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

All ongoing clinical trials need to be converted to Clinical Trials Information System ("CTIS") in accordance with Regulation (EU) 536/2014 ("CTR") by January 31, 2025. This date marks the end of a three-year transition period that began when the CTR came into force in the EU. Clinical trials that are not converted by the sponsor in time lose their legal basis and will have to be terminated by the National authority.

The committee on herbal medicinal products (HMPC) of the European Medicines Agency (EMA) published the revised Public Statement on the use of herbal medicinal products1 containing estragole.

Recall of a batch due to visible crystalline particles

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 one offspring of donor 8212 WITTE has been diagnosed with autosomal recessive hearing loss 77 (DFNB77).

Recall due to possible non-sterility

Recall due to exceeding the limit value of the parameter "known impurities"

Up-to-date information from the 19.02.-22.02.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

Recall due to nitrosamine contamination above the permitted daily dose

Recall due to deviations from the specified values regarding appearance and pH value