Australia

v. 26 – Q2 2023

Market Executive Summary The Australian 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 Therapeutic Goods Order (TGO) No.91 and TGO No.92 are:

  1. Enhance safety and supply security
  2. Improve inventory management and financial sustainability
  3. Increase efficiencies
  4. Facilitate global compliance and benchmarking
  5. Minimizing the risk of prescribing and dispensing errors
  6. Optimizing identification and usability of necessary information

Scope:

  • 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)

Requirements Summary:

  • TGO No. 106 mandates the following of GS1 standards on the usage and application of 2D data matrix codes on prescription medicines that are / are not serialised.
  • TGO No. 106 originally suggested to include a requirement for aggregation during the 2020 industry consultation however this was modified to ensure that at least information between different packaging levels was consistent.
  • TGO No. 106 still allows non-serialised units as long as the standards for usage of 2D data matrix code is followed.

Excellis Observations and Recommendations
EAN linear barcode:

  • Companies are required to use a GS1 machine-readable code (i.e. EAN)
  • (optional) If a company chose to, they could replace the EAN and with a 2D matrix code (without serialisation – only GTIN, LOT, EXP), which would allow serialisation to be easily added at a later point in time

Serialisation

  • There are no specific requirements to serialise.
  • (optional) If companies chose to serialise, they must follow TGO 106 (which requires to follow GS1 General Specification for application of serialisation)
Key Dates
  • September 2020: TGO No. 91 & No. 92 in effect, mandating machine-readable GS1 coding on prescription pharmaceuticals.
  • Since 1 Sept. 2020, a machine-readable GS1 code (i.e. EAN13 and/or 2D data matrix code) is required to be applied to prescription medicines. If using EAN13, it is encouraged to also apply a 2D data matrix code to encode the GTIN-14 in additional to LOT, EXP and SN.
  • January 1, 2023: TGO No. 106 mandate the following of standards for application of serialisation and 2D data matrix codes for prescription medicines.
  • TGO performed an industry consultation on TGO No. 106 which resulted in extending the requirement from July 1, 2021 to January 1, 2023

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