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New MIR form - Mandatory as from Nov 2025 PMSV reporting forms - European Commission PMSV reporting formsPMSV reporting formshealth.ec.europa.eu

As mentioned in our previous regulatory update, the European Commission (EC) released (May 5) the long-awaited version 7.3.1 of the Manufacturer Incident Report (MIR) form to report serious incidents. Additionally, the EC has also published a new help text file with information on completing the form, as well as the corresponding XSD and XML schema files to facilitate the integration of complain..

The Medicines & Healthcare products Regulatory Agency (MHRA) unveiled new guidance outlining the implementation of new manufacturer incident (MIR) and field safety corrective action (FSCA) report XML schema definitions (XSD) for Great Britain (GB) for the Manufacturer’s Online Reporting Environment (MORE) reporting system. This timing is aligned with the European Union (EU) MIR version 7.3.1 rel..

MIR PDF 7.3.1New MIR form - mandatory as from November 2025New manufacturer incident report (MIR 7.3.1. PDF form)The published MIR form is password-protected, so it may be necessary to unlock it for specific purposes (e.g. translating the form, implementing it into in-house systems).You can request the password for specific authorised uses.New manufacturer incident report XSD files and XSL files..

MIR version 7.3.1 is releasedThe European Commission (EC) has at last released (May 5) the long-awaited version 7.3.1 of the Manufacturer Incident Report (MIR) form to report serious incidents. Additionally, the EC has also published a new help text file with information on completing the new report form, as well as the corresponding XSD and XML schema files to facilitate the integration of comp..