v. 2.0 – 05/06/17

Serialization Model End-Point Authentication
Governing Body Ministry of Health
Compliance Date
  • 2010: Phase 1
  • 2012: Phase 2
Randomization Requirements No
Aggregation Requirements Not legislated, but required to meet Phase 2
Reporting Requirements
  • Product Data and Serial Numbers
  • Serial Number Hierarchies and Product Movement/Serialized Transactional Data
Date Repositories
  • iTS System is the central repository where the product data from supply chain partners is sent and stored.
  • Package Transfer System (PTS) is a file sharing platform where drug suppliers upload the serialization hierarchy and transactional data
Saleable Unit Data Carrier GS1 Data Matrix encoded with GTIN, Serial Number, Lot, and Expiry Date
Saleable Unit HRI GTIN, Serial Number, Lot, Expiry Date – preferred location next to GS1 Data Matrix
Shipping Case Data Carrier GS1 Data Matrix or SSCC18/GS1-128
Shipping Case HRI Not specified, assume at minimum data encoded in data carrier must be displayed in HRI/td>
Logistics Unit Data Carrier GS1-128
Logistics Unit HRI SSCC18
Additional Notes