Technical Brief for Russian E2B (R3) Submissions
(Doc ID 2686991.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety - Version 8.1 and laterOracle Life Sciences Argus Interchange - 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:
- 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
Details
To view full details, sign in with your My Oracle Support account. |
|
Don't have a My Oracle Support account? Click to get started! |
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 |