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E2B R3 XML File is Not Including Assessment Information For Second Product (Doc ID 3078853.1)

Last updated on MARCH 31, 2025

Applies to:

Oracle Life Sciences Argus Safety Cloud Service - Version 8.4.2 and later
Oracle Life Sciences Argus Safety - Version 8.4.2 and later
Information in this document applies to any platform.

Goal

Created a Case with two Suspect Products
Draft E2B to EMA / R3
There is no Assessment information (G.k.9.i.2.r missing) for the 2nd Product.

Because of this getting Negative ACK from EMA (No Assessment).

Solution

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In this Document
Goal
Solution

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