Name: National Medicines Verification System (NMVS)
Brand: TraceLink

Products

Advanced compliance intelligent data management and reporting solution for NMVS country compliance.

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Product overview

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

Industry challenges

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.

Complex product status reporting requirements

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.

Coordination across multiple national systems

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.

Integration with NMVS to initiate updates

Product benefits

Connect with an expansive network of ready-to-go partners

Leverage an extensive network of pre-integrated trading partners already on the TraceLink platform to speed access to key compliance information.

Product benefits

Meet risk-based verification requirements

The NMVS solution supports the EU FMD risk-based verification requirements. It initiates verification requests against the product pack identifier to a national system for returned products that will be further resold or involved in multiple supply chain transactions.

Product benefits

Capture serialization data for reporting

NMVS supports articles 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.

Product benefits

Manage product pack status changes

NMVS supports management of required product pack status changes due to product damage, quality sampling, or other supply chain exceptions.

Product benefits

Scale compliance across multiple markets

The NMVS solution is built on the TraceLink Global Compliance Platform. This enables companies to meet the unique requirements for reporting to the NMVS while also establishing an easily extendable foundation for compliance reporting and data management in accordance with regulatory requirements established in other markets.

Capabilities

TraceLink NMVS

The NMVS solution provides an advanced compliance data management and reporting system to support diverse product pack, identity, verification, and status management requirements as products move through the supply chain under EU FMD regulations.

Manage workflows and data

Update pack status and access product data

Automate and customize reporting

Utilize flexible workflows, business rules, and data configuration capabilities needed for complex operational and supply chain requirements.

Connect to and exchange integrated data with the Arvato-, SolidSoft-, and SecurPharm-based national medicines verifications systems.

Submit verification request transactions as required for risk-based verification processes.

Download product pack information (serialized product identifiers, status, etc.) for products in an NMVS compliance report.

Update product pack status across a broad range of states (export, sample, dispense, lock, and more) with the required national system based on business operations.

Automate reporting based on business operations and scanning activities or manual updates.

National Medicines Verification System (NMVS)