Automated Tracking and Management of EU FMD Alerts for Possible Falsified Medicines

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The EU Falsified Medicines Directive (FMD) provides a serialization and verification framework by which individual items are scanned at the time of dispense to determine their authenticity.   In situations where these verifications fail an alert is raised to the dispenser, the National Medicine Verification Organization (NMVO) and the pharmaceutical manufacturer.  Alerts may be the result of an unknown product code, an unknown serial number, a mismatch in lot/expiry data and many other causes.  

Under the FMD regulation manufacturers have a responsibility to address alerts received, which may include investigating the root cause of the alert, quarantining the product and maintaining active communication with supply chain trading partners and government agencies.   

For manufacturers distributing in many markets throughout Europe the complexity of alert management is ensuring adherence to the specific requirements defined by each market- including the time-frame in which alerts must be investigated and the necessary authorities who must be kept up-to-date on alert resolution.

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To address this complexity the Jennason EU FMD Alert Manager provides a simple, cost effective solution to help pharma companies manage the entire alert handling process including

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• Automated or manual alert entry

• Management of market specific alert management requirements- including contact lists for NMVOs and NCAs

• Response tracking and automated reminders to ensure alerts are resolved within market-defined time-frames

• Automated summary document generation for use in trading partner, NMVO and NCA communications

• Full auditing of alert management workflows

• Reporting on alert frequencies, alert types and alert locations

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The Jennason EU FMD Alert Manager leverages a common delivery platform as other Jennason solutions which provides

• Web accessible platform for rapid collaboration across functional teams

• Role-based user access ensures data integrity and security

• Direct integration with 3rd party systems such as ERP, regulatory and serialization platforms

• Single-tenant architecture allows for solution customization

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