European Union Falsified Medicines Directive

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

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

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.

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.

How TraceLink EU FMD drives efficiency

• Unlock extensive data, workflow, and configuration capabilities
• Control data, status, and other critical information
• Access complete integration and support
• Identify, investigate, and resolve alerts