{"id":"tas:sr-2015-054","name":"Therapeutic Goods (Exemption) Order 2015","slug":"therapeutic-goods-exemption-order-2015","collection":"regulation","jurisdiction":"tas","status":"in_force","isInForce":true,"actNumber":"54 of 2015","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":186446,"registerId":"tas-tas:sr-2015-054-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> This order may be cited as the [Therapeutic Goods (Exemption) Order 2015](/view/html/inforce/2026-04-12/sr-2015-054) .","sortOrder":0},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"### 2 Commencement\n\n> This order takes effect on the day on which its making is notified in the *Gazette*.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Interpretation","content":"### 3 Interpretation\n\n> > (1)  In this order –\n> > \n> > > ***authorised premises*** means premises at which the supply of needles and syringes by way of a dispensing machine is authorised under a permit issued and in force under [Division 1A of Part 3](/view/html/inforce/2026-04-12/act-1997-086#HP3@HD1A@EN) of the [Public Health Act 1997](/view/html/inforce/2026-04-12/act-1997-086) ;\n> > \n> > > ***dispensing machine*** has the same meaning as in [section 56A](/view/html/inforce/2026-04-12/act-1997-086#GS56A@EN) of the [Public Health Act 1997](/view/html/inforce/2026-04-12/act-1997-086) .\n> \n> > (2)  The [Acts Interpretation Act 1931](/view/html/inforce/2026-04-12/act-1931-059) applies to the interpretation of this order as if it were by-laws.","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Exemptions","content":"### 4 Exemptions\n\n> > (1)  A person is exempt from the operation of [section 22(1)](/view/html/inforce/2026-04-12/act-2001-097#GS22@Gs1@EN) of the [Therapeutic Goods Act 2001](/view/html/inforce/2026-04-12/act-2001-097) in respect of the following:\n> > \n> > > > (a) the installation of a dispensing machine, if the person is installing the dispensing machine on authorised premises;\n> > > \n> > > > (b) the supply of needles or syringes by means of a dispensing machine installed on authorised premises.\n> \n> > (2)  A person who occupies or controls authorised premises is exempt from the operation of [section 22(2)](/view/html/inforce/2026-04-12/act-2001-097#GS22@Gs2@EN) of the [Therapeutic Goods Act 2001](/view/html/inforce/2026-04-12/act-2001-097) in respect of the following:\n> > \n> > > > (a) the installation of a dispensing machine on the premises;\n> > > \n> > > > (b) the storage of needles or syringes in a dispensing machine installed on the premises;\n> > > \n> > > > (c) the supply of needles or syringes by means of a dispensing machine installed on the premises.","sortOrder":3},{"sectionNumber":"5","sectionType":"section","heading":"Legislation revoked","content":"### 5 Legislation revoked\n\n> The legislation specified in [Schedule 1](#JS1@EN) is revoked.","sortOrder":4},{"sectionNumber":"SCHEDULE 1 - Legislation revok","sectionType":"part","heading":"SCHEDULE 1 - Legislation revoked","content":"# SCHEDULE 1 - Legislation revok SCHEDULE 1 - Legislation revoked\n\n[Clause 5](#GS5@EN)\n\n| Therapeutic Goods (Exemption) Order 2011 (No. 65 of 2011) |\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 29 July 2015\n\nThis order is administered in the Department of Health and Human Services.","sortOrder":5}],"analysis":{"issue_detection":{"absurdities":[],"contradictions":[]},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"This Order replaces the earlier 2011 exemption (s5 / Schedule 1) and confines exemptions to installation, storage and supply of needles/syringes via dispensing machines on authorised premises (s4), with definitions tied to the Public Health Act (s3). The instrument itself adds no new categories beyond those activities, so its textual scope does not appear expanded compared with the prior exemption it revokes; practical scope depends on permit practice under the Public Health Act."},"complexity_factors":["Narrow, focused subject-matter (single exemption for dispensing machines) reduces complexity.","Cross-references to other statutes: Therapeutic Goods Act 2001 (s22) and Public Health Act 1997 (Division 1A, s56A) require readers to consult external provisions to understand coverage.","Application of the Acts Interpretation Act 1931 as if the order were by‑laws (s3(2)) adds a specific interpretive lens.","Regulatory discretion and compliance hinge on permits issued under the Public Health Act; the order does not set permit conditions — reliance on another regime increases legal interdependence.","Revocation of the 2011 Order (Schedule 1 / s5) creates a continuity/transition question but no substantive new mechanisms in this text."],"plain_english_summary":"This Order exempts people who install or operate needle-and-syringe dispensing machines on authorised premises from certain prohibitions in the Therapeutic Goods Act 2001, allowing installation, storage and supply of needles and syringes through those machines. It applies to installers, occupiers and suppliers on premises authorised under the Public Health Act 1997; permit-holders carry the compliance burden, while regulators retain permit-based discretion. The Order takes effect on Gazette notice and revokes the 2011 exemption."},"summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"Insufficient legislative text was provided to determine whether the scope of this order changed from its original intent. The document supplied is a status/metadata page only, without the operative provisions of the order."},"complexity_factors":["The document provided is largely a metadata/status page — the substantive legal content of the order itself is not included, making full analysis impossible","Therapeutic goods regulation involves interaction between state (Tasmanian) and federal (Commonwealth) frameworks, which can create layered complexity","Exemption orders by nature require cross-referencing the parent legislation to understand what is being exempted from","The order has been in force since 2015 and may have been amended, requiring review of the Table of Amendments to understand the current state of the law"],"plain_english_summary":"This Tasmanian order permits certain therapeutic goods (medicines, devices or health products) to be exempted from some regulatory requirements, allowing their manufacture, supply or use in Tasmania without the usual full approvals. It affects manufacturers, suppliers, healthcare providers and potentially users by easing regulatory barriers for specified circumstances (e.g. emergencies or specialised use).\n\nThe provided record lacks the actual list and conditions, so the precise goods and waived requirements are not discernible from this text."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The legislation maintains its original narrow purpose. It has not expanded beyond creating specific exemptions for needle and syringe dispensing machines operating under the Tasmanian Public Health Act permit system. The 2015 version simply revokes and replaces the 2011 order without broadening the scope."},"complexity_factors":["Only 2 defined terms in the interpretation section ('authorised premises' and 'dispensing machine')","No nested exceptions or conditional logic — exemptions are straightforward and unconditional","Single cross-reference to the Public Health Act 1997 for definitions and permit requirements","Very short document — 5 clauses plus a single-item schedule","Clear structure: definitions, two simple exemption provisions, and a revocation clause","No operative conditions beyond the 'authorised premises' requirement"],"plain_english_summary":"**What this legislation does:**\n\nThis order creates a legal exemption (a 'free pass') for specific needle and syringe dispensing machines in Tasmania. Normally, the *Therapeutic Goods Act 2001* tightly controls who can supply therapeutic goods (including medical devices like needles and syringes). This order says that certain people don't have to follow those usual rules.\n\n**Who it affects:**\n\n- **People installing dispensing machines** — they don't need the usual approvals to set up automated machines that give out needles and syringes\n- **People who own or control the premises** where these machines are located — they don't need the usual approvals to store or supply needles and syringes through these machines\n- **The general public** — specifically people who use needle and syringe programs, which are public health initiatives to reduce harm from drug use and prevent disease transmission\n\n**The catch — 'authorised premises' only:**\n\nThese exemptions only apply at **'authorised premises'** — locations that have a special permit under Tasmania's *Public Health Act 1997*. This means the machines must be approved under the state's public health needle exchange program, not just anywhere.\n\n**Why it matters:**\n\nThis is a **harm reduction** measure. It allows automated dispensing machines to operate in supervised locations without getting bogged down in therapeutic goods licensing requirements. This makes it easier to run needle exchange programs that help prevent blood-borne diseases like HIV and hepatitis C among people who inject drugs.\n\nThe order also **replaces an older 2011 version** of the same exemption (listed in Schedule 1), updating the legal framework for these programs."},"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"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-exemption-order-2015","history":"/api/acts/therapeutic-goods-exemption-order-2015/history","analysis":"/api/acts/therapeutic-goods-exemption-order-2015/analysis","conflicts":"/api/acts/therapeutic-goods-exemption-order-2015/conflicts","importantCases":"/api/acts/therapeutic-goods-exemption-order-2015/important-cases","documents":"/api/acts/therapeutic-goods-exemption-order-2015/documents"}}