Therapeutic Goods (Reportable Medicines) Determination 2025

The instrument is structured around a few core legal concepts it imports from the Act and applies in a concrete list:

• Reportable medicine: The instrument determines which registered goods qualify as reportable medicines for subparagraph 30EH(1)(b)(ii) of the Act (s 5). The instrument does not define the substantive consequences of that status; those consequences are set out in the Act (s 4 note refers to subsection 3(1) of the Act, which defines "reportable medicine" among other expressions).

• Registered goods: The Schedule applies only to medicines that are registered goods. This condition is explicit in s 5: "The medicines set out in Schedule 1, being medicines that are registered goods, are determined to be reportable medicines" (s 5). The instrument therefore ties the determination to the registration status under the Act rather than to unregistered products.

• Active ingredient focus: Schedule 1 principally uses active-ingredient identification to classify medicines (for example, items listing cyproheptadine, levonorgestrel, theophylline, ulipristal, etc.). Where an ingredient is used as the sole active ingredient, the Schedule states that expressly (for example, "contain 0.9% sodium chloride as the only active ingredient" (Schedule 1, item 6)).

• Dosage form specificity: Several categories limit coverage by dosage form: injections, intravenous infusions, nasal sprays, sublingual formulations, powders for inhalation, preparations for inhalation, topical preparations (Schedule 1, items 2, 3, 4, 5, 6, 8, 9, 10). That means the legal status of a product under this determination depends both on its composition and on its pharmaceutical presentation.

• Cross-reference to Poisons Standard: Two items in Schedule 1 are explicitly conditional on scheduling entries in the current Poisons Standard: folinic acid (as calcium folinate) when included in Schedule 2 to the current Poisons Standard (Schedule 1, item 2(c)); and isosorbide dinitrate when included in Schedule 3 to the current Poisons Standard (Schedule 1, item 2(g)). This introduces a dependency on an external instrument for the scope of coverage.

• Repeal and substitution: The instrument repeals the 2018 Reportable Medicines Determination in full (s 6; Schedule 2). That means the current list replaces the prior list entirely, rather than amending it incrementally.

The instrument therefore operates as a technical, declaratory device: it applies statutory power in subsection 30EH(2) to make explicit which registered goods are captured as reportable medicines, using active-ingredient, dosage-form and external scheduling criteria to define the set.

The instrument affects three principal groups directly within the statutory framework it uses, and it has potential operational implications for other actors:

• Sponsors and manufacturers of registered goods: The primary group affected comprises sponsors or manufacturers of medicines that are registered goods which meet the Schedule 1 descriptions. Section 5 makes clear the determination applies to "medicines that are registered goods" set out in Schedule 1. If a sponsor’s product contains a listed active ingredient in the specified dosage form (or meets the other Schedule 1 criteria), that product is now classified as a reportable medicine for the purposes of the cited subparagraph of the Act. Which products are in scope therefore depends on sponsors’ portfolios and on whether particular items are registered goods.

• Regulators and the Department of Health and Aged Care: The instrument was made by a delegate of the Minister (signature dated 5 March 2025) acting under s 30EH(2). The Department and delegate decision‑makers will use this schedule as the authoritative list when applying the Act’s reporting and regulatory provisions. The instrument shifts the set of products for which the regulator’s statutory regime (as framed by the Act) applies.

• Downstream healthcare providers, wholesalers, pharmacies and institutional purchasers: While the instrument does not itself create duties on these parties, changes to the set of "reportable medicines" under the Act may have downstream effects in how products are handled, recorded, reported or supplied if the Act imposes obligations touching those stakeholders. The instrument makes no express provision for persons other than registered goods’ sponsors; however, any obligations that the Act attaches to the reportable-medicine status will flow to the persons the Act specifies.

Other affected axes and conditional effects:

• Products contingent on the Poisons Standard: For items conditioned on the status of a substance in the current Poisons Standard (Schedule 1, items 2(c) and 2(g)), the affected set of products can expand or contract as the Poisons Standard changes. Therefore parties with products that include folinic acid (as calcium folinate) or isosorbide dinitrate must monitor the Poisons Standard to know whether their registered goods are captured.

• Products that are similar but not identical: The Schedule often specifies "only active ingredient" or particular dosage forms. Products that include the same active ingredient but also include other active components, or are presented in a different dosage form to those specified, will not be captured by this determination. Sponsors must therefore audit product formulations and presentations precisely.

• Repeal of the 2018 instrument: Entities that had previously been subject to the 2018 list must map the changes: some products previously captured may be removed or changed, and some previously uncaptured products may now be included. The instrument repeals the earlier instrument in whole (s 6; Schedule 2).

Who pays, who decides, and who changes behaviour: sponsors bear the immediate compliance and monitoring costs of determining whether their registered goods meet Schedule 1 criteria; the Minister’s delegate (and Departmental officers) decide which medicines are reportable through this schedule (s 3). Downstream behaviour,such as internal reporting, pharmacovigilance or supply practices,will change only to the extent the Act imposes obligations once a product is classified as a reportable medicine.

This instrument itself does not enumerate new duties, rights, or penalties; rather, it identifies which registered goods are to be treated as reportable medicines under the Act. The operative duty- and rights-framework therefore remains located in the Therapeutic Goods Act 1989, with this instrument operating to classify additional registered goods within that framework (s 5; s 3 references subsection 30EH(2)). The instrument is therefore best read as a scope-determination, not as a standalone regulation that creates reporting procedures, sanctions, or appeals mechanics.

What the instrument does specify that affects duties and rights in practice:

• Triggering of Act-based obligations: By declaring specified registered goods to be reportable medicines for the purposes of subparagraph 30EH(1)(b)(ii) of the Act (s 5), the instrument causes whatever duties and rights the Act attaches to reportable medicines to apply to those goods. The instrument itself does not restate those duties; it relies on the statutory text and definitions referenced in subsection 3(1) of the Act (s 4 note).

• Definition reliance and interpretive effect: Section 4 notes that a number of expressions are defined in subsection 3(1) of the Act, including "active ingredient", "current Poisons Standard", "medicine", "registered goods" and "reportable medicine". The practical content of registration status, dosage forms (for example, "preparation for inhalation", "preparation for topical use", "injection", "intravenous infusion") and the meaning of "only active ingredient" all depend on those Act definitions. That matters because rights (for example, rights to administrative review or to submit information) and duties (for example, to report incidents or supply certain information) will be engaged according to how those terms are interpreted under the Act.

• Conditions and exclusions embedded in the Schedule: The Schedule’s phrasing creates material distinctions that determine who has duties under the Act. Examples include:

  • "Only active ingredient" formulations exclude combination products from coverage (Schedule 1, items 4 and 6).
  • Dosage-form limitations (for example, injections, sublingual, nasal spray, inhalation preparations) mean identical active ingredients in other presentations may fall outside the determination (Schedule 1, items 2, 3, 6, 8, 9).
  • Poisons Standard dependencies make inclusion contingent on entries external to this instrument (Schedule 1, items 2(c) and 2(g)).

• Repeal of prior instrument and procedural consequence: The replacement of the 2018 instrument (s 6; Schedule 2) alters the landscape of which registered goods are reportable medicines. Sponsors have rights and potentially obligations under the Act; the instrument reconfigures which products attract those duties, and parties will need to reassess their rights to seek administrative review or provide information under the Act if they are newly captured.

Absent from this instrument are procedural details about how duties attach, timelines for reporting, thresholds for mandatory reporting, available administrative remedies, or penalties for non-compliance; those details remain in the Act and associated regulations. The instrument therefore functions as a scope-defining annex: it determines which registered goods are within the Act’s previously defined duty/right architecture.

The determination itself contains no penalty provisions and does not set out enforcement mechanisms. Its legal effect is limited to classifying certain registered goods as reportable medicines for the purpose of the referenced subparagraph of the Act (s 5). Any enforcement, sanctions, or penalties that flow from a product being a reportable medicine derive from the Act and any subordinate instruments to which the Act refers; this instrument does not add or alter penalties directly.

What is explicit in the source that bears on enforcement and compliance:

• Delegated power and administrative authority: The instrument is made by a delegate of the Minister (signed by Nicholas Henderson, First Assistant Secretary, Medicines Regulation Division, Health Products Regulation Group) under subsection 30EH(2) of the Act (s 3). That reflects an administrative mechanism by which the Executive can specify the set of reportable medicines. Enforcement of any ensuing duties will therefore be carried out under the Act by the authorised statutory or administrative bodies to which the Act assigns those functions.

• Repeal and continuity considerations: By repealing the 2018 Determination in full (s 6; Schedule 2), the instrument replaces the prior list. For enforcement agencies, that means the set of products subject to the Act’s reportable-medicine-linked enforcement regime changes as of the instrument’s commencement (s 2). The instrument does not specify transitional enforcement arrangements, or savings or grandfathering provisions; it simply repeals the earlier instrument and substitutes the new list.

• Reliance on Act definitions for scope: Because key terms are defined in subsection 3(1) of the Act (s 4), any enforcement action will hinge on the statutory meanings of terms such as "registered goods" and "reportable medicine". For example, enforcement decisions over whether a product is captured by a Schedule 1 entry will rest on whether the product is a "registered good" under the Act and whether it matches the Schedule’s active‑ingredient/dosage‑form criteria as interpreted under the Act.

• No independent inspection, penalty or compliance regime created: The instrument creates no new inspection powers, civil penalties, criminal offences, or administrative fines; it simply alters the universe of products subject to the existing statutory provisions that contain those enforcement tools. To know what penalties may attach or how they will be applied in practice, readers must consult the Act itself.

Practical enforcement implication: regulators will apply the Act’s enforcement tools to a redefined set of registered goods once the instrument commences. Sponsors whose products now qualify as reportable medicines should assume that any compliance obligations and enforcement mechanisms contained in the Act are now applicable to those products, and should review the Act for specifics. The instrument positions enforcement by changing scope, not by changing substantive sanctions.

This instrument is explicitly integrated with the Therapeutic Goods Act 1989 and, by cross-reference within its Schedule, the current Poisons Standard. Its interaction with other instruments and regimes is therefore precise and procedural rather than substantive.

Direct statutory interaction:

• Therapeutic Goods Act 1989: The instrument is made under subsection 30EH(2) of the Act (s 3), and its principal legal operation is to determine which registered goods are reportable medicines under subparagraph 30EH(1)(b)(ii) (s 5). Section 4 also notes that a number of expressions used in the instrument are defined in subsection 3(1) of the Act, thereby importing the Act’s definitions (s 4). The practical effect is that this instrument functions as an enumerative annex to the Act: it determines scope while leaving duties, rights, enforcement, and definitions to the Act.

• Current Poisons Standard: Schedule 1 includes conditional references to entries in the current Poisons Standard (Schedule 1, items 2(c) and 2(g)). That creates an operational dependency: changes to the Poisons Standard can cause Schedule 1’s coverage to change without any further amendment to this instrument. Consequently, the instrument interacts dynamically with the Poisons Standard regime: regulators, sponsors and other stakeholders must monitor that instrument to determine applicability.

Interaction with subordinate instruments and departmental practice:

• Repealed instrument: The Determination 2018 is repealed in full (s 6; Schedule 2). The repeal replaces one subordinate instrument with another; any administrative practices, forms, or compliance processes built around the old list will need to be adjusted to the new list. The instrument does not create transitional measures; operational continuity therefore depends on administrative implementation by the regulator.

• Definitions and administrative procedure under the Act: Because the instrument imports definitional terms from subsection 3(1) of the Act (s 4), it interacts with other parts of the Act and any related regulations that use and interpret those definitions. For instance, the meaning of "registered goods", "injection", "preparation for inhalation" and similar phrases will be governed by the Act’s text and any extant interpretive guidance.

Broader legal and market interactions (as implied by the instrument’s design):

• Pharmaceutical regulatory matrix: By selecting specific active ingredients and dosage forms to be reportable medicines, the instrument changes which products fall into the Act’s reporting regime. That affects regulatory oversight, pharmacovigilance coverage, and any statutory reporting chains that reference reportable medicine status. Although the instrument does not itself create obligations beyond classification, its choice of substances and forms can influence compliance costs and regulatory attention across a range of healthcare supply chains.

• Interaction with product labelling, scheduling and registration processes: Since registration status is a condition of the Schedule (s 5), interactions between this determination and registration procedures under the Act matter for compliance. Likewise, where the Poisons Standard determines inclusion, updating poison scheduling or product scheduling in other frameworks will alter the instrument’s practical effect without direct amendment.

The instrument therefore operates as a focused point of legal interaction: it imports statutory definitions and external scheduling instruments and plugs into the Act’s regulatory architecture to expand or contract the set of products subject to the Act’s reportable-medicine-linked provisions.

The instrument sets out its own initial amendment history and immediate predecessor relationship. Key facts from the source:

• New instrument in 2025: The instrument is titled Therapeutic Goods (Reportable Medicines) Determination 2025 and is dated 5 March 2025 (header and signature block).

• Commencement provision: The entire instrument commences the day after registration (s 2, commencement table, item 1). The commencement table includes the standard note that it applies as originally made; it also contains the note that any information in column 3 is not part of the instrument (s 2(1)-(2)).

• Repeal of 2018 instrument: Schedule 2 explicitly repeals the whole of the Therapeutic Goods (Reportable Medicines) Determination 2018 (s 6; Schedule 2). The Schedule instructs: "Repeal the instrument." There is no partial repeal; the preceding instrument is extinguished in full.

• No other amendments listed: The instrument contains no schedule or provision that amends other instruments except the repeal of the 2018 Determination. There are no saving clauses, transitional provisions, or temporal staging provisions set out in this instrument.

• Delegation and signature: The instrument is signed by a delegate of the Minister, Nicholas Henderson, First Assistant Secretary, Medicines Regulation Division, Health Products Regulation Group, Department of Health and Aged Care. That indicates customary administrative-degree execution rather than a ministerial signature; the instrument records its maker and date.

• Notes about publication: Section 2 contains a typical statutory drafting note that the commencement table relates only to the instrument as originally made and will not be updated for later amendments; it also states that column 3 information is not part of the instrument and can be edited in published versions (s 2). This is an editorial/practical detail about the instrument’s presentation rather than a substantive amendment mechanism.

In short, the amendment history recorded in the instrument is immediate and straightforward: the 2018 Determination is repealed and replaced by the 2025 Determination, which commences the day after registration and which will govern which registered goods are reportable medicines unless and until it is revoked or amended in future.

The instrument text supplied contains no references to legal proceedings, judicial interpretation, or litigation concerning either this Determination or the instrument it repealed. It names no cases, and includes no note of judicial review or challenged decisions. The only judicially-relevant material present in the instrument is the statutory authority cited for its making: subsection 30EH(2) of the Therapeutic Goods Act 1989 (s 3). Any litigation that might arise,such as a dispute about whether a particular registered good falls within a Schedule 1 entry, or a challenge to the lawfulness of the determination under administrative law,would by necessity engage statutory text from the Act and probably administrative law principles, but neither the instrument nor its Schedule contain case law or litigation history.

Consequently, based solely on the instrument:

• There are no reported cases or judicial interpretations cited in the instrument that construe the language used in Schedule 1, nor are there notes of prior litigation concerning the 2018 Determination in the instrument’s text.

• Any future litigation would likely focus on (1) interpretation of the Act’s definitions (imported via s 4), (2) whether a given product is a "registered good" and thus captured under s 5, (3) whether a product’s formulation and dosage form meet the Schedule 1 criteria (for example, what qualifies as "preparation for inhalation" or "only active ingredient"), or (4) administrative law challenges to the delegate’s exercise of power under subsection 30EH(2). None of these issues are litigated in the instrument; they would depend on subsequent factual disputes and legal argument in the courts.

• The absence of litigation history in the instrument means there is no publicly declared interpretive guidance within this document about ambiguous phrases; that interpretive work will fall to decision-makers in the Department and, ultimately, to tribunals or courts if disputes arise.

For practitioners preparing for potential disputes, the instrument signals those likely points of contention (definitions, registration status, dosage form classification, Poisons Standard dependencies) even though it does not itself catalogue litigation history.

The instrument is concise, but the drafting choices create several practical, interpretive and operational traps for sponsors, regulators and other stakeholders. The following "gotchas" are grounded in the instrument’s text and identify likely sources of confusion, compliance cost, and interpretive dispute:

• Dependency on registration status: Section 5 applies the determination only to "medicines that are registered goods" (s 5). If a product is supplied in unregistered form, compounding form, or as a medicine exempt from registration, the instrument does not on its face capture it. Parties should not assume that the presence of a listed active ingredient alone is sufficient; registration status is an explicit gatekeeper.

• "Only active ingredient" language excludes combination products: Multiple Schedule entries require that the listed substance be the "only active ingredient" (for example, sodium bicarbonate entry at Schedule 1, item 6; items 4 and others). That phrasing excludes combination products. Sponsors with combination products that include a listed ingredient plus others must not assume coverage; instead they must map formulations precisely.

• Dosage-form specificity creates split coverage for the same active: The Schedule frequently conditions inclusion on dosage form,for example, naloxone is captured only if in injection or nasal spray form (Schedule 1, item 2(k)), salbutamol only when in a preparation for inhalation (Schedule 1, item 2(l)), and glyceryl trinitrate only for sublingual use (Schedule 1, item 2(e)). The same active ingredient in another presentation (tablet, oral syrup, patch) may not be included. Sponsors must review product presentations carefully.

• Cross-dependence on the Poisons Standard: Two entries are conditional on the current Poisons Standard (Schedule 1, items 2(c) and 2(g)). This means applicability can change without amendment to this instrument. Sponsors and compliance teams need active monitoring processes for the Poisons Standard.

• Repeal of the 2018 Determination without transitional detail: Section 6 repeals the 2018 instrument in full (s 6; Schedule 2). The new list could materially alter which goods are reportable without any transitional grandfathering or phased implementation in this instrument. Entities relying on older status must not assume continuity.

• Potential for broad coverage of common products: Some entries are phrased broadly in ways that could reach commonly used single-ingredient products if they are registered goods,for example, "0.9% sodium chloride as the only active ingredient, and are in the dosage form of an injection or an intravenous infusion" (Schedule 1, item 6). That could encompass routine normal saline products where they are registered goods. The instrument itself does not quantify scope, so sponsors must audit portfolios.

• Ambiguity of pharmaceutical terms absent definitions in this instrument: The instrument imports definitions from subsection 3(1) of the Act (s 4), but it does not reproduce them. Terms such as "preparation for topical use", "preparation for inhalation", "injection", "intravenous infusion" and "dosage form" may admit borderline cases. Because the instrument delegates definitional clarity to the Act, disputes will require cross-referencing that statutory text.

• Overlap and duplication within the Schedule: Annotations show some overlapping entries: e.g., sodium bicarbonate appears in item 4 as an injection-only product and in item 10 for oral supplementation. Sponsors with multiple presentation types must map each product to the correct item to avoid misclassification.

• Administrative mapping requirement: The Schedule’s mixture of ingredient, sole-ingredient, dosage-form and external-scheduling criteria means sponsors must perform a detailed, product-by-product classification exercise. That creates an upfront compliance burden that is not mitigated by this instrument’s text.

• No procedural guidance in this instrument: The instrument does not set out how a sponsor should notify the regulator, what records to keep, or timelines for any reporting. Those procedural matters remain in the Act or other instrument, so relying solely on this Determination for compliance steps is a potential trap.

These features are not defects in isolation; they are the predictable consequences of a compact instrument that functions as a scope designation. The practical effect is to shift onus onto sponsors and regulators to perform careful mapping against the Act’s definitions and any operational guidance the Department provides.

The Determination is a scope-defining instrument. Compliance therefore consists primarily of identifying whether and which registered goods in a sponsor’s portfolio are captured by Schedule 1, and then applying the Act’s existing reporting and regulatory requirements for reportable medicines. The instrument itself does not provide procedural steps or timelines; the steps below map to the instrument’s drafting features and the statutory cross-references it makes.

1. Run a product audit mapped to Schedule 1 language (immediate priority)

   • Identify every product in your portfolio that is a registered good under the Act (s 5 requires registered‑goods status).
   • For each registered good, determine the active ingredients exactly as described in your registration documentation (Schedule 1 is active‑ingredient centric, and s 4 notes that "active ingredient" is defined in subsection 3(1) of the Act).
   • Apply the Schedule 1 conditions precisely: check for "only active ingredient" language, dosage form limitations (injection, intravenous infusion, sublingual, nasal spray, preparation for inhalation, topical preparation) and the specific active ingredients listed (Schedule 1, items 1-10). Map each product to the closest Schedule 1 item.

2. Check external-schedule dependencies

   • For products containing folinic acid (as calcium folinate) and isosorbide dinitrate, verify whether those substances are currently included in the specified Schedules of the current Poisons Standard, since inclusion in Schedule 1 is contingent on that status (Schedule 1, items 2(c) and 2(g)).
   • Implement periodic review processes to detect changes to the Poisons Standard, because Schedule 1’s applicability may change without amendment to the Determination.

3. Prepare internal compliance and recordkeeping measures

   • Where a product is captured and thus becomes a reportable medicine under the Act (s 5), identify where the Act imposes specific reporting duties, obligations, or timeframes; this Determination does not itself specify those. Consult the Act and any applicable subordinate instruments for the procedural steps and reporting formats.
   • Document the audit trail of your mapping exercise, including extracts from registration dossiers, batch documentation showing dosage forms, and product specifications demonstrating whether an ingredient is the only active ingredient in the product.

4. Update regulatory interactions and templates

   • Adjust pharmacovigilance, adverse‑event reporting, and internal escalation pathways to include products newly captured by Schedule 1.
   • If your legal/regulatory team relies on prior status under the 2018 Determination, reconcile differences arising from the 2025 Determination’s repeal of the 2018 instrument (s 6; Schedule 2).

5. Seek clarifications early for borderline cases

   • Where the meaning of a term in Schedule 1 is uncertain for a given product,e.g., whether a formulation qualifies as a "preparation for inhalation" or whether an ingredient is the "only active ingredient",seek a regulatory clarification from the Department or obtain legal advice about likely interpretations under the Act. The instrument imports definitions from subsection 3(1) of the Act (s 4), so the Act will be the authoritative source for contested definitions.

6. Monitor commencement and act promptly

   • The instrument commences the day after registration (s 2). Make sure your audit and any necessary reporting or notification steps are aligned with that timing.

7. Engage operational teams in supply chain and procurement

   • For products that now qualify as reportable medicines, coordinate with manufacturing, supply chain, wholesalers, and purchasers to ensure downstream processes align with any statutory requirements triggered by reportable medicine status in the Act.

8. Record and retain decision and compliance documents

   • Retain the mapping decisions, internal memos, regulatory correspondence, and evidence of monitoring the Poisons Standard to demonstrate a good-faith compliance effort should any enforcement or audit arise. The Determination itself does not require a particular recordkeeping regime; however, records that show how you concluded a product’s status will be material if questions arise.

9. Reassess after Poisons Standard updates or registration changes

   • If product formulations, presentations or registration statuses change, repeat the mapping exercise to confirm continued applicability or removal from Schedule 1.

10. Consider legal review for material commercial implications

• If classification as a reportable medicine would meaningfully affect supply contracts, liability exposure, or commercial terms, obtain legal advice to understand how the Act’s obligations interact with commercial arrangements. The Determination triggers statutory change but does not itself state commercial consequences.

In short, compliance is a two-stage process: (1) identify which registered goods are captured by Schedule 1 through a detailed mapping of active ingredients and dosage forms (including monitoring Poisons Standard entries); and (2) apply the Act’s reporting and regulatory rules to those goods, using the Act and any regulatory guidance or subordinate instruments to determine concrete operational duties and timings. The instrument supplies the scope; compliance requires connecting that scope to the Act’s operative mechanics.