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Update Conformance Rules For J2.5.k And J2.6.k (Doc ID 2448722.1)

Last updated on FEBRUARY 27, 2019

Applies to:

Oracle Argus Safety Cloud Service - Version 8.0 and later
Information in this document applies to any platform.

Symptoms

During PMDA E2B R3 report generation, below validation errors are displayed
when
-- MHLWSTATUSCATEGORYOFNEWDRUGS (J2.4.k) = '5? (Not applicable)
-- MHLWRISKCATEGORYOFOTCDRUGS (J2.5.k) or MHLWROUTEFORACQUIRINGOTCDRUGS (J2.6.k) has data

(i)  Value for J2.5.k[MHLWRISKCATEGORYOFOTCDRUGS] should not exist for a drug if J2.4k[MHLWSTATUSCATEGORYOFNEWDRUGS] is not 6 or 7
(ii) Value for J2.6.k[MHLWROUTEFORACQUIRINGOTCDRUGS] should not exist for a drug if J2.4k[MHLWSTATUSCATEGORYOFNEWDRUGS] is not 6 or 7

As per regulations it is possible that J2.4.k could be 5 (Not applicable) for intervention required drug and OTC drug (J2.5.k = 6 or 7)

 

 



Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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