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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.
If you have questions outside of the above or require further assistance, please raise a ticket through the EMA Service Desk.
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