Sending E2B R3 reporting to COFEPRIS (Mexico) – White Paper
(Doc ID 2722330.1)
Last updated on OCTOBER 24, 2020
Applies to:Oracle Argus Safety - Version 8.1 and later
Oracle Argus Interchange - Version 8.1 and later
Information in this document applies to any platform.
COFEPRIS, Health Authority of MEXICO is using Vigiflow as their safety system for electronic reporting of ICSRs.
Vigiflow provided by WHO-UMC allows the import of E2B R2 and E2B R3 XMLs.
COFEPRIS stands for Federal Commission for Protection of Sanitary Risks (Commission Federal para la Protection contra Riesgos Sanitarios)
COFEPRIS published guidelines “Reporting of Adverse Events, Adverse Drug Reactions and Suspected Adverse Drug Reactions (Version 1.1), Mar-2020”.
This Guideline covers Pharmacovigilance details on how to report Adverse Events, Adverse Drugs Reactions, Suspected Drug Reactions and any other security problem related to the use of medicinal products and vaccines through the electronic platform https://vigiflow.who-umc.org/ VigiFlow.
It is based on the Norm NOM-220-SSA1-2016 on Pharmacovigilance that specifies the requirements applicable to pharmacovigilance activities in Mexico.
This article is applicable to Argus version AS 8.1+.
This article explains steps to submit ICSRs for Drugs and Biologics to the COFEPRIS Mexican Health Authority in E2B R3 format.
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