Description
TraceLink’s European Union Compliance (EU Compliance) application supports companies in creating, submitting to, and managing reports and related compliance data within the European Medicines Verification System (EMVS) as required by the European Union Falsified Medicines Directive (EU FMD), related Delegated Acts, and related country-level mandates created by national competent authorities (NCAs).
Benefits
EU Compliance provides Marketing Authorization Holders (MAHs) and parallel importers with the compliance solution capabilities and support needed as companies package, introduce into commerce, and maintain pharmaceutical products in the European supply chain. Benefits include:
- Extensive data, workflow, and configuration capabilities to help meet the varied EU FMD compliance requirements based on different packaging and distribution ecosystems
- Reporting and data management requirements documented by the EU Delegated Acts
- Policies and procedures defined by the European Medicines Verification Organization for connection and data exchange to the EMVS Hub
- Policies and procedures impacting MAHs and parallel importers as defined by individual country National Medicines Verification Systems (NMVS) and the unique country-specific requirements mandated related to the EU Delegated Acts
- Flexible controls to help manage product master data, product pack identifier, product pack status, and other information critical to ensure products continue to flow in the supply chain
- Deep integration and support for interfaces into the EMVS Hub
- Alert management support to help identify and resolve alerts generated from the EMVS Hub or individual NMVS
Capabilities and Features
EU Compliance provides a comprehensive compliance data management and reporting solution for companies needing to manage product information and compliance reporting for products produced for and distributed into or within European countries following the EU FMD (most European Union countries and the EEA countries).
- Create product master data, serialized product pack data, pack identifier status changes, product pack verification requests, and other reports required of MAHs and parallel importers under the diverse rules of EU FMD
- Configure reports for unique target markets and unique product code (GTIN, NTIN, national code) requirements based on specific rules for each country following EU FMD
- Submit properly configured reports and updates to the EU Hub, and monitor submitted report status
- Enable flexible report triggering based on product type, market, status, and operational event when used in conjunction with TraceLink Serialized Operations Manager or manually submit for special situations
- Keep product pack status codes in the EMVS up to date with status modification and update capabilities provided to support business operations or to meet EU FMD requirements in areas such as Article 23
- View and manage EU alert reports for alerts generated through the EMVS Hub for product packs previously submitted, drill down into details of the specific alert code, target markets involved, products affected, and more
- Configure email alerting to internal stakeholders for report submission exceptions, alert messages received by the EU Hub, and more
- Search EMVS Hub messages based on product, lot, event, serial number, date range, and more, drilling down into specific details
- Leverage TraceLink’s time-tested integration to the EMVS Hub and continuous support for EMVS Hub schema and configuration updates to simplify startup and reduce ongoing risk
