FMD — The Falsified Medicines Directive Explained
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FMD — The Falsified Medicines Directive Explained

10 June 2026 7 min readby SeriSoft Editorial Team
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A complete guide to the EU Falsified Medicines Directive — what it requires, who it affects, and how to achieve compliance.

What is the Falsified Medicines Directive?

The EU Falsified Medicines Directive (FMD, Directive 2011/62/EU and Delegated Regulation 2016/161) requires all prescription medicines sold in the EU to carry a unique identifier and tamper-evident seal.

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