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 | 21/01/2025

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.

BASG "All-in-One Register" provides compact medication information in a new design Top-News

messages in brief | 21/01/2025

The pilot phase for the new medicines information system of the Federal Office for Safety in Health Care (BASG) begins on 21 January 2025.

CHMP Meeting Highlights February 2025 New

CHMP Monthly News | 14/03/2025

Up-to-date information from the 24.02.-27.02.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

Amoxilan 500mg/5ml - Trockensaft

Recall | Medicines | 06/03/2025

Recall due to possible contamination with glass splinters

Safety information on the quality defect/recall of „Amoxilan 500 mg/5 ml – Trockensaft“

Safety warnings | Medicines | 06/03/2025

Precautionary batch recall, as there may be glass splinters in the 60 ml bottles

Revozyn RTU 400 mg/ml Injektionssuspension für Rinder

Recall | Veterinary Medicines | 05/03/2025

Recall due to deviations from the specified values regarding resuspendability

Update: Dengue - France (overseas territories)

Safety warnings | Blood & Tissue | 05/03/2025

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 dengue cases have been recorded in the French overseas territories: Guadeloupe, Martinique, Saint-Martin, Saint-Barthélemy, French Guiana and French Polynesia.

Cryos International - Aarhus ApS, donor: Bjarke

Safety warnings | Blood & Tissue | 27/02/2025

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 Cryos International - Aarhus ApS that one of the offspring of the sperm donor Bjarke has been diagnosed with Usher syndrome. The donor/gametes have been permanently blocked.

Cryos International - Aarhus ApS, donor: Gilmore

Safety warnings | Blood & Tissue | 27/02/2025

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 Cryos International - Aarhus ApS that one of the offspring of the sperm donor Gilmore, Leber has been diagnosed with congenital amaurosis. The donor/gametes were permanently blocked.

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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.

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