v. 2.0 – 05/06/17

Serialization Model Track and Trace
Governing Body Islamic Republic of Iran’s Ministry of Health & Medical Education
Compliance Date December 22, 2014
Randomization Requirements No
Aggregation Requirements Not Currently Required
Primary Package Data Carrier N/A
Primary Package HRI N/A
Saleable Unit Data Carrier GS1 Data Matrix encoded with UID, GTIN, Lot, and Expiry Date (20x40mm with white background and yellow margin)
Saleable Unit HRI UID, GTIN, Lot, Expiry Date, and Scratch-off on the label
Intermediate Package Data Carrier Not specified
Intermediate Package HRI Not specified
Logistics Unit Data Carrier Not specified
Logistics Unit HRI Not specified
Additional Notes
  • To satisfy this requirement, some organizations may apply a sticker to the saleable units being sold in Iran, which contains the required data carrier and HRI. Previously labeled packages should be re-labeled.
  • D / 644 / 18756
  • UID = is required to be a 20-digit number: the first 4 or 5 digits of the UID identify the company generating the UID and the remaining numbers are randomly generated
  • Label: in addition, a 16-digit number has to be printed under the scratch label for the patient or end user to use for authentication purposes