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EMA E2B Mapping G.k.3.1 / B.4.k.4.1 <DRUGAUTHORIZATIONNUMB> Was Changed In Argus 8.1.2 (Doc ID 2436440.1)

Last updated on AUGUST 19, 2018

Applies to:

Oracle Argus Interchange - Version 8.1.2 to 8.1.2 [Release 8.1]
Information in this document applies to any platform.

Goal

In Argus 8.1.2 EMA E2B Mapping G.k.3.1 / B.4.k.4.1 was changed as follows;

Argus 8.1.1 - Same as ICH - LM / Licenses / License Information / Number
Argus 8.1.2 - Direct Mapping - Case Form / Product / Product Information / Authorization Number

In Argus 8.1.1 the license information for the country to which the report is submitted was included in the ICSR, however with the new mapping in 8.1.2 the license from the case form is included in the ICSR. Therefore if a case is booked in with a JAPAN license, then when the ICSR is generated for EMA the JAPAN license details will be included in the ICSR.

I have not found any EMA regional guidance for G.k.3.1, therefore assume that the ICH guidance for this field.

Why was the mapping changed for G.k.3.1 / B.4.k.4.1 in 8.1.2 and provide a reference to the relevant EMA regulation / guidance which supports this change?

 


 

Solution

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