{"id":"tas:sr-2022-046","name":"Therapeutic Goods Regulations 2022","slug":"therapeutic-goods-regulations-2022","collection":"regulation","jurisdiction":"tas","status":"in_force","isInForce":true,"actNumber":"46 of 2022","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":179652,"registerId":"tas-tas:sr-2022-046-current","compilationNumber":null,"startDate":"2026-04-05","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Short title","content":"### 1 Short title\n\n> These regulations may be cited as the [Therapeutic Goods Regulations 2022](/view/html/inforce/2026-04-12/sr-2022-046) .","sortOrder":0},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"### 2 Commencement\n\n> These regulations take effect on 1 August 2022.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Wholesaler of therapeutic goods to comply with Code","content":"### 3 Wholesaler of therapeutic goods to comply with Code\n\n> > (1)  In this regulation –\n> > \n> > > ***Code*** means the \"*Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8*\", first published by the former entity of the Commonwealth known as the National Coordinating Committee on Therapeutic Goods on 1 April 2011, and as republished from time to time by the Therapeutic Goods Administration of the Commonwealth.\n> \n> > (2)  A person who supplies therapeutic goods by wholesale must comply with the Code.\n> > \n> > Penalty:  Fine not exceeding 20 penalty units.","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Labelling of certain therapeutic substances","content":"### 4 Labelling of certain therapeutic substances\n\n> > (1)  In this regulation –\n> > \n> > > ***container***, when used in relation to any therapeutic substance, means any vessel, bottle, tube, capsule, tin, box, case, wrapper, cover or other like receptacle or envelope that immediately contains the substance;\n> > \n> > > ***Poisons List*** has the same meaning as in the [Poisons Act 1971](/view/html/inforce/2026-04-12/act-1971-081) ;\n> > \n> > > ***therapeutic substance*** means a substance supplied for therapeutic use;\n> > \n> > > ***therapeutic use*** has the same meaning as in the Commonwealth Act;\n> > \n> > > ***unscheduled therapeutic substance*** means a therapeutic substance that is not specified in any of the Schedules to the Poisons List.\n> \n> > (2)  A person specified in item 1, 2 or 4 of Schedule 8 to the *Therapeutic Goods Regulations 1990* of the Commonwealth must not supply an unscheduled therapeutic substance for therapeutic use unless the person complies with the standards constituted by the following orders made under section 10 of the *Therapeutic Goods Act 1989* of the Commonwealth:\n> > \n> > > > (a) *Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines*;\n> > > \n> > > > (b) *Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines*.\n> > \n> > Penalty:  Fine not exceeding 20 penalty units.\n> \n> > (3)  The label on a container containing a therapeutic substance must show the following details:\n> > \n> > > > (a) the words \"KEEP OUT OF REACH OF CHILDREN\" in red on a white background;\n> > > \n> > > > (b) if the substance is intended for external use only, the word \"POISON\", or the words \"FOR EXTERNAL USE ONLY\", in red on a white background;\n> > > \n> > > > (c) if the substance is intended for the treatment of a person, the name of the person;\n> > > \n> > > > (d) if the substance is intended for the treatment of an animal, the species of animal and the name of the animal's owner.\n> \n> > (4)  In addition to the requirements of [subregulation (3)](#GS4@Gs3@EN) , the label on a container containing a therapeutic substance that is supplied on prescription must show the following details:\n> > \n> > > > (a) the directions for use;\n> > > \n> > > > (b) the prescription reference number;\n> > > \n> > > > (c) the date on which the prescription was supplied, unless that date is clear from the prescription reference number.\n> \n> > (5)  The provisions of [subregulations (3)](#GS4@Gs3@EN) and [(4)](#GS4@Gs4@EN) are complied with if the information referred to in those subregulations is shown by tags, brands or marks, or statements printed or in clear writing on the container.\n\nDisplayed and numbered in accordance with the *[Rules Publication Act 1953](/view/html/inforce/current/act-1953-050)*.\n\nNotified in the *Gazette* on 13 July 2022\n\nThese regulations are administered in the Department of Health.","sortOrder":3}],"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"},"issue_detection":{"absurdities":[],"contradictions":[]},"summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"Insufficient content is available to determine whether the scope of the regulations changed from their original intent. Only administrative metadata is present in the provided document. No substantive provisions, definitions, or operative clauses are visible to allow a meaningful comparison between original and current scope."},"complexity_factors":["Insufficient substantive content provided — only metadata and status information is visible, preventing full analysis","Therapeutic goods law generally involves technical scientific and medical standards, which can be complex","Interplay between state (Tasmanian) and federal (Commonwealth TGA) therapeutic goods frameworks adds a layer of jurisdictional complexity","The existence of amendments since commencement (last modified March 2025) suggests evolving obligations that require tracking over time","Score is conservatively low due to absence of actual regulatory content to assess"],"plain_english_summary":"These regulations set out the detailed rules under Tasmania’s Therapeutic Goods Act for the handling, supply, importation and sale of therapeutic goods (medicines, devices and related health products). They affect manufacturers, suppliers, importers, pharmacists, healthcare providers and consumers in Tasmania.\n\nThey establish licensing, safety and compliance frameworks for those activities. The instrument has been in force since 1 August 2022 and was last updated in March 2025."},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"This appears to be a focused, narrow regulation addressing specific operational requirements (wholesaling standards and labelling) under the broader Therapeutic Goods Act framework. The scope remains tightly constrained to its original purposes without significant expansion."},"complexity_factors":["Short length (5 regulations total)","Minimal defined terms (approximately 6 defined terms across the instrument)","Simple conditional structure with straightforward prohibitions and requirements","Some cross-referencing to external documents (Commonwealth Therapeutic Goods Orders, Poisons Act 1971, Therapeutic Goods Regulations 1990) but these are clearly identified","No nested exceptions or complex logical operators","Clear penalty provisions (flat 20 penalty units)"],"plain_english_summary":"**What this legislation does:**\n\nThese regulations set rules for how therapeutic goods (medicines and medical substances) are handled and labelled in Australia. They have two main purposes:\n\n1. **Wholesaling rules** — Anyone who sells medicines by wholesale (selling in bulk to retailers or healthcare providers, not directly to patients) must follow a specific professional code called the \"Code of Good Wholesaling Practice for Medicines.\" This ensures medicines are stored and distributed safely.\n\n2. **Labelling requirements** — Certain people who supply therapeutic substances must put specific safety information on the packaging, including:\n   - A warning to keep medicines away from children (in red text)\n   - \"POISON\" or \"FOR EXTERNAL USE ONLY\" labels for external-use products\n   - The patient's name, or for animals, the species and owner's name\n   - For prescription medicines: directions for use, prescription number, and supply date\n\n**Who it affects:**\n- Pharmaceutical wholesalers\n- Pharmacists and other authorised suppliers listed in Commonwealth regulations\n- Anyone packaging therapeutic substances for supply\n\n**Why it matters:**\nThese rules protect public health by ensuring medicines are properly tracked during distribution and clearly labelled so people know how to use them safely. The \"keep out of reach of children\" requirement and poison warnings help prevent accidental poisoning, while patient-specific labelling ensures the right person gets the right medication."},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"The instrument imposes and clarifies compliance and labelling requirements but does not state any alteration to the statutory coverage of therapeutic goods. The text references existing schedules and orders rather than expanding or narrowing scope; no explicit change of regulatory scope is declared in the supplied text."},"complexity_factors":["Cross-references to multiple external instruments: Code of Good Wholesaling Practice, Poisons Act 1971, Therapeutic Goods Act 1989, and Therapeutic Goods Orders (adds interpretive burden).","Defined technical terms (e.g. 'unscheduled therapeutic substance', 'container') that rely on statutory and scheduling context.","Targeted application to persons identified by reference to Schedule 8 of the 1990 Regulations rather than spelled out in full (requires checking another instrument).","Specific, prescriptive labelling format requirements (colour/contrast and exact wording) that increase compliance detail.","Monetary penalty (up to 20 penalty units) creates clear enforcement risk but not tiered sanctions — binary compliance outcome.","Permitted means of compliance include tags, brands or marks, which provide some operational flexibility but require judgment on equivalence."],"plain_english_summary":"These regulations require wholesalers to follow the Code of Good Wholesaling Practice for specified medicines and set mandatory labelling rules for therapeutic substances — e.g. “KEEP OUT OF REACH OF CHILDREN” (red on white), patient or animal identification, and, for prescription supplies, directions, prescription reference and supply date. Non‑compliance carries a fine up to 20 penalty units. They apply to persons supplying therapeutic goods (including those listed in Schedule 8 to the 1990 Regulations), shifting compliance costs to suppliers and creating enforcement incentives via fines and cross‑references to other Acts and Orders."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-regulations-2022","history":"/api/acts/therapeutic-goods-regulations-2022/history","analysis":"/api/acts/therapeutic-goods-regulations-2022/analysis","conflicts":"/api/acts/therapeutic-goods-regulations-2022/conflicts","importantCases":"/api/acts/therapeutic-goods-regulations-2022/important-cases","documents":"/api/acts/therapeutic-goods-regulations-2022/documents"}}