Canada – Recommended

v. 2.1 – 10/16/17

Serialization Model	TBD
Governing Body	Public Health Agency of Canada
Compliance Date	December 1, 2012: GTIN in GS1 Data Carrier December 1, 2017: Lot and Expiry Date added to GS1 Data Carrier
Randomization Requirements	TBD
Aggregation Requirements	TBD
Reporting Requirements	Register GTIN and DIN with ECCnet Registry (GS1 – GDSN Standard Database)
UoU Data Carrier	GS1 DataBar or Linear OR GS1 Data Matrix Recommended encoded with GTIN
UoU HRI	DIN and GTIN Lot & Expiry (if space is available)
Saleable Unit Data Carrier	GS1 Databar or Linear OR GS1 Data Matrix encoding GTIN (2012) Lot and Expiry Date (2017)
Saleable Unit HRI	Drug Name, Manufacturer Name, Potency, Recommended Dose, Lot Number, Expiry Date, and DIN
Intermediate Package Data Carrier	GS1-128 Linear and GS1 Data Matrix encoding GTIN (2012) Lot and Expiry Date (2017) HRI – Not Specified
Additional Notes	No Serialization Regulation exists The Canadian Pharmaceutical Barcoding Project has provided recommendations for Product Identification and for preparation for anticipated Serialization Regulation Vaccines must contain GTIN and Lot Number on the primary packaging level encoded in GS1 2D Datamatrix; Expiry is recommended but optional. Secondary packaging level for vaccines can contain either GS1 2D Datamatrix or Linear encoding GTIN, Lot Number, and Expiry Date. Case level must contain a Linear barcode encoded with GTIN, Lot number and Expiry date.