EU-FMD-FALSIFIED-MEDICINES

EU anti-counterfeiting pharma directive.

Definition

FMD = Directive 2011/62/EU + Delegated Regulation 2016/161. Mechanisms: per-box Data Matrix serialisation, anti-tampering device (vignette or seal), upload to national EMVS hub (NMVO), dispensing verification, decommission. EMVO (European Medicines Verification Organisation) coordinates. 33 countries connected in 2024.

Origin

Directive 2011/62/EU adopted 8 June 2011 ; application 9 February 2019.

Example in context

Sanofi serialises its Plavix 75mg box ; each serial uploaded to CIP-Medicaments (France NMVO) ; pharmacist scans and verifies in 250ms.

Related terms

• GS1 DataMatrix Pharma — marking.