Following the
successful go-live of IRIS for managing post-authorisation procedures, EMA is focusing on the next phase this year: the transition to IRIS of
initial marketing authorisation application procedures (MAAs) and selected pre-submission activities (including eligibility for the centralised procedure and letter of intent).
The IRIS team will work on the development of activities to support this transition, ensuring a smooth implementation for Applicants. To provide clarity on upcoming steps, an
updated roadmap is now available (attached below).
We will continue to engage with you throughout this process and appreciate your collaboration in preparing for this transition.
To assist MAHs in using IRIS for post-authorisation procedures, the
PDF support document (attached below)
previously shared remains available, providing key resources such as:
- Actions for MAHs
- Training materials for MAHs
- Service desk triage guidelines for support requests
If you have questions outside the above or require further assistance, please
raise a ticket through the EMA Service Desk.
