{"id":"C2004A03953","name":"Therapeutic Goods (Charges) Act 1989","slug":"therapeutic-goods-charges-act-1989","collection":"act","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":"22 of 1990","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":26487,"registerId":"commonwealth-C2004A03953-current","compilationNumber":null,"startDate":"2026-04-01","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Short title","content":"#### 1 Short title\n\n  This Act may be cited as the Therapeutic Goods (Charges) Act 1989.","sortOrder":0},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"#### 2 Commencement\n\n  This Act commences on 1 July 1990.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Incorporation","content":"#### 3 Incorporation\n\n  (1) The Therapeutic Goods Act 1989 is incorporated, and is to be read as one, with this Act.\n\n> Note: Subsection (1) applies the interpretation provisions of the Therapeutic Goods Act 1989 (such as subsection 3(8) of that Act, which says a reference to the registration of therapeutic goods includes a reference to the provisional registration of a medicine).\n\n  (1A) For the purposes of this Act, if a suspension of the registration or listing of therapeutic goods has effect under Part 3‑2 of the Therapeutic Goods Act 1989, the goods are taken to be included in the Register under that Part.\n  (1B) For the purposes of this Act, if a suspension of a biological from the Register has effect under Part 3‑2A of the Therapeutic Goods Act 1989, the biological is taken to be included in the Register under that Part.\n  (2) For the purposes of this Act, if a suspension of a kind of medical device, or any medical devices of a particular kind, has effect under Chapter 4 of the Therapeutic Goods Act 1989, that kind of medical device is taken to be included in the Register under that Chapter.\n  (3) For the purposes of this Act, if a suspension of a conformity assessment body determination has effect under regulations made for the purposes of Part 4‑4A of the Therapeutic Goods Act 1989, the determination is taken to be in force for the period of the suspension.","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Charges","content":"#### 4 Charges\n\n  (1) Annual charges of such amounts as are prescribed are payable in respect of the registration or listing of therapeutic goods, other than grouped therapeutic goods, that is in force at any time during a financial year.\n\n> Note: The reference to registration of therapeutic goods includes a reference to the provisional registration of a medicine (see subsection 3(8) of the Therapeutic Goods Act 1989 as applied by subsection 3(1) of this Act).\n\n  (1A) If the registration or listing of one or more grouped therapeutic goods, being goods covered by a single registration or listing number, is in force at any time during a financial year, an annual charge of such amount as is prescribed is payable in respect of all of the registrations or listings concerned.\n  (1AA) An annual charge of such amount as is prescribed is payable in respect of the inclusion of a biological in the Register under Part 3‑2A of the Therapeutic Goods Act that has effect at any time during a financial year.\n  (1B) Annual charges of such amounts as are prescribed are payable in respect of the inclusion of kinds of medical devices in the Register under Chapter 4 of the Therapeutic Goods Act that has effect at any time during a financial year.\n  (2) An annual charge of such amount as is prescribed is payable in respect of a licence that is in force at any time during a financial year.\n  (2A) An annual charge of such amount as is prescribed is payable in respect of a conformity assessment body determination that is in force at any time during a financial year.\n  Corresponding State laws\n  (3) If, because of the operation of section 6AAE of the Therapeutic Goods Act, goods are included in the part of the Register for goods known as registered goods, this section has effect as if the goods had been registered under Part 3‑2 of that Act.\n  (3A) If, because of the operation of section 6AAE of the Therapeutic Goods Act, goods are included in the part of the Register for goods known as provisionally registered goods, this section has effect as if the goods had been registered under Part 3‑2 of that Act.\n  (4) If, because of the operation of section 6AAE of the Therapeutic Goods Act, goods are included in the part of the Register for goods known as listed goods, this section has effect as if the goods had been listed under Part 3‑2 of that Act.\n  (4A) If, because of the operation of section 6AAE of the Therapeutic Goods Act, a biological is included in the part of the Register for biologicals included under Part 3‑2A, this section has effect as if the biological had been included in the Register under Part 3‑2A of that Act.\n  (5) If, because of the operation of section 6AAE of the Therapeutic Goods Act, goods are included in the part of the Register for medical devices included under Chapter 4, this section has effect as if the goods had been included in the Register under Chapter 4 of that Act.\n  (6) If:\n    (a) because of the operation of section 6AAA, 6AAB or 6AAC of the Therapeutic Goods Act, the Secretary issues a licence; and\n    (b) the licence is issued for the purposes of provisions of a corresponding State law that correspond to Part 3‑3 of the Therapeutic Goods Act;\n  this section has effect as if the licence had been issued under Part 3‑3 of that Act.\n  Definitions\n  (7) In this section:\n\n> amount includes a nil amount.\n\n> Therapeutic Goods Act means the Therapeutic Goods Act 1989.","sortOrder":3},{"sectionNumber":"5","sectionType":"section","heading":"Regulations","content":"#### 5 Regulations\n\n  (1) The Governor‑General may make regulations, not inconsistent with this Act, prescribing the amounts of charges.\n  (2) The regulations may prescribe different charges in relation to:\n    (a) different classes of goods (including medical devices); or\n    (b) in the case of annual licensing charges—different steps in the manufacture of goods; or\n    (c) conformity assessment body determinations of different kinds.","sortOrder":4}],"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":3,"scope_assessment":{"changed":false,"description":"The Act confines itself to prescribing annual charges and to adopting definitions and register‑treatment rules from the Therapeutic Goods Act. The text does not expand regulatory subject‑matter beyond fee imposition or alter the classes of regulated goods; it centralises fee setting in subsidiary regulations but does not indicate a change from the Act’s original fee‑imposition role."},"complexity_factors":["Short, focused scheme limited to imposing annual charges rather than substantive regulation","Heavy reliance on cross‑reference to the Therapeutic Goods Act for definitions and effect","Multiple categories of chargeable items (registrations, grouped goods, biologicals, device kinds, licences, conformity determinations)","Treatment of suspensions and corresponding State law entries as if on the Register — creates legal fictions to trigger charges","Delegation of key parameters (charge amounts, differentiated rates) to regulations (executive discretion)","Potential administrative complexity in identifying grouped goods and periods in which charges are payable"],"plain_english_summary":"This Act requires annual charges for registrations, listings, grouped entries, biologicals, kinds of medical devices, licences and conformity‑assessment determinations under the Therapeutic Goods Act. It incorporates the Therapeutic Goods Act’s definitions and treats certain suspensions and corresponding State‑law registrations as if on the Register. Amounts are set by regulation. The stated purpose is to recover regulatory costs; mechanically that shifts recurring costs onto rights‑holders and gives the executive discretion to set rates (see s5)."},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":true,"description":"The original 1989 Act appears to have been a straightforward charging mechanism for medicine registration and manufacturing licences. It has since expanded to cover: biological products (Part 3-2A, added via subsection 4(1AA)), medical devices (Chapter 4, added via subsection 4(1B)), conformity assessment body determinations (Part 4-4A, added via subsection 4(2A)), and complex interactions with corresponding State laws (subsections 4(3)-(6)). The deeming provisions for suspended registrations (section 3) also represent a broadening beyond simple 'active registration' charging to ensure revenue continuity during regulatory suspensions."},"complexity_factors":["Extensive cross-referencing to the Therapeutic Goods Act 1989 (incorporated by reference in section 3)","Multiple deeming provisions treating suspended registrations as active for charging purposes (subsections 3(1A), 3(1B), 3(2), 3(3))","Corresponding State law provisions creating parallel application scenarios (subsections 4(3) through 4(6))","Layered definitions: 'amount' explicitly includes nil amounts; 'Therapeutic Goods Act' defined locally but imports external definitions","Conditional logic for grouped therapeutic goods (single charge for multiple goods under one registration number)","Six distinct charging categories with subtly different legislative triggers (registration/listing, biologicals, medical devices, licences, conformity assessment determinations)"],"plain_english_summary":"This law sets up a system for charging annual fees to companies and organisations that register therapeutic goods (medicines, medical devices, and biological products) with the Australian Government.\n\n**What it does:**\n- **Establishes annual charges** for:\n  - Registering or listing medicines and therapeutic goods on the Australian Register of Therapeutic Goods (ARTG)\n  - Including biological products (like blood products, tissues, and cell therapies) on the Register\n  - Including medical devices on the Register\n  - Holding a manufacturing licence\n  - Holding a conformity assessment body determination (a certification for bodies that assess whether medical devices meet standards)\n\n- **Groups similar products:** If multiple therapeutic goods are covered under a single registration number, they pay one combined charge rather than separate fees for each item.\n\n- **Deals with suspended products:** Even if a product's registration is temporarily suspended, it still counts as being on the Register for charging purposes.\n\n- **Covers state-based registrations:** If a state or territory law corresponds to the federal Therapeutic Goods Act and results in goods being included on the federal Register, those goods are treated the same as federally registered goods for charging purposes.\n\n**Who it affects:**\n- Pharmaceutical companies registering prescription and over-the-counter medicines\n- Medical device manufacturers\n- Companies dealing with biological therapies\n- Manufacturing facilities holding licences to produce therapeutic goods\n- Conformity assessment bodies (organisations that certify medical devices meet Australian standards)\n\n**Why it matters:**\nThis law allows the Government to recover costs for regulating therapeutic products. The fees fund the Therapeutic Goods Administration (TGA), which checks that medicines, devices, and biological products are safe and effective before they reach Australian consumers. Without this charging mechanism, taxpayers would bear the full cost of product safety regulation."},"summary":{"complexity_score":5,"scope_assessment":{"changed":true,"description":"The Act's original scope was straightforward — annual charges for registered and listed therapeutic goods and manufacturing licences. Over time it has expanded significantly to cover biologicals (a distinct regulatory category created later), medical devices (brought under a separate regulatory chapter), conformity assessment body determinations, grouped therapeutic goods, provisional registration of medicines, and goods registered under corresponding State laws. The core charging mechanism is unchanged, but the range of products and authorisations subject to charges has grown substantially as Australian therapeutic goods regulation became more complex."},"complexity_factors":["Heavy reliance on cross-referencing: the Act is read as one with the Therapeutic Goods Act 1989, requiring readers to consult that separate, lengthy Act to fully understand obligations","Multiple categories of chargeable goods (registered goods, listed goods, biologicals, medical devices, grouped goods) each with separate provisions","Suspension rules create a counterintuitive outcome — suspended goods still attract charges — requiring careful reading","Corresponding State law provisions add a layer of federalism complexity, mapping State-authorised products onto Commonwealth fee obligations","Actual fee amounts are entirely absent from the Act itself, delegated to regulations that must be found and read separately","Specialised terminology (biologicals, conformity assessment body determinations, provisional registration) that requires knowledge of the parent Act","Multiple amending subsections (1A, 1AA, 1B, 2A, 3A, 4A etc.) suggest significant legislative history layered onto a simple original framework"],"plain_english_summary":"This Act requires annual fees to keep therapeutic goods (medicines, biologicals, medical devices) and related permissions (manufacturing licences, conformity assessment body approvals) registered or listed in Australia. It applies to manufacturers, sellers, licence holders and certifying organisations.\n\nThese charges—set by regulation—fund the TGA and must be paid even if a product is suspended or registered under equivalent State laws. Non‑payment can lead to loss of registration or licence and prevent legal sale."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-charges-act-1989","history":"/api/acts/therapeutic-goods-charges-act-1989/history","analysis":"/api/acts/therapeutic-goods-charges-act-1989/analysis","conflicts":"/api/acts/therapeutic-goods-charges-act-1989/conflicts","importantCases":"/api/acts/therapeutic-goods-charges-act-1989/important-cases","documents":"/api/acts/therapeutic-goods-charges-act-1989/documents"}}