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Workaround for Populating New Object Identifier for WHODrug Medicinal Product ID for E2B R3 Elements to Mexico (Doc ID 2965643.1)

Last updated on JANUARY 08, 2024

Applies to:

Oracle Life Sciences Argus Interchange - Version 8.2.2 and later
Information in this document applies to any platform.

Goal

COFEPRIS, the Mexico regulatory authority, has mandated to transmit WHODrug Medicinal Product ID (MPID) and WHODrug Version in the E2B R3 report from 1 Jan 2024. This is to be used in pre-marketed and post-marketed cases – all drugs/vaccines (Suspect / Concomitant / Interacting / Historical Drugs).

Relevant documents are published in COFEPRIS website –

The WHO MPID and WHODrug Version need to be transmitted in the following elements in the specified format and Code System Object Identifier (OID):

E2B R3 Element and Description E2B R3 Element Value E2B R3 COFEPRIS Configuration Guidance
D.8.r.2a
Patient Past Drug therapy
WHODrug Version Number WHODrug version in the format ‘MMM YYYY’ (e.g., ‘MAR 2023’)
D.8.r.2b WHODrug Medicinal Product Identifier (MPID) Use Code System OID 2.16.840.1.113883.6.294
D.10.8.r.2a
Parent Past Drug Therapy
WHODrug Version Number WHODrug version in the format ‘MMM YYYY’ (e.g., ‘MAR 2023’)
D.10.8.r.2b WHODrug Medicinal Product Identifier (MPID) Use Code System OID 2.16.840.1.113883.6.294
G.k.2.1.1a
Suspect / Concomitant / Interacting/ Drug not administered Drugs
WHODrug Version Number WHODrug version in the format ‘MMM YYYY’ (e.g., ‘MAR 2023’)
G.k.2.1.1b WHODrug Medicinal Product Identifier (MPID) Use Code System OID 2.16.840.1.113883.6.294

This is logged as enhancement request Enh 35574863 - WHODrug MPID from C3 format mandatory for Mexico E2B reporting.  

This workaround solution is to provide steps to populate the Code System OID as “2.16.840.1.113883.6.294” instead of “MPID”. In current Argus version (8.2x and above) the Code System OID for these elements is populated as “MPID”.

Note: The workaround solution to populate the WHODrug MPID and Version in the D.8.r.2a/b, D.10.8.r.2a/b, G.k.2.1.1a/b elements is provided in Doc ID 2972963.1. We recommend to review the mapping updates explained in this article and apply as appropriate.

 

Solution

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In this Document
Goal
Solution
References


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