v. 2.0 – 05/07/17

Serialization Model	Serialization No aggregation or verification requirements Blood products only
Governing Body	Australian Government Department of Health and Aging
Compliance Date	January 1, 2016: Transition Labeling begins January 1, 2017: GS1 Data Matrix encode with GTIN, Lot, Expiry, and Serial Number January 1, 2018: Transition labels cease January 1, 2019: Supply Chain ISBT 128 (fresh blood products) transition marking cease
Randomization Requirements	TBD
Registration Requirements	Register all GTINS with National Blood Product Catalogue; No Database
Aggregation Requirements	No
Fresh Blood Products	ISBT 128 Data Matrix DIN
Unit Data Carrier	2D Data Matrix GTIN, Lot, Expiry, and Serial Number provided in a form
Unit HRI	2D Data Matrix GTIN, Lot, Expiry, and Serial Number provided in a form
Intermediate Package Data Carrier	GS1 Data Matrix or GS1 – 128 Linear Bar Code encoded with GTIN, Serial Number, Lot, Expiry Date
Intermediate Package HRI	GS1 Data Matrix or GS1 – 128 Linear Bar Code encoded with GTIN, Serial Number, Lot, Expiry Date
Logistics Unit Data Carrier	SSCC-18
Logistics Unit HRI	SSCC-18
Additional Notes	GS1 Generation Specification accepted; recommended use of GLN All products supplied must fully comply with the GS1 Data Matrix elements identified in the Barcode specifications for blood and blood products funded under the National Blood Arrangements Guidance Documents (3): Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (link is external) (TGO 91) Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (link is external) (TGO 92)