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Posted Thu, 10 Jul 2025 11:22:40 GMT by Isha Arora Dr.
What is the ''RPI contact person'', why is this requested, for which purpose, and how does it connect or not to a product contact person, and procedure contact person ?
 
Posted Wed, 23 Jul 2025 14:17:06 GMT by Caterina Scarpati
Dear Isha,
Please consult Chapter 8 of this guidance document for further information on RPI: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/iris-guide-registration_en.pdf
For further information, please open a ticket on Service Desk following the support path described here: https://iris.ema.europa.eu/forums/whats-new/6455338f-d73b-f011-a2d9-7c1e524ef6ac
Best regards,
On behalf of the IRIS team
Posted Tue, 29 Jul 2025 08:53:40 GMT by Isha Arora Dr.
Dear Caterina,
the guidance document mentioned does not describe the concept of ''RPI contact person''. This is a new field requested during some submissions (e.g. paediatrics etc) and it should be clarified what it is referred to please. Can you please clarify. Thank you

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