The new safety module introduces updated processes for the submission and management of Annual Safety Reports (ASRs). It will reduce administrative burden and provide greater flexibility for sponsors while supporting more harmonised procedures across Member States.
What this means for sponsors
- Ongoing ASRs will continue to be managed and finalised in the current system.
- From go-live, all new ASRs must be submitted and managed in the new safety module. Submission in the current system will no longer be possible.
- Access to finalised ASRs in the current system will no longer be available after the transition period ends.
What sponsors need to do
- Watch the recording of the dedicated CTIS bitesize talk on the topic, available soon on the event page.
- Use the training environment (see access instructions in section 6.2.3 of the sponsor handbook) and related guidance document available from Friday 31 July 2026 to prepare for the change.
- For support with blocking issues in the safety module training environment, raise a ticket in the CTIS Service Desk following the instructions in section 4 of the guidance available from 31 July 2026. For non-blocking issues or questions, use the dedicated slido for sponsors.
- Respond to requests for information (RFIs) for ongoing ASRs in the current system within the applicable timelines.
- Prepare to submit all new ASRs in the new safety module from Monday 28 September 2026.