Technical Brief for Russian E2B (R3) Submissions
(Doc ID 2686991.1)
Last updated on APRIL 15, 2021
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.
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.
The scope of this document includes:
- Creating a Russian E2B R3 message profile using the out of the box (ootb) ICH E2B R3 profile
- Setting up a Reporting Destination for the Russian authority (Roszdravnadzor)
- Entering local language data
- Transmission of E2B R3 files to RZN
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In this Document
|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|