Posted Tue, 23 Feb 2021 18:35:21 GMT by Paolo Tomasi EMA

The communication model for IRIS is that while there can be any number of Industry managers and Industry contributors associated to a single submission, only one of them is the "submission contact", also called the "portal contact" i.e. the primary contact person to whom all communication is sent (by default) for a given submission. The default "submission contact" is the Industry manager who submits the application. 

The "submission contact" role can be reassigned at any moment, and repeatedly, by any of the Industry managers associated to a draft or ongoing submission (but not for completed submissions). EMA users of the IRIS system will send communications only to the "submission contact", by default. This is for efficiency and security reasons. 

Applicants can nominate additional Industry managers,  and reassign the "submission contact" role as required, for example before a period of leave of the "submission contact". This can be done in IRIS, for draft or ongoing submissions, by clicking on the V to the right of the submission, and selecting "Manage submission contact". 

In addition, applicants may also wish to set up appropriate auto-forwarding rules in the email system of the "submission contact". 

IRIS is being built to allow applicants to self-manage their "submission contact" role for each draft or ongoing submission. In future, EMA plans to extend this concept  to self-management of the contact person and contact data for interested parties assigned to Regulatory Entitlement, and potentially also for Authorisation Products. Changes will be made by sponsor/marketing authorisation holders directly in the IRIS Industry portal.

Posted Fri, 05 Mar 2021 15:01:34 GMT by Isha Arora Dr.
Dear Paolo,
Thank you, this is very useful information. Could you please include the full information as stated into the IRIS guide for applicants ? As for the moment, reading through the guide, it seems like it is possible to select contact person only at draft submission.
Best Regards,
Isha
 

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