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.
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
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).
This article is applicable to Argus version AS 8.2 +. This article is not applicable to 126.96.36.199 and above as EDQM related functionality is provided as OOTB feature in Argus 188.8.131.52 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.
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.
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In this Document
|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:|