With the AMG amendment of 14.02.2022, § 21(2) was changed to the effect that the BASG must now be notified four months (instead of the previous two months) in advance of a temporary or permanent discontinuation of the marketing of medicinal products.

The new Veterinary Medicinal Products Regulation is to be applied as of 28.01.2022.

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

On Monday 31st January 2022 at 9:00 a.m. CET, the Clinical Trials Information System (CTIS) has gone live. CTIS is the backbone of the Clinical Trials Regulation that will harmonise the assessment and supervision of clinical trials in the EU and the EEA.

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 the donor HANDY has been diagnosed with sclerosis.

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 developed congenital dilated cardiomyopathy in connection with the use of semen from sperm donor 27012-ROLAND.

Recall due to the contamination of the capsule shell with ethylene oxide.

Up-to-date information from the 13.12.-16.12.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

Recall due to particles.

Recall of doctor's samples due to deviations in regularly conducted stability tests.