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

Last updated on JULY 13, 2023

Applies to:

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

• A valid ICSR has a patient, drug, reaction and reporter, certain fields are mandatory or conditional-mandatory in order to confirm that the ICSR is valid.
• If DF and RoA (EDQM) are turned into mandatory fields in the business rules, it means that these fields must always be populated for all suspect/interacting/concomitant drugs, in GVP VI these fields are not considered mandatory for a valid ICSR.
• DF and RoA can be left blank, however if they are provided as codes these codes must be valid in the EDQM lists (this is the meaning of mandatory use of EDQM, i.e. other code systems will not be accepted).

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

My Oracle Support provides customers with access to over a million knowledge articles and a vibrant support community of peers and Oracle experts.