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 Cryos International (DK257551) that two children with autism (ASD) have been diagnosed in connection with the donation of the sperm donor DARYL.

Currently, there is no evidence of a causal relationship with vaccination.

In cooperation with the pharmaceutical industry, the BASG has produced a guideline for processing DHPC (Direct Healthcare Professional Communication) and Educational Material.

The Federal Office for Safety in Health Care was informed by the Polish authorities that PBKM (Polish Stemm Cell Bank SA) had taken over various biological material and the associated documents from CryoSave AG.

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.