Last updated on MARCH 08, 2017
Applies to:Oracle Argus Safety Japan - Version 8.0 and later
Information in this document applies to any platform.
When a foreign case has Non-Company product with having J-Drug Code, Product Name and Generic Name <> 'UNKNOWNDRUG'
on Case Form - Products tab, and Reporting category is D on PMDA Info tab,
E2B cannot be generated for PMDA agency with error for B.4.k.2.2 by PMDA ICSR Validation Report.
Error Message on PMDA ICSR Validation Report:
English: Value of element [ACTIVESUBSTANCE (B.4.k.2.2)] cannot be UNKNOWNDRUG for Suspect or Interacting Non-Company Marketed Product.
Japanese: [DRUGCHARACTERIZATION (B.4.k.1)] が1=被疑薬、または3=相互作用の時、他社医薬品の [ACTIVESUBSTANCENAME (B.4.K.2.2)]は”UNKNOWNDRUG”にはできません。[製品 | 製品情報 | 一般名]
How To Repeat:
1) Create a new Foreign Spontaneous case by J user with a J license product.
2) On Case Form >> Analysis >> PMDA Info >> General, select Reporting Category = D, and enter rest data for E2B.
3) Schedule E2B for PMDA agency and click Draft link of E2B.
--->E2B Viewer opens.
4) On Case Form >> Products tab, add a Non-Company product.
--Drug Type = Suspect
--Product Name = 'NCDrugA'
--Generic Name = 'NCDrugA'
--J Drug Code = 123456789
--Formulation = 'Tablet'
5) On Case Form >> Regulatory Reports tab, click Draft link of E2B.
--->PMDA ICSR Validation Report opens with having error for B.4.k.2.2.
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