Caterina Scarpati

Dear Ana, 
Please consult section 3.4 of the IRIS guide for applicants for further details on this topic.

Dear Veera,
For details on ODD transfer, please consult the IRIS guide for applicants: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/iris-guide-applicants_en.pdf
For technical issues, please open a ticket via EMA Service Desk.

Dear Katja, 
As a contributor, you can edit submissions where you have been added as a Contributor by a Manager.

Dear Karl,
For this type of queries, please raise a query via EMA Service Desk.
Concerning search function, there is no such function at the moment in this Forum.
Kind regards.

Dear Maria,
For this type of queries, please raise a query via EMA Service Desk.

Dear Isha,
Please consult Chapter 8 of this guidance document for further information on RPI: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/iris-guide-registration_en.pdf
For further information, please open a ticket on Service Desk following the support path described here: https://iris.ema.europa.eu/forums/whats-new/6455338f-d73b-f011-a2d9-7c1e524ef6ac
Best regards,
On behalf of the IRIS team

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:

• Actions for MAHs
• Updated training materials for MAHs
• Revised service desk triage guidelines for support requests
   

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:

• Contact an Industry SME (list available here)
• Raise a ticket via the EMA Service Desk

Support document for MAHs

If you have worked on a post-authorisation procedure on IRIS since 1 January 2025, you are invited to participate in a brief user survey designed to gather your feedback on the adoption of IRIS for post-authorisation procedures following the January 2025 transition. The survey will take approximately 5 minutes to complete.
Goal of the survey:

• Measure adoption levels across users and teams
• Identify areas of success where IRIS has improved your workflow
• Pinpoint any remaining challenges that may need further attention or support

How to participate:

• Click here to access the survey.
• The survey will remain open until 27 June 2025.

Participation in this survey is anonymous.
Your honest and constructive feedback will guide continuous improvements and support initiatives to ensure that IRIS fully meets your needs and expectations.
We greatly appreciate your time and contribution.
Please consult this overview document for useful training and guidance resources on procedure management in IRIS for Marketing Authorisation Holders.

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:
 

• 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.