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Important: Restore your IRIS access for post-authorisation submissions
If you notice that you can no longer see a submission in IRIS, it may be because your contact was automatically removed due to not having the proper access rights.
To restore your access for submissions in IRIS, please note the following key steps required to perform for the Portal Contact (i.e. Submission Contact):
Resources to support you
For further guidance on IRIS access and navigation, and contacts for support, please refer to the Home - news · IRIS
Actions, support & training resources for MAHs for procedure management in IRIS
To assist Marketing Authorisation Holders in using IRIS for post-authorisation procedures, the PDF support document (attached below) is available, providing key resources such as:
If you have questions outside the above or require further assistance, please raise a ticket through the EMA Service Desk.
PSURs cannot be submitted without IRIS-affiliated contact after 1 September 2025
As of 1 September 2025, Marketing Authorisation Holders (MAHs) will no longer be able to create PSUR submissions if the primary contact indicated in the PSUR submission form does not have an IRIS account affiliated with the MAH of the product.
To ensure business continuity, we strongly encourage all MAHs to verify that their contacts meet this requirement well in advance of the deadline.
Please note the following:
All key actions and instructions for updating product contacts and requesting IRIS access are explained in the PDF document available at this page, which also includes an overview of training resources for MAHs for using IRIS and EMA service desk triage guidelines for support requests.
If you have questions outside of the above or require further assistance, please raise a ticket through the EMA Service Desk.
IRIS transition update: revised go-live timeline and updated support materials
The IRIS team has updated the roadmap for initial marketing authorisation applications (iMAAs), shifting the go-live to Q1 2026.
This updated schedule allows for an expanded scope of procedures to be transitioned, further development, testing, and engagement.
Please find the updated roadmap attached below, outlining the next steps in this transition.
In addition, the PDF support document for MAHs has been revised to include the latest information. It continues to provide essential resources, including:
Upcoming events: A refresh training on post-authorisation procedures has been scheduled on 30 September. Register here.
For questions beyond the scope of the support materials, or if further assistance is needed:
