TraceLink's NMVS Compliance solution integrates with NMVS systems like Arvato, SolidSoft, and SecurPharm to meet EU FMD requirements. It supports verification, serialization data capture, and product status management for pharmaceuticals across various supply chain scenarios.
Vendor
TraceLink
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National Medicines Verification System (NMVS)
Advanced compliance intelligent data management and reporting solution for NMVS country compliance.
Comply with NMVS serialization and reporting requirements
The TraceLink National Medicines Verification System Country solution provides integration with country-specific NMVS blueprint systems offered by Arvato, SolidSoft, and SecurPharm. It supports NMVS verification and compliance reporting for 3PL, wholesale distribution, hospital, and pharmacy use cases as required under the EU Falsified Medicines Directive (EU FMD).
With NMVS Pharmaceuticals, you can:
- Confidently meet NMVS country-specific compliance requirements
- Streamline regional compliance operations and processes
- Insulate internal enterprise systems from regional compliance demands
New compliance requirements demand new compliance solutions
Today’s marketing authorization holders and pharmaceutical manufacturers face immense challenges managing regulatory compliance and navigating evolving requirements in the NMVS markets. These challenges include:
Complex product status reporting requirements
After initial reporting of product data to the EMVS, product movement through internal distribution ecosystems and external supply channels may cause product state or status to change, which requires additional reporting.
Coordination across multiple national systems
Depending on the specific country in which the product is located or where activity took place, companies must find and report product state changes to the appropriate National Medicines Verification System.
Integration with NMVS to initiate updates
Given the architecture of the EMVS and the diversified nature of country-based requirements as a part of EU FMD, product manufacturers, 3PLs, product distributors, or other parties may be required to connect directly to an NMVS to initiate updates on the product pack information contained in that repository system.
How TraceLink NMVS drives efficiency
- Connect with an expansive network of ready-to-go partners
- Meet risk-based verification requirements
- Capture serialization data for reporting
- Manage product pack status changes
- Utilize a common global compliance platform