Posted Tue, 21 Nov 2023 10:02:30 GMT by Isha Arora Dr.

Hello,
I have a question in regards to the Public List of Opinions on Orphan Medicinal Product Designation, where the email for public enquiries is visible.
1- How is this email maintained, in IRIS or not ?
2- If correct in above mentioned public list, How is the correct email reflected in related EMA webpage ?
Thanks,
Isha 

Posted Tue, 21 Nov 2023 14:19:30 GMT by Paolo Tomasi EMA
Contact email and phone numbers for interested parties can be edited directly by the owner of the Regulatory Entitlement, in the IRIS Industry Portal under the "Org. Reg. Entitl." tab. The change should be immediately visible in the Orphan Register. The EMA standard website will contain references to the register, and the contacts will be removed from there eventually. There is no need to update both entries, the IRIS entry is sufficient. 
Posted Tue, 21 Nov 2023 14:45:19 GMT by Isha Arora Dr.
Thank you for your quick reply. This is very helpful.
We appreciate that the EMA standard website will be updated in a timely manner (as currently there may be some mismatch).
 
Posted Tue, 05 Dec 2023 14:00:57 GMT by Isha Arora Dr.
Hi, following my last question, I was wondering if the same could/will be applied for the email for public enquiries for Paediatrics Submissions?
1- Can we maintain that via IRIS as well ?
2- If not, how can we request update of emails displayed on EMA webpages ?
Thanks, Isha 
Posted Mon, 11 Dec 2023 14:24:31 GMT by Paolo Tomasi EMA
The IRIS system currently does allow holders of Paediatric Regulatory entitlements to add/edit contact data for EMA and for interested parties, for PIP and waivers. However, for technical reason at present most Paediatric Regulatory entitlements are not assigned to the actual holder, but to EMA; therefore, they will not be visible to the holder until data are reconciled to the correct organisation and location ID. The reconciliation is foreseen to be completed by June next year.

There is the intention to create a "Paediatric register" similar to the already existing List of Opinions on Orphan Medicinal Product Designation in the IRIS public website, which would replace the information currently published in the standard EMA website. Until this happens, the standard procedure to amend contact information for interested parties remains unchanged.

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