{"id":"therapeutic-goods-law-application-local-regulations-regulations-2024","name":"Therapeutic Goods Law Application (Local Regulations) Regulations 2024","slug":"therapeutic-goods-law-application-local-regulations-regulations-2024","collection":"regulation","jurisdiction":"wa","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":182224,"registerId":"wa-therapeutic-goods-law-application-local-regulations-regulations-2024-current","compilationNumber":null,"startDate":"2026-04-05","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods Law Application (Local Regulations) Regulations 2024","content":"![Crest]()Western Australia\n\nTherapeutic Goods Law Application Act 2024\n\nTherapeutic Goods Law Application (Local Regulations) Regulations 2024\n\nWestern Australia\n\nTherapeutic Goods Law Application (Local Regulations) Regulations 2024\n\nContents\n\n1. Citation 1\n\n2. Commencement 1\n\n3. Rules modified (Act s. 15) 1\n\nNotes\n\nCompilation table 3\n\n  \n\nTherapeutic Goods Law Application Act 2024\n\nTherapeutic Goods Law Application (Local Regulations) Regulations 2024\n\n##### 1. Citation\n\n\t\tThese regulations are the *Therapeutic Goods Law Application (Local Regulations) Regulations 2024*.\n\n##### 2. Commencement\n\nThese regulations come into operation as follows —\n\n(a) regulations 1 and 2 — on the day on which these regulations are published on the WA legislation website;\n\n(b) the rest of the regulations — immediately after the *Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024* (Commonwealth) comes into operation for the purposes of Part 2 of the Act.\n\n##### 3. Rules modified (Act s. 15)\n\n(1) For the purposes of section 15 of the Act, the *Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022* (Commonwealth) apply as if amended as set out in this regulation.\n\n(2) In section 5A:\n\n(a) before subsection (3) in the heading delete “*—with prescription*”;\n\n(b) delete subsection (3)(b) and insert:\n\n(b) the supply is —\n\n(i) for a therapeutic good that contains nicotine — consistent with the pharmacist’s authority to supply the therapeutic good under the *Medicines and Poisons Act 2014* (WA); or\n\n(ii) for a therapeutic good that does not contain nicotine — authorised in writing by the treating practitioner; and\n\n(c) in subsection (3)(g) delete “subsection (4)” and insert:\n\nsubsections (4) and (7)\n\n(d) before subsection (5) delete “Supply by a pharmacist—without prescription”;\n\n(e) delete subsections (5) and (6).\n\n![]()\n\nNotes\n\nThis is a compilation of the *Therapeutic Goods Law Application (Local Regulations) Regulations 2024*. For provisions that have come into operation see the compilation table.\n\nCompilation table\n\n| **Citation** | **Published** | **Commencement** |\n| --- | --- | --- |\n| *Therapeutic Goods Law Application (Local Regulations) Regulations 2024* | SL 2024/258 11 Dec 2024 | r. 1 and 2: 11 Dec 2024 (see r. 2(a));   Regulations other than r. 1 and 2: 12 Dec 2024 (see r. 2(b) and SL 2024/257 cl. 3) |\n\n\n© State of Western Australia 2024.\n\nThis work is licensed under a Creative Commons Attribution 4.0 International Licence (CC BY 4.0). To view relevant information and for a link to a copy of the licence, visit www.legislation.wa.gov.au.\n\nAttribute work as: © State of Western Australia 2024.\n\nBy Authority: GEOFF O. LAWN, Government Printer\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":4,"scope_assessment":{"changed":true,"description":"Yes. These regulations amend how the Commonwealth Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022 operate in WA by altering section 5A: they remove the ‘—with prescription’ heading (reg 3(2)(a)), require nicotine products be supplied consistent with a pharmacist’s authority under the Medicines and Poisons Act 2014 (WA) (reg 3(2)(b)(i)), require written authorisation from the treating practitioner for non‑nicotine products (reg 3(2)(b)(ii)), update cross‑references (reg 3(2)(c)), remove the ‘without prescription’ heading (reg 3(2)(d)), and delete subsections (5) and (6) (reg 3(2)(e)). These changes narrow and re‑allocate the authorised supply pathways applicable in WA compared with the unamended rule."},"complexity_factors":["Cross-jurisdictional amendment: applies Commonwealth Rules as modified for WA (reg 3(1)).","Specific amendment of section 5A headings and subsections, involving deletions and insertions that change legal triggers (reg 3(2)(a),(b),(c),(d),(e)).","Distinction between nicotine and non‑nicotine products, tying nicotine to pharmacist authority under a separate WA Act (Medicines and Poisons Act 2014) (reg 3(2)(b)(i)).","Imposes written authorisation requirement for non‑nicotine therapeutic goods from the treating practitioner (reg 3(2)(b)(ii)), creating an evidentiary/compliance step.","Removes prior ‘without prescription’ supply subsections, altering prior supply pathways and potential defences (reg 3(2)(e)).","Commencement linked to a Commonwealth Act coming into operation, so timing depends on external instrument (reg 2(b)).","Practical compliance burden concentrated on pharmacists and treating practitioners who must adjust supply practices and record‑keeping (see reg 3(2)(b))."],"plain_english_summary":"These regulations change how a Commonwealth rule about authorised supply of therapeutic goods operates in Western Australia. They make nicotine-containing products subject to a pharmacist’s authority under the WA Medicines and Poisons Act 2014, require written authorisation from the treating practitioner for non‑nicotine products, and remove certain ‘without prescription’ supply provisions. This affects pharmacists, treating practitioners and suppliers by shifting who must authorise supply and what compliance steps are required."},"issue_detection":{"absurdities":[],"contradictions":[]},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The legislation remains tightly focused on its original purpose: ensuring the Commonwealth therapeutic goods rules apply appropriately in Western Australia by making specific technical amendments to avoid conflicts with state pharmacy laws. The modifications are narrow and targeted, dealing only with supply authorisation mechanisms for pharmacists."},"complexity_factors":["Very short instrument (only 3 substantive regulations)","Single modification target (one Commonwealth instrument)","Simple amendment structure (deletions and insertions to specific subsections)","No defined terms section — relies entirely on external legislation","Conditional commencement tied to external Commonwealth Act","Cross-references to multiple external statutes (Commonwealth Rules, WA Medicines and Poisons Act, Commonwealth Amendment Act)"],"plain_english_summary":"These regulations modify how Commonwealth therapeutic goods rules apply in Western Australia, specifically regarding who can supply certain medicines and vaping products.\n\n**What it does:**\n- Changes the Commonwealth *Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022* so they work properly with Western Australia's own laws.\n- **For nicotine products:** Allows pharmacists to supply them according to their existing authority under WA's *Medicines and Poisons Act 2014* (rather than needing a specific prescription in writing from a doctor).\n- **For non-nicotine products:** Still requires written authorisation from the treating practitioner (doctor).\n- Removes redundant sections about supplying medicines without prescriptions.\n\n**Who it affects:**\n- **Pharmacists in WA** — changes how they can legally supply therapeutic goods, particularly vaping products containing nicotine.\n- **Patients** accessing these products through pharmacies.\n- **Medical practitioners** — their role in authorising non-nicotine products remains unchanged.\n\n**Why it matters:**\nThis ensures WA's pharmacy laws and the Commonwealth therapeutic goods laws work together smoothly. Without this change, pharmacists might have faced conflicting requirements about how they could supply nicotine vaping products — potentially needing both Commonwealth prescription requirements AND state authorisation, or worse, the two systems contradicting each other. This harmonises the rules so WA pharmacists can rely on their existing state licensing to supply nicotine products."},"summary":{"complexity_score":2,"scope_assessment":{"changed":false,"description":"Scope cannot be assessed as the legislative text was not available for review. No comparison between original intent and final form is possible."},"complexity_factors":["No legislative text was retrievable — the source page returned a 'no longer available' error","Cannot assess cross-referencing complexity, definitions, or regulatory burden without the actual content","The title suggests potential interaction between Commonwealth and State law, which is typically complex, but this cannot be confirmed","Score reflects inability to analyse, not simplicity of the law itself"],"plain_english_summary":"This WA regulation sets out how national therapeutic goods laws are applied or adapted within Western Australia, establishing local rules, exemptions or modifications where needed. It affects healthcare providers, pharmacists, manufacturers, suppliers and consumers of medicines, devices and related products in WA, and matters because it determines which national requirements operate locally and how compliance is enforced."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-law-application-local-regulations-regulations-2024","history":"/api/acts/therapeutic-goods-law-application-local-regulations-regulations-2024/history","analysis":"/api/acts/therapeutic-goods-law-application-local-regulations-regulations-2024/analysis","conflicts":"/api/acts/therapeutic-goods-law-application-local-regulations-regulations-2024/conflicts","importantCases":"/api/acts/therapeutic-goods-law-application-local-regulations-regulations-2024/important-cases","documents":"/api/acts/therapeutic-goods-law-application-local-regulations-regulations-2024/documents"}}