Last updated on MAY 12, 2015
Applies to:Oracle Argus Safety Japan - Version 7.0.4 and later
Information in this document applies to any platform.
In a rare situation that the E2B generation / submission is somehow not working due to system issue,
we will need to submit via paper- i.e. we will generate a report and mark it as submitted, then submit the report via sending the physical copy to PMDA.
In that case, when we receive a follow-up information later on and the schedule the follow-up report,
E2B M2/J2 - safetyreport version- displays as 1 and does not count it up.
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