European Union

v. 2.0 – 05/06/17

Serialization Model
  • End-to-End Verification
  • All prescription medicines (unless white-listed)
  • No OTC medicines (unless blacklisted)
Governing Body European Union
Compliance Date
Randomization Requirements Yes
Aggregation Requirements No

  • However, trading partners may require aggregation. Delegated regulation allows for verification using aggregation
Reporting Requirements EMVO/NMVO Registration
Aggregation Requirements
  • Europe-wide Repository
  • Setup and managed by stakeholders, with supervisory access granted to National Authorities
Saleable Unit Data Carrier 2D DataMatrix containing GTIN, Serial Number, Lot, and Expiry Date (plus an additional natural reimbursement number if required by some member states, see additional notes)
Saleable Unit HRI GTIN, Serial Number, Lot, and Expiry Date
Intermediate Package Data Carrier Not specified
Intermediate Package HRI Not specified
Logistics Unit Data Carrier Not specified
Logistics Unit HRI Not specified
Additional Notes