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Posted Thu, 28 Nov 2024 10:17:51 GMT by Izzy Arnold
In the Iris guide to applicants it details how to change the contact person for a PIP, however it does not mention what document requirements there are in order to do this. Is there are guidance that details what is required?
Posted Thu, 28 Nov 2024 15:52:22 GMT by Paolo Tomasi EMA
If you are referring to the procedure to change the "portal contact" (a.k.a. "submission contact") during an ongoing procedure in IRIS (not limited to PIPs), this is described in the IRIS guide to applicants (creation of submissions) (section 2.4, page 12). There are no requirements for any documents, it is sufficient that the new "portal contact" has already been added to the submission as an IRIS Industry manager.

After conclusion of the procedure, it is not possible to change the "portal contact" anymore, however it is possible, if desired, to change the contact person of the related regulatory entitlement record (for all types of Regulatory Entitlements), directly in the IRIS portal, in page Regulatory Entitlements · IRIS. Also in this case, no documents are required. 

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