Therapeutic Goods (Vaping Goods—Other Indications) Determination 2024

The instrument relies on a small set of statutory concepts and cross-references. Those concepts are defined either in the instrument itself or by express reference to other instruments.

Definitions and cross-references: Section 4 states that a number of expressions are defined in subsection 3(1) of the Act, including included in the Register, indications, medical device, medical practitioner, medicine, Register, registered goods, therapeutic goods, vaping device, vaping goods and vaping substance. The instrument also defines several terms within itself: Act means the Therapeutic Goods Act 1989; intended purpose has the same meaning as in the MD Regulations; medicinal cannabis products has the same meaning as in the Regulations; MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002; Regulations means the Therapeutic Goods Regulations 1990 (see s 4).

Statutory purpose and scope: The instrument operates for the specific statutory purpose in paragraph 41QB(11)(a) of the Act, by determining "other indications" (that is, indications other than smoking cessation or management of nicotine dependence) for which vaping goods may be used. Section 5 makes explicit that, for each item in Schedule 1, the indications listed in column 3 are "determined" to be such "other indications" for the vaping goods in column 2. Thus the key legal operation is a determination under the Act that attaches permitted indications to certain categories of vaping goods.

Categories of vaping goods: Schedule 1 divides vaping goods into three categories:

• Item 1: "a vaping good" more generally, with sub-categories determined by whether the good is approved under paragraph 19(1)(b) of the Act, is a medical device approved under paragraph 41HB(1)(e), is exempt under item 3 of Schedule 5A to the Regulations, or is a medical device exempt under item 2.3 in Part 2 of Schedule 4 to the MD Regulations (Schedule 1, Item 1, subparas (a)-(d)).
• Item 2: "a medicinal cannabis vaping good", with indications tied to Register inclusion, approvals under subsection 41HB(1)(d), authorisations under subsection 41HC(1), rules under subsection 41HC(6), and certain exemptions under reg 7.2 of the MD Regulations for Category A patients (Schedule 1, Item 2, subparas (a)-(e)).
• Item 3: a "vaping substance" that is either a medicinal cannabis product or a medicine containing synthetic cannabis, with indications tied to registration, approvals and authorisations under subsection 19(1)(a), 19(5), rules under 19(7A), and exemptions under reg 12A for Category A patients (Schedule 1, Item 3, subparas (a)-(e)).

Form of permissible indications: The instrument does not itself list clinical indications in the sense of disease names or therapeutic claims; instead, the permissible indications are those that are accepted in relation to the inclusion of a medical device or registered goods in the Register, those specified in approvals or authorisations under the identified subsections of the Act, those specified in rules under the identified subsections, and those set out in notices required by the specified exemption items. For Category A patients, the instrument identifies that the permitted use is "the use of the device in relation to the treatment of the person’s condition, as set out in the statement" referred to by the relevant subregulations (see Schedule 1, Items 2(e) and 3(e)).

Conditional commencement and metadata: Section 2 sets a single commencement rule that ties the instrument to the commencement of the Vaping Reforms Act parts. The table in section 2 contains a note that any information in column 3 of that table is not part of the instrument, and a further note that the table relates only to the provisions of this instrument as originally made and will not be amended for later amendments. The instrument is formally made by the delegate of the Minister and dated 29 June 2024.

Terminology differences: The instrument uses both "indications" and "intended purposes" depending on whether the relevant product is regulated as a medicine or as a medical device; it instructs the reader which term applies by cross-reference to the approvals, register entries, authorisations or notices referred to in Schedule 1. The term intended purpose is explicitly aligned with the MD Regulations by the definitions section.

The instrument affects several identifiable groups by changing the statutory mapping between product status (registered, approved, authorised, exempt) and the non‑cessation indications that may lawfully be associated with vaping goods for the narrow purpose of paragraph 41QB(11)(a) of the Act.

Sponsors and manufacturers. Sponsors and manufacturers of vaping goods are affected because the determination ties permissible indications to their current regulatory pathway outcomes. If a product is included in the Register, approved under the cited Act provisions, authorised, or exempt with a notice, then the indications contained in those regulatory instruments, approvals, authorisations or notices are, for the purposes of paragraph 41QB(11)(a), the indications for which the vaping good may be used (see s 5 and Schedule 1). Sponsors must therefore ensure that product labelling, promotional materials, and clinical use align with the indications or intended purposes specified in the approvals, register entries, authorisations, rules or notices that the Schedule points to.

Manufacturers of medical devices and medicinal cannabis products. Item 2 of Schedule 1 specifically addresses medicinal cannabis vaping goods treated as medical devices and links permitted indications to Register inclusions and approvals under sections of the Act that relate to medical devices, and to particular subregulatory exemptions for Category A patients in the MD Regulations. Manufacturers whose device is included in the Register or approved or authorised under the specified subsections will have their product’s accepted intended purposes treated as the permitted indications for this statutory purpose.

Pharmaceutical sponsors and medicine manufacturers. Item 3 concerns vaping substances that are medicinal cannabis products or medicines containing synthetic cannabis and maps permitted indications to the medicine regulatory pathways: registered goods, approvals under subsection 19(1)(a), authorisations under subsection 19(5), and rules under subsection 19(7A), together with category-based exemptions in regulation 12A. Pharmaceutical sponsors of these substances must rely on the indications accepted or specified in those outputs.

Clinicians and patients. Medical practitioners and other prescribers encounter an impact because the instrument signals which indications are officially determined for certain vaping goods for paragraph 41QB(11)(a). For Category A patients as defined in subregulation 7.2(2) of the MD Regulations and subregulation 12A(5) of the Regulations, the instrument makes clear that the permitted use in such exemption circumstances is the use described in the required statement referred to in the relevant subregulation (Schedule 1, Items 2(e) and 3(e)). Clinicians prescribing or recommending medicinal cannabis or device-based vaping interventions for these patients must therefore follow the statements and notices required under the exemption provisions to remain within the scope of the determined indications.

Regulators and delegates. The instrument is made by a delegate of the Minister under s 41RA (see s 3). It will be relevant to regulators in interpreting paragraph 41QB(11)(a) in regulatory decisions and enforcement. Operational regulators responsible for maintaining the Register, approving or issuing authorisations, and administering exemptions will see the instrument as allocating which approvals, entries, authorisations or notices provide the eligible non‑cessation indications for vaping goods under the named statutory purpose.

Suppliers and retailers. Entities supplying vaping goods, whether through clinical pathways or other authorised channels, must align product information and supply practices with the indications specified in the approvals, register entries, authorisations or notices that the Schedule identifies. Where a product lacks the referenced approval or registration, this determination does not create new permissible indications; supply that purports to rely on other indications will not be supported by the determination.

Legal and compliance advisers. Lawyers, compliance teams and auditors advising sponsors, clinicians, or suppliers will need to map products to the precise subsection or exemption referenced in Schedule 1 to ascertain which indications are determined by the instrument. They must also track the conditional commencement in section 2, and the fact that the instrument’s legal effect depends on commencement of the Vaping Reforms Act parts specified.

Who is not made to have new rights. The instrument does not itself create a new registration or approval for any product. It does not on its face confer a new market access right beyond clarifying, for the statutory purpose of paragraph 41QB(11)(a), which existing approvals, inclusions, authorisations, rules or notices constitute the permissible non‑cessation indications.

The instrument is a determiner rather than a primary licensing or offences instrument. Its operative effect is to fix, for the purposes of paragraph 41QB(11)(a) of the Act, which indications count as permitted "other indications" for particular classes of vaping goods. That mapping creates predictable legal consequences for how regulated parties must state and rely on indications, and therefore creates duties in practice even though it does not itself prescribe operational obligations beyond the determination.

Rights created or clarified. Where a vaping good is the subject of any of the approvals, inclusions, authorisations, rules or notices identified in Schedule 1, the indications or intended purposes specified in those instruments are, by operation of section 5, the "other indications" for which the vaping good may be used for the purpose referenced. In other words, the instrument recognises and treats those prior regulatory outcomes as the source of permitted non‑cessation indications. For example, if a medicinal cannabis vaping good is included in the Register and an intended purpose is accepted in relation to its inclusion, that accepted intended purpose is among the indications determined for the good (Schedule 1, Item 2(a)).

Duties implied by the determination. The determination produces practical duties for sponsors, manufacturers, clinicians, and suppliers to ensure that any non‑cessation indication relied on in labelling, advertising, clinical use or supply corresponds to an indication or intended purpose accepted or specified in the enumerated approvals, register entries, authorisations, rules or notices. Parties who rely on an indication not specified by the relevant approval, registration, authorisation, rule or notice will not be operating under the shield of this determination for the purposes of paragraph 41QB(11)(a).

Obligations for Category A patient exemptions. Items 2(e) and 3(e) identify that for persons who are Category A patients, as defined in the relevant subregulations of the MD Regulations or the Regulations, the permitted use is expressly limited to the use set out in the statement referred to in those subparagraphs. Practically, that requires compliance with the statement format and content mandated by the exemption provisions in the MD Regulations or the Regulations, and adherence to the scope of the treatment as set out in such statements.

Interfacing with approvals and authorisations. The instrument makes no substantive change to the content of approvals, register inclusions, authorisations, rules or notices; rather, it imports those existing documents as the source of permissible indications. Accordingly, duties that arise from those underlying regulatory instruments (for instance, obligations to supply accurate information to the regulator, maintain records, comply with conditions of approval or authorisation, or observe post-market requirements) remain governed by their own statutory bases; the determination does not displace those duties.

Administrative discretion and delegation. The instrument is made by a delegate of the Minister (Nicholas Henderson, Acting Deputy Secretary, Health Products Regulation Group, Department of Health and Aged Care). The instrument does not itself allocate decision-making powers for approvals, authorisations or inclusion in the Register, nor does it confer new delegation arrangements. It operates within the existing framework where the Act and the Regulations allocate powers to approve, authorise, register, or exempt goods.

No penalty-creating clauses in the instrument. The instrument does not create penalties or criminal offences of its own. It determines which indications apply for a statutory purpose. Enforcement, compliance and sanctioning mechanisms, if any, are to be found in the Act and the Regulations governing approvals, registrations, authorisations and exemptions. Parties should therefore treat the determination as a mapping tool whose practical effect is to make clear which prior regulatory outputs design the permissible non‑cessation indications for vaping goods.

Record-keeping and evidentiary implications. Because the determination ties permissible indications to specified approvals, inclusions, authorisations, rules or notices, an evidentiary duty arises in practice: sponsors, suppliers and clinicians will need to be able to produce the relevant approval, register entry, authorisation, rule or notice to demonstrate that a given non‑cessation indication is within the scope determined by this instrument for the purposes of paragraph 41QB(11)(a).

Contingent legal effect. The legal force of the whole instrument is subject to the commencement condition in section 2. If the specified parts of the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 do not commence, this instrument does not commence and therefore creates no rights or duties under the Act.

The instrument itself contains no penalty provisions, and does not create new criminal or civil sanctions. Its legal operation is to determine for the purposes of paragraph 41QB(11)(a) of the Act which indications are to be treated as other-than-cessation indications for the stated categories of vaping goods. Enforcement and penalties remain matters for the Act, the Regulations, the MD Regulations and the specific approval, registration or authorisation instruments referenced in Schedule 1.

No penalties in the instrument. There are no sections in the instrument that specify monetary penalties, infringement notices, criminal offences, administrative sanctions, or enforcement powers. The instrument does not amend existing penalty provisions in the Act or Regulations; it simply determines the source of indications for the statutory purpose referenced.

Interaction with enforcement under the Act and Regulations. Because the instrument allocates the permitted indications to approvals, register entries, authorisations or notices, any non‑compliance or misrepresentation about indications will be actionable under the statutory regime that governs those approvals, inclusions or exemptions. For example, if a sponsor represents an indication that is not accepted in the Register entry or not specified in an approval or authorisation that the Schedule identifies, that misrepresentation would be a matter for enforcement under the Act or the Regulations and under the terms of the approval, registration or authorisation. The instrument itself does not specify which enforcement mechanism will be used; it imports the existing regulatory structure.

Evidential utility for regulators. The determination creates a clear evidential reference: regulators enforcing the Act in relation to paragraph 41QB(11)(a) may look to the approvals, register entries, authorisations, rules and notices listed in Schedule 1 to determine whether a vaping good has a determined indication for the non‑cessation purposes. That reduces uncertainty about where to find the authorised indication for the purposes of that paragraph, but it does not limit the regulator from using other applicable enforcement powers in the Act and Regulations.

Delegation and administrative action. The instrument is made under section 41RA by a delegate of the Minister (s 3). It does not create or alter enforcement delegation arrangements; any exercise of enforcement powers continues to be governed by the Act and the Regulations and the existing administrative law framework.

Practical compliance risk. Even though the instrument does not itself define penalties, parties may face enforcement action if they rely on indications not included in the referenced approvals, registrations or notices. Therefore the practical risk of enforcement is present but mediated through the Act and subordinate instruments that specify the penalties and sanctions for non-compliance with registration, approval, authorisation or exemption requirements.

Commencement contingency and enforcement timing. Because section 2 makes commencement contingent on Parts 1 to 3 of Schedule 1 of the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commencing, there is a timing risk for enforcement reliance on this determination. If the Vaping Reforms Act parts do not commence, the determination will not commence and cannot be used as the basis for enforcement under paragraph 41QB(11)(a).

The determination is expressly cross‑referential and designed to operate within the existing therapeutic goods legislative architecture. It repeatedly points to specific provisions in the Therapeutic Goods Act 1989, to the Therapeutic Goods Regulations 1990, and to the Therapeutic Goods (Medical Devices) Regulations 2002. Those cross-references are the core of its interaction with other laws.

Made under the Act. Section 3 states the instrument is made under section 41RA of the Act. Section 5 expressly applies the determination for the purposes of paragraph 41QB(11)(a) of the Act. Thus the instrument’s legal force is nested within the Act: it does not create standalone regulatory regimes, but clarifies the application of existing Act provisions.

Mapping to approvals, registrations and authorisations. Schedule 1 cross-references multiple provisions in the Act. For non-device vaping goods, Schedule 1 Item 1(a) refers to goods approved under paragraph 19(1)(b) of the Act; Item 1(b) refers to medical devices approved under paragraph 41HB(1)(e) of the Act. Item 2 points to medical device pathways including inclusion in the Register, approvals under subsection 41HB(1)(d), authorisations under subsection 41HC(1), and rules under subsection 41HC(6). Item 3 points to the medicine pathways under subsection 19(1)(a), subsection 19(5), and rules under subsection 19(7A). These references mean the instrument’s determinations are applied by consulting the content of those other statutory instruments and decisions, and therefore the substance of permitted indications is located in those separate legal sources.

Interaction with Regulations and MD Regulations. The instrument relies on the MD Regulations and the Regulations for definitions and for certain exemption mechanisms. Section 4 defines MD Regulations and Regulations by name, and aligns intended purpose and medicinal cannabis products to those instruments. Schedule 1 refers to exemptions under item 3 of Schedule 5A to the Regulations, and to item 2.3 in Part 2 of Schedule 4 to the MD Regulations. It also refers to regulation 7.2 of the MD Regulations and regulation 12A of the Regulations for Category A patient exemptions. This means that the effect of the determination will vary depending on the substance of those Regulations and the Notices or statements they require; for instance, the determination treats the content of the notices and statements required by those Regulations as the operative indications for Category A exemptions.

Evidential and definitional cross-use. Section 4 notes that subsection 3(1) of the Act contains a number of definitions used by the instrument. That embeds the instrument within the definitional regime of the Act, so that terms such as included in the Register, indications, medical device, medicine, and vaping substance are read with their statutory meanings from the Act. Consequently, the instrument interacts with other laws by depending on those definitions to determine which items in Schedule 1 apply to a given product.

No alteration of registration or approval standards. The instrument does not amend or substitute the criteria, standards or procedural requirements in the Act, the Regulations, or the MD Regulations for approvals, registrations or authorisations. It does not purport to alter the content of the Register, or to change the substantive grounds on which the regulator may grant approvals or authorisations. Instead, it instructs which existing approvals, inclusions, authorisations, rules or notices provide the permissible non‑cessation indications under paragraph 41QB(11)(a).

Commencement dependency on other legislation. Section 2 conditions commencement on the start of parts of the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024. Therefore the instrument interacts temporally with that amendment Act; it will not take legal effect unless and until the specified parts of that Act commence. The instrument thus depends on an allied statutory change for its operational start date.

Administrative and procedural interplay. Because the instrument maps indications to approvals, registrations, authorisations and notices, administrative activity under those regimes (for example, an application for approval under subsection 19(1)(a) or for inclusion in the Register) will produce the operative indications the instrument recognises for paragraph 41QB(11)(a). That creates an interaction in practice: applicants must comply with the procedural and substantive requirements of those other laws to obtain the document that the determination will read as the source of permitted indications.

This instrument contains a limited internal amendment history note. Section 2 includes a commencement table and a note stating: "This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument." The instrument itself does not list any subsequent amendments, and no amending instrument or historical variations are recorded within the provided text.

Date and maker. The instrument is dated 29 June 2024 and is signed by Nicholas Henderson, Acting Deputy Secretary, Health Products Regulation Group, Department of Health and Aged Care, as a delegate of the Minister for Health and Aged Care. That is the only entry that reflects the making of the instrument.

Commencement clause and conditionality. The commencement clause (section 2) sets the single special commencement rule that links the instrument’s operation to the commencement of Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024. The clause also states that the instrument does not commence at all if that amendment Act does not commence. That conditional commencement functions as a temporal limitation in the instrument’s original form.

No recorded amendments in the instrument text. The instrument as provided does not contain any variation, schedule of amendments, or later dates of amendment. The instrument’s own note anticipates that published versions may edit or insert information in the non‑operative third column of the commencement table, but that such material is not part of the instrument (see s 2(2)). There is no material in the supplied text indicating any amendment after the instrument was made on 29 June 2024.

Implication for users. Because the instrument states that its commencement and any other stated effect are as in the table, and the table will not be amended within the instrument itself, any future amendments to the instrument would be expected to be made by a separate amending instrument. The instrument contains no transitional provisions, savings clauses, or retrospective amendments. Users requiring authoritative amendment history should therefore consult consolidated legislative records or the federal register of legislative instruments for any later amending instruments, noting that none are recorded within the instrument text supplied here.

The instrument does not provide, and does not refer to, any litigation history. There are no cases, appeals, or judicial determinations mentioned in the instrument text. It contains no schedules or appendices that record legal challenges, tribunal actions, or litigation outcomes.

Absence of judicial references. The instrument does not cite any judicial authority, does not identify settled points of law through case law, and does not record prior adjudications about the scope of paragraph 41QB(11)(a) of the Act, Schedule 1 items, or the meaning of intended purpose or indications. It is a standalone administrative determination and the text contains no commentary on, or record of, litigation.

Implications for research and dispute resolution. Because the instrument provides no litigation history, practitioners seeking precedents or judicial interpretation of how paragraph 41QB(11)(a) is to be applied in light of this instrument will not find guidance within this instrument text. Any disputes as to the application of the determination, or as to whether a particular product’s indication is captured by an approval, inclusion, authorisation, rule or notice referenced in Schedule 1, will need to be resolved through the normal administrative review, merits review or judicial review pathways available under the Act and general administrative law; the instrument itself contains no material about such processes.

Practical note. When advising clients on the legal effect or enforceability of the instrument’s determinations in a contested context, legal advisers must look to the underlying Act and Regulations for remedies, jurisdictional boundaries, and enforcement powers, because this instrument does not create or cite litigation channels or outcomes.

This instrument is short and tightly framed, but it contains multiple practical traps and points of potential misunderstanding. Below are the key concrete risks and operational pitfalls that arise directly from the instrument’s text and structure.

Conditional commencement. The whole instrument does not commence unless Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence. If those parts do not commence, this instrument does not commence at all (see s 2). Parties who act as if the determination is in force before that condition is met risk relying on a non‑operative instrument.

The instrument does not itself list clinical indications. Some readers may expect the determination to enumerate clinical conditions or therapeutic claims for vaping goods. It does not. Instead, it points to the specific approvals, register entries, authorisations, rules or notices as the place where the indications or intended purposes are stated (see s 5 and Schedule 1). That means there is no single consolidated list of permitted indications in the instrument; users must consult the underlying approvals and Register entries.

Two different statutory vocabularies. The instrument mixes "indications" (medicine terminology) and "intended purpose" (medical device terminology). Section 4 aligns intended purpose with the MD Regulations, and Schedule 1 uses intended purpose when dealing with medical devices and indications when dealing with medicines. Failure to map those conceptually distinct terms could produce compliance errors; sponsors must ensure they are referencing the correct term in the relevant regulatory instrument.

Reliance on notices and statements for exemptions. For some exempt categories the instrument identifies the indication as the one set out in a notice (Schedule 1, Item 1(c) and 1(d)) or in a statement for Category A patients (Schedule 1, Items 2(e) and 3(e)). Those notices or statements are created according to the requirements of separate regulatory items (item 3 of Schedule 5A, item 2.3 of Part 2 of Schedule 4 to the MD Regulations, subregulation 7.2(1)(b)(ii), subregulation 12A(2)(a)(iii)). Parties must ensure that the notices or statements meet the procedural and content requirements of those instruments, because the determination makes the contents of the notices and statements the operative indications for paragraph 41QB(11)(a).

No change to approval or registration content. The determination does not alter the content of approvals, Register entries, authorisations, or exemptions. If an approval or registration itself is limited or conditional, this determination does not expand that scope; it references what is in those instruments. Parties should not infer that the determination broadens indications beyond what the approvals or registrations contain.

Evidentiary burden. Because permissible indications are sourced in separate documents, parties bear an evidentiary burden to produce the relevant approval, Register entry, authorisation, rule or notice to justify reliance on any given indication for paragraph 41QB(11)(a). Absent that documentation, the determination provides no standalone justification.

Potential for misalignment across regimes. The instrument spans medicine and device regimes and different exemption mechanisms. A product or substance could be regulated differently depending on classification. Sponsors and advisers must confirm under which regime a product falls, and then consult the corresponding subparagraph in Schedule 1. Misclassification can lead to reliance on the wrong set of permitted indications.

Non‑operative metadata in the commencement table. Section 2(2) says any information in column 3 of the commencement table is not part of the instrument. Users copying the table content from a published version must not treat column 3 narrative as authoritative law; it is explicitly not part of the instrument.

No transitional or transitional complexity explained. The instrument contains no transitional or savings clauses. It does not say how existing supplies, representations or products in the supply chain are to be treated on commencement. Sponsors should not assume grandfathering; the instrument does not make that assumption explicit.

Narrow statutory purpose. The determination is made only "for the purposes of paragraph 41QB(11)(a) of the Act" (s 5). It is not expressed to apply generally across all provisions of the Act or Regulations. Users must be careful not to apply the instrument’s determinations to legal questions or statutory provisions beyond the explicit purpose.

Ambiguity around "medicinal cannabis products" and "synthetic cannabis". Section 4 delegates the meaning of "medicinal cannabis products" to the Regulations and Schedule 1 distinguishes medicinal cannabis vaping goods from vaping substances that are medicinal cannabis products or synthetic cannabis medicines. Users must consult the Regulations for the technical definitions and classification tests; the determination itself does not provide the definitional content.

Compliance with this determination requires a paper trail linking a given vaping good to the approval, registration, authorisation, rule or notice identified in Schedule 1, and ensuring that any non‑cessation indication used in labelling, promotion, supply, or clinical use is exactly the indication or intended purpose specified in the referenced instrument. Below are practical, source‑grounded steps derived from the instrument’s text.

1. Confirm instrument commencement. Before relying on the determination, verify whether the instrument has commenced. Section 2 conditions the instrument’s commencement on the commencement of Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024. If those parts have not commenced, this instrument does not commence and does not provide any legal cover for indications.

2. Classify the product under the Act’s definitions. Section 4 notes that many expressions are defined in subsection 3(1) of the Act, and that intended purpose, medicinal cannabis products, MD Regulations, and Regulations are defined or aligned by the instrument. Determine whether the product is a medicine, a medical device, a vaping good, a vaping substance, or a medicinal cannabis product under the Act and the Regulations, because Schedule 1 applies different subparagraphs depending on that classification (see s 4 and Schedule 1).

3. Identify the relevant Schedule 1 item and subparagraph. Map the product to Item 1, Item 2, or Item 3 in Schedule 1. For a general vaping good, consult Item 1; for a medicinal cannabis vaping good that is a medical device, consult Item 2; for vaping substances that are medicinal cannabis products or medicines containing synthetic cannabis, consult Item 3. Within the relevant Item, identify whether the product is included in the Register, approved under the cited subsection, authorised for supply, covered by rules made under the cited subsections, or exempt under the specified regulation or schedule item.

4. Obtain and retain the underlying approval, Register entry, authorisation, rule or notice. The instrument makes the content of those underlying documents the source of permissible indications. Therefore, to rely on an indication for the purposes of paragraph 41QB(11)(a), retain a copy of the approval, Register entry, authorisation, rule, notice, or for Category A patients, the statement required by the exemption subregulation. That documentation will be the evidentiary source relied upon under the instrument.

5. Align labelling, promotion and supply strictly to the specified indication or intended purpose. The determination imports precisely the indications accepted or specified in the referenced approvals, Register entries, authorisations, rules or notices. Ensure that any labelling, promotional material, clinical guidelines, or supply instructions match the wording and scope of those documents. If an approval authorises a narrow intended purpose, do not expand that language in marketing or instructions.

6. For Category A patient exemptions, ensure statements comply with the Regulations or MD Regulations. Schedule 1 Items 2(e) and 3(e) make clear that for Category A patients the allowed use is the use set out in the statement referenced by the relevant subregulations. Ensure that those statements are prepared, signed and retained in the format mandated by the exemption provisions and that clinical use adheres strictly to the statement content.

7. Track classification changes and regulatory updates. Because the determination depends entirely on approvals, registrations, authorisations, rules and notices that may be amended or revoked over time, maintain an active compliance process to track any changes to the Register entry, approval, authorisation, rule or notice that supplies the indication. A change in the underlying instrument may narrow or remove the indications this determination recognises.

8. Consult the Act and Regulations for procedural obligations. The determination references approvals, inclusions, authorisations and exemption mechanisms created under various subsections of the Act and the Regulations. Compliance therefore requires meeting the substantive and procedural obligations of those instruments,application requirements, evidence standards, conditions of approval, and post-market reporting. The determination does not alter those requirements; it depends on them.

9. Retain legal and clinical advice where necessary. Because the instrument spans medicine and device regimes and references exemptions and Category A patient statements, engage legal and clinical advisers to confirm classification and to draft or review notices or statements required under the exempting provisions in Schedule 5A, the MD Regulations, or regulation 12A. That will reduce the risk of misapplication.

10. Do not assume broader application. Use this determination only for the explicit statutory purpose it references, paragraph 41QB(11)(a) of the Act. Do not treat the determination as affecting other regulatory questions, market authorisations, or civil liability beyond what follows from the underlying approvals, registrations, authorisations or notices.

Following these steps will align practical compliance activity with the text and structure of the instrument, and will provide the documentary evidence necessary to show that a vaping good’s non‑cessation indication falls within the scope of this determination as required by section 5 and Schedule 1.