Austrian Federal Office for Safety in Health Care

Recent updates

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

News

Implementation of new QRD templates (veterinary) New

messages in brief | 24/05/2022

For the new QRD templates Vers. 9 veterinary, which take into account the requirements of the Veterinary Medicinal Products Regulation (EU) 2019/6, updated accessible Word templates are available for download.

Affenpocken - Rapid Risk Assessment New

Safety warnings | Blood & Tissue | 24/05/2022

The Federal Office for Public Health Safety would like to draw attention to the current Rapid Risk Assessment of the ECDC (European Centre for Disease Prevention and Control) on monkeypox.

CHMP Meeting Highlights April 2022 New

CHMP Monthly News | 18/05/2022

Aktuelles aus dem Meeting vom 19.04.-22.04.2022 zu Neuzulassungen, Indikationserweiterungen, neu veröffentlichten EPARs und kürzlich gestarteten Verfahren.

CHMP Meeting Highlights March 2022 New

CHMP Monthly News | 18/05/2022

Aktuelles aus dem Meeting vom 21.03.-24.03.2022 zu Neuzulassungen, Indikationserweiterungen, neu veröffentlichten EPARs und kürzlich gestarteten Verfahren.

Xofluza 40 mg Filmtabletten New

Recall | Medicines | 17/05/2022

Recall due to incorrect expiry date

Tradolan retard 100 mg - Filmtabletten New

Recall | Medicines | 13/05/2022

Recall of one batch due to incorrect patient information leaflet

SPC harmonisation of veterinary medicinal products

messages in brief | 09/05/2022

With the entry into force of the Regulation (EU) 2019/6 a new procedure, the SPC harmonisation procedure, was created as per Section 4 of this Regulation.

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Information

COVID-19

Here you will find an overview of BASG information on prevention and treatment of COVID-19, as well as links to additional websites.

Medicine,,People,And,Healthcare,Concept,-,Female,Doctor,Or,Nurse

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.

Register of authorised medicinal products

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.

Shortages

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

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.