Recall due to particles

Recall of one batch due to presence of ciclosporine cristals.

Up-to-date information from the 11.10.-14.10.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

Current information from the meeting on 16.08.-18.08.2021: special issue Ipilimumab

Up-to-date information from the 19.09.-22.09.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

Recall due to a deviation of the active substance content

This webinar is an introduction to Organisation Management Service (OMS) and Referentials Management Service (RMS) services and activities for industry users.

This event aims to inform SMEs and academic sponsors of clinical trials on how to prepare for the main changes brought by the Regulation and its impact on their trial-related activities.

The aim of this event is to help future CTIS users prepare for submitting and evaluating clinical trial applications in CTIS after its go-live on 31 January 2022.

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