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.

Update: West Nile Virus (WNV) - Turkey New

Safety warnings | Blood & Tissue | 18/11/2024

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 Turkey in Antalya, Hatay, Kırklareli and Muğla, in addition to the regions already announced.

Update: West Nile Virus (WNV) - Spain New

Safety warnings | Blood & Tissue | 18/11/2024

The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that in Spain, in addition to the regions already announced, confirmed human WNV infections have been recorded in Toledo.

Update: West Nile Virus (WNV) - Germany New

Safety warnings | Blood & Tissue | 18/11/2024

The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that in Germany, in addition to the regions already announced, confirmed human WNV infections have been recorded in Spree-Neiße.

Romefen PR 10% New

Recall | Veterinary Medicines | 15/11/2024

Recall due to delivery of an incorrect batch in Austria

CHMP Meeting Highlights October 2024 New

CHMP Monthly News | 14/11/2024

Up-to-date information from the 14.10.-17.10.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

Hydromorphon ratiopharm Retardtabletten New

Recall | Medicines | 11/11/2024

Recall due to incorrect information in the patient information leaflet

Show all News

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.

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Austrian Federal Office for Safety in Health Care

Recent updates

News

Transition of clinical trials of medicinal products - the countdown is on! Top-News

Update: West Nile Virus (WNV) - Turkey New

Update: West Nile Virus (WNV) - Spain New

Update: West Nile Virus (WNV) - Germany New

Romefen PR 10% New

CHMP Meeting Highlights October 2024 New

Hydromorphon ratiopharm Retardtabletten New

Information

Shortages

Reporting to BASG

Online form for adverse reactions

Austrian Medicinal Product Index

For Consumers

For Health Care Professionals

For Companies

Market Surveillance

Your privacy settings

Your data protection settings

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Marketing & Analytics

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