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eVAERS GENC2 Regulatory Updates November 2020 (Doc ID 2812878.1)

Last updated on OCTOBER 12, 2021

Applies to:

Oracle Argus Safety - Version 8.2 and later
Oracle Argus Interchange - Version 8.2 and later
Oracle Argus Safety Cloud Service - Version 8.2 and later
Information in this document applies to any platform.

Goal

The purpose of this document is to generate eVAERS reports with GENC2 codes for COUNTRY code list as per CBER guidance published in November 2020.

You can refer to the updated guideline using the URL:
https://www.fda.gov/media/138670/download

These requirements are logged as an Argus enhancement request Enh 33415880 - 'eVAERS GENC2 Regulatory Updates November 2020'

Solution

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In this Document
Goal
Solution
References

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