Falsified Medicines Directive (FMD) Implementation
The EU Falsified Medicines Directive mandates comprehensive safety features designed to prevent counterfeit medicines from reaching patients. Pharmaceutical companies must implement unique identifier verification systems, verify product authenticity at dispensing points, manage decommissioning processes for legitimate products, maintain end-to-end traceability throughout distribution, and respond to suspected falsifications according to regulatory protocols. Many organizations struggle with technical integration challenges, personnel training requirements, repository connectivity and data management, operational workflow changes, and audit trail documentation that satisfies regulatory expectations.
Non-compliance exposes organizations to regulatory sanctions, supply chain disruptions, and reputational damage. Effective FMD implementation requires both technical infrastructure and operational procedures that verify every product without impeding distribution efficiency.
Our Falsified Medicines Directive Implementation services guide pharmaceutical and biotech companies through establishing compliant verification systems and operational procedures. We assess your current infrastructure and identify gaps against FMD requirements, implement or enhance verification systems and repository connections, develop Standard Operating Procedures for authentication and decommissioning, train personnel on verification workflows and exception handling, establish alert and suspected falsification response protocols, and validate system functionality through testing and documentation review.
Our implementation approach balances regulatory compliance with operational efficiency, ensuring verification processes integrate seamlessly into existing workflows without creating bottlenecks or delays. We provide ongoing support for system maintenance, regulatory updates, and audit preparation.
Falsified Medicines Directive compliance protects both patients and your business from the serious risks posed by counterfeit pharmaceutical products. Our implementation services ensure your operations meet all regulatory requirements while maintaining efficient distribution.
Contact us today to learn how our FMD Implementation services can establish compliant verification systems and protect your supply chain integrity.
