GST-free Supply (Drugs and Medicinal Preparations) Determination 2025

The Determination operates by mapping regulatory classification and product characteristics to tax treatment. Its primary legal mechanism is presumptive classification: it declares that, for the purposes of a defined paragraph of the GST Act (paragraph 38-50(5)(b)), a specified group of supplies are GST-free where the three stated conditions are all satisfied (s 6(1)).

Three core concepts structure the rule:

1. Regulatory trigger: required registration or listing under the Therapeutic Goods Act 1989 (s 6(1)(a)). The tax effect depends on the product’s status under another statute. That cross-reference converts a regulatory status (TGA registration/listing, or inclusion in a class that must be registered or listed) into a tax determinant. The Determination therefore imports administrative classifications from the Therapeutic Goods Act regime into GST law.

2. Active ingredient content: the product must contain aspirin, paracetamol or ibuprofen (s 6(1)(b)). The Determination is not framed by therapeutic category alone; it requires (positively) presence of specified active ingredients. The condition is satisfied by containing at least one of the three named drug substances. The instrument contains no concentration threshold, formulation cut-off or exemption for ancillary presence; it is silent on quantification and leaves that to interpretive application.

3. Route of administration: the product must be intended to be taken by mouth (s 6(1)(c)). The determination therefore limits GST-free status to oral-use products. The instrument does not define “taken by mouth” within its text. Because the Determination cross-refers to intent, the route-of-administration requirement may turn on labelling, product instructions, marketing claims, and the therapeutic indications that appear in TGA registration/listing documents.

Additional structural concepts present in the instrument:

• Statutory authority: the instrument explicitly records the head of power under which it is made, paragraph 177-10(4)(c) of the GST Act (s 3). The instrument does not include an explanatory memorandum or express policy statement within its text; its legal effect is as a statutory instrument made under that paragraph.

• Definitions framing: the instrument declares that “Act” means the GST Act and notes that key terms are defined in the Act (s 4). Therefore, the meanings of “supply” and “GST-free” are controlled by the Act rather than the Determination itself.

• Repeal mechanism: Schedule 1 repeals the whole of the GST-free Supply (Drugs and Medicinal Preparations) Determination 2015, indicating that the 2015 instrument no longer applies from the commencement date (Schedule 1 item 1).

Because the rule is conjunctive, all three elements must be satisfied for GST-free treatment to apply. The Determination provides a qualifying gateway that is narrow in structure (regulatory status plus specific active ingredients plus oral administration) rather than broad (for example, all therapeutic drugs or all over-the-counter medicines). The instrument’s silence on evidentiary mechanics, thresholds, and transitional rules leaves those matters to implementation under the Act and to the administrative practice of relevant regulators and the Commissioner of Taxation.

The Determination affects any party involved in the manufacture, importation, supply, distribution, retailing, accounting for, or purchase of drugs and medicinal preparations that could fall within the three-part test in s 6(1). That includes, at minimum:

• Manufacturers and formulators who produce products containing aspirin, paracetamol or ibuprofen and who seek or hold TGA registration or listing, or whose products fall within a class required to be registered or listed under the Therapeutic Goods Act 1989 (s 6(1)(a)-(b)). The interaction with TGA classification means upstream producers will need to check how their products are registered or listed, and whether class-based registration/listing obligations apply.

• Importers and overseas suppliers whose goods are imported for supply in Australia if the imported goods contain one of the specified active ingredients and are intended for oral use, and are required to be registered or listed under the Therapeutic Goods Act (s 6(1)). Importers often control customs classification and GST accounting at the border; the Determination will affect how those entities classify goods for GST purposes from the commencement date.

• Wholesalers, pharmacies, supermarkets and other retailers who supply these products to end consumers. Where a supply meets the s 6(1) criteria, the supply will be GST-free, with implications for pricing, invoicing and GST accounting at point of sale. Retailers therefore must be able to identify qualifying SKUs and apply GST treatment accordingly.

• Accountants, tax agents and compliance advisers who prepare GST returns, tax invoices and compliance systems for suppliers and retailers. The Determination creates a categories-based rule that will require updates to GST coding, point-of-sale systems, and internal controls. Because the instrument refers to TGA registration/listing, advisers will need to liaise with clients’ regulatory documentation when advising on GST treatment.

• Consumers are indirectly affected through changes in GST application. Supplies that meet the test will be GST-free from 1 October 2025 (s 2), which may change final prices or allocation of tax-inclusive pricing. The instrument itself does not mandate pass-through of any tax saving to consumers; that is a commercial pricing decision of suppliers.

• Traders of related products: firms selling similar analgesic products that do not meet one or more of the criteria,such as topical formulations, inhaled formulations, or products without the specified ingredients,will be affected by relative price and competitive positioning changes.

• Regulatory bodies: the Therapeutic Goods Administration (TGA) and the Commissioner of Taxation are implicated administratively. The Determination imports TGA status into tax classification (s 6(1)(a)), which will require alignment between TGA registers and suppliers’ GST treatment. The Determination does not itself create obligations for the TGA, but it raises an administrative interface between TGA registers and GST compliance.

• Entities relying on the earlier 2015 Determination: the Schedule 1 repeal overturns that instrument in full. Any supplier who relied on the 2015 Determination should reassess product treatment against the 2025 Determination’s criteria.

The instrument does not distinguish between commercial and non-commercial supplies; the operative phrase in s 6(1) is framed by reference to the Act’s paragraph 38-50(5)(b). The Note in s 4 emphasises that “GST-free” and “supply” are defined in the Act rather than in this Determination, so the population of affected transactions (taxable supplies, GST-free supplies, and interactions with input tax credits) will be determined through the Act’s definitions and rules as applied to qualifying products.

In practical terms, the immediate burden of assessment falls on suppliers and their advisers, who must check product formulations, TGA registration/listing status, labelling and intended use documentation to decide whether a supply qualifies. The commercial effect will be felt most strongly by businesses with mixed product lines where some SKUs meet the s 6(1) criteria and others do not.

The Determination itself prescribes tax classification, not duties and offences. Its legal effect is to declare that, for the purposes of paragraph 38-50(5)(b) of the Act, supplies meeting the s 6(1) criteria are GST-free. That declaration gives suppliers a right to treat qualifying supplies as GST-free under the GST Act, and conversely imposes an implicit duty to apply GST treatment consistent with the Act and supporting administrative practice. The instrument does not set out record-keeping requirements, evidentiary thresholds or procedural steps; those obligations originate in the Act and in the administrative practice of the Commissioner of Taxation.

Immediate practical duties and entitlements arising from the Determination are these:

• Right to GST-free treatment where s 6(1) is satisfied: suppliers are entitled to classify a supply as GST-free if the supplied product is required to be registered or listed under the Therapeutic Goods Act 1989 (or is included in a class of goods required to be registered or listed), contains aspirin, paracetamol or ibuprofen, and is intended to be taken by mouth (s 6(1)). That entitlement should be exercised in accordance with the Act’s definitions of “GST-free” and “supply”, which the Determination incorporates by reference (s 4 Note).

• Duty to correctly determine GST treatment: while the Determination does not create a separate offence for misclassification, suppliers have an obligation under the GST Act to correctly account for GST in tax returns and on tax invoices. Because the Determination affects classification, suppliers must perform due diligence to ensure that supplies coded as GST-free actually meet s 6(1).

• Duty to maintain supporting documentation: the Determination’s reliance on TGA registration/listing and on product intent implies a need for suppliers to retain documentary evidence that supports GST treatment. Evidence will include TGA registration or listing numbers, product information and labelling that show oral administration intent, and ingredient declarations demonstrating presence of aspirin, paracetamol or ibuprofen. The Determination does not prescribe what constitutes sufficient evidence but the Act’s record-keeping and substantiation framework will be the operative source for any administrative review.

• Interaction with input tax credits: suppliers who make both GST-free and taxable supplies will continue to be governed by the Act’s apportionment and input tax credit rules. The Determination changes which supplies are GST-free for that purpose. Rights to input tax credits and obligations to apportion remain matters of the Act and administrative practice.

• Obligation to monitor regulatory status: because the Determination depends on TGA registration/listing (s 6(1)(a)), suppliers must monitor changes to a product’s TGA status. If a product’s registration/listing lapses, is cancelled, or its class determination changes under the Therapeutic Goods Act, its GST treatment may change.

• Effect of repeal: entities that previously relied on the 2015 Determination must reassess under the 2025 Determination because Schedule 1 repeals the earlier instrument in full. That repeal extinguishes the prior instrument’s operative rules from the commencement date; suppliers must apply the 2025 rules for supplies on or after 1 October 2025.

The Determination offers no express discretion to the Commissioner or to suppliers to extend GST-free status beyond the specified criteria. Any deviation must be effected through amendment of the Determination or by operation of other provisions of the Act. The instrument does not create a bespoke appeals process; disputes about classification will be resolved by reference to the Act and to administrative review channels available under tax law.

The Determination contains no provision creating criminal offences or bespoke penalty regimes; it is an instrument that modifies tax classification under the Act and thus is enforced and implemented through the Act’s existing compliance architecture. The instrument is explicit about its statutory pedigree, being made under paragraph 177-10(4)(c) of the Act (s 3), and it cross-refers to the Act for definitions (s 4 Note). Those references indicate that any enforcement, assessments, or penalties resulting from misapplication of GST treatment will be pursued under the GST Act and associated administrative law, not under this Determination’s text.

Concrete enforcement implications arising from the Determination are as follows:

• Classification disputes and audits: where a supplier treats a supply as GST-free under s 6(1) but the Commissioner of Taxation considers the supply does not satisfy the criteria, the supplier will be exposed to audit adjustments, liabilities for unpaid GST, interest and any penalties that apply under the Act. The Determination itself does not change the Commissioner’s powers to audit, assess or apply civil penalties; those powers are governed by the Act and general tax administration law.

• Reliance on external registers: because s 6(1)(a) imports the Therapeutic Goods Act registration/listing requirement, enforcement may involve examination of TGA registers and documents. The Commissioner will treat a supplier’s claim of TGA registration/listing as a material fact; incorrect or misrepresented registration status may lead to enforcement action under the Act.

• Evidence burden: the Determination’s silence on evidentiary thresholds implies that suppliers will need to rely on the Act’s record-keeping rules. If a supplier cannot substantiate that a product contained one of the specified active ingredients, was registered/listed as required by the Therapeutic Goods Act, or was intended to be taken by mouth, the Commissioner may disallow GST-free treatment in an audit.

• No new administrative penalty powers created here: the Determination does not create new penalty heads. Any civil penalties for false statements, incorrect GST returns, or failing to lodge returns arise under the Act’s enforcement provisions.

• Interaction with prior instrument repeal: the full repeal of the 2015 Determination in Schedule 1 could give rise to scrutiny of historical GST treatment for transactions straddling the repeal date. The Determination contains no transitional rules. Therefore, enforcement exposure for past periods is determined by the law in force for those historical periods; this instrument applies from its commencement date (s 2). Suppliers should therefore ensure their current and future GST treatments align with the 2025 Determination.

In short, enforcement is effected through the Act’s enforcement machinery rather than through new penal provisions in this Determination. The practical consequence is that misclassification can produce assessments, interest and penalties under the GST law. The Determination changes which supplies are GST-free from 1 October 2025 (s 2), thereby shifting the scope of what the Commissioner will scrutinise under the Act’s compliance framework.

This Determination is explicitly cross-referential. It declares tax treatment contingent on regulatory status under the Therapeutic Goods Act 1989 and operates under the authority of the GST Act. Two statutes are therefore directly implicated by the instrument: the A New Tax System (Goods and Services Tax) Act 1999 (the Act) and the Therapeutic Goods Act 1989.

Key interactions:

• With the GST Act: the Determination is an instrument made under the Act, specifically paragraph 177-10(4)(c) (s 3). Its operative content modifies what is GST-free “for paragraph 38-50(5)(b) of the Act” (s 6(1)). The Determination therefore sits within the Act’s statutory architecture and must be read together with the Act’s definitions and mechanisms. The instrument’s Note (s 4) points out that “GST-free” and “supply” are defined in the Act; those definitions will determine the legal effect of the Determination for particular transactions.

• With the Therapeutic Goods Act 1989: s 6(1)(a) makes GST-free status contingent on TGA registration or listing, or inclusion in a class of goods required to be registered or listed. The Determination thus imports administrative and statutory classifications from the therapeutic goods regime into tax law. That creates an interface where a product’s regulatory categorisation under the Therapeutic Goods Act directly determines tax classification under the GST Act via this Determination.

Interactions that follow from that cross-reference include:

• Administrative dependency: suppliers’ ability to claim GST-free status turns on their TGA status. If a product is listed or registered, or falls within a class requiring listing/registration, that documentation becomes the material fact for GST purposes. Changes in TGA status (registration, cancellation, reclassification) therefore affect tax treatment.

• Interpretive overlap: the concepts of “class of goods required to be registered or listed”, “contents” and “intended to be taken by mouth” may be interpreted under both regimes. The Determination does not itself define these terms and therefore the interpretation may require cross-referencing TGA definitions, product labels, TGA public assessments and the Act’s definitions. This can produce interpretive questions about whether a particular product falls within a TGA class or whether an advertised route of administration constitutes being “intended to be taken by mouth”.

• Repeal of the 2015 Determination: Schedule 1 repeals the 2015 instrument in full. That repeal interacts with prior legal positions. Any supplies previously regarded as GST-free under the 2015 Determination must now be reassessed under the 2025 Determination. The instrument does not include transitional provisions; the commencement date (s 2) determines when the new classification takes effect.

• No alteration to other regulatory obligations: the Determination does not change product-safety, labelling, advertising, therapeutic claims, manufacturing or import licensing obligations under the Therapeutic Goods Act. It uses TGA classification as an input to GST treatment but does not substitute for or modify the TGA’s regulatory control.

• Administrative coordination: because TGA registers are public, the Commissioner and suppliers can commonly cross-check claims of registration/listing. Nonetheless, the Determination introduces practical inter-agency reliance, meaning consistent record-keeping and communications between suppliers, the TGA and taxation advisers are likely to be necessary.

• No express conflict resolution mechanism: the instrument does not provide a procedure for resolving conflicts between the TGA’s classification and a supplier’s GST position. Any disputes will be managed through the Act’s review and objection processes, and through the TGA’s administrative mechanisms, as applicable.

Overall, the Determination creates a direct legal bridge between therapeutic regulation and tax treatment. The statutory cross-reference aligns tax outcomes with regulatory classification and product characteristics, but it also imports the interpretive complexity and administrative interdependence that arise when one statute’s entitlement depends on the operation of another.

The text of the Determination as provided contains its foundational history and immediate amendment event. It is the GST-free Supply (Drugs and Medicinal Preparations) Determination 2025 and contains the following amendment-history facts within the instrument itself:

• Commencement: the entire instrument commences on 1 October 2025, as specified in the commencement table in s 2. The instrument notes that the commencement table’s Column 3 is not part of the instrument and may be edited in published versions, but the Column 2 commencement date is operative (s 2(1)-(2)).

• Authority of making: the instrument states that it is made under paragraph 177-10(4)(c) of the Act (s 3). That identifies the statutory power used to make the Determination.

• Repeal of the 2015 instrument: Schedule 1 effects a repeal of the GST-free Supply (Drugs and Medicinal Preparations) Determination 2015. Item 1 in Schedule 1 repeals the whole of that earlier instrument. The 2025 Determination therefore replaces the earlier instrument from its commencement date (Schedule 1).

• No further amendments contained: s 5 states that each instrument specified in a Schedule is amended or repealed as set out in the applicable items, and that any other item in a Schedule has effect according to its terms. Other than Schedule 1’s repeal of the 2015 Determination, no other schedules or amendment items are present in the text provided.

• Definitions and Notes: s 4 establishes that “Act” refers to the GST Act and that a number of expressions used here are defined in the Act (s 4 and its Note). That is an internal definitional history point rather than an amendment history, but it affects interpretation.

The instrument contains an internal note about the commencement table: any information in Column 3 of the table is not part of the instrument and may be edited in published versions (s 2(2)). That is an administrative detail about the instrument’s publication metadata rather than an operational amendment power.

No other past amendments, saving provisions, transitional rules or staged commencements are set out in the instrument as provided. The only express historical action is the repeal of the 2015 Determination via Schedule 1. The instrument does not state whether its substantive content departs from or reproduces the content of the 2015 Determination; it simply repeals that instrument and provides a new rule. Parties affected by the change should compare the 2015 text (which is repealed) to the 2025 text to identify differences in scope or substantive effect.

Because the instrument is a statutory instrument made under the Act, future amendments to its content would similarly be effected by instruments made under the statutory power in paragraph 177-10(4)(c) of the Act. The 2025 Determination records only the present state of law: a new GST-free classification, an authority citation, a commencement date, and a schedule repealing the prior determinations listed.

The Determination contains no litigation history, case citations or references to judicial decisions. The instrument is silent on disputes, court outcomes or precedent. It is a legislative instrument that operates by modifying the GST classification of certain supplies; any litigation that arises from its operation will be in the future and will be litigated under the Act and general administrative law.

What can be stated from the instrument text:

• No cases or disputes are named or cited. The instrument makes no reference to judicial interpretation or to administrative rulings that informed its drafting.

• No specific dispute resolution or review pathway is created by the Determination itself. Disputes about GST classification that flow from this Determination will therefore be addressed through the normal objection, review and appeal mechanisms available under the GST Act and the general taxation dispute framework.

• The Determination relies on registration and listing under the Therapeutic Goods Act 1989 (s 6(1)(a)). Disputes over whether a product is, in fact, required to be registered or listed, or over whether it is included within a class required to be registered or listed, will engage the administrative and potentially judicial review processes available under that Act. The Determination does not alter those processes.

• Repeal of the 2015 Determination could give rise to litigation concerning retrospective practices, transitional issues, or reliance arguments if suppliers believed prior treatment established a settled expectation. The instrument contains no transitional provisions; any such litigation would engage ordinary principles of statutory interpretation and administrative law under the Act and relevant procedural regimes.

Because the instrument provides no litigation history, practitioners and affected parties should anticipate that disputes will be processed under the standard tax and administrative law frameworks. Where an issue involves interpretation of what it means to be “intended to be taken by mouth”, what constitutes inclusion in a “class of goods required to be registered or listed”, or whether a product “contains” one of the named substances, those interpretive issues will be central to any future disputes brought to the Commissioner or to the courts.

In sum, as of the instrument’s text there is no litigation history to report. Future litigation potential exists in the ordinary way and will depend on fact patterns and the application of the GST Act and the Therapeutic Goods Act to contested supplies.

The Determination’s operative rule is compact but carries several practical pitfalls and interpretive risks that suppliers, advisers and regulators should note. The instrument is short and highly conditional; the hazards below arise from what the instrument says and from what it omits.

1. Conjunctive test: all three conditions in s 6(1) must be satisfied. It is not enough for a product to be registered with the TGA, or to contain paracetamol, or to be for oral use alone. Each element is necessary. Misapplying the conjunctive nature is a common pitfall: a product that meets two but not all three criteria will not be GST-free under this Determination.

2. “Required … to be registered or listed”: s 6(1)(a) ties tax treatment to regulatory obligation, not merely to voluntary registration. The phrase “required, under the Therapeutic Goods Act 1989, to be registered or listed, or is included in a class of goods required to be registered or listed” can create complexity where a product’s regulatory treatment depends on whether it falls into a mandatory class. The Determination does not define what constitutes that inclusion. Suppliers must establish whether the product is actually required to be registered/listed or whether it is merely permitted to be registered/listed. The distinction matters.

3. “Contains aspirin, paracetamol or ibuprofen”: the Determination is not dosage- or concentration-specific. The presence of one of the named active ingredients, irrespective of concentration, appears sufficient on its face. This raises issues for formulations where the ingredient is present in trace amounts, in combination with other actives, or as an impurity. The instrument contains no de minimis threshold and is silent on whether pharmaceutical salts, derivatives, pro-drugs or chemically related substances count as the named compounds.

4. “Intended to be taken by mouth”: the Determination uses an intent criterion which will turn on product labelling, consumer instructions, marketing and possibly TGA registration/listing documents. Ambiguities arise for buccal, sublingual, chewable, or oromucosal forms, for which suppliers will need to assess whether “taken by mouth” is satisfied. The instrument does not define “taken by mouth” or list excluded or included routes, so disputes could emerge over borderline formulations such as orally dissolving films, throat lozenges, or chewables.

5. Repeal of 2015 Determination: Schedule 1 repeals the entire 2015 instrument. Businesses that previously relied on the 2015 Determination must check whether their products continue to qualify. The 2025 text may narrow, broaden or otherwise change scope relative to the 2015 instrument; the instrument itself does not state policy reasons or transitional spacing. Failure to reassess could result in incorrect GST treatment post-1 October 2025.

6. Evidence and record-keeping silence: the Determination does not specify what documentation suffices to prove TGA registration/listing, ingredient content, or route of administration. The absence of express statutory evidentiary rules means suppliers must retain TGA registration/listing documents, ingredient specifications and labelling to support GST-free claims. Lack of documentation will leave a supplier vulnerable to an audit adjustment.

7. Borderline products and substitution effects: products containing the named actives but intended for non-oral administration (topical, rectal, inhalational) are excluded by s 6(1)(c). Commercial substitution from excluded products to qualifying oral products could change competitive dynamics. Equally, reformulation to include a named analgesic or to adjust intended use could shift products into GST-free status. Those commercial decisions will have tax consequences and potential regulatory implications under the Therapeutic Goods Act.

8. No transitional provisions: the Determination contains no express transitional rules or saving clauses. The commencement table states the whole instrument commences on 1 October 2025 (s 2). Practitioners should assume supplies made on or after that date fall under the new classification and check historical periods separately.

9. Interface with the Act’s definitions: s 4 Note points out that “GST-free” and “supply” are defined in the Act. The Determination does not alter the Act’s substantive definitions. For example, whether a given arrangement is a GST “supply” for the Act’s purposes will remain an Act question. Misunderstanding this interaction may lead to misclassification in complex transactions such as bundled supplies, promotional giveaways or supplies made under welfare or government programs.

10. Potential administrative friction: the Determination relies on TGA status, but there is no formal mechanism in the Determination for the Commissioner of Taxation to automatically access TGA records or for the TGA to notify tax authorities of status changes. Suppliers may need to provide proof proactively in the event of an audit.

These “gotchas” arise from the Determination’s compact wording and from the fact it links tax outcomes to external regulatory categories while omitting details about evidence, thresholds and transitional arrangements. Practical vigilance is required where formulations, route-of-administration descriptions, or TGA classifications are complex or ambiguous.

The Determination creates a clear but tightly circumscribed set of conditions for GST-free treatment. Compliance requires both substantive assessment of products and administrative steps to support GST positions. The following is a practical compliance checklist derived from the instrument’s text and the statutory references it contains.

1. Identify candidate products: compile a list of all products that (a) contain aspirin, paracetamol or ibuprofen; (b) are intended to be taken by mouth; and (c) are registered or listed, or are included in a class required to be registered or listed, under the Therapeutic Goods Act 1989 (s 6(1)). Use label ingredient lists, formulation specifications, and TGA registers to screen SKUs.

2. Verify TGA status: obtain and record the TGA registration or listing number for each candidate product. If a product is part of a class required to be registered or listed, obtain documentary evidence that demonstrates the product’s class status under the Therapeutic Goods Act. Keep contemporaneous copies of TGA listings and registration certificates. The Determination makes registration/listing an explicit precondition for GST-free treatment (s 6(1)(a)).

3. Substantiate active ingredient presence: maintain formulation specs and certificates of analysis showing the presence of aspirin, paracetamol or ibuprofen. The Determination requires that the product “contains” one of those substances (s 6(1)(b)). Given the instrument’s silence on concentrations, have records that show the ingredient is an active constituent rather than a trace contaminant where that distinction is material.

4. Demonstrate intended route of administration: keep copies of product labels, consumer instructions, marketing materials and the TGA product information that show the product is intended to be taken by mouth (s 6(1)(c)). For products with multiple routes (for example, formulations that can be swallowed or applied topically), clarify the principal intended use and document the basis for any position that the product is “intended to be taken by mouth”.

5. Update accounting systems and GST codes: map qualifying SKUs to a GST-free code in ERP and POS systems effective from the commencement date, 1 October 2025 (s 2). Ensure that tax invoices, tills and e-commerce platforms reflect GST-free status where applicable and that stock-keeping reconciliations distinguish taxable and GST-free supplies.

6. Amend tax invoices and pricing where appropriate: check whether goods have displayed GST-inclusive pricing and adjust price displays and tax invoices as needed. While suppliers have commercial discretion over pricing, GST-free treatment affects how GST is shown on tax invoices.

7. Maintain a compliance file: for each GST-free SKU keep a file with TGA registration/listing evidence, formulation specs, labelling and marketing materials, and a written basis for the GST classification. Make sure the file records the effective date from which GST-free treatment is applied (commencement is 1 October 2025, s 2).

8. Monitor TGA and product changes: implement an internal control to monitor any changes to TGA registration/listing, product reformulation, or labelling that could affect GST classification. Because s 6(1)(a) depends on TGA status, a subsequent revocation or change could affect ongoing GST treatment.

9. Reassess archived positions following the 2015 repeal: if previously relying on the 2015 Determination, perform a gap analysis to identify any products whose GST treatment will change under the 2025 Determination (Schedule 1). Document decisions and, where necessary, engage the tax adviser to manage any adjustments in GST return filings from the commencement date.

10. Seek specialist advice for borderline cases: where there is doubt about whether a product is “intended to be taken by mouth”, whether its active ingredient presence is sufficient, or whether a product is within a class required to be registered or listed, obtain advice from a tax specialist with experience in GST issues involving therapeutic goods. Borderline interpretive points may also require input from regulatory counsel knowledgeable about the Therapeutic Goods Act.

11. Prepare for audits and enquiries: because the Determination imposes technical conditions for GST-free treatment but does not specify evidentiary rules, be prepared to produce TGA documentation, ingredient specifications and labelling on request by the Commissioner. Maintain records in a retrievable format and keep version control for reformulated products.

12. Document transitional positions and stock on hand: since the Determination commences in full on a specified date (s 2), identify any supplies straddling that date and document the treatment applied for those transactions. The instrument contains no transitional clause, so suppliers should apply the law as in force at the time of supply.

Following these steps will align an entity’s GST treatment with the Determination’s criteria and reduce the risk of post-commencement reclassification or audit adjustments. The Determination itself sets the eligibility test; compliance therefore consists of applying that test, retaining evidence that supports the test’s elements (TGA registration/listing, active ingredient presence, oral route intention), and integrating the classification into accounting and commercial systems from 1 October 2025 (s 2).