As part of EMA’s commitment to continuous improvement and transparency, a new release notes section is now available on the IRIS portal.
This page will be updated monthly and will provide information on system developments, including new functionalities, enhancements, and other relevant changes. Users are encouraged to consult it regularly to stay informed about the latest updates.
Important: Restore your IRIS access for post-authorisation submissions
Actions, support & training resources for MAHs for procedure management in IRIS
PSURs cannot be submitted without IRIS-affiliated contact after 1 September 2025
IRIS transition update: revised go-live timeline and updated support materials
EMA IRIS team has updated the roadmapfor initial Marketing Authorisation Applications (iMAAs) and selected pre-submission activities for Human (H) and Veterinary (V) CAPs, introducing a phased go-live approach.
Go-live dates
18 August 2026 - Eligibility (H&V), Letter of Intent (H&V), Accelerated assessment (H&V), Pre-submission interactions (H)
21 August 2026 – Pre-submission interactions (V)
1 September 2026 – iMAAs (H&V)
Please refer to the transition plan for an overview of upcoming activities and practical implications for applicants.
Important - action required:
For both human and veterinary iMAA, all designated contacts must:
Hold an active IRIS account
Be correctly associated with their organisation
Have up-to-date contact details
We kindly invite you to review contact details where necessary (please refer to section 1 of the IRIS guide to registration).
To support the IRIS go-live, EMA has reviewed the interactive PDF MAAelectronic Application Forms (eAFs) for H & V medicinal products to improve usability, data quality and alignment with the ISO IDMP data model. Industry must use the updated eAFs, Version 1.28.0.0, for any new CAP iMAA submission to EMA from 28 July 2026 onwards. For all other types of products, use of the updated eAFs is expected to become mandatory after 1 September, at a later date which will be announced after alignment with relevant stakeholders. The date and further transition details will be shared through the eSubmission website.
Upcoming events: join the Quarterly System Demo on 25 June at 09:15 CEST for the Regulatory Procedure Management (RPM) session, where the latest updates on the transition of iMAAs and pre-submission activities to IRIS, including key milestones, upcoming support activities, and what industry stakeholders can expect as we move towards go-live will be shared.
