| Market Executive Summary |
The Therapeutic Goods Administration (TGA) issued requirements to improve the accuracy of medicine dispensing via labelling changes, which include the addition of a mandatory machine readable GS1 Barcode for prescription medicines. The documented objectives of TGO No.91 & TGO No.92:
- Enhance safety and supply security
- Improve inventory management and financial sustainability
- Increase efficiencies
- Facilitate global compliance and benchmarking
- Minimizing the risk of prescribing and dispensing errors
- Optimizing identification and usability of necessary information
- Prescription medicines (product coding mandated by TGO No.91, serialization mandated by TGO No.106)
- OTC medicines (product coding recommended but not mandated under TGO No. 92)
Serialization requirements are not being placed upon OTC and prescription medicines; however, it is mandated at minimum that a machine-readable GS1 code (i.e. EAN-13 or GS1 2D Data Matrix) is applied to prescription medicines from September 1, 2020. The EAN-13 linear barcode should remain on the packaging to support legacy systems. It is encouraged to use an additional machine-readable code (Data Matrix), which will contain the GTIN and additional information, such as LOT, EXP, S/N, and potentially Date of Manufacture:
- TGO No.106 specifies that prescription medicines must be individually serialized when they carry any GS1 machine readable code, which contains the GTIN.
- If the secondary packaging contains (i.e.) a GS1 Digital-Link code with an embedded GTIN and Serial Number, then an additional 2DM must be applied, which contains the same information in addition to the additional required information.
- TGO No.106 also specifies that when serialized units are packaged within logistics units, they must be able to be identified from the logistical unit with the use of aggregation.
COVID-19 Update:
Publication/News: No impacts to labeling regulation timeline. |
| Key Dates |
Pharmaceutical Products
- July 1, 2021: TGO No.106 in effect mandating serialization for prescription pharmaceuticals that carry a GS1 Data Matrix, which contains a GTIN, in addition to mandating aggregation where serialized products are transported in logistic units.
- September 1, 2020: TGO No. 91 & No. 92 in place effecting new coding mandates on prescription pharmaceuticals.
- July 1, 2020: TGO No.106 implemented with a 12-month delayed commencement period.
- July 1, 2017: TGO No. 69 enforced until August 31, 2020 when TGO No.91 and 92 come into effect.
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