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Use of EDQM Terminologies for Dose Forms (DF) and Routes of Administration (ROA) (Doc ID 2830452.1)

Last updated on JUNE 27, 2022

Applies to:

Oracle Argus Interchange - Version 8.2 to 8.2.3 [Release 8.2]
Oracle Argus Safety - Version 8.2 to 8.2.3 [Release 8.2]
Information in this document applies to any platform.
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27-Jun-2022
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Revision notes: Provide fix for minor bug found during internal testing to EMA R3 XSL file submitting free text route of administration.
New section added: Modifying EMA R3 XSL file

Purpose

The purpose of this document is to provide recommendations on the configuration updates required in Argus Safety to support regulations pertaining to use of European Directorate for the Quality of Medicines (EDQM) terminologies for Dose Forms (DF) and Routes of Administration (RoA) for ICSRs in E2B(R3) message stated in ICH User Guide v 1.1.


EMA Clarification on Mandatory Use of EDQM

Scope

This article is applicable to Argus version AS 8.2 +.  This article is not applicable to 8.2.3.1 and above as EDQM related functionality is provided as OOTB feature in Argus 8.2.3.1 release.


This article explains steps to submit ICSRs to EMA Health Authority in E2B R3 format to avoid rejections of ICSRs containing non-current EDQM RoA or DF.


This note provides steps to modify a copy of the OOTB R3 profile for EMA to remove mappings for Routes of Administration that sends ICH codes. In case a customized EMA profile is being used, please modify the SQL logic that is highlighted for DOSAGEINFORMATION.

This note also provides steps to fix a minor bug found during internal testing to EMA R3 XSL file submitting free text route of administration. 

Note: No changes are required for MFDS profile. Data is not transmitted for these tags: [G.k.4.r.9.2a] DRUGPHARMADOSEFORMTERMIDVER / [G.k.4.r.9.2b] DRUGPHARMADOSEFORMTERMID, [G.k.4.r.10.2a] DRUGADMINISTRATIONROUTETEXT / [G.k.4.r.10.2b] DRUGROUTEOFADMINTERMID and [G.k.4.r.11.2a] DRUGPARADMINISTRATIONTEXT / [G.5.4.r.11.2b] DRUGPARROUTEOFADMINTERMID.

Pre-requisite

Stop Argus Interchange service and Argus Safety Services, prior to the execution of the below-mentioned steps.

Care to be taken that E2B (R3) reports are not getting generated by any Argus user for EMA.

Details

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In this Document
Purpose
Scope
 Pre-requisite
Details
 EMA E2B(R3) - Export
 Custom R3 Profile for EMA
 Modifying the R3 Profile
 Setting up a Reporting Destination
 Modifying EMA R3 XSL file
 Transmitting E2B R3 file with DF and RoA compliant with EMA
 EMA E2B(R3) - Import
 Importing E2B R3 ICSR without EDQM details:
 Importing E2B R3 ICSR with EDQM details:

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