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PSUR/PSUSA IRIS cases for non-CAP
PSUR/PSUSA IRIS cases for non-CAP
Posted
Tue, 29 Jul 2025 08:59:05 GMT
by
Isha Arora
Dr.
Hi, can you please clarify under which ORG the PSUR/PSUSA case is meant to be opened for a non-CAP product, e.g. MRP with lots of RMS and CMS countries?
EMA information mentions ''For PSURs, contact is the person indicated in the PSUR submission form (and not in the cover letter)''
How can EMA know to which ORG ID the contact person is affiliated to open the IRIS case ?
thanks
Posted
Fri, 08 Aug 2025 14:36:59 GMT
by
Caterina Scarpati
Dear Arora,
Please submit your question to
AskEMA
, the official EMA channel for submitting general questions.
Kind regards
Posted
Tue, 02 Sep 2025 13:10:09 GMT
by
Isha Arora
Dr.
Dear Caterina,
The question is not a general question, but on EMA IRIS Portal, how the case (or several cases) are opened for MRP and national procedures products.
How can EMA know to which ORG ID the contact person is affiliated to open the IRIS case ?
KR, Isha
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