Taiwan – Chinese Taipei

v. 2.0 – 05/06/17

Serialization Model Traceability
Governing Body Taiwan FDA
Compliance Date
  • 01/01/18: GTIN/Batch and Expiry in the relevant code with GS1 standards on Secondary and Tertiary level packs
  • 01/01/19: GTIN/Batch, Expiry and Serial Number
  • 01/01/20: “Traceability Platform” login (at risk products)
  • 01/01/21: API Serial Number (remaining products added to Traceability Platform)
Randomization Requirements No
Aggregation Requirements Not specified
Dispensing Package Data Carrier
  • Barcode (TBD): Schedule 1 and 2 controlled drugs: GTIN, Lot, and Expiry
  • All other drugs: GTIN
Dispensing Package HRI Not specified
Sales Package Data Carrier
  • Barcode (TBD): Schedule 1 and 2 controlled drugs: GTIN-14, Lot, and Expiry Date
  • All other drugs: GTIN
Sales Package HRI Not specified
Transport Package Data Carrier Barcode (TBD): GTIN, Lot, Expiry, Serial Number
Transport Package HRI Not specified
Additional Notes
  • Proposed rules specifies GS1-128 barcode carrier; however, this will likely have to be revised to allow GS1 Data Matrix, due to space considerations on labeling
  • Regulations Governing Traceability of Drugs (Translated, Original)

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