Government agency: regulated at the country level, guided by European Medicines Verification Organisation (EMVO). Normative: Falsified Medicines Directive (FMD) / Delegated Act on safety features. Regulatory scope: serialization, reporting, product verification. Product scope: most pharmaceuticals. Participants: all. Deadline: February 2019. Codification: GS1 standard. Reporting: manufacturers reports to European Hub. Status: ongoing.