been recorded in Romania in Timiş.
Update: West Nile Virus (WNV) - Romania Read more

Update: West Nile Virus (WNV) - Germany New

Safety warnings | Blood & Tissue | 21/10/2024
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 Germany, in addition to the regions already announced, in Jerichower Land and Teltow-Fläming.
Update: West Nile Virus (WNV) - Germany Read more

West Nile Virus (WNV) - Cyprus New

Safety warnings | Blood & Tissue | 14/10/2024
The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that human WNV infections have been recorded in Cyprus.
West Nile Virus (WNV) - Cyprus Read more

Update: West Nile Virus (WNV) - Bulgaria New

Safety warnings | Blood & Tissue | 14/10/2024
The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that human WNV infections have been recorded in Bulgaria, in Burgas.
Update: West Nile Virus (WNV) - Bulgaria Read more

Update: West Nile Virus (WNV) - Albania New

Safety warnings | Blood & Tissue | 14/10/2024
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 Albania in Kruje.
Update: West Nile Virus (WNV) - Albania Read more

Update: Dengue - Italy New

Safety warnings | Blood & Tissue | 14/10/2024
The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that confirmed autochthonous human dengue cases have been recorded in the regions of Marche, Tuscany, Veneto and Abruzzo.
Update: Dengue - Italy 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.

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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