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Australia Regulatory

Regulatory For

Pharma

Regulatory Agency


Therapeutic Goods Administration (TGA) — under the Australian Government Department of Health is responsible for medicines regulation in Australia, including serialization guidance.

Regulation Name


Therapeutic Goods (Medicines – Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021 — technical standard outlining serialization and data matrix code requirements for medicines.

Compliance Dates


Effective from: 1 January 2023 for medicines released for supply that are serialized or using a GTIN-encoded data matrix.

Applies to

Applies to medicines supplied in Australia that are:

• Serialized; or
• Contain a data matrix code with GTIN encoding.

Non-serialized products without GTIN-encoded data matrix have no requirements under TGO 106.

Free Samples must be marked?There is no specific requirement in TGO 106 that free samples must be marked with serialization or data matrix codes. The order applies only to products meeting serialization or data matrix criteria.

SECONDARY PACKAGING

(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)

Barcode Symbology
GS1 DataMatrix (2D) barcode is required for serialized units.

Other machine-readable codes (QR, linear) can be present but do not substitute the GS1 DataMatrix for serialization purposes
Barcode Content


For serialized primary packs under TGO 106, the minimum data elements
in the DataMatrix are:

  • GTIN
  • Batch/Lot Number
  • Expiry Date
  • Serial Number


If the container is serialized, the DataMatrix must encode:

GTIN

Serial Number only.

 

Serial Number Randomization
Serialization guidance recommends serial numbers be randomized to avoid predictability, as per GS1 General Specifications referenced in the TGO 106 guidance.
Serial Number Reuse


GS1 standards, referenced by TGO 106, state serial numbers should
not be duplicated for the same GTIN, effectively no reuse within
the same GTIN context.

Human Readable Expiry Date Format


The guidance requires that human-readable transcription of encoded
data align with GS1 formatting and standard expiry notation as per
GS1. This means expiry must be clearly human-readable adjacent to
the DataMatrix.

Barcode Data Encoding


Encoded using GS1 Application Identifiers (AIs) and formatted
according to GS1 General Specifications for a GS1 DataMatrix.

Product Code Notes

•    TGO 106 does not require serialization of every medicine;
compliance is conditional on whether the product is serialized or
has a GTIN-encoded DataMatrix.

Free Samples must be marked?

no explicit serialization/marking requirement for free samples in
TGO 106.

AGGREGATION DATA CAPTURE

Parent-Child Mapping Aggregation Capture?
 
•  TGO 106 recommends labeling of logistic units such that hierarchical parent-child relationships can be established, but this is advisory, not a strict reporting mandate.

DATA EXCHANGE

Send Unit Data to Government Repository?
No.
TGO 106 does not include any requirement for reporting serialized
data to a government repository or central database. It focuses on label
content requirements.
Send Unit Data to Third-Party Repository?


No mandatory requirement. Australia’s standard does not mandate
submission of serialized unit data to any third-party repository.

Send Unit Data to Trading Partner?


Not mandated under TGO 106. While GS1 standards and supply chain
best practices support partner data sharing, the Australian
regulation does not require this.

Send Aggregation Data to Government Repository?
No — aggregation data reporting is not required by TGO 106. The standard
only recommends hierarchical labeling.
Send Aggregation Data to Third-Party Repository?


Not required. Australia’s current regulatory standard does not
mandate submission of aggregation data to third-party systems.

Send Aggregation Data to Trading Partner?

Not required by regulation. Sharing such data is a business
practice, not a statutory mandate.

AUTHENTICATION

Who Offers Data Repository for Authentication?Australia does not currently have a centralized government repository or
authentication database for serialized pharmaceutical units. Any such
capability would be part of future traceability initiatives; it is not
mandated by TGO 106.
Manufacturers Must Register Shipments in Repository?

No. There is currently no governmental serialization repository to
register shipments against per TGO 106.

Downstream Trading Partners Must Authenticate on Receipt?

No. TGO 106 does not mandate scanning or authentication at receipt
for downstream partners, as it does not define a traceability
ecosystem with repositories.

Downstream Trading Partners Must Authenticate on Shipment?
 No. Similarly, there is no regulatory requirement for verification at
shipment in the current standard.

GOVERNMENT REPORTING

Manufacturer Activity Reported? No reporting requirement exists in the current serialization standard (TGO 106) for manufacturers to submit activity data to any database.
Downstream Trading Partner Activity Reported?

No. TGO 106 does not require downstream partners to report
activities in any national system.

Source and Credit: This information is fully or partly based on the GS1 master document (all rights reserved). As GS1 does not control the content of the information, GS1 shall not be held liable, under any circumstance, if it differs from the master document.

DISCLAIMER

This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just a possible interpretation of information available in the public domain and that interpretation is subject to change. This information does not constitute legal advice.

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