{"id":"F2024L00842","name":"Therapeutic Goods (Vaping Goods—Other Indications) Determination 2024","slug":"therapeutic-goods-vaping-goods-other-indications-determination-2024","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":442480,"registerId":"F2024L00842-fast-fetch-1775957467487","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Vaping Goods—Other Indications) Determination 2024","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n![Commonwealth Coat of Arms of Australia](image.001.jpeg)\n\n \n\nTherapeutic Goods (Vaping Goods—Other Indications) Determination 2024\n\nI, Nicholas Henderson, as delegate of the Minster for Health and Aged Care, make the following determination.\n\nDated 29 June 2024\n\nNicholas Henderson\n\nActing Deputy Secretary  Health Products Regulation Group  Department of Health and Aged Care\n\n \n\n \n\n \n\nContents\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Definitions\n\n5  Other indications for which vaping goods may be used\n\nSchedule 1—Other indications for which vaping goods may be used\n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Vaping Goods—Other Indications) Determination 2024.\n\n2  Commencement\n\n (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.\n\n \n\n- Commencement information\n- Column 1 Column 2 Column 3\n- Provisions Commencement Date/Details\n- 1. The whole of this instrument At the same time as Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.However, this instrument does not commence at all if the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 does not commence.\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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.\n\n (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.\n\n3  Authority\n\n  This instrument is made under section 41RA of the Therapeutic Goods Act 1989.\n\n4  Definitions\n\nNote: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n(a) included in the Register;\n\n(b) indications;\n\n(c) medical device;\n\n(d) medical practitioner;\n\n(e) medicine;\n\n(f) Register;\n\n(g) registered goods;\n\n(h) therapeutic goods;\n\n(i) vaping device;\n\n(j) vaping goods;\n\n(k) vaping substance.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nintended purpose has the same meaning as in the MD Regulations.\n\nmedicinal cannabis products has the same meaning as in the Regulations.\n\nMD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\n5  Other indications for which vaping goods may be used\n\n  For the purposes of paragraph 41QB(11)(a) of the Act, in relation to each item of the table in Schedule 1, the indications in column 3 are determined to be indications (other than smoking cessation or management of nicotine dependence) for which the vaping goods in column 2 may be used.\n\n\n\n\nSchedule 1—Other indications for which vaping goods may be used\n\nNote: See section 5.\n\n- Other indications for which vaping goods may be used\n- Column 1 Column 2 Column 3\n- Item Vaping goods Indications\n- 1 a vaping good the following:(a) for goods approved under paragraph 19(1)(b) of the Act—one or more indications specified in the approval;(b) for a medical device approved under paragraph 41HB(1)(e) of the Act—one or more intended purposes specified in the approval;(c) for goods exempt under item 3 of Schedule 5A to the Regulations—one or more indications set out in the notice that is given in accordance with that item; (d) for medical devices exempt under item 2.3 in Part 2 of Schedule 4 to the MD Regulations—the intended purpose set out in the notice that is given in accordance with that item\n- 2 a medicinal cannabis vaping good the following:(a) for a medical device included in the Register—one or more intended purposes accepted in relation to the inclusion of the medical device in the Register;(b) for a medical device approved under subsection 41HB(1)(d) of the Act—one or more intended purposes specified in the approval;(c) for a medical device authorised for supply under subsection 41HC(1) of the Act—one or more intended purposes specified in the authorisation;(d) for a medical device authorised for supply under rules made under subsection 41HC(6) of the Act—one or more purposes specified in the rules;(e) for medical devices exempt under regulation 7.2 of the MD Regulations, in relation to a person who is a Category A patient within the meaning of subregulation 7.2(2)—the use of the device in relation to the treatment of the person’s condition, as set out in the statement referred to in subparagraph 7.2(1)(b)(ii) of the MD Regulations\n- 3 a vaping substance that is:(a) a medicinal cannabis product; or(b) a medicine that contains synthetic cannabis the following:(a) for registered goods—one or more indications that are accepted in relation to the inclusion of the goods in the Register;(b) for goods approved under subsection 19(1)(a) of the Act—one or more indications specified in the approval;(c) for goods authorised for supply under subsection 19(5) of the Act—one or more indications specified in the authorisation;(d) for goods authorised for supply under rules made under subsection 19(7A) of the Act—one or more indications specified in the rules;(e) for goods exempt under regulation 12A of the Regulations, in relation to a person who is a Category A patient within the meaning of subregulation 12A(5)—the use of the good in relation to the treatment of the person’s condition, as set out in the statement referred to in subparagraph 12A(2)(a)(iii) of the Regulations\n\n\n \n","sortOrder":0}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":false,"description":"The instrument exercises delegated authority under section 41RA to identify 'other indications' for vaping goods by reference to existing approvals, registrations, authorisations and exemption notices. It does not itself amend the Act or the definitions in the Regulations; it clarifies which therapeutic uses are treated as permitted under the existing statutory framework (see section 5 and Schedule 1)."},"complexity_factors":["Extensive cross‑referencing to other primary and delegated instruments (Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990, Therapeutic Goods (Medical Devices) Regulations 2002) (see sections 3, 4, 5 and Schedule 1).","Delegated determination power invoked (instrument made under section 41RA of the Act) concentrating substantive choice with the delegate (section 3).","Commencement conditional on the separate Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commencing, creating temporal dependence (section 2).","Three parallel product categories with distinct regulatory pathways (devices, medicinal cannabis vaping devices, vaping substances) each mapped to multiple approval/registration/authorisation/exemption routes (Schedule 1, items 1–3).","Multiple administrative pathways referenced (Register inclusion, approvals under ss19/41HB, authorisations under ss19(5)/41HC, rules under ss19(7A)/41HC(6), and statutory exemptions/notices), increasing interpretive burden (Schedule 1).","Reliance on defined terms located in external provisions (e.g. 'intended purpose', 'medicinal cannabis products', 'Category A patient'), requiring cross‑check to other instruments to resolve scope and eligibility (section 4; Schedule 1 items 2(e), 3(e)).","Tabular and nested paragraph drafting (Schedule 1) raises practical complexity for compliance and legal interpretation (Schedule 1 formatting and cross‑links).","Compliance burden: sponsors and practitioners must match a product's regulatory status to the listed indication pathway to lawfully supply or use the product, so operational compliance requires checking multiple registers and notices (section 5 and Schedule 1)."],"plain_english_summary":"*Therapeutic Goods (Vaping Goods—Other Indications) Determination 2024* specifies non‑smoking‑cessation therapeutic indications for vaping goods by tying permitted uses to existing approvals, registrations, authorisations or exemption notices for devices, vaping substances and medicinal cannabis products. It affects manufacturers, sponsors, health practitioners and patients by defining which therapeutic uses are lawful under the Therapeutic Goods Act."},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"The legislation maintains a narrow, technical scope consistent with its purpose. It serves a single function: specifying 'other indications' for vaping goods as permitted by section 41QB(11)(a) of the Therapeutic Goods Act 1989. It does not expand beyond this delegated legislative purpose."},"complexity_factors":["Heavy reliance on cross-references to external instruments (Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990, Therapeutic Goods (Medical Devices) Regulations 2002) rather than setting out substantive rules directly","Nested conditional logic in Schedule 1: each item contains 4-5 alternative pathways (a)-(e) depending on which approval mechanism applies","11 defined terms or term references in section 4, including 9 terms imported by reference from the parent Act","Conditional commencement clause tied to another Act not yet commenced (section 2)","Dense tabular format in Schedule 1 with three columns and multiple sub-paragraphs creating parsing difficulty"],"plain_english_summary":"This instrument defines which medical conditions and purposes allow lawful use of vaping products in Australia beyond smoking cessation, by listing approved therapeutic uses for devices and vaping substances and relying on existing approval systems (TGA register, special access, exemptions).\n\nIt affects patients prescribed inhaled therapies, clinicians who prescribe them, suppliers and pharmacists, and matters because it creates a clear legal pathway for prescribed medicinal vaping while keeping recreational restrictions in place."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-vaping-goods-other-indications-determination-2024","history":"/api/acts/therapeutic-goods-vaping-goods-other-indications-determination-2024/history","analysis":"/api/acts/therapeutic-goods-vaping-goods-other-indications-determination-2024/analysis","conflicts":"/api/acts/therapeutic-goods-vaping-goods-other-indications-determination-2024/conflicts","importantCases":"/api/acts/therapeutic-goods-vaping-goods-other-indications-determination-2024/important-cases","documents":"/api/acts/therapeutic-goods-vaping-goods-other-indications-determination-2024/documents"}}