{"id":"therapeutic-goods-law-application-act-2024","name":"Therapeutic Goods Law Application Act 2024","slug":"therapeutic-goods-law-application-act-2024","collection":"act","jurisdiction":"wa","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":110679,"registerId":"wa-therapeutic-goods-law-application-act-2024-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods Law Application Act 2024","content":"![Crest]()Western Australia\n\nTherapeutic Goods Law Application Act 2024\n\nWestern Australia\n\nTherapeutic Goods Law Application Act 2024\n\nContents\n\nPart 1 — Preliminary\n\n1. Short title 2\n\n2. Commencement 2\n\n3. Terms used 2\n\n4. Act binds Crown 3\n\nPart 2 — Applying Commonwealth therapeutic goods law as State law\n\n5. Application of Commonwealth therapeutic goods Act as State law 4\n\n6. Tabling amending Acts 5\n\n7. Disallowance of amending Acts 5\n\n8. Commencement of provisions of amending Acts 6\n\n9. Tabling of amending Act taken to be publication for Standing Orders 7\n\n10. Therapeutic legislative instruments 7\n\n11. Therapeutic legislative instruments made under or for purposes of amending Act 8\n\n12. Publication of therapeutic legislative instruments 9\n\n13. Tabling and disallowance of therapeutic legislative instruments 9\n\n14. Application of interpretation legislation to applied therapeutic goods law 11\n\n15. Local regulations may modify applied therapeutic goods law 12\n\nPart 3 — Functions and powers under applied therapeutic goods law\n\n16. Commonwealth authorities and officers have functions under applied therapeutic goods law 13\n\n17. Delegations under applied therapeutic goods law 13\n\nPart 4 — Offences\n\n18. Object of Part 14\n\n19. Application of Commonwealth criminal laws to offences against applied therapeutic goods law 15\n\n20. Functions and powers conferred on Commonwealth authorities and officers relating to offences 15\n\n21. No double jeopardy for offences against applied therapeutic goods law 16\n\nPart 5 — Commonwealth administrative laws\n\n22. Application of Commonwealth administrative laws to applied therapeutic goods law 17\n\n23. Functions and powers conferred on Commonwealth authorities and officers 17\n\nPart 6 — Miscellaneous\n\n24. Fees payable under applied therapeutic goods law 19\n\n25. Reference in Commonwealth law to provision of another law 19\n\n26. Local regulations 19\n\nPart 7 — Transitional provisions\n\n27. Term used: commencement day 20\n\n28. Amending Acts enacted on or after 27 November 2023 but before commencement day 20\n\n29. Therapeutic legislative instruments made on or after 27 November 2023 but before commencement day 20\n\n30. Liability of persons acting lawfully before commencement of applied therapeutic goods law as law of State 20\n\n31. Transitional regulation‑making power 21\n\nPart 8 — Consequential amendments\n\nDivision 1 — *Human Tissue and Transplant Act 1982* amended\n\n32. Act amended 22\n\n33. Section 29A amended 22\n\nDivision 2 — *Medicines and Poisons Act 2014* amended\n\n34. Act amended 23\n\n35. Section 3 amended 23\n\n36. Section 12 amended 23\n\n37. Section 28 amended 23\n\n38. Section 60 amended 24\n\nNotes\n\nCompilation table 25\n\nDefined terms\n\n  \n\nWestern Australia\n\nTherapeutic Goods Law Application Act 2024\n\nAn Act —\n\n- to apply the *Therapeutic Goods Act 1989* (Commonwealth) and legislative instruments under that Act as laws of the State; and\n- to make consequential amendments to various other Acts; and\n- for related purposes.\n\n\n## Part 1 — Preliminary\n\n##### 1. Short title\n\nThis is the *Therapeutic Goods Law Application Act 2024*.\n\n##### 2. Commencement\n\nThis Act comes into operation as follows —\n\n(a) Part 1 — on the day on which this Act receives the Royal Assent;\n\n(b) the rest of the Act — on a day fixed by proclamation.\n\n##### 3. Terms used\n\n(1) In this Act —\n\namend includes replace;\n\namending Act means a Commonwealth Act that receives the Royal Assent on or after 27 November 2023 to the extent that it —\n\n(a) amends the *Therapeutic Goods Act 1989* (Commonwealth); or\n\n(b) makes or amends a therapeutic legislative instrument;\n\napplied therapeutic goods law means the provisions that apply as a law of the State because of sections 5 and 10;\n\nCommonwealth administrative laws means the following —\n\n(a) the *Administrative Appeals Tribunal Act 1975* (Commonwealth) (excluding Part IVA);\n\n(b) the *Freedom of Information Act 1982* (Commonwealth);\n\n(c) the *Ombudsman Act 1976* (Commonwealth);\n\n(d) the *Privacy Act 1988* (Commonwealth);\n\n(e) the legislative instruments in force under those Acts;\n\nCommonwealth therapeutic goods law means —\n\n(a) the *Therapeutic Goods Act 1989* (Commonwealth); and\n\n(b) the legislative instruments under that Act;\n\nlocal regulations means the regulations made under section 26;\n\ntherapeutic legislative instrument means a regulation or other legislative instrument for the time being in force under the *Therapeutic Goods Act 1989* (Commonwealth).\n\n(2) If a term used in this Act is given a meaning in the *Therapeutic Goods Act 1989* (Commonwealth), it has the same meaning in this Act.\n\n##### 4. Act binds Crown\n\nThis Act binds the Crown in right of Western Australia and, so far as the legislative power of the Parliament permits, the Crown in all its other capacities.\n\n## Part 2 — Applying Commonwealth therapeutic goods law as State law\n\n##### 5. Application of Commonwealth therapeutic goods Act as State law\n\n(1) In this section —\n\nCommonwealth therapeutic goods Act means the *Therapeutic Goods Act 1989* (Commonwealth) as in force on 27 November 2023 as amended by —\n\n(a) a provision of a law of the Commonwealth that amends the *Therapeutic Goods Act 1989* (Commonwealth) that is made before 27 November 2023 but has not come into operation on or before 27 November 2023; and\n\n(b) each provision that —\n\n(i) is in an amending Act that has effect for the purposes of this Part under section 7; and\n\n(ii) has come into operation for the purposes of this Part under section 8.\n\n(2) The Commonwealth therapeutic goods Act applies as a law of the State.\n\n(3) The Commonwealth therapeutic goods Act applies under subsection (2) —\n\n(a) as modified by local regulations (if any) made for the purposes of section 15; and\n\n(b) as if it extended to matters in relation to which the State may make laws —\n\n(i) whether or not the Commonwealth may make laws in relation to those matters; and\n\n(ii) even though the terms of the Commonwealth therapeutic goods Act provides that it applies only to specified matters with respect to which the Commonwealth may make laws.\n\nNote for this subsection:\n\nFor paragraph (b)(ii), the *Therapeutic Goods Act 1989* (Commonwealth) section 6 sets out specified matters to which that Act applies.\n\n(4) The provisions of the Commonwealth therapeutic goods Act that apply as a law of the State because of this section apply as a part of this Act.\n\n##### 6. Tabling amending Acts\n\nAn amending Act must be laid before each House of Parliament within 18 sitting days of the House after the day on which the Act receives the Royal Assent.\n\n##### 7. Disallowance of amending Acts\n\n(1) In this section —\n\ndisallowance period, in relation to a disallowance resolution of which notice is given in a House of Parliament, means the period of 30 sitting days of the House after the day on which the notice is given;\n\ndisallowance resolution means a resolution that an amending Act be disallowed;\n\nnotice period, in relation to an amending Act laid before a House of Parliament under section 6, means the period of 14 sitting days of the House after the day on which the amending Act is laid before it.\n\n(2) An amending Act has effect for the purposes of this Part if the amending Act is laid before each House of Parliament under section 6 and either —\n\n(a) no notice of a disallowance resolution is given in either House within the notice period; or\n\n(b) at least 1 notice of a disallowance resolution is given in a House within the notice period and, for each such notice, 1 of the following applies —\n\n(i) the notice is withdrawn or discharged within the disallowance period;\n\n(ii) the disallowance resolution is lost in the House or not agreed to within the disallowance period.\n\n(3) For the purposes of this section and section 6 —\n\n(a) the period specified in section 6, a notice period or a disallowance period continues to run even though a House of Parliament is prorogued or dissolved or expires; and\n\n(b) notice of a disallowance resolution given in a House of Parliament, or a motion that an amending Act be disallowed in the House, does not lapse even though the House is prorogued or dissolved or expires.\n\n##### 8. Commencement of provisions of amending Acts\n\n(1) If an amending Act has effect for the purposes of this Part under section 7(2), the Governor must declare that fact by proclamation as soon as practicable.\n\n(2) If a provision of the amending Act has come into operation in the Commonwealth before the proclamation is published —\n\n(a) the proclamation must fix a day on which the provision comes into operation for the purposes of this Part, which must be on or after the day on which the proclamation is published; and\n\n(b) the provision comes into operation for the purposes of this Part on that day.\n\n(3) If a provision of the amending Act has not come into operation in the Commonwealth before the proclamation is published, the provision comes into operation for the purposes of this Part when the provision comes into operation in the Commonwealth.\n\n##### 9. Tabling of amending Act taken to be publication for Standing Orders\n\n(1) In this section —\n\nparliamentary committee means a committee established by either or both of the Houses of Parliament.\n\n(2) If a Standing Order of a House of Parliament provides that on the publication of an instrument under a written law the instrument is referred to a parliamentary committee for consideration, the laying of an amending Act before the House under section 6 is taken to be publication of the amending Act for the purposes of the Standing Order.\n\n(3) This section does not apply if the Standing Orders of the House provide specifically for an amending Act to be considered by a parliamentary committee.\n\n##### 10. Therapeutic legislative instruments\n\n(1) A therapeutic legislative instrument applies as a law of the State.\n\n(2) A therapeutic legislative instrument has effect for the purposes of its application under subsection (1) subject to —\n\n(a) any modifications made by local regulations for the purposes of section 15; and\n\n(b) to the extent the therapeutic legislative instrument is made under the *Therapeutic Goods Act 1989* (Commonwealth) on or after 27 November 2023 — sections 11 and 13; and\n\n(c) to the extent the therapeutic legislative instrument is made by a provision of an amending Act — subsection (3).\n\n(3) A therapeutic legislative instrument, to the extent made by a provision of an amending Act, has effect for the purposes of its application under subsection (1) if —\n\n(a) the amending Act has effect for the purposes of this Part under section 7; and\n\n(b) the provision has come into operation for the purposes of this Part under section 8.\n\n(4) The provisions of a therapeutic legislative instrument that apply as a law of the State because of this section apply as subsidiary legislation for the purposes of this Act.\n\nNote for this section:\n\nUnder section 14, the *Interpretation Act 1984* does not apply to therapeutic legislative instruments that are subsidiary legislation for the purposes of this Act.\n\n##### 11. Therapeutic legislative instruments made under or for purposes of amending Act\n\n(1) This section applies to a provision of a therapeutic legislative instrument made under the *Therapeutic Goods Act 1989* (Commonwealth) if the provision is made under or for the purposes of —\n\n(a) a provision inserted into the *Therapeutic Goods Act 1989* (Commonwealth) by a provision of an amending Act; or\n\n(b) a provision of the *Therapeutic Goods Act 1989* (Commonwealth) as amended by a provision of an amending Act.\n\n(2) The provision of the therapeutic legislative instrument does not have effect for the purposes of its application under section 10(1) until the later of —\n\n(a) the day on which the provision of the amending Act comes into operation for the purposes of this Part under section 8; and\n\n(b) the day on which the provision of the therapeutic legislative instrument comes into operation in the Commonwealth.\n\n(3) However, if the amending Act does not have effect for the purposes of this Part under section 7, the provision of the therapeutic legislative instrument does not have effect for the purposes of its application under section 10(1).\n\n##### 12. Publication of therapeutic legislative instruments\n\n(1) This section applies to a therapeutic legislative instrument made under the *Therapeutic Goods Act 1989* (Commonwealth) on or after 27 November 2023.\n\n(2) No later than 18 days after the day on which the therapeutic legislative instrument is made, 1 of the following must occur —\n\n(a) the therapeutic legislative instrument is published in the *Gazette*;\n\n(b) the therapeutic legislative instrument is published on the WA legislation website;\n\n(c) notice is published in the *Gazette* —\n\n(i) stating that the therapeutic legislative instrument is published on a website; and\n\n(ii) stating the website on which the instrument is published.\n\n(3) For the purposes of subsection (2)(c), the website must be a website maintained by or on behalf of the State or the Commonwealth.\n\n##### 13. Tabling and disallowance of therapeutic legislative instruments\n\n(1) This section applies to a therapeutic legislative instrument made under the *Therapeutic Goods Act 1989* (Commonwealth) on or after 27 November 2023.\n\n(2) A therapeutic legislative instrument must be laid before each House of Parliament within 6 sitting days of the House after —\n\n(a) if notice of the instrument’s publication is published under section 12(2)(c) — the day on which the notice is published; or\n\n(b) otherwise — the day on which the instrument is published under section 12(2)(a) or (b).\n\n(3) A therapeutic legislative instrument ceases to have effect for the purposes of its application under section 10(1) if —\n\n(a) the instrument is not published, or notice of its publication is not published, under section 12; or\n\n(b) the instrument is not laid before each House of Parliament in accordance with subsection (2); or\n\n(c) the instrument is laid before each House of Parliament in accordance with subsection (2) and —\n\n(i) notice of a resolution to disallow the instrument is given in 1 of those Houses within 14 sitting days of the House after the instrument is laid before the House under subsection (2); and\n\n(ii) the resolution to disallow the instrument is agreed to by the House.\n\n(4) A therapeutic legislative instrument that ceases to have effect under subsection (3) ceases to have effect at the end of the day on which the circumstance in subsection (3)(a), (b) or (c) occurs.\n\n(5) If a resolution is agreed to under subsection (3)(c), notice of the resolution must be published in the *Gazette* or on the WA legislation website within 21 days after the day on which the motion is passed.\n\n(6) If a therapeutic legislative instrument (the  relevant instrument) ceases to have effect under subsection (3), a therapeutic legislative instrument that was amended or repealed by the relevant instrument revives, for the purposes of its application under section 10(1), on the day after the day on which the relevant instrument ceases to have effect.\n\n(7) For the purposes of this section —\n\n(a) the period specified in subsection (2) or (3)(c)(i) continues to run even though a House of Parliament is prorogued or dissolved or expires; and\n\n(b) notice of a resolution to disallow a therapeutic legislative instrument given in a House of Parliament, or a motion that a therapeutic legislative instrument be disallowed in the House, does not lapse even though the House is prorogued or dissolved or expires.\n\n##### 14. Application of interpretation legislation to applied therapeutic goods law\n\n(1) In this section —\n\nCommonwealth interpretation laws means —\n\n(a) the *Acts Interpretation Act 1901* (Commonwealth); and\n\n(b) another law of the Commonwealth that is relevant to the interpretation of a Commonwealth Act or legislative instrument.\n\nExample for this definition:\n\n\t\t*Legislation Act 2003* (Commonwealth) section 13.\n\n(2) The *Interpretation Act 1984* does not apply to the applied therapeutic goods law.\n\n(3) The Commonwealth interpretation laws apply as laws of the State in relation to the interpretation of the applied therapeutic goods law and so apply as if the applied therapeutic goods law were a Commonwealth Act or were a legislative instrument under a Commonwealth Act, as the case requires.\n\n##### 15. Local regulations may modify applied therapeutic goods law\n\nThe local regulations may modify the applied therapeutic goods law.\n\n## Part 3 — Functions and powers under applied therapeutic goods law\n\n##### 16. Commonwealth authorities and officers have functions under applied therapeutic goods law\n\nA Commonwealth authority or Commonwealth officer referred to in the applied therapeutic goods law has the same functions and powers under the applied therapeutic goods law as they have under the Commonwealth therapeutic goods law, as that law applies to the Commonwealth.\n\n##### 17. Delegations under applied therapeutic goods law\n\nAny delegation under the Commonwealth therapeutic goods law, as that law applies to the Commonwealth, is taken to extend to, and have effect for the purposes of, the corresponding provision of the applied therapeutic goods law.\n\n## Part 4 — Offences\n\n##### 18. Object of Part\n\n(1) The object of this Part is to further the purpose of this Act by providing for an offence against the applied therapeutic goods law to be treated as if it were an offence against a law of the Commonwealth.\n\n(2) The purposes for which an offence is to be treated as mentioned in subsection (1) include, but are not limited to —\n\n(a) the investigation and prosecution of offences; and\n\n(b) the arrest, custody, bail, trial and conviction of offenders or persons charged with offences; and\n\n(c) proceedings relating to a matter referred to in paragraph (a) or (b); and\n\n(d) appeals and reviews relating to criminal proceedings and to proceedings of the kind referred to in paragraph (c); and\n\n(e) the sentencing, punishment and release of persons convicted of offences; and\n\n(f) fines, penalties and forfeitures; and\n\n(g) infringement notices in connection with offences; and\n\n(h) liability to make reparation in connection with offences; and\n\n(i) proceeds of crime; and\n\n(j) spent convictions.\n\n(3) For the purposes of this Part, offences include contraventions for which a civil penalty may be imposed.\n\n##### 19. Application of Commonwealth criminal laws to offences against applied therapeutic goods law\n\n(1) In this section —\n\nrelevant Commonwealth criminal law means a law of the Commonwealth relating to a purpose referred to in section 18(2).\n\n(2) The relevant Commonwealth criminal laws apply as laws of the State in relation to an offence against the applied therapeutic goods law as if the applied therapeutic goods law were a law of the Commonwealth and not a law of the State.\n\n(3) For the purposes of a law of the State, an offence against the applied therapeutic goods law —\n\n(a) is taken to be an offence against the laws of the Commonwealth in the same way as if the applied therapeutic goods law were a law of the Commonwealth; and\n\n(b) is taken not to be an offence against the laws of the State.\n\n(4) Subsection (3) has effect for the purposes of a law of the State except as provided by the local regulations.\n\n##### 20. Functions and powers conferred on Commonwealth authorities and officers relating to offences\n\n(1) A Commonwealth law applying because of section 19 that confers on a Commonwealth authority or Commonwealth officer a function or power in relation to an offence against the Commonwealth therapeutic goods law also confers on the authority or officer the same function or power in relation to an offence against the corresponding provision of the applied therapeutic goods law.\n\n(2) In performing a function or exercising a power conferred by this section, the Commonwealth authority or Commonwealth officer must act as nearly as practicable as the authority or officer would act in performing or exercising the same function or power in relation to an offence against the corresponding provision of the Commonwealth therapeutic goods law.\n\n##### 21. No double jeopardy for offences against applied therapeutic goods law\n\n(1) Subsection (2) applies if —\n\n(a) an act or omission is both an offence against the applied therapeutic goods law and an offence against the corresponding provision of the Commonwealth therapeutic goods law; and\n\n(b) an offender has been punished for that offence under the corresponding provision of the Commonwealth therapeutic goods law.\n\n(2) The offender is not liable to be punished for the offence under the applied therapeutic goods law.\n\n## Part 5 — Commonwealth administrative laws\n\n##### 22. Application of Commonwealth administrative laws to applied therapeutic goods law\n\n(1) The Commonwealth administrative laws apply as laws of the State to any matter arising in relation to the applied therapeutic goods law as if the applied therapeutic goods law were a law of the Commonwealth and not a law of the State.\n\n(2) For the purposes of a law of the State, a matter arising in relation to the applied therapeutic goods law —\n\n(a) is taken to be a matter arising in relation to laws of the Commonwealth in the same way as if the applied therapeutic goods law were a law of the Commonwealth; and\n\n(b) is taken not to be a matter arising in relation to laws of the State.\n\n(3) Subsection (2) has effect for the purposes of a law of the State except as provided by the local regulations.\n\n(4) A provision of a Commonwealth administrative law applying because of this section that purports to confer jurisdiction on a federal court is taken not to have that effect.\n\n(5) For the purposes of this section, a reference in a provision of the *Administrative Appeals Tribunal Act 1975* (Commonwealth) (as that provision applies as a law of the State) to the whole or any part of Part IVA of that Act is taken to be a reference to the whole or part of that Part as it has effect as a law of the Commonwealth.\n\n##### 23. Functions and powers conferred on Commonwealth authorities and officers\n\n(1) A Commonwealth administrative law applying because of section 22 that confers on a Commonwealth authority or Commonwealth officer a function or power also confers on the authority or officer the same function or power in relation to a matter arising in relation to the applied therapeutic goods law.\n\n(2) In performing a function or exercising a power conferred by this section, the Commonwealth authority or Commonwealth officer must act as nearly as practicable as the authority or officer would act in performing or exercising the same function or power under the Commonwealth administrative law.\n\n## Part 6 — Miscellaneous\n\n##### 24. Fees payable under applied therapeutic goods law\n\nThe Commonwealth may retain fees paid to, or recovered by, the Commonwealth, a Commonwealth authority or Commonwealth officer in respect of the performance or exercise of functions or powers conferred on them by the applied therapeutic goods law.\n\n##### 25. Reference in Commonwealth law to provision of another law\n\nFor the purposes of sections 19 and 22, a reference in a Commonwealth law to a provision of that or another Commonwealth law is taken to be a reference to that provision as applying because of those sections.\n\n##### 26. Local regulations\n\nThe Governor may make regulations prescribing matters —\n\n(a) required or permitted by this Act to be prescribed; or\n\n(b) necessary or convenient to be prescribed for giving effect to this Act or the applied therapeutic goods law.\n\n## Part 7 — Transitional provisions\n\n##### 27. Term used: commencement day\n\nIn this Part —\n\ncommencement day means the day on which this section comes into operation.\n\n##### 28. Amending Acts enacted on or after 27 November 2023 but before commencement day\n\nIf an amending Act receives the Royal Assent on or after 27 November 2023 but before commencement day, sections 6 to 8 apply to the amending Act as if it received the Royal Assent on commencement day.\n\n##### 29. Therapeutic legislative instruments made on or after 27 November 2023 but before commencement day\n\nIf a therapeutic legislative instrument is made on or after 27 November 2023 but before commencement day, section 12(2) applies as if the therapeutic legislative instrument were made on commencement day.\n\n##### 30. Liability of persons acting lawfully before commencement of applied therapeutic goods law as law of State\n\n(1) This section applies if a person —\n\n(a) dealt with or used therapeutic goods immediately before commencement day in a manner (the transitioned conduct) that was not unlawful; and\n\n(b) would, but for this section, contravene a provision of the applied therapeutic goods law by engaging in the transitioned conduct on commencement day.\n\n(2) For the period of 2 years beginning on commencement day, the person —\n\n(a) may engage in the transitioned conduct; and\n\n(b) does not contravene a provision of the applied therapeutic goods law by engaging in the transitioned conduct.\n\n##### 31. Transitional regulation‑making power\n\n(1) In this section —\n\npublication day, in relation to transitional regulations, means the day on which the transitional regulations are published in accordance with the *Interpretation Act 1984* section 41(1)(a);\n\ntransitional regulations means local regulations made for the purposes of subsection (2).\n\n(2) Local regulations may deal with matters of a transitional, savings or application nature arising in connection with the enactment of this Act.\n\n(3) Transitional regulations cannot be made after the end of the period of 2 years beginning on commencement day.\n\n(4) If transitional regulations provide that a state of affairs is taken to have existed, or not to have existed, on and from a day that is earlier than publication day, but not earlier than commencement day, the regulations have effect according to their terms.\n\n(5) If transitional regulations contain a provision referred to in subsection (4), the provision does not operate so as to —\n\n(a) affect, in a manner prejudicial to any person (other than the State or an authority of the State), the rights of that person existing before publication day; or\n\n(b) impose liabilities on any person (other than the State or an authority of the State) in respect of anything done or omitted to be done before publication day.\n\n## Part 8 — Consequential amendments\n\n### Division 1 — *Human Tissue and Transplant Act 1982* amended\n\n##### 32. Act amended\n\nThis Division amends the *Human Tissue and Transplant Act 1982*.\n\n##### 33. Section 29A amended\n\n(1) In section 29A(1) insert in alphabetical order:\n\nTG law provision means —\n\n(a) a TGA provision; or\n\n(b) a provision or portion of the applied therapeutic goods law as defined in the *Therapeutic Goods Law Application Act 2024* section 3(1).\n\n(2) In section 29A(1) in the definition of ***TGA provision*** delete “Act.” and insert:\n\nAct;\n\n(3) In section 29A(4):\n\n(a) in paragraph (d)(i) delete “TGA provision; and” and insert:\n\nTG law provision; and\n\n(b) in paragraph (d)(ii) delete “TGA provision” and insert:\n\nTG law provision\n\n### Division 2 — *Medicines and Poisons Act 2014* amended\n\n##### 34. Act amended\n\nThis Division amends the *Medicines and Poisons Act 2014*.\n\n##### 35. Section 3 amended\n\nIn section 3 insert in alphabetical order:\n\ntherapeutic goods law means —\n\n(a) the *Therapeutic Goods Act 1989* (Commonwealth); or\n\n(b) the applied therapeutic goods law as defined in the *Therapeutic Goods Law Application Act 2024* section 3(1);\n\n##### 36. Section 12 amended\n\nIn section 12 in the definition of ***appropriate licence*** paragraph (e) delete “the *Therapeutic Goods Act 1989* (Commonwealth);” and insert:\n\na therapeutic goods law;\n\n##### 37. Section 28 amended\n\nDelete section 28(1)(a)(v) and insert:\n\n(v) a therapeutic goods law;\n\n##### 38. Section 60 amended\n\nDelete section 60(1)(a)(v) and insert:\n\n(v) a therapeutic goods law;\n\n![]()\n\nNotes\n\nThis is a compilation of the *Therapeutic Goods Law Application Act 2024*. For provisions that have come into operation see the compilation table.\n\nCompilation table\n\n| **Short title** | **Number and year** | **Assent** | **Commencement** |\n| --- | --- | --- | --- |\n| *Therapeutic Goods Law Application Act 2024* | 19 of 2024 | 14 May 2024 | Pt. 1: 14 May 2024 (see s. 2(a));   Act other than Pt. 1: 30 Aug 2024 (see s. 2(b) and SL 2024/177 cl. 2) |\n\n\nDefined terms\n\n*[This is a list of terms defined and the provisions where they are defined. The list is not part of the law.]*\n\n**Defined term Provision(s)**\n\namend 3(1)\n\namending Act 3(1)\n\napplied therapeutic goods law 3(1)\n\ncommencement day 27\n\nCommonwealth administrative laws 3(1)\n\nCommonwealth interpretation laws 14(1)\n\nCommonwealth therapeutic goods Act 5(1)\n\nCommonwealth therapeutic goods law 3(1)\n\ndisallowance period 7(1)\n\ndisallowance resolution 7(1)\n\nlocal regulations 3(1)\n\nnotice period 7(1)\n\nparliamentary committee 9(1)\n\npublication day 31(1)\n\nrelevant Commonwealth criminal law 19(1)\n\nrelevant instrument 13(6)\n\ntherapeutic legislative instrument 3(1)\n\ntransitional regulations 31(1)\n\ntransitioned conduct 30(1)\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":7,"scope_assessment":{"changed":true,"description":"The Act goes beyond a straightforward copying of Commonwealth therapeutic goods rules and extends the Commonwealth Therapeutic Goods Act and its instruments to operate as WA law even in areas \"in relation to which the State may make laws\" (s5(3)(b)).  It also imports Commonwealth administrative and criminal frameworks to govern those applied provisions (ss19, 22), and creates procedures to adopt future Commonwealth amending Acts and instruments into WA law subject to WA tabling/disallowance and proclamation steps (ss6–13, 8).  Concretely, this broadens the territorial and subject‑matter reach of the Commonwealth regime within WA and shifts enforcement, administrative review and fee retention toward Commonwealth mechanisms — changes that meaningfully expand the original narrow purpose of simply aligning State law with Commonwealth therapeutic goods regulation."},"complexity_factors":["Multiple cross‑jurisdictional mappings: applies Commonwealth Act, instruments, and Commonwealth administrative/criminal laws as State law (ss5, 10, 19, 22)","Conditional adoption mechanics for Commonwealth amending Acts (tabling, notice, disallowance, proclamation) with running periods that survive prorogation/dissolution (ss6–8, 7(3), 8(2)–(3))","Therapeutic legislative instruments subject to separate publication, tabling and disallowance rules and revival rules (ss11–13)","Replacement of WA interpretation regime by Commonwealth interpretation laws (s14) and explicit list of Commonwealth administrative laws applied (s3(1), s22)","Local modification power and constraints (ss15, 26) creating a two‑layer regulatory framework","Transitional architecture including a 2‑year grandfathering/safe harbour and permitted post‑commencement transitional regulations with limits (ss30–31)","Delegation and function carry‑over provisions linking Commonwealth delegations to State application (ss16–17)","Consequential amendments to multiple existing WA Acts requiring coordinated updates (Part 8, ss32–38)","Defined‑term density and cross‑references (around 15–20 defined terms plus references to multiple Commonwealth Acts and instruments; see s3 and compilation)","Exceptions and savings (e.g. limits in ss19(4), 22(4) on judicial jurisdiction, and revival mechanism in s13(6))"],"plain_english_summary":"**What this law does (mechanics first)**\n\n- The Act makes the Commonwealth Therapeutic Goods Act 1989 (and the Commonwealth regulations and instruments under it) operate in Western Australia as if they were WA law (see s5 and s10).  It also treats many Commonwealth amendments and legislative instruments as having effect in WA subject to specified conditions (see ss5–13).\n\n- It exempts the WA Interpretation Act and instead applies Commonwealth interpretation rules when reading the applied therapeutic goods law (s14).\n\n- Commonwealth administrative regimes (AAT, FOI, Ombudsman, Privacy and their instruments) are applied to matters under the applied therapeutic goods law (s22).  Commonwealth criminal laws and criminal processes are also applied so that offences under the applied therapeutic goods law are treated as if they were Commonwealth offences (ss18–21).\n\n- Commonwealth authorities and officers named in the Commonwealth law keep the same functions and powers when that law is applied in WA (ss16–17, 20, 23).  Fees collected under the applied law may be retained by the Commonwealth (s24).\n\n- The Governor can make local WA regulations to modify the applied Commonwealth law where necessary or convenient, and to handle transitional matters (ss15, 26, 31).  The Act establishes tabling, publication and limited parliamentary disallowance procedures for Commonwealth amending Acts and therapeutic legislative instruments that will operate in WA (ss6–13).\n\n- The Act contains transitional protections: people who lawfully used therapeutic goods before the state application begins have a 2‑year safe harbour to continue that conduct (s30); other transitional timing rules are in Part 7 (ss27–31).\n\n- Consequential technical amendments update the Human Tissue and Transplant Act 1982 and the Medicines and Poisons Act 2014 to refer to the applied therapeutic goods law (Part 8, ss32–38).\n\n\n**Who is affected**\n\n- Businesses and individuals that make, import, supply, advertise or use therapeutic goods in WA (manufacturers, sponsors, wholesalers, pharmacists, hospitals, clinicians).\n- The Commonwealth regulator (Therapeutic Goods Administration) and any Commonwealth officers/authorities who exercise powers under the Commonwealth Act.\n- WA government agencies and courts, because the Act changes which statutory interpretation and administrative regimes apply and how offences are treated.\n- Persons relying on prior State regulatory settings: some State rules are replaced or subsumed by the applied Commonwealth regime unless modified by local regulations.\n\n\n**Why it matters (stated purpose and functional effects)**\n\n- The Act’s stated purpose is to \"apply the Therapeutic Goods Act 1989 and legislative instruments under that Act as laws of the State\" (long title; s5).  That is implemented by treating the Commonwealth Act and instruments as WA law and by bringing Commonwealth administrative/criminal mechanisms to bear on WA matters (ss5, 19, 22).\n\n- Practical effects: WA operators will largely be regulated under the Commonwealth regime as if it were WA law.  Regulatory decision‑making, appeals, FOI/privacy/Ombudsman access, and criminal/enforcement pathways will follow Commonwealth models and processes rather than WA‑only models (ss14, 19, 22).  Fees collected for these functions may flow to the Commonwealth (s24).\n\n\n**Costs, incentives, trade‑offs and implementation risks (concrete mechanisms)**\n\n- Compliance burden and transaction costs shift to whichever regime applies: businesses must comply with the Commonwealth Act and instruments as they apply in WA (s5, s10).  That can reduce duplication if WA previously mirrored Commonwealth law; it can also import new requirements set by future Commonwealth amending Acts and instruments (ss5(1), 11).\n\n- Parliamentary oversight: WA Parliament gets a tabling and limited disallowance role over which amending Commonwealth Acts and therapeutic legislative instruments operate in WA (ss6–8, 12–13).  The Act also requires the Governor to proclaim amending Acts that will have effect (s8).  These are procedural controls, but the operational effect is that Commonwealth changes can preview into WA once conditions in this Act are satisfied.\n\n- Centralisation of enforcement and administration: Commonwealth authorities retain their Commonwealth functions and are given the same functions in WA (ss16, 20, 23).  That concentrates decision‑making with the Commonwealth regulator for applied matters; WA can modify some effects by local regulations but the baseline is Commonwealth law (s15, s26).\n\n- Criminal and administrative law overlay: by treating offences as if they were Commonwealth offences (s19) and applying Commonwealth administrative laws (s22), the Act changes the legal pathways for prosecutions, penalties, reviews and appeals; it also removes double‑jeopardy risk where an offender has already been punished under the Commonwealth provision (s21).  This has practical consequences for trials, jurisdiction and appeals.\n\n- Fiscal effects: fees paid for applied regulatory services may be retained by the Commonwealth (s24).  That shifts revenue from WA to the Commonwealth for those activities unless local arrangements are agreed.\n\n- Scope expansion risk: the Act makes the Commonwealth therapeutic goods Act apply in WA \"as if it extended to matters in relation to which the State may make laws\" (s5(3)(b)).  That means a Commonwealth Act drafted for federal matters will be read to cover State law matters when applied here; WA can mitigate by local regulations but the Act itself permits the broader application (s5(3), s15).\n\n- Transitional certainty vs uncertainty: the 2‑year grandfathering for lawful conduct (s30) reduces immediate disruption, but continuing reliance on future Commonwealth instruments and amending Acts creates ongoing regulatory dependence (ss7–13, 28–29).\n\n\n**Who pays, who decides, and how behaviour changes (short)**\n\n- Who pays: regulated entities pay fees required under the applied therapeutic goods law; the Commonwealth may retain those fees (s24).\n- Who decides: the Commonwealth therapeutic goods framework (and the Commonwealth regulator and officers) exercise the substantive regulatory, administrative and some enforcement functions in WA (ss16–17, 20, 22–23).  The WA Governor and WA Parliament retain limited roles via local regulations, proclamation and tabling/disallowance procedures (ss8, 13, 15, 26).\n- Behaviour changes: WA businesses will plan and comply with the Commonwealth TGA regime as it applies in WA, track Commonwealth instruments and amending Acts, and may rely on the 2‑year transitional protection for existing lawful activity (s30).\n\n\n**Key sections to consult**: application of Commonwealth Act (s5), therapeutic legislative instruments (ss10–13), interpretation rules (s14), application of Commonwealth criminal and administrative laws (ss19, 22), functions of Commonwealth authorities (ss16, 23), fees (s24), local modification power (s15, s26), transitional safe harbour (s30).\n"},"kimi_summary":{"content_quality":"ok","complexity_score":7,"scope_assessment":{"changed":false,"description":"The legislation remains tightly focused on its original purpose of applying Commonwealth therapeutic goods law as State law. The scope includes necessary machinery provisions (criminal law alignment, administrative review, transitional arrangements) that are standard for this type of \"application of Commonwealth law\" statute. The consequential amendments to the Human Tissue and Transplant Act 1982 and Medicines and Poisons Act 2014 are minor definitional updates to ensure consistency, not scope creep."},"complexity_factors":["Extensive cross-referencing to Commonwealth legislation (Therapeutic Goods Act 1989, Acts Interpretation Act 1901, Administrative Appeals Tribunal Act 1975, etc.)","Complex temporal mechanics with multiple reference dates (27 November 2023, commencement day, publication day) and conditional commencement provisions","Nested conditional logic for disallowance procedures (sections 6-8, 13) with multiple pathways for amending Acts to take effect","Dual legal characterisation where state law is treated as Commonwealth law for specific purposes (criminal and administrative law application)","17 defined terms in section 3(1) plus additional definitions scattered throughout (e.g., section 5(1), 7(1), 9(1), 14(1), 19(1), 27, 31(1))","Sophisticated transitional provisions with retrospective effect limitations (section 31(4)-(5))","Modification powers allowing local regulations to alter the applied Commonwealth law (section 15)","Interplay between primary legislation and subordinate instruments with different publication/tabling requirements"],"plain_english_summary":"**What this law does:**\n\nThis Act brings the Commonwealth's *Therapeutic Goods Act 1989* (the federal law that regulates medicines, medical devices, and other therapeutic goods) into Western Australia's state law system. Instead of WA writing its own separate therapeutic goods laws, it \"adopts\" the federal law and applies it as if it were a WA law.\n\n**Who it affects:**\n\n- **Businesses and individuals** who manufacture, import, supply, or advertise therapeutic goods in WA (pharmaceutical companies, medical device suppliers, pharmacies, etc.)\n- **Commonwealth agencies** like the Therapeutic Goods Administration (TGA), which will continue to administer and enforce these rules in WA\n- **Healthcare professionals** and consumers who use therapeutic goods\n\n**Key features:**\n\n- **Automatic updates:** When the Commonwealth amends its therapeutic goods laws, those changes can flow through to WA law via a special parliamentary scrutiny process (tabling and disallowance)\n- **Local modifications:** WA can make specific changes to the applied federal law through \"local regulations\" to suit state needs\n- **Criminal and administrative law alignment:** Offences under this law are treated as if they were Commonwealth offences, meaning federal criminal procedures apply. Similarly, federal administrative review processes (like appeals to the Administrative Appeals Tribunal) apply\n- **No double jeopardy:** You can't be punished twice for the same conduct under both state and federal versions of the law\n- **Transitional protection:** People who were lawfully dealing with therapeutic goods before this Act starts get a 2-year grace period to continue that conduct\n\n**Why it matters:**\n\nThis creates a single, consistent national scheme for regulating therapeutic goods across Australia. WA businesses don't need to comply with two different sets of rules—state and federal. It reduces red tape while maintaining safety standards for medicines and medical devices."},"summary":{"complexity_score":2,"scope_assessment":{"changed":false,"description":"Scope cannot be assessed. The full text of the Act was not retrievable, so no comparison between original intent and final form is possible. The complexity score of 2 reflects the near-total absence of analysable content, not the likely complexity of the Act itself."},"complexity_factors":["Legislation text is entirely unavailable — only an error page was retrieved","Cannot assess actual provisions, definitions, obligations or penalties","Title alone provides only limited inferential basis for analysis","Intergovernmental application Acts (if that is what this is) can themselves be complex, but that cannot be confirmed here"],"plain_english_summary":"The Therapeutic Goods Law Application Act 2024 (WA) appears to set out how Commonwealth therapeutic goods laws (eg. those administered by the TGA) apply within Western Australia. It matters because it determines which federal rules govern medicines, medical devices and related products in the state.\n\nThis primarily affects manufacturers, importers, distributors, sellers, healthcare providers and consumers in WA. The Act’s full text should be checked on the WA legislation site or Parliamentary Counsel for authoritative detail."},"issue_detection":{"absurdities":[],"contradictions":[]}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-law-application-act-2024","history":"/api/acts/therapeutic-goods-law-application-act-2024/history","analysis":"/api/acts/therapeutic-goods-law-application-act-2024/analysis","conflicts":"/api/acts/therapeutic-goods-law-application-act-2024/conflicts","importantCases":"/api/acts/therapeutic-goods-law-application-act-2024/important-cases","documents":"/api/acts/therapeutic-goods-law-application-act-2024/documents"}}