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Falsified Medicines Directive

Meaning

The Falsified Medicines Directive (FMD), officially Directive 2011/62/EU, is a legislative act implemented by the European Union to establish a robust framework for combating the growing threat of counterfeit and substandard medicinal products infiltrating the legal supply chain. This directive mandates a comprehensive set of security features, including a unique, verifiable identifier (a 2D data matrix) on the packaging of all prescription medicines and a tamper-evident seal. The FMD represents a critical regulatory safeguard for protecting patient safety in the administration of essential hormonal therapies.