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Posted Fri, 08 Aug 2025 14:49:32 GMT by Caterina Scarpati
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):
  1. Registration for IRIS access with the organisation for the product.
  2. Liaise with your MAH IRIS Industry coordinator to assign you to the submission
  1. Requesting access to IRIS
    • IRIS access must be requested for the organisation under which the product is authorised (MAH ORG ID should be the same as in PMS/OMS) via the EMA Account Management portal. Only the user itself can raise this access request.
  2. Contact assignment to the submission
    • Once you have been granted access to IRIS for the MAH of the product, please liaise with your MAH Industry Coordinator to assign you to the submission as Procedure manager and Submission contact/Portal contact via IRIS Portal.
Resources to support you
For further guidance on IRIS access and navigation, and contacts for support, please refer to the Home - news  · IRIS
Posted Mon, 22 Sep 2025 09:48:34 GMT by Klodiana Meyer Regulatory Affairs Manager
Hello,

I'm registered in IRIS as Industry Manager but still can not see my "ongoing submissions" and "draft submissions"  related to the post-authorisation submissions.
Only "completed submissions" is accessable.
The other users of my organisations can see all these submissions (variations) 

Thank you very much for your reply!
K.Meyer

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