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Clarification of PMDA Nullification Reports (Doc ID 1683184.1)

Last updated on AUGUST 05, 2020

Applies to:

Oracle Argus Safety Japan - Version 6.0.5 and later
Oracle Argus Interchange - Version 6.0.5 and later
Information in this document applies to any platform.

Goal

When Nullification E2B report to Pharmaceuticals and Medical Devices Agency (PMDA) is generated for a case which has one or more E2B reports already submitted to PMDA, the values for A.1.13.1(nullificationreason) and A.1.13 (icsrmessagesenderidentifier) are generated correctly on Nullification E2B report.
Although A.1.13.1(nullificationreason) and A.1.13 (icsrmessagesenderidentifier) were successfully populated on the report, A.1.7 (should be the most recent information receipt date) is not updated with latest date.

Even for the Nullification report, we need to have the latest receipt date for A.1.7.
This issue is not only for A.1.7 but also for other fields such as narrative, J comments (J.10) etc. For these fields, we have old values which were in the previous report. However, most critical one is A.1.7 since if this field has the old date, it might be considered as the delay for the time frame)

Is there any way (steps to generate Nullification E2B etc.) to solve this issue?
 

Solution

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In this Document
Goal
Solution
References


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