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.

Vendal retard 10 mg - Filmtabletten New

Recall | Medicines | 23/01/2025

Recall due to increased release of active ingredient

European Sperm Bank - Donor - 28257/Florens New

Safety warnings | Blood & Tissue | 21/01/2025

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 European Sperm Bank (DK257572) that the sperm donor 28257/Florens is a carrier of the autosomal recessive disease spinal muscular atrophy (SMA). The donor/gametes were permanently blocked.

Update: Chikungunya - France New

Safety warnings | Blood & Tissue | 20/01/2025

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 cases of chikungunya have been recorded in the overseas department of La Réunion (Saint Pierre: Le Tampon).

CHMP Meeting Highlights December 2024

CHMP Monthly News | 09/01/2025

Up-to-date information from the 09.12.-12.12.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

Report supply interruptions of medical devices

Medical devices | 02/01/2025

If a manufacturer expects that there will be interruptions in the supply of a medical device, it must report this to the competent authority in accordance with Article 10a of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). You can find more information here: https://www.basg.gv.at/fuer-unternehmen/medizinprodukte/hersteller#c24702

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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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