Precautionary batch recall as a glass splinter was discovered in a 60 ml bottle.

Recall due to possible contamination with glass splinters

Up-to-date information from the February 27.03.-30.03.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

Recall due to appearance of the solution

Recall due to a possible incorrect closure of the crimp caps

Das BASG warns against the product "Prostapax Forte", because it is categorised as an illegal medicinal product (medicinal product by presentation) due to its claims in the advertising brochure.

Recall due to a possible incorrect closure of the crimp caps

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 Federal Office for Safety in Health Care has been informed by the Italian authorities that ID WNV NAT testing for donations of blood and blood components has been introduced in the province of Cosenza (Calabria region) due to a horse testing positive for WNV NAT. Throughout Italy, donors who have spent at least one night in the specified region are excluded from donating for 28 days.