In view of the transition of post-authorisation procedure management to the IRIS platform in January 2025, this means the majority of EMA-led procedures will be managed through IRIS. Marketing Authorisation Holders need to take action to effectively prepare for this change.

Important: Submissions for all regulatory procedures of the product lifecycle will continue to be performed via the current systems (i.e. Gateway and PSUR repository)
To ensure proper access to the IRIS platform, the EMA requires that all Marketing Authorisation Holders (MAHs) product contact points register in the EMA Account Management System by 30 November 2024. This is essential for seamless email communication, access to case information, and document management.

Upcoming training session: The EMA is organising a training session on 12 November 2024 (10:00 – 11:30 (CET)) to provide you with key instructions to be prepared for the transition, showcase the IRIS system and answer your questions. Register here.

Important instructions for you:
1) Request access via the EMA Account Management System for all affiliated roles. Detailed instructions are available in the IRIS guide to registration and RPIs.
2) Ensure the access is requested for the relevant organisations affiliated with the products you are contact for (Request Access · EMA Account Management (europa.eu)).
3) Use of personal mailboxes as product contacts: For security reasons, IRIS does not accept generic mailboxes as contact points for regulatory procedure application submissions.
If your products currently list generic mailboxes, please update all product contacts to personal mailboxes associated with responsible individuals within your organisation:
a.    Submit the updated form using the following template: template_letter-change_contact_person_en.doc (live.com).
b.    Instructions to submit the form are available here: If you have already an IRIS Account that complies with the above guidelines, please ignore this request.