v. 28 – Q4 2023

v.28 Q4 2023 update: Updates on Italy and Greece and e-PIL.

Market Executive Summary Process: Systematic end-to-end verification (“before being dispensed to patients e.g. at pharmacy level”) supplemented by risk-based verifications by wholesale distributors: “Medicines at higher risk of falsification (returns or medicines not being distributed directly by manufacturers or marketing authorisation holders or wholesalers distributing on their behalf)”

System: Central European Hub and National Medicines Verification Systems in every participating market (Note: Belgium/Luxembourg and Switzerland/Liechtenstein both share a multi-market repository)

Safety Features: 4-data Element Unique Identifier plus mandatory anti-tamper device

Key Dates
  • Q3 2025: Compliance becomes mandatory in Switzerland (see note 6)
  • February 9, 2025: Compliance date for Italy and Greece
  • December 31, 2024: End of EU-FMD application to UK-NI
  • December 31, 2020: Potential end-date for UK (Brexit)
  • February 9, 2019: Compliance across all 26 Member States (+ 3 EEA)