messages in brief | 29/01/2021
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Recall | Medicines | 29/01/2021
Recall due to a deviation during filling.
Recall | Veterinary Medicines | 22/01/2021
Recall of a batch of Norocarp due to a deviation during stability monitoring analysis.
messages in brief | 22/01/2021
The United Kingdom has left the European Union and the transition period ended on 31 December 2020. This article gives a short overview about the current applicable rules.
messages in brief | 12/01/2021
On 06. January 2021, "COVID-19 Vaccine Moderna" was authorised in the European Union as the second vaccine against SARS-CoV2.
Safety warnings | Blood & Tissue | 11/01/2021
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 a child has become ill in connection with the donation of the sperm donor 25231-RUNE.
messages in brief | 22/12/2020
Based on the recommendation by the European Medicines Agency (EMA), the European Commission issued the marketing authorisation for the COVID-19 vaccine Comirnaty (BioNTech).
messages in brief | 18/12/2020
In Austria, adverse reactions can be voluntarily reported directly to the Federal Office for Safety in Health Care (BASG) by patients as well as their relatives.
Recall | Medicines | 18/12/2020
Recall due to potential microbiological contamination.
messages in brief | 17/12/2020
Due to current events, FAQ No. 2 on accessible information for use has been revised, to better reflect the current approach.