Representatives of PEI and AGES-MEA again discussed national legal requirements and cooperation on allergens.

The new legal framework for veterinary medicines (Regulation 2019/6 and 2021/16, Article 9(h)) requires the following changes to the EudraGMDP database, which will be implemented from 28 January 2022.

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.

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.