EU Falsified Medicines Directive
EU Falsified Medicines Directive is Directive 2011/62/EU, which amended the EU medicines code to keep falsified medicines out of the legal supply chain through safety features, stricter wholesale rules and controls on online pharmacies.
What it requires
Since 9 February 2019 in most Member States, prescription medicines must carry a unique identifier in a 2D barcode and an anti-tampering device, under Delegated Regulation 2016/161. Manufacturers upload identifiers to the European Medicines Verification System, and pharmacies decommission packs on dispensing. Wholesalers must verify returned and higher-risk packs, follow good distribution practice and hold licences. Online pharmacies must be registered and display the common EU logo. Member States set penalties.
Why it matters
The FMD means anyone storing or distributing prescription medicines in the EU must handle serialized packs and verification, not just licensed storage. Returns are a pressure point, because returned packs must be verified before they go back into saleable stock. For example, a pharmaceutical 3PL in Belgium handling hospital returns must scan each pack against the national verification system and quarantine any that fail, and online pharmacy clients must show the EU common logo on their sites.
Related laws
Sources
- European Commission: Falsified medicines health.ec.europa.eu
- Directive 2011/62/EU (EUR-Lex) eur-lex.europa.eu
Not legal advice.