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.

The Federal Office for Public Health Safety would like to draw attention to the current Rapid Risk Assessment of the ECDC (European Centre for Disease Prevention and Control) on monkeypox.

Up-to-date information from the 19.04.-22.04.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

Up-to-date information from the 21.03-24.03.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

Recall due to incorrect expiry date

Recall of one batch due to incorrect patient information leaflet

With the entry into force of the Regulation (EU) 2019/6 a new procedure, the SPC harmonisation procedure, was created as per Section 4 of this Regulation.

The new EU Veterinary Medicinal Products Regulation, which entered into force on 27/01/2019, is applicable from 28/01/2022. According to Article 9 of this Regulation, applications for approval of clinical trials of veterinary medicinal products shall be submitted to the competent authority of the Member State in which the clinical trial is to be conducted.

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 pathogenic variant in the PHA gene has been identified in donor 8458-IDOR and that he is a carrier of PKU (phenylketonuria).