Name: European Union Falsified Medicines Directive
Brand: TraceLink
Availability: OnlineOnly

Products

Advanced data management and reporting solutions to meet traceability compliance requirements in the European Union

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Product Overview

Comply with data management and reporting requirements in the European Union

The TraceLink EU FMD compliance solution provides a comprehensive platform for managing the diverse product master data, product pack data, and product status compliance management requirements under the European Union Falsified Medicines Directive, the related Delegated Acts, and the related country-level mandates created by national competent authorities (NCAs).

With TraceLink EU FMD Compliance, you can:

Confidently meet EU FMD traceability 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 European Union. These challenges often include:

Complex EU FMD data management requirements

Manufacturers and parallel reporters that distribute products in the 30 countries governed by FMD must manage product master data, serialized product pack data, pack identifier status changes, and product pack verification requests.

Complex EU FMD data management requirements

Different requirements on a product-by-product basis

Compliance with EU FMD means that companies must also design operations, configure reports, and manage product data in ways determined by the ultimate target market and the supply network path the product takes to get to the target market.

Different requirements on a product-by-product basis

Product benefits

Unlock extensive data, workflow, and configuration capabilities

Extensive data, workflow, and configuration capabilities help meet the varied EU FMD compliance requirements based on different packaging and distribution ecosystems.

Product benefits

Control data, status, and other critical information

Flexible controls help manage product master data, product pack identifiers, product pack status, and other information across the product portfolio and target markets. This is critical to ensure products continue to flow through the supply chain.

Product benefits

Integrate all CMOs, 3PLs, and LSPs with a single network connection

Get tight integration with and high performance interfaces for connecting with the EMVS Hub. Comprehensive integrated connections to CMOs, 3PLs, LSPs, and other partners in a company's supply network ensure EU FMD Compliance customers get the product master data, pack data, and status information critical for secure compliance and efficient operations.

Product benefits

Identify, investigate, and resolve alerts

Alert management capabilities help companies identify alerts published from the EMVS Hub and individual country NMVS platforms, investigate the root causes for the alerts, define actions to take, and resolve the alerts with the reporting entity.

Capabilities

TraceLink European Union Compliance

Trusted by hundreds of companies, this solution helps companies manage information and compliance reporting for products produced for and distributed into or within European countries following the EU FMD.

Manage workflows and data

Customize reports and alerts

Submit reports

Create product master data, serialized product pack data, pack identifier status changes, product pack verification requests, and other reports required of MAHs and parallel importer.
Keep product pack status codes in the EMVS up-to-date to meet EU FMD requirements, such as Article 23, or to support unique business operations.
Search EMVS Hub messages based on product, lot, event, serial number, date range, and more, drilling down into specific details.

Configure reports for unique target markets and unique product code (GTIN, NTIN, national code) requirements based on specific rules for each country.
Configure email alerting to internal stakeholders for report submission exceptions and alert messages received by the EU Hub.

Submit properly configured reports and updates to the EU Hub, and monitor submitted report status.
Enable automated report triggering based on product type, market, status, and operational events, or manually submit reports for special situations.
View details of and manage EU alert reports for alerts generated through the EMVS Hub for product packs previously submitted.