Up-to-date information from the November 23.01.-26.01.2023 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

Up-to-date information from the November 20.02.-23.02.2023 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

Up-to-date information from the November 27.03.-30.03.2023 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

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

Recall due to possible particles

Recall due to possible contamination with metal particles

Recall due to incorrect name on the bottle label

The Federal Office for Safety in Health Care has been informed via the Maltese authority that a recall of Gynemed GmbH&Co KG products (Denu tips and aspiration needles for oocyte puncture) has occurred due to insufficient documentation of testing and control of raw material.

The BASG warns against the product "Crusader Savon Médicinal" due to the classification as an illegal medicinal product by presentation.

The Federal Office for Safety in Health Care has been notified by the Netherlands Authority that sterility issues have occurred with Medtronic's Grafton DBM products (demineralized bone allografts).