FMD

Falsified Medicines Directive.

The Falsified Medicines Directive (FMD) is a European Union regulation that aims to prevent the entry of falsified medicines into the legal supply chain. The regulation was introduced in 2011 and became fully effective in 2019. The FMD requires pharmaceutical manufacturers, wholesalers, and other stakeholders to implement a series of measures to ensure the integrity of the medicines supply chain. These measures include the use of unique identifiers on individual medicine packs, such as a 2D barcode and anti-tampering device, to enable tracking and tracing of the product throughout the supply chain.

The FMD also requires pharmaceutical manufacturers to verify the authenticity of individual medicine packs before they are distributed to the market. This is done through a centralized database known as the European Medicines Verification System (EMVS), which enables the verification of the unique identifier on each medicine pack. The FMD aims to protect patients from the harm caused by falsified medicines, which can be ineffective, harmful, or even deadly. By ensuring the integrity of the medicines supply chain, the FMD helps to ensure that patients receive safe and effective medicines.