FALSIFIED MEDICINES DIRECTIVE IN A EUROPEAN COUNTRY: GS1 STANDARDS STRENGTHEN PATIENT SAFETY By 2019 in Europe, prescribed medicines will be labelled with a serial number for an end-to-end authentication system along the supply chain. STEP 1 : PLACING THE SAFETY FEATURES All the medicine boxes must bear safety features: a unique identifier and an anti-tempering device.

p

manufacturer of Manufacturer medicinal product

(01) product code: 03000240000003 (21) serial number: patientsafety24 (10) lot: 0509 (17) expiry date: 990101

anti-tempering device unique identifier DataMatrix

STEP 2 : UPLOADING THE UNIQUE IDENTIFIERS Manufacturers of medicinal products upload in the European or Local repositories the mandatory data and all the unique identifiers from their production.

manufacturer of Manufacturer medicinal product

poster A0.indd 1

manufacturer of Manufacturer medicinal product

Transport

wholesaler Distribution Centre

hospital

Transport

Healthcare Provider

Transport

pharmacy Pharmacy

STEP 4 : DISPENSING MEDICINES When a pharmacist dispenses a medicine to a patient, authenticity of the unique identifier is verified and desactivated in the repositories. If the unique identifier has already been desactivated, the pharmacist does not dispense and informs the authorities.

hospital or pharmacy

unique identifier A unique identifier B unique identifier C

STEP 3 : DELIVERING THE MEDICINES Manufacturers of medicinal products deliver through intermediaries along the supply chain. A wholesaler suspecting a falsified medicine can verify the safety features in the repositories.

repositories answer uploading

repositories system

DataMatrix scanning

box supplied or kept

verification in the repositories system

10/10/2016 16:25

The impact of the Falsified Medicine Directive - GS1 France.pdf ...

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