Draft Icon >> E2B shows Error after Initial E2B was Submitted

(Doc ID 1615658.1)

Last updated on APRIL 01, 2018

Applies to:

Oracle Argus Safety Japan - Version 7.0.2 to 8.1 [Release 7.0.0 to 8.1]
Information in this document applies to any platform.

Goal

After Initial E2B is submitted to PMDA agency, unable to Generate E2B using [Draft] icon >> E2B with PMDA ICSR Validation report.

Error on PMDA ICSR Validation report:
----------------------------------------
J.4b MHLWADMICSRCASENUMB
Case Form / Analysis / PMDA Info / General / PMDA Number of Suspected License
Though J.4b (MHLWADMICSRCASENUMB) value cannot exist in Initial report, the value exists [Domestic specific information : PMDA number]

 

 

Solution

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