Description

TraceLink’s National Medicines Verification System Country Compliance (NMVS Compliance) application provides integration with country-specific NMVS blueprint systems offered by Arvato, SolidSoft and SecurPharm to support NMVS verification and compliance reporting for 3PL, wholesale distribution, hospital, and pharmacy use cases as required under the EU Falsified Medicines Directive (EU FMD). 

Benefits

NMVS Compliance provides the intelligent compliance data management and reporting system needed for the complex master data, verification, and pack status reporting as documented in EU FMD regulations

• Supports the EU FMD risk-based verification requirements to initiate verification requests against the product pack identifier to a national system for returned products which will be further resold or involved in multiple supply chain transactions
• Support article 16, 22, and 23 requirements for the capture of serialization data and reporting for products involved in clinical trials, being exported from the ecosystem of countries following EU FMD requirements, or being distributed to entities as documented in article 23
• Supports management of required product pack status changes due to product damage, quality sampling, or other supply chain exceptions
• Provides a common global platform for compliance reporting and compliance data management when used as part of TraceLink’s global track and trace compliance network  
• Leverages the extensive network of pre-existing integrations with 3PLs and other supply chain entities to speed access to key compliance information

Capabilities and Features

NMVS Compliance provides the intelligent compliance data management and reporting system needed for diverse product pack identity verification and status management requirements as products move through the supply chain under EU FMD regulations

• Delivers flexible workflows, business rules, and data configuration capabilities needed for complex operational and supply chain requirements
• Connection to and integrated data exchange with the Arvato-, SolidSoft-, and SecurPharm-based national medicines verifications systems
• Submission of verification request transactions as required for risk-based verification processes
• Update of product pack status across a broad range of states (export, sample, dispense, lock, and more) with the required national system based on business operations
• Automated reporting based on business operations and scanning activities or manual updates
• Provides search, viewing, and audit trailing of submitted reports and system responses
• Enables download of product pack information (serialized product identifiers, status, etc.) for products in an NMVS compliance report