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J-Drug Code Is Not Populated At B.4.k.2.1 For Non-Company Product On Foreign Case (Doc ID 2167745.1)

Last updated on FEBRUARY 21, 2019

Applies to:

Oracle Argus Safety Japan - Version 7.0.0 to 8.0 [Release 7.0.0 to 8.0]
Information in this document applies to any platform.


When case product tab with Non-Company Product (non configured at Argus Console) has J-Drug Code for foreign case and PMDA E2B Report category D is generated, the corresponding B.4.k.2.1 has Product Name J of the case product tab, not J-Drug Code.

According to the User's Manual "Oracle Argus Interchange PMDA DTD 2.1 Mapping Reference Guide Version 7.0 E20630-01 April 2011" this behavior is as expected.
3) For Foreign Marketed Non-Company Product: Japanese Product Name is transmitted if available, otherwise English Product Name is transmitted.

Is there any Enhancement for specification of generating B.4.k.2.1 DTD item in E2B to be J-Drug Code on foreign case?




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