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

The Federal Office for Safety in Health Care has been informed by the Danish authority that informed by the Danish tissue bank European Sperm Bank (DK257572) that a pathogenic variant in the pathogenic variant in the PHA gene has been identified in sperm donor 27019-NIMBUS and that he is a carrier of of phenylketonuria (PKU).

The Federal Office for Safety in Health Care has been informed by the Danish authority that has been informed by the Danish tissue bank European Sperm Bank (DK257572) that there has been a in connection with the use of semen from the sperm donor 8481-RAVN in a child for the Alpha-1 antitrypsin deficiency (AATD) has occurred.

The Federal Office for Safety in Health Care has been informed by the Danish authority that the Danish tissue bank European Sperm Bank (DK257572) that the sperm donor 8338-REMON has been diagnosed with sperm donor 8338-REMON has been diagnosed with Bipolar Disorder Type II.

Precautionary recall due to possible contamination

Recall due to suspected microbial contamination

Recall due to nitrosamine contamination above the permitted daily dose.

Precautionary recall due to possible microbial contamination.

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 in connection with the use of semen from sperm donor 8981-PARMO a child has been diagnosed with: galactosemia.

For the new QRD templates Vers. 9 veterinary, which take into account the requirements of the Veterinary Medicinal Products Regulation (EU) 2019/6, updated accessible Word templates are available for download.