| Serialization Model |
Track and Trace |
| Governing Body |
ANMAT |
| Compliance Date |
- January 26, 2017 – API Products List Annex I & II, all new + Special Condition Product
|
| Randomization Requirements |
No |
| Aggregation Requirements |
Yes – for logistical efficiencies |
| Reporting Requirements |
Supply chain event data and statuses |
| Date Repositories |
ANMAT central repository – National Traceability System (GLN required to be reported, along with other key data) |
| Saleable Unit Data Carrier |
GS1 Data Matrix encoded with GTIN, Serial Number, Lot, Expiry Date |
| Saleable Unit HRI |
GTIN and Serial Number |
| Intermediate Package Data Carrier |
GS1 Data Matrix or GS1 – 128 Linear Bar Code encoded with GTIN, Serial Number, Lot, Expiry Date |
| Intermediate Package HRI |
GTIN and Serial Number |
| Logistics Unit Data Carrier |
SSCC-18 is recommended by ANMAT |
| Logistics Unit HRI |
N/A |
| Additional Notes |
|
