Austrian Federal Office for Safety in Health Care

Recent updates

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

News

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.

Cryos International - Aarhus ApS, donor: KRISS New

Safety warnings | Blood & Tissue | 08/05/2025

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 the donor KRISS is a carrier of haemochromatosis type 1. The donor/gametes have been permanently blocked.

Safety warning for medical devices of the manufacturer SEBBIN

Safety warnings | Medical devices | 14/04/2025

The Federal Office for Safety in Health Care (BASG) has been informed that the manufacturer SEBBIN, which went bankrupt in March 2025, has no legal successor who continues to fulfil the manufacturer obligations arising from the Regulation (EU) 2017/745 on medical devices („MDR“), as amended.

CHMP Meeting Highlights March 2025

CHMP Monthly News | 10/04/2025

Up-to-date information from the 24.03.-27.03.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

Current issue of “RMS NEWS”

messages in brief | 31/03/2025

This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.

Update: Chikungunya - France

Safety warnings | Blood & Tissue | 31/03/2025

The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that a confirmed autochthonous case of chikungunya has been recorded in the overseas department of Mayotte.

CHMP Meeting Highlights February 2025

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

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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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