Suppression of Downgrade and Nullification Reports to European National Competent Authorities in Argus Safety 7.x and 8.x

(Doc ID 2327090.1)

Last updated on NOVEMBER 13, 2017

Applies to:

Oracle Argus Safety - Version 7.0.0 and later
Information in this document applies to any platform.

Goal

From 22 Nov 2017, a Marketing Authorization Holder (MAH) will no longer be required to send European domestic post-marketing ICSRs directly to European National Competent Authorities (NCAs); instead they will be submitted to the European Medicinal Agency (EVHUMAN).


The configuration changes in Argus to accomplish this business process change will have the following impact.

This requirement is logged as an enhancement request ER 26867152 - Centralized Reporting to EMA - Workaround for 7x/8x customers

Solution

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