The aim of this event is to help future CTIS users prepare for submitting and evaluating clinical trial applications in CTIS after its go-live on 31 January 2022.

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

Distribution of an unauthorised medicinal product through illegal websites

Recall of batches with nitrosamine levels above the acceptable daily limit.

Recall due to azido contamination above the acceptable limit.

Recall due to azido contamination above the acceptable limit.

The Product Information has been updated with the new shelf-life for the frozen vial, that has been extended from 6 months to 9 months. The storage conditions remain unchanged (-90 °C to -60 °C).

The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that a human WNV infection has been reported for the first time in the Spree-Neiße region in Germany during the current season.

Recall due to contamination

Recall following a Commission Decision concerning veterinary medicinal products for injection containing vitamin A as active substance