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.

The Product Information has been updated with the new shelf-life for the frozen vial, that has been extended from 6 months to 9 months. The storage conditions remain unchanged (-90 °C to -60 °C).

The registry lists in a new form - with search and filter options - those SARS-CoV-2 rapid antigen tests that can be placed on the Austrian market for self-testing.

Up-to-date information from the 21.06.-24.06.2021 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.

Up-to-date information from the 17.05.-20.05.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

On May 28, 2021, the use "for active immunization of individuals 12 years of age and older" was extended by the EMA.

As of 22.5.2021, the function "Withdrawal according to §23 AMG" will be available in the area "Overview Medicinal Products".

The EMA adopted the new recommendations for the composition of seasonal influenza vaccines for the season 2021/2022 (published 30 March 2021)