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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:
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
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.
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Related resources
COUNTRIES
Compliance around the globe
Explore specific country compliance solutions offered to the TraceLink network.
