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European Falsified Medicine Directive

EU FMD Compliance Module

Enhance operational efficiency.

Compliance with the EU Falsified Medicine Directive

LSPedia's EU FMD Compliance Module is a bolt-on to the OneScan Suite. Fully integrated to OneScan, The EU FMD Compliance Module is a powerful tool designed to facilitate compliance with the European Medicines Verification System (EMVS) under the Falsified Medicine Directive by Commission Delegated Regulation (EU) 2016/161. By automating the conversion and upload of serialized batch data to the European Hub, the EU FMD Compliance Module enables manufacturers to commercialize in the EU market with ease and confidence while ensuring turnkey regulatory adherence.

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Master Data Upload

Effortlessly upload critical master data, aligning with EMVS Article 33 regulations.

Product Pack Data Upload

Automate the upload of product pack data, enhancing data accuracy and compliance.

Product Pack Data Update Upload

Stay agile with the ability to update product pack data swiftly and accurately.

Recall Batch

Proactively manage batch recalls, maintaining safety and regulatory compliance.

Issue Product Withdrawal

Efficiently manage product withdrawals to ensure patient safety and compliance.

Export Pack and Export Bulk

Accurately maintain product status with EMVS to process the products that have exited the EU market.

Decommission Pack and Decommission Bulk

Seamlessly decommission packs and bulk items, meeting EMVS requirements.

EMVS Benefits

Enhanced Compliance

Meet EMVS requirements with ease and confidence, ensuring regulatory adherence.

Efficiency Amplified

Streamline serialization processes, reducing manual efforts and enhancing operational efficiency.

Real-time Updates

Stay agile with the ability to update product data promptly, ensuring accurate records.

Seamless Integration

Natively integrate with OneScan, EMVS SDK can also seamlessly integrate with other existing L3 and L4 systems, therefore consolidating various existing technologies to a standard EU process.

Future-Ready

Prepare for the integration with the European Medicines Agency (EMA) SPOR data repository, ensuring continued compliance.

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OneScan suite is the leading traceability solution, designed and proven to increase productivity, profitability, and supply chain visibility. LSPedia's seamless, cloud-based compliance solution streamlines the track and trace requirements with little impact on your daily processes.

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