PMDA E2B follow-up report after nullifying/downgrading the report (Doc ID 2018954.1)

Last updated on MAY 24, 2016

Applies to:

Oracle Argus Safety Japan - Version 7.0.5 and later
Information in this document applies to any platform.

Goal

The PMDA E2B (downgrade / nullification) report has already been submitted.

For this case, the follow-up information received and the user needs to submit the follow-up report again.

Does the follow-up report has the same A.1.0.1 <safetyreportid> and J.4b <mhlwadmicsrcasenumb>?

Solution

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