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Clarification On PMDA Nullification Report (Doc ID 1683184.1)

Last updated on FEBRUARY 20, 2019

Applies to:

Oracle Argus Safety Japan - Version 6.0.5 and later
Oracle Argus Interchange - Version 8.0.1 to 8.0.1 [Release 8.0]
Information in this document applies to any platform.


When Nullification E2B report to PMDA is generated for a case which has one or more E2B reports already submitted to PMDA, the value 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) was the old date.

Even for the nullification report, we need to have the correct latest info - 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? Is this Argus Known issue or defined functionality?


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