There are indications that the COVID-19 mRNA vaccine "Comirnaty" is being offered as counterfeit on the internet and directly by telephone.

On 29. January 2021, "COVID-19 Vaccine AstraZeneca" was authorised in the European Union as the third vaccine against SARS-CoV2.

To simplify the reporting of suspected adverse reactions of medicines and vaccines a revised online form is now available for patients.

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

Recall due to a deviation during filling.

Recall of a batch of Norocarp due to a deviation during stability monitoring analysis.

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.

On 06. January 2021, "COVID-19 Vaccine Moderna" was authorised in the European Union as the second vaccine against SARS-CoV2.

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.

Based on the recommendation by the European Medicines Agency (EMA), the European Commission issued the marketing authorisation for the COVID-19 vaccine Comirnaty (BioNTech).