v. 1.2 – 09/16/17

Serialization Model No central reporting or traceability model in effect
Governing Body Ministry of Health
Compliance Date
  • July 18, 2014 – December 31, 2015 is grandfathering period for old vignette requirements
  • January 1, 2016 is the effective date for new rule
Randomization Requirements Not specified
Aggregation Requirements N/A
Reporting Requirements N/A
Data Repositories N/A
Saleable Unit Data Carrier Three (3) total:

  • 1 linear bar code containing the AIC (marketing/product code assigned by Italian government)
  • 1 linear bar code containing the Serial Number
  • 2D Data Carrier encoded with AIC and Serial Number
Secondary Packaging Level
  • Must have an identifier called the “Bollini System”
  • Mandatory for all prescription drugs
  • Three (3) total
    • Two (2) linear barcodes (CODE 39 and ITF)
    • 2D DataMatrix (AIC and Serial Number)
  • 9-digit number assigned by the AIFA (Italian Medicines Agency)
  • Manufacturers pay AIFA for marketing authorization/purchase labels directly from the Italian Ministry of Health
Saleable Unit HRI AIC, quantity, dosage form, name of the Marketing Authorization Holder, Serial Number
Shipping Case Data Carrier Not specified
Shipping Case Package HRI Not specified
Logistics Unit Data Carrier Not specified
Logistics Unit HRI Not specified
Additional Notes
  • Does not follow GS1 standards
  • Does not adopt European Commission Model
  • Tamper evident seal required
  • Bollini’s must be applied for domestic sale; Product for export must be identified; Samples identified