WHODrug MPID - E2B(R3) updates

Summary

Transmit WHO Medicinal Product ID (MPID) in E2B(R3) reports (Enhancements 36697225 and 36634110)

Description

To ensure precise identification and tracking of medicinal products, LATAM countries like Mexico (COFEPRIS), Colombia (INVIMA), and Argentina (ANMAT) require WHO Medicinal Product ID (MPID) in the E2B(R3) reports.

The ICH E2B(R3) and EMA E2B(R3) factory profiles are enhanced to include the transmission and validation of WHO Medicinal Product ID (MPID) for each drug, as well as for any historical drugs taken by the patient or their parent.

To transmit WHO MPID and its version in the following elements, enable the Transmit WHO Medicinal Product ID option from the Argus Console > Reporting Destination > Reports tab.

• PATPASTDRUGMPIDVERSION [D.8.r.2a]
• PATPASTDRUGMEDICINALPRODID [D.8.r.2b]
• PARPASTDRUGMPIDVERSION [D.10.8.r.2a]
• PARPASTDRUGMEDICINALPRODID [D.10.8.r.2b]
• DRUGMPIDVERSION [G.k.2.1.1a]
• DRUGMEDICINALPRODID [G.k.2.1.1b]

If a case contains a WHO Drug code in B3 format, but the dictionary is configured in C3 format in the Common Profile Switch > Reporting > E2B > Regional Drugs Dictionary, then WHO MPID is automatically derived from the regional drugs dictionary.

Validations also ensure that WHO MPID used for the drug is current and available in the active WHODRUG C3 dictionary or configured regional dictionary.

In the E2B(R3) report, WHODrug MPID uses the code system OID 2.16.840.1.113883.6.294.

The E2B(R3) import for EMA and ICH remains unaffected as WHO MPID is updated in the case based on the product configuration in Argus Console.