Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021

Serialisation is defined in section 4 as the unique identification of each unit of a medicine in a batch at a relevant level of packaging. This is a batch level concept: every individual unit must bear an identifier that is distinct from every other unit in the same batch across all manufacturers, not merely unique within a brand. The definition deliberately leaves open the level of packaging: it can be the primary pack, the container, or single unit packaging within a container (such as a blister segment). Serialisation does not mandate the use of a data matrix code; a medicine could be serialised using other technologies (e.g., RFID). But if a serialised medicine uses a data matrix code, it must comply with the standard.

Data matrix code is defined as a two dimensional arrangement of data consisting of blocks or dots in a square or rectangular pattern, explicitly excluding a QR code. This is a GS1 DataMatrix standard. The code is the carrier for the product and unit identifiers.

GTIN (Global Trade Item Number) is the GS1 identification key used to identify trade items. It comprises a GS1 company prefix (a licence fee based identifier), an item reference, and a check digit. The GTIN is a fixed identifier for a product, not a unique unit identifier. The combination of GTIN plus serial number yields global uniqueness.

Relevant level of packaging has three possible layers: primary pack (the complete pack supplied to consumers), container (the immediate covering such as a bottle, blister, or vial, but excluding articles intended for ingestion), and single unit packaging within a container (an individual segment of a strip or blister pack that immediately covers one dosage unit). The order does not require serialisation at all three levels - the choice is left to the manufacturer or sponsor - but whichever level is chosen must be applied consistently.

GS1 General Specifications is the private standard published by GS1 Belgium, a not for profit organisation. TGO 106 requires the data matrix code to be formatted in accordance with the GS1 DataMatrix specification as described in that standard (section 9(a)). Because the standard is incorporated “as in force from time to time”, changes to the GS1 General Specifications after 1 January 2023 are automatically mandatory.

Serial number means a number that uniquely identifies a unit of a medicine. The order does not prescribe the format or length of the serial number beyond that it must be unique when taken together with the GTIN. There is no requirement for serial numbers to be random or unpredictable (as is common in anti counterfeiting schemes used in Europe or the United States). The serial number may be generated by the manufacturer.

The order also introduces the concept of information consistency: the data matrix code must be consistent with any human readable information on the packaging (including higher and lower levels) and with any other machine readable code present. This prevents contradictory data across labelling layers. For codes on primary packs, the information must be transcribed in human readable text adjacent to the code where space permits, in accordance with GS1 General Specifications, and in a form interpretable without knowledge of GS1.

The primary duty holders are sponsors and manufacturers of medicines registered or listed on the Australian Register of Therapeutic Goods (ARTG) that are supplied in Australia. Any medicine that is not an export only medicine, not a blood product under the National Blood Arrangements, not a section 19/19A supply, and not a Schedule 5 item 1 import, must comply if it uses serialisation or if it bears a data matrix code containing a GTIN at a relevant level of packaging.

The order does not mandate serialisation. It only sets requirements for those who voluntarily adopt serialisation or who voluntarily apply a GTIN bearing data matrix code. However, the practical reality is that many manufacturers already apply GS1 DataMatrix codes for supply chain efficiency or international regulatory compliance (e.g., European Falsified Medicines Directive or US DSCSA). Those manufacturers will now need to ensure their codes include a unique serial number (if they serialise) and comply with the format and readability requirements.

Pharmacists, medical practitioners, dentists, and optometrists who extemporaneously compound or dispense medicines are indirectly affected by the exemption in section 7(2)-(3). If they receive serialised medicines without a data matrix code (i.e., serialised using other means) but the medicine already has a data matrix code containing a GTIN for a purpose other than serialisation (e.g., for stock control), those units must still comply with sections 9 and 10. This imposes obligations on the supply chain for compounded medicines that are not themselves subject to serialisation by the manufacturer.

Small manufacturers face a disproportionate compliance burden. The cost of obtaining a GS1 company prefix, implementing serial number generation systems, printing high quality DataMatrix codes, and verifying machine readability over shelf life, can be significant. The order does not provide any transitional relief or cost sharing mechanism. Because the GS1 General Specifications are incorporated by reference as amended from time to time, small entities must monitor changes to that private standard or face non compliance without notice.

Contract packers and repackagers who apply labels to medicines must ensure that any data matrix code they apply meets all requirements. If a medicine is repackaged into a different primary pack that already carries a GTIN code from the original manufacturer, the repackager may inadvertently create a unit that is not globally unique (if they reuse the original serial number) or may cause inconsistency between the code and the new label. The order does not address repackaging; the duties likely fall on the entity that applies the label.

Regulators including the Therapeutic Goods Administration must enforce the standard. They may need to develop guidance on what constitutes “minimise the risk of inadvertent reading” (section 9(b)) and what “adjacent” means for human readable transcription (section 10(4)(a)).

The order imposes no obligation to serialise or to apply a data matrix code. The duties are conditional: if a medicine is serialised, the data matrix code (if used) must contain GTIN plus serial number (section 8(1)). If the code is applied to the primary pack, it must also contain batch number and expiry date (section 8(3)). The data elements must, when taken together, globally uniquely identify each unit (section 8(2)). This is not simply uniqueness per manufacturer but global uniqueness.

Formatting duties under section 9: the code must conform to GS1 DataMatrix format as in the GS1 General Specifications (section 9(a)). It must be applied to the label to minimise the risk of inadvertent reading of other machine readable codes (section 9(b)). This prevents interference with existing barcodes (e.g., traditional linear barcodes). The code must remain machine readable for the entire shelf life of the medicine (section 9(c)). This duty is demanding: if the ink fades, the label is smudged, or the packaging degrades, the code becomes non compliant. The manufacturer bears the risk of label durability.

Information consistency duties under section 10: the data in the code must be consistent with all human readable information on the packaging at any level, and with any other machine readable code. This includes product information and consumer medicine information if the code provides access to those documents. If the code links to product information, it must identify the current approved version (section 10(2)). If it links to consumer medicine information, it must identify the most current version (section 10(3)). For codes on primary packs, the data elements (GTIN, serial number, batch, expiry) must be transcribed in human readable format adjacent to the code, where space permits, and in a form that a user can interpret without knowledge of GS1 specifications (section 10(4)). The “where space permits” qualification leaves room for subjective interpretation; the TGA may need to provide guidance on what constitutes insufficient space.

Rights: The order confers no new rights on manufacturers or sponsors. It does not create a right to use a serialisation system or to access GS1 specifications free of charge. It does not provide for exemptions or individual dispensations beyond those already listed in section 6.

Exemptions: Medicines supplied under section 19 (emergency or individual patient supply) or section 19A (imported unapproved therapeutic goods) are wholly excluded. Blood and blood products under the National Blood Arrangements that follow the Barcode Specifications are excluded. Export only medicines are excluded. Medicines in Schedule 5 item 1 (importer’s own use) are excluded.

TGO 106 does not itself prescribe penalties. It is a standard made under section 10 of the Therapeutic Goods Act 1989. A failure to comply with the standard means the medicine may not be compliant with its ARTG listing or registration conditions. The Therapeutic Goods Act 1989 provides for a range of enforcement actions for non compliance with standards, including:

• suspension or cancellation of the medicine’s registration or listing;
• issuance of a recall notice;
• civil penalties for supplying goods that do not conform to a prescribed standard;
• criminal prosecution in serious cases (e.g., knowingly supplying non compliant goods that could cause harm or deception).

Because the order references the GS1 General Specifications as in force from time to time, any change to that private standard can immediately render existing stock non compliant. The enforcement risk is asymmetric: manufacturers bear the cost of ensuring their codes remain compliant without any public notice of changes to the incorporated standard.

The order does not require the submission of serial numbers to the TGA or any government database. There is no Australian central repository for serial numbers. The penalty risk arises only if the physical code is found to be non compliant during an inspection or audit. The standard does not require batch inventory reconciliation or verification of serial numbers at the point of dispensing, so enforcement may be limited to label inspection rather than supply chain integrity.

The order also does not require verification of serial numbers at subsequent packaging levels or at import. A medicine that is serialised in compliance with the order could still be counterfeit if the serial numbers are copied; the standard does not include cryptographic authentication mechanisms.

Because the order is a legislative instrument, failure to comply may also be a contravention of the Therapeutic Goods Act 1989 with potential criminal penalties under sections 41, 46, or 61 (depending on the nature of the supply). The maximum penalties for supplying non compliant therapeutic goods can be significant (hundreds of penalty units for individuals and corporations). However, the order itself does not specify penalty amounts.

TGO 106 operates under the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990. It is one of many therapeutic goods orders (TGOs) that prescribe standards for medicines. It interacts with:

The TGA’s existing labelling and packaging requirements (including TGO 91, TGO 92, TGO 95, and others) which require certain information in human readable form. The data matrix code must be consistent with those requirements (section 10(1)). If a medicine’s label already includes a batch number and expiry date in text, they must match the information in the code.

The GS1 General Specifications is incorporated by reference as a dynamic standard. This means any updating of that standard by GS1 automatically amends TGO 106 without parliamentary scrutiny. The TGA may choose to publish a notice when GS1 changes its specifications, but is not obliged to. This raises rule of law concerns: regulated entities must monitor a private organisation’s publications to know their legal duties.

The Barcode Specifications for blood and blood products (published by the National Blood Authority) applies instead of TGO 106 to those products that comply with it. This creates a separate regime for blood products compared to other medicines, potentially increasing complexity for entities that handle both categories.

State and territory poisons legislation is not directly affected, but the data matrix code could be used to identify schedule 4 or schedule 8 medicines. The order does not mandate that the code indicate the poisons schedule.

The Privacy Act 1988 may be relevant if serial numbers are linked to patient dispensing records. The order does not address data protection, but the unique identification of each unit could be used to track individual patient usage if linked by a pharmacy system.

The Competition and Consumer Act 2010 may apply if compliance with TGO 106 imposes barriers to entry or if GS1’s licensing fees constitute an anti competitive practice. The order effectively mandates the use of GS1 identifiers, which is a private proprietary system, potentially creating a monopoly.

International regulatory harmonisation: TGO 106 is similar to but not identical with the EU Falsified Medicines Directive or the US Drug Supply Chain Security Act. The Australian standard does not require tamper evident packaging, cryptographic verification, or point of dispense authentication. Manufacturers exporting to Australia from the US or EU may need to modify their codes to comply.

The instrument as provided is the original order made on 24 March 2021, with commencement of all provisions on 1 January 2023. There is no amendment history recorded in the text. The order was made by Dr Jane Cook as delegate of the Minister for Health and Aged Care.

Because the order incorporates the GS1 General Specifications “as in force from time to time”, it has effectively been amended each time GS1 updates that private standard. Such amendments are not legislative and do not go through parliamentary processes. From the perspective of the Commonwealth legislative register, no formal amendments have been made to the sections of TGO 106 itself as of the date of this analysis.

The commencement table shows only one provision (the whole instrument) commencing on 1 January 2023. No transitional provisions or savings provisions are included. The order applies immediately upon commencement to all medicines that meet the criteria on that date, without a phase in period. Manufacturers and sponsors had approximately 21 months from the making date (24 March 2021) to the commencement date to achieve compliance, but that period was not prescribed as a transition.

The note to section 6 explains that the Barcode Specifications for blood and blood products is the version existing at commencement, meaning it is static, not dynamic. This creates an inconsistency within the instrument: one incorporated standard is static, the other is dynamic.

There is no reported litigation concerning TGO 106 as of the text provided. The instrument was made in March 2021 and commenced in January 2023. The absence of litigation may reflect that the compliance period had not yet passed or that challenges are likely to arise rather from enforcement actions than from pre emptive challenges.

Potential grounds for future litigation include: (1) challenge to the validity of the dynamic incorporation reference on the grounds that it delegates legislative power to a private body without adequate parliamentary oversight (a common law rule against sub delegation); (2) challenge that the order is ultra vires section 10 of the Therapeutic Goods Act if it imposes a standard that is not a “standard” within the Act’s definition (e.g., if it imposes a requirement that is not related to quality, safety, or efficacy); (3) challenge that the order creates an unreasonable restraint of trade by mandating use of GS1 identifiers, which require payment of fees; (4) challenge on the basis that the requirement for global uniqueness of serial numbers is impossible to verify or that it imposes an unreasonable burden on small business without legislative authority.

No case law has been cited in the instrument or explanatory materials. The lack of litigation may also reflect that most major pharmaceutical companies already comply with similar requirements in other jurisdictions and have not resisted the domestic standard.

The TGA has not published any enforcement actions specifically under TGO 106. However, the broader scheme of the Therapeutic Goods Act includes numerous successful prosecutions for supply of non compliant goods. It is reasonable to expect that compliance with TGO 106 will be checked during routine inspections and that non compliance could lead to costly recalls.

Gotcha 1 - Serialisation is voluntary but the code may not be. Many manufacturers may assume that because serialisation is not mandatory, they have no obligations. However, if they apply any data matrix code containing a GTIN to a unit (even for non serialisation purposes such as inventory management), sections 9 and 10 apply immediately. This catches medicines coded for internal purposes. The only way to avoid the standard entirely is to use no data matrix code with a GTIN at all.

Gotcha 2 - GS1 General Specifications can change without notice. The dynamic incorporation means that a change to the GS1 DataMatrix format (e.g., new error correction requirements) would automatically become part of Australian law. Manufacturers could find their existing labels non compliant overnight. There is no grandfathering for stock already labelled under the previous version, unless the TGA issues a transitional instrument (which it has not done).

Gotcha 3 - Global uniqueness is required, not just Australian uniqueness. Section 8(2) says the data elements must “uniquely identify each unit of the medicine globally.” This means the same GTIN plus serial number combination cannot exist anywhere in the world on a different unit of the same product. Manufacturers must coordinate with their contract manufacturers, overseas affiliates, and third party repackagers to avoid duplication. There is no clearinghouse for serial numbers in Australia; the obligation is on the manufacturer.

Gotcha 4 - Human readable transcription requirement is ambiguous. Section 10(4) requires the information in the code to be “transcribed in human readable format … located adjacent to the data matrix code, where space permits.” The phrase “adjacent” is not defined. A code in a corner of a blister pack may have limited adjacent space. The TGA’s interpretation of “adjacent” could vary. Also, the transcription must be “in a form that would enable a user to interpret the information without knowledge of the GS1 General Specifications” - meaning a user must be able to read the GTIN digits, serial number, batch, and expiry without a decoder. This could force larger font sizes and additional space on already crowded labels.

Gotcha 5 - Machine readable for the entire shelf life is a material durability requirement. If a label fades, smudges, or becomes damaged during storage or dispensing, the code may cease to be readable. The manufacturer bears the risk for the entire period from manufacture to expiry. This may require expensive label materials and printing verification systems.

Gotcha 6 - No exemption for existing stock. The order commenced on 1 January 2023 with no transitional provisions. Any medicine manufactured before that date but supplied after must comply if it carries a GTIN bearing data matrix code and is not excluded. This could require relabelling of already packed stock.

Gotcha 7 - Narrow dispenser exemption is easily lost. The section 7(2) exemption only applies if the medicine is “serialised without the application of a data matrix code” and has a code containing a GTIN for a purpose other than serialisation, and the medicine is dispensed/compounded for a particular person by an authorised practitioner. If any of these conditions is missing (e.g., the medicine is also serialised via a data matrix code, or the code is applied for serialisation purposes, or the supply is not patient specific), then sections 9 and 10 apply fully.

Step 1 - Determine whether TGO 106 applies. Review the medicine’s ARTG entry. If it is an export only medicine, a section 19/19A supply, a blood product under the National Blood Arrangements, or a Schedule 5 item 1 medicine, it is excluded. For all other medicines, determine whether the medicine is serialised and whether any data matrix code containing a GTIN is applied at a relevant level of packaging (primary pack, container, or single unit packaging).

Step 2 - Obtain a GS1 company prefix if you do not already have one. A data matrix code must contain a GTIN, which requires a GS1 company prefix. The prefix is obtained from GS1 Australia, a member organisation of GS1. Fees apply and are based on annual revenue. Without a valid prefix, the GTIN will not be globally unique.

Step 3 - Choose a relevant level of packaging for serialisation. Most commonly this is the primary pack (the unit dispensed to the patient). Consider whether the primary pack is the same as the container (e.g., a bottle) or whether there is a separable single unit (e.g., a blister segment). Serialisation at multiple levels is permitted but not required. Ensure consistency: if both levels have codes, the GTIN must be consistent and the serial numbers must be unique.

Step 4 - Generate serial numbers that are unique globally when combined with the GTIN. There is no prescribed format, but numbers must not duplicate any other unit of the same GTIN in the batch. A serial number must be unique at least per batch; ideally it should be random to reduce counterfeiting risk.

Step 5 - Design the data matrix code in accordance with the GS1 DataMatrix specification (current version in the GS1 General Specifications). The code must include at minimum: GTIN (application identifier 01) and serial number (application identifier 21). If applied to the primary pack, also include batch number (application identifier 10) and expiry date (application identifier 17). The code must be formatted per GS1 syntax.

Step 6 - Print the code on the label using a process that ensures high quality and durability. The code must remain machine readable for the shelf life. Conduct readability testing under simulated storage conditions (temperature, humidity, light, abrasion). Avoid placing the code near folds, creases, or areas prone to wear.

Step 7 - Minimise interference with other machine readable codes. If the label already has a linear barcode or other 2D code, position the data matrix code so that a scanner is unlikely to read the other code inadvertently. This may require different orientations, gaps, or area separation.

Step 8 - Ensure information consistency. Check that the GTIN, batch number, expiry date, and serial number in the data matrix code exactly match the human readable text on the label. Also check consistency with any other machine readable code. If the code links to an electronic version of product information or consumer medicine information, ensure the link points to the current approved version.

Step 9 - Add human readable transcription for primary pack codes. Place the decoded information (GTIN digits, serial number, batch, expiry) next to the data matrix code, where space permits. The font must be legible without scanning. If space does not permit, document the reason.

Step 10 - Maintain records of serial number allocations to demonstrate uniqueness. While not required by the order, good practice is to keep a log of serial numbers for each batch to assist in event of a recall or non compliance investigation.

Step 11 - Monitor changes to the GS1 General Specifications. Subscribe to GS1 update notifications. When a new version is published, assess whether your codes remain compliant. If not, update your label designs and implement the change before the effective date.

Step 12 - Verify ongoing compliance through periodic audits of labelled stock and supplier compliance. If using contract manufacturers, include TGO 106 compliance in supply agreements and conduct due diligence.

Step 13 - For non serialised medicines that carry a GTIN code, only steps 1, 2, 5, 6, 7, 8, and 11 apply. Step 9 (human readable transcription) does not apply unless the code is on the primary pack, but note the “where space permits” exception. The duties under sections 9 and 10 still bind, including the machine readability and consistency obligations.