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Posted Mon, 09 Sep 2024 12:35:42 GMT by Barbora Bujdosova
Good afternoon,

I would like to ask regarding PSUR evaluation. As the submission will stay the same and during the PSUR repository step we fill contact person for pharmacovigilance, will this contact person for pharmacovigilance need to have granted some role/access in IRIS and will the person recieve the notification when the new document will appear during the evaluation phase? Even if it will be different person from contact person for a product? 

Thank you very much for the answer

Kind regards,
B.B.
Posted Fri, 20 Sep 2024 13:18:12 GMT by Caterina Scarpati
Dear Barbora,

For CAP products we continue use the product contact as default and the MAH can edit the contact for the procedure in the industry portal as per the IRIS guide for applicants. The product contact (i.e. portal contact) will be the one receiving the notification.
Hope this clarifies.

Best regards,
Caterina

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