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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 provides 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.
2025-08-04 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:
For Centrally Authorised Products (CAPs): For any type of procedure with CAPs, it is a CAP Person authorised for communication with the Agency (referred in section 2.4.3 of the application form).
For non-CAPs: For PSURs with non-CAPs, the MAH contact associated with the email address as indicated in the PSUR submission form (and NOT in the cover letter) when generating the delivery file.
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.
2026-06-30 IRIS transition update: revised go-live timeline and updated support materials
EMA IRIS team has updated the roadmap for initial Marketing Authorisation Applications (iMAAs) and selected pre-submission activities for Human (H) and Veterinary (V) CAPs, introducing a phased go-live approach.
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Go-live dates
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Please refer to the transition plan for an overview of upcoming activities and practical implications for applicants.
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Important - action required: For both human and veterinary iMAA, all designated contacts must:
We kindly invite you to review contact details where necessary (please refer to section 1 of the IRIS guide to registration). |
Changes to the interactive PDF MAA eAFs
To support the IRIS go-live, EMA has reviewed the interactive PDF MAA electronic 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.
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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. |
Questions & Support
Contact EMA via Ask EMA
Consult the FAQs
For further assistance, please raise a ticket through the EMA Service Desk.
2026-08-19 Presubmission activities now managed through IRIS
From 19 August 2026, applicants for human and veterinary medicinal products are required to use the IRIS platform for the following activities:
Eligibility requests;
Intent to submit / letter of intent
Accelerated assessment requests;
Notification of change, transfer and withdrawal of eligibility;
Pre-submission interactions.
What do you need to know about this change:
A valid research product identifier (RPI) is required to submit new requests for the procedures listed above.
In the absence of an appropriate RPI for a single medicinal product, a new RPI must be requested through IRIS.
Principles apply for the use of RPI for human medicines, including medical devices as companion diagnostic and medical devices with an ancillary medicinal substance, and veterinary medicines.
Detailed guidance on RPI principles, requests and transfers can be found in Section 8 of the IRIS guide to registration and RPIs.
If you have questions outside of the above or require further assistance, please raise a ticket through the EMA Service Desk.
2026-09-01 Initial Marketing Authorisation Applications (iMAAs) now managed through IRIS
From 1 September 2026, all new initial marketing authorisation applications (iMAA) for both human and veterinary CAPs will be managed on the IRIS platform.
What do you need to know about this change:
The dossier submission process remains unchanged and should continue to be completed through the eSubmission Gateway. IRIS will be used for the management of the regulatory procedure.
To support this change, EMA has updated the electronic application form (eAF) for both human and veterinary medicinal products.
Human and veterinary applicants/marketing authorisation holders are required to use eAF version 1.28.0.0 for all iMAA applications and variation applications.
For veterinary medicinal products, applicants are kindly informed that the eAF file name now must follow a new naming convention. Detailed guidance, including examples of acceptable filenames, is available in the “What is New in eSubmission Today?” section.
Further information is available in the eAF news section of the eSubmission website. Stakeholders may also wish to consult the recording of Industry webinar on new electronic application form (eAF) version, held on 22 July 2026.
Ongoing procedures managed outside of IRIS will continue to follow the former process until further notice.
Other procedures going live on IRIS
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1 September |
Initial and change consultations for companion diagnostics and ancillary medicinal substances; |
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Q4 |
Maximum Residue Limit (MRL) procedures*, including:
*Excluding: requests for assessment of a biological substance not requiring an MRL evaluation and requests for inclusion in the list of substances not within the scope of Regulation (EC) No. 470/2009. |
Supporting resources:
To support you manage your cases through IRIS, EMA has the following resources:
IRIS guide for applicants (updated for iMAA)
Frequently Asked Questions and Answers document (updated for iMAA)
Ask EMA for regulatory and procedural guidance.
EMA Service Desk for technical support and system-related issues.
