DeutschEnglish

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
News

CHMP Meeting Highlights December 2024 New

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.
CHMP Meeting Highlights December 2024 Read more

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). You can find more information here: https://www.basg.gv.at/fuer-unternehmen/medizinprodukte/hersteller#c24702
Report supply interruptions of medical devices Read more

Cardisure Flavour 2,5 mg Tabletten für Hunde New

Recall | Veterinary Medicines | 02/01/2025
Recall due to exceeding the active ingredient content
Cardisure Flavour 2,5 mg Tabletten für Hunde Read more

Katinko Ointment

Enforcement | 18/12/2024
"Katinko Ointment" contained the declared substances methyl salicylate, menthol and camphor and is therefore to be classified as an illegal medicinal product.
Katinko Ointment Read more

Aboniki Balm

Enforcement | 18/12/2024
"Aboniki Balm" contained the declared substances methyl salicylate, menthol, camphor and eucalyptol and is therefore to be classified as an illegal medicinal product.
Aboniki Balm Read more

Robb Well Being

Enforcement | 18/12/2024
"Robb Well Being" contained the declared substances methyl salicylate, menthol, camphor and eucalyptol and is therefore to be classified as an illegal medicinal product.
Robb Well Being Read more
Show all News

Information

Shortages

Shortages

Based on reports from pharmaceutical companies, BASG informs about current shortages.

Shortages read more
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).

read more

For Health Care Professionals

This is the subpage with information from the BASG directed to health care professionals (physicians, dentists, veterinarians, midwives and pharmacists).

read more

For Companies

This is the subpage with information by the BASG directed to companies producing, controlling or distributing medicinal products or medical devices.

read more

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.

read more