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White Paper for Russian E2B (R3) Submissions (Doc ID 2686991.1)

Last updated on JULY 03, 2020

Applies to:

Oracle Argus Interchange - Version 8.1 and later
Oracle Argus Safety - Version 8.1 and later
Information in this document applies to any platform.

Purpose

The Russian health authority posted a notice in their official website about E2B R3 implementation (information letter dated March 29, 2019 No. 01I-841/19).

According to the notice, Ministry of Health Care, Federal Service For Surveillance In Healthcare “Roszdravnadzor” accepts ICSRs only in E2B R3 format starting 1st September 2019. 

A Q & A document was published on 1st November 2019 clarifying requirements for local language data, domestic/foreign cases, batch reporting, MedDRA and so on.

This article explains the requirements of the Russian Health Authority for E2B R3 reporting.

Scope

The scope of this document includes:

  1. Creating a Russian E2B R3 message profile using the out of the box (ootb) ICH E2B R3 profile
  2. Setting up a Reporting Destination for the Russian authority (Roszdravnadzor)
  3. Entering local language data
  4. Transmission of E2B R3 files to RZN

Details

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In this Document
Purpose
Scope
Details
 1. Creating a Russian E2B R3 Message Profile Using the OOTB ICH E2B R3 Profile
 2. Setting up a Reporting Destination for the Russian Authority RZN
 3. Entering Local Language Data
 4. Transmission of E2B R3 files to Russian RZN

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