This Act makes the Commonwealth Therapeutic Goods Laws operate in Queensland as if they were Queensland laws: it extends those laws to non‑corporate actors and to trade within Queensland, applies Commonwealth administrative and criminal procedures, and lets the Commonwealth Secretary and agencies exercise their powers and retain fees. The stated purpose is to manage health and safety risks from therapeutic goods; the Act also provides a 2‑year safe harbour for individuals lawfully dealing with goods immediately before commencement.
This Act applies the Commonwealth therapeutic goods regulatory regime to Queensland by making the Commonwealth Therapeutic Goods Laws operate as laws of Queensland, subject to limited qualifications in the Act and any modifying regulations. Section 7 declares that the Therapeutic Goods Act 1989 (Cwlth) and its regulations, orders and manufacturing principles (defined collectively in s 5 as the Commonwealth Therapeutic Goods Laws) are to be applied as Queensland law, and that they are to be treated as if they extended to things done by non‑corporate entities and to things done in the course of trade and commerce within the limits of Queensland (s 7(1)). The applied Commonwealth provisions, as modified by regulation, are called the applied therapeutic goods provisions (s 7(3)).
Mechanically, the Act does the following:
It declares its purpose in s 4: to manage health and safety risks posed by therapeutic goods by applying Commonwealth regulatory controls in Queensland to the extent those controls do not otherwise apply. The Act says that purpose is achieved by applying relevant Commonwealth laws in Queensland in a way that permits uniform administration by Commonwealth entities and that treats offences under the applied laws as if they were offences against Commonwealth laws (s 4(1)-(2)).
It adopts Commonwealth definitions and interpretive machinery. Section 5 imports terms from the Commonwealth Therapeutic Goods Laws to the extent context permits. Section 6 makes the Acts Interpretation Act 1901 (Cwlth) apply to any applied law as if the applied law were a Commonwealth law and, to that extent, displaces Queensland Acts Interpretation and statutory instruments regimes (s 6(2)-(3)).
It makes Commonwealth entities the decision makers for matters under the applied provisions. A Commonwealth entity that has functions or powers under the Commonwealth Therapeutic Goods Laws is taken to have the same function or power for the applied provisions (s 8(1)-(2)), and must, to the extent practicable, act as if exercising those functions under the Commonwealth law (s 8(3)). Delegations and appointments made under Commonwealth law are taken to have effect for the applied provisions (s 8(4)).
Current sections
Direct links to the current provisions in Therapeutic Goods Act 2019.
24
pt.1
Preliminary
Preliminary
pt.1-div.1
Introduction
Introduction
sec.1
Short title
sec.1 Short title
This Act may be cited as the Therapeutic Goods Act 2019 .
sec.2
Commencement
sec.2 Commencement
This Act commences on a day to be fixed by proclamation.
sec.3
Act binds all persons
sec.3 Act binds all persons
This Act binds all persons, including the State.
Nothing in this Act makes the State liable to be prosecuted for an offence.
(sec.3-ssec.1) This Act binds all persons, including the State.
(sec.3-ssec.2) Nothing in this Act makes the State liable to be prosecuted for an offence.
sec.4
Purpose of Act
sec.4 Purpose of Act
The purpose of this Act is to manage health and safety risks posed by therapeutic goods by applying Commonwealth regulatory controls on therapeutic goods in Queensland, to the extent those controls do not otherwise apply.
The purpose is achieved by applying relevant Commonwealth law s in Queensland in a way that allows—
the uniform administration of the applied laws by Commonwealth entities; and
offences against the applied laws to be treated as if they were offences against Commonwealth laws.
(sec.4-ssec.1) The purpose of this Act is to manage health and safety risks posed by therapeutic goods by applying Commonwealth regulatory controls on therapeutic goods in Queensland, to the extent those controls do not otherwise apply.
(sec.4-ssec.2) The purpose is achieved by applying relevant Commonwealth law s in Queensland in a way that allows— the uniform administration of the applied laws by Commonwealth entities; and offences against the applied laws to be treated as if they were offences against Commonwealth laws.
(a) the uniform administration of the applied laws by Commonwealth entities; and
(b) offences against the applied laws to be treated as if they were offences against Commonwealth laws.
pt.1-div.2
Interpretation
Interpretation
sec.5
Definitions
sec.5 Definitions
In this Act—
applied therapeutic goods provisions see section 7 .
Commonwealth entity means a Commonwealth authority or Commonwealth officer.
For the meaning of Commonwealth authority and Commonwealth officer, see subsection (2) and the Therapeutic Goods Act 1989 (Cwlth) , section 3 .
Commonwealth Therapeutic Goods Laws means—
the Therapeutic Goods Act 1989 (Cwlth) ; and
the regulations, orders and manufacturing principles under the Therapeutic Goods Act 1989 (Cwlth) .
Secretary means the Secretary of the department of the Commonwealth in which the Commonwealth Therapeutic Goods Laws are administered.
Other terms used in this Act and also defined in the Commonwealth Therapeutic Goods Laws have the same meanings in this Act as they have in the Commonwealth Therapeutic Goods Laws, to the extent the context permits.
(sec.5-ssec.1) In this Act— applied therapeutic goods provisions see section 7 . Commonwealth entity means a Commonwealth authority or Commonwealth officer. For the meaning of Commonwealth authority and Commonwealth officer, see subsection (2) and the Therapeutic Goods Act 1989 (Cwlth) , section 3 . Commonwealth Therapeutic Goods Laws means— the Therapeutic Goods Act 1989 (Cwlth) ; and the regulations, orders and manufacturing principles under the Therapeutic Goods Act 1989 (Cwlth) . Secretary means the Secretary of the department of the Commonwealth in which the Commonwealth Therapeutic Goods Laws are administered.
(sec.5-ssec.2) Other terms used in this Act and also defined in the Commonwealth Therapeutic Goods Laws have the same meanings in this Act as they have in the Commonwealth Therapeutic Goods Laws, to the extent the context permits.
(a) the Therapeutic Goods Act 1989 (Cwlth) ; and
(b) the regulations, orders and manufacturing principles under the Therapeutic Goods Act 1989 (Cwlth) .
sec.6
Interpretation of applied laws
sec.6 Interpretation of applied laws
This section applies to a Commonwealth law (an applied law ) applied as a law of Queensland under this Act.
The Acts Interpretation Act 1901 (Cwlth) applies in relation to the interpretation of an applied law as if the applied law were a Commonwealth law and not a Queensland law.
To the extent subsection (2) applies, the Acts Interpretation Act 1954 and Statutory Instruments Act 1992 do not apply in relation to the interpretation of the applied law.
(sec.6-ssec.1) This section applies to a Commonwealth law (an applied law ) applied as a law of Queensland under this Act.
(sec.6-ssec.2) The Acts Interpretation Act 1901 (Cwlth) applies in relation to the interpretation of an applied law as if the applied law were a Commonwealth law and not a Queensland law.
(sec.6-ssec.3) To the extent subsection (2) applies, the Acts Interpretation Act 1954 and Statutory Instruments Act 1992 do not apply in relation to the interpretation of the applied law.
pt.2
Applied therapeutic goods provisions
Applied therapeutic goods provisions
sec.7
Application of Commonwealth Therapeutic Goods Laws
sec.7 Application of Commonwealth Therapeutic Goods Laws
The Commonwealth Therapeutic Goods Laws apply as laws of Queensland as if the Commonwealth Therapeutic Goods Laws extended to—
things done or omitted to be done by entities that are not corporations; and
things done or omitted to be done in the course of trade and commerce within the limits of Queensland.
For the meaning of corporation, see section 5 (2) and the Therapeutic Goods Act 1989 (Cwlth) , section 3 .
A regulation may modify the application, as a law of Queensland, of the Commonwealth Therapeutic Goods Laws.
The Commonwealth Therapeutic Goods Laws, as applied and modified under this section, are the applied therapeutic goods provisions .
(sec.7-ssec.1) The Commonwealth Therapeutic Goods Laws apply as laws of Queensland as if the Commonwealth Therapeutic Goods Laws extended to— things done or omitted to be done by entities that are not corporations; and things done or omitted to be done in the course of trade and commerce within the limits of Queensland. For the meaning of corporation, see section 5 (2) and the Therapeutic Goods Act 1989 (Cwlth) , section 3 .
(sec.7-ssec.2) A regulation may modify the application, as a law of Queensland, of the Commonwealth Therapeutic Goods Laws.
(sec.7-ssec.3) The Commonwealth Therapeutic Goods Laws, as applied and modified under this section, are the applied therapeutic goods provisions .
(a) things done or omitted to be done by entities that are not corporations; and
(b) things done or omitted to be done in the course of trade and commerce within the limits of Queensland. Note— For the meaning of corporation, see section 5 (2) and the Therapeutic Goods Act 1989 (Cwlth) , section 3 .
sec.8
Functions and powers of Commonwealth entities
sec.8 Functions and powers of Commonwealth entities
This section applies to a Commonwealth entity that has a function or power under the Commonwealth Therapeutic Goods Laws.
The Commonwealth entity is taken to have the same function or power for the applied therapeutic goods provisions.
The Secretary may include, or cancel the inclusion of, therapeutic goods in the register maintained under the Therapeutic Goods Act 1989 (Cwlth) , section 9A for the applied therapeutic goods provisions.
When performing the function or exercising the power for the applied therapeutic goods provisions, the Commonwealth entity must, to the extent practicable, act as if the entity were performing the function or exercising the power under the Commonwealth Therapeutic Goods Laws.
To remove any doubt, it is declared that a delegation, or the appointment of a person, made by a Commonwealth entity in the performance of a function or exercise of a power under the Commonwealth Therapeutic Goods Laws is taken to have effect for the applied therapeutic goods provisions.
(sec.8-ssec.1) This section applies to a Commonwealth entity that has a function or power under the Commonwealth Therapeutic Goods Laws.
(sec.8-ssec.2) The Commonwealth entity is taken to have the same function or power for the applied therapeutic goods provisions. The Secretary may include, or cancel the inclusion of, therapeutic goods in the register maintained under the Therapeutic Goods Act 1989 (Cwlth) , section 9A for the applied therapeutic goods provisions.
(sec.8-ssec.3) When performing the function or exercising the power for the applied therapeutic goods provisions, the Commonwealth entity must, to the extent practicable, act as if the entity were performing the function or exercising the power under the Commonwealth Therapeutic Goods Laws.
(sec.8-ssec.4) To remove any doubt, it is declared that a delegation, or the appointment of a person, made by a Commonwealth entity in the performance of a function or exercise of a power under the Commonwealth Therapeutic Goods Laws is taken to have effect for the applied therapeutic goods provisions.
pt.3
Administrative matters
Administrative matters
sec.9
Application of Commonwealth administrative laws
sec.9 Application of Commonwealth administrative laws
The following laws apply as laws of Queensland to a matter arising in relation to the applied therapeutic goods provisions as if the provisions were Commonwealth laws and not Queensland laws—
the Administrative Review Tribunal Act 2024 (Cwlth) ;
the Freedom of Information Act 1982 (Cwlth) ;
the Ombudsman Act 1976 (Cwlth) ;
the Privacy Act 1988 (Cwlth) ;
a regulation under a Commonwealth Act mentioned in paragraphs (a) to (d) .
For applying a Queensland law, a matter arising in relation to the applied therapeutic goods provisions is taken—
to be a matter arising in relation to a Commonwealth law; and
not to be a matter arising in relation to a Queensland law.
A regulation may modify the application, as a law of Queensland, of a Commonwealth law mentioned in subsection (1) .
s 9 amd 2024 No. 47 s 78 sch 2
(sec.9-ssec.1) The following laws apply as laws of Queensland to a matter arising in relation to the applied therapeutic goods provisions as if the provisions were Commonwealth laws and not Queensland laws— the Administrative Review Tribunal Act 2024 (Cwlth) ; the Freedom of Information Act 1982 (Cwlth) ; the Ombudsman Act 1976 (Cwlth) ; the Privacy Act 1988 (Cwlth) ; a regulation under a Commonwealth Act mentioned in paragraphs (a) to (d) .
(sec.9-ssec.2) For applying a Queensland law, a matter arising in relation to the applied therapeutic goods provisions is taken— to be a matter arising in relation to a Commonwealth law; and not to be a matter arising in relation to a Queensland law.
(sec.9-ssec.3) A regulation may modify the application, as a law of Queensland, of a Commonwealth law mentioned in subsection (1) .
(a) the Administrative Review Tribunal Act 2024 (Cwlth) ;
(b) the Freedom of Information Act 1982 (Cwlth) ;
(c) the Ombudsman Act 1976 (Cwlth) ;
(d) the Privacy Act 1988 (Cwlth) ;
(e) a regulation under a Commonwealth Act mentioned in paragraphs (a) to (d) .
(a) to be a matter arising in relation to a Commonwealth law; and
(b) not to be a matter arising in relation to a Queensland law.
sec.10
Functions and powers of Commonwealth entities for administrative matters
sec.10 Functions and powers of Commonwealth entities for administrative matters
This section applies to a Commonwealth entity that has a function or power under a Commonwealth law mentioned in section 9 (1) .
The Commonwealth entity is taken to have the same function or power in relation to a matter arising under the applied therapeutic goods provisions.
When performing the function or exercising the power for the applied therapeutic goods provisions, the Commonwealth entity must, to the extent practicable, act as if the entity were performing the function or exercising the power under the Commonwealth law.
(sec.10-ssec.1) This section applies to a Commonwealth entity that has a function or power under a Commonwealth law mentioned in section 9 (1) .
(sec.10-ssec.2) The Commonwealth entity is taken to have the same function or power in relation to a matter arising under the applied therapeutic goods provisions.
(sec.10-ssec.3) When performing the function or exercising the power for the applied therapeutic goods provisions, the Commonwealth entity must, to the extent practicable, act as if the entity were performing the function or exercising the power under the Commonwealth law.
pt.4
Criminal matters
Criminal matters
sec.11
Application of Commonwealth criminal laws
sec.11 Application of Commonwealth criminal laws
This section applies to a Commonwealth law relevant to an offence against the Commonwealth Therapeutic Goods Laws, including, for example, a Commonwealth law about any of the following matters—
the investigation and prosecution of offences;
the arrest, custody, bail, trial and conviction of persons charged with offences;
the sentencing, punishment and release of persons convicted of offences;
fines and penalties for offences;
the proceeds from, or forfeitures in relation to, the commission of offences;
spent convictions;
proceedings, appeals and reviews relating to matters mentioned in paragraphs (a) to (f) .
The Commonwealth law applies as a law of Queensland in relation to an offence against the applied therapeutic goods provisions as if the provisions were Commonwealth laws and not Queensland laws.
For applying a Queensland law, an offence against the applied therapeutic goods provisions is taken—
to be an offence against a Commonwealth law; and
not to be an offence against a Queensland law.
A regulation may modify the application, as a law of Queensland, of the Commonwealth law.
(sec.11-ssec.1) This section applies to a Commonwealth law relevant to an offence against the Commonwealth Therapeutic Goods Laws, including, for example, a Commonwealth law about any of the following matters— the investigation and prosecution of offences; the arrest, custody, bail, trial and conviction of persons charged with offences; the sentencing, punishment and release of persons convicted of offences; fines and penalties for offences; the proceeds from, or forfeitures in relation to, the commission of offences; spent convictions; proceedings, appeals and reviews relating to matters mentioned in paragraphs (a) to (f) .
(sec.11-ssec.2) The Commonwealth law applies as a law of Queensland in relation to an offence against the applied therapeutic goods provisions as if the provisions were Commonwealth laws and not Queensland laws.
(sec.11-ssec.3) For applying a Queensland law, an offence against the applied therapeutic goods provisions is taken— to be an offence against a Commonwealth law; and not to be an offence against a Queensland law.
(sec.11-ssec.4) A regulation may modify the application, as a law of Queensland, of the Commonwealth law.
(a) the investigation and prosecution of offences;
(b) the arrest, custody, bail, trial and conviction of persons charged with offences;
(c) the sentencing, punishment and release of persons convicted of offences;
(d) fines and penalties for offences;
(e) the proceeds from, or forfeitures in relation to, the commission of offences;
(f) spent convictions;
(g) proceedings, appeals and reviews relating to matters mentioned in paragraphs (a) to (f) .
(a) to be an offence against a Commonwealth law; and
(b) not to be an offence against a Queensland law.
sec.12
Functions and powers of Commonwealth entities for criminal matters
sec.12 Functions and powers of Commonwealth entities for criminal matters
This section applies to a Commonwealth entity that has a function or power under a Commonwealth law mentioned in section 11 (1) .
The Commonwealth entity is taken to have the same function or power in relation to an offence against the applied therapeutic goods provisions.
When performing the function or exercising the power for the applied therapeutic goods provisions, the Commonwealth entity must, to the extent practicable, act as if the entity were performing the function or exercising the power under the Commonwealth law.
(sec.12-ssec.1) This section applies to a Commonwealth entity that has a function or power under a Commonwealth law mentioned in section 11 (1) .
(sec.12-ssec.2) The Commonwealth entity is taken to have the same function or power in relation to an offence against the applied therapeutic goods provisions.
(sec.12-ssec.3) When performing the function or exercising the power for the applied therapeutic goods provisions, the Commonwealth entity must, to the extent practicable, act as if the entity were performing the function or exercising the power under the Commonwealth law.
sec.13
No double jeopardy for offences
sec.13 No double jeopardy for offences
This section applies if—
an act or omission constitutes an offence against both the applied therapeutic goods provisions and the Commonwealth Therapeutic Goods Laws; and
a person has been punished for the offence under the Commonwealth Therapeutic Goods Laws.
The person is not liable to be punished for the offence under the applied therapeutic goods provisions.
(sec.13-ssec.1) This section applies if— an act or omission constitutes an offence against both the applied therapeutic goods provisions and the Commonwealth Therapeutic Goods Laws; and a person has been punished for the offence under the Commonwealth Therapeutic Goods Laws.
(sec.13-ssec.2) The person is not liable to be punished for the offence under the applied therapeutic goods provisions.
(a) an act or omission constitutes an offence against both the applied therapeutic goods provisions and the Commonwealth Therapeutic Goods Laws; and
(b) a person has been punished for the offence under the Commonwealth Therapeutic Goods Laws.
pt.5
Miscellaneous
Miscellaneous
sec.14
Commonwealth may keep fees
sec.14 Commonwealth may keep fees
The Commonwealth may keep fees paid to, or recovered by, the Secretary for the exercise of any functions conferred on the Secretary under the applied therapeutic goods provisions.
sec.15
References in Commonwealth laws
sec.15 References in Commonwealth laws
For sections 9 and 11 , a reference in a Commonwealth law to a provision of that law or another Commonwealth law is taken to be a reference to that provision as applying because of those sections.
pt.6
Transitional provision
Transitional provision
sec.16
Liability of particular individuals for offences
sec.16 Liability of particular individuals for offences
This section applies to an individual if—
immediately before the commencement it was not unlawful for the individual to deal with goods; and
on the commencement—
the goods are therapeutic goods under the applied therapeutic goods provisions; and
but for this section, the individual would be liable to be prosecuted, or subject to a civil proceeding, for contravention of an applied offence provision for dealing with the goods.
For 2 years after the commencement—
the individual may deal with the goods to the same extent as the individual was dealing with the goods immediately before the commencement; and
the individual is not liable to be prosecuted, or subject to a civil proceeding, for contravention of an applied offence provision for dealing with the goods to the extent mentioned in paragraph (a).
This section does not prevent the individual from complying with the applied offence provision.
In this section—
applied offence provision means an applied therapeutic goods provision creating an offence or civil penalty.
The Therapeutic Goods Act 1989 (Cwlth) , Chapter 3 , Part 3 -2, as applied under this Act, creates offences and civil penalties relating to the registration or listing of imported, exported, manufactured or supplied therapeutic goods.
deal , with goods, means import, export, manufacture, supply or otherwise use the goods.
(sec.16-ssec.1) This section applies to an individual if— immediately before the commencement it was not unlawful for the individual to deal with goods; and on the commencement— the goods are therapeutic goods under the applied therapeutic goods provisions; and but for this section, the individual would be liable to be prosecuted, or subject to a civil proceeding, for contravention of an applied offence provision for dealing with the goods.
(sec.16-ssec.2) For 2 years after the commencement— the individual may deal with the goods to the same extent as the individual was dealing with the goods immediately before the commencement; and the individual is not liable to be prosecuted, or subject to a civil proceeding, for contravention of an applied offence provision for dealing with the goods to the extent mentioned in paragraph (a).
(sec.16-ssec.3) This section does not prevent the individual from complying with the applied offence provision.
(sec.16-ssec.4) In this section— applied offence provision means an applied therapeutic goods provision creating an offence or civil penalty. The Therapeutic Goods Act 1989 (Cwlth) , Chapter 3 , Part 3 -2, as applied under this Act, creates offences and civil penalties relating to the registration or listing of imported, exported, manufactured or supplied therapeutic goods. deal , with goods, means import, export, manufacture, supply or otherwise use the goods.
(a) immediately before the commencement it was not unlawful for the individual to deal with goods; and
(b) on the commencement— (i) the goods are therapeutic goods under the applied therapeutic goods provisions; and (ii) but for this section, the individual would be liable to be prosecuted, or subject to a civil proceeding, for contravention of an applied offence provision for dealing with the goods.
(i) the goods are therapeutic goods under the applied therapeutic goods provisions; and
(ii) but for this section, the individual would be liable to be prosecuted, or subject to a civil proceeding, for contravention of an applied offence provision for dealing with the goods.
(i) the goods are therapeutic goods under the applied therapeutic goods provisions; and
(ii) but for this section, the individual would be liable to be prosecuted, or subject to a civil proceeding, for contravention of an applied offence provision for dealing with the goods.
(a) the individual may deal with the goods to the same extent as the individual was dealing with the goods immediately before the commencement; and
(b) the individual is not liable to be prosecuted, or subject to a civil proceeding, for contravention of an applied offence provision for dealing with the goods to the extent mentioned in paragraph (a).
Source text: opening excerpt
Sourced from Queensland Legislation (legislation.qld.gov.au), CC BY 4.0.
pt.1 Preliminary
Preliminary
pt.1-div.1 Introduction
Introduction
sec.1 Short title
sec.1 Short title
This Act may be cited as the Therapeutic Goods Act 2019 .
sec.2 Commencement
sec.2 Commencement
This Act commences on a day to be fixed by proclamation.
sec.3 Act binds all persons
sec.3 Act binds all persons
This Act binds all persons, including the State.
Nothing in this Act makes the State liable to be prosecuted for an offence.
(sec.3-ssec.1) This Act binds all persons, including the State.
(sec.3-ssec.2) Nothing in this Act makes the State liable to be prosecuted for an offence.
sec.4 Purpose of Act
sec.4 Purpose of Act
The purpose of this Act is to manage health and safety risks posed by therapeutic goods by applying Commonwealth regulatory controls on therapeutic goods in Queensland, to the extent those controls do not otherwise apply.
The purpose is achieved by applying relevant Commonwealth law s in Queensland in a way that allows—
the uniform administration of the applied laws by Commonwealth entities; and
offences against the applied laws to be treated as if they were offences against Commonwealth laws.
(sec.4-ssec.1) The purpose of this Act is to manage health and safety risks posed by therapeutic goods by applying Commonwealth regulatory controls on therapeutic goods in Queensland, to the extent those controls do not otherwise apply.
(sec.4-ssec.2) The purpose is achieved by applying relevant Commonwealth law s in Queensland in a way that allows— the uniform administration of the applied laws by Commonwealth entities; and offences against the applied laws to be treated as if they were offences against Commonwealth laws.
(a) the uniform administration of the applied laws by Commonwealth entities; and
(b) offences against the applied laws to be treated as if they were offences against Commonwealth laws.
pt.1-div.2 Interpretation
Interpretation
sec.5 Definitions
sec.5 Definitions
In this Act—
applied therapeutic goods provisions see section 7 .
Commonwealth entity means a Commonwealth authority or Commonwealth officer.
For the meaning of Commonwealth authority and Commonwealth officer, see subsection (2) and the Therapeutic Goods Act 1989 (Cwlth) , section 3 .
Commonwealth Therapeutic Goods Laws means—
the Therapeutic Goods Act 1989 (Cwlth) ; and
the regulations, orders and manufacturing principles under the Therapeutic Goods Act 1989 (Cwlth) .
Secretary means the Secretary of the department of the Commonwealth in which the Commonwealth Therapeutic Goods Laws are administered.
Other terms used in this Act and also defined in the Commonwealth Therapeutic Goods Laws have the same meanings in this Act as they have in the Commonwealth Therapeutic Goods Laws, to the extent the context permits.
(sec.5-ssec.1) In this Act— applied therapeutic goods provisions see section 7 . Commonwealth entity means a Commonwealth authority or Commonwealth officer. For the meaning of Commonwealth authority and Commonwealth officer, see subsection (2) and the Therapeutic Goods Act 1989 (Cwlth) , section 3 . Commonwealth Therapeutic Goods Laws means— the Therapeutic Goods Act 1989 (Cwlth) ; and the regulations, orders and manufacturing principles under the Therapeutic Goods Act 1989 (Cwlth) . Secretary means the Secretary of the department of the Commonwealth in which the Commonwealth Therapeutic Goods Laws are administered.
(sec.5-ssec.2) Other terms used in this Act and also defined in the Commonwealth Therapeutic Goods Laws have the same meanings in this Act as they have in the Commonwealth Therapeutic Goods Laws, to the extent the context permits.
It imports Commonwealth administrative and criminal machinery. Specified Commonwealth administrative laws (the Administrative Review Tribunal Act 2024 (Cwlth), Freedom of Information Act 1982 (Cwlth), Ombudsman Act 1976 (Cwlth) and Privacy Act 1988 (Cwlth)) apply as laws of Queensland to matters arising under the applied provisions (s 9(1)). Likewise, Commonwealth laws relevant to offences against the Commonwealth Therapeutic Goods Laws apply as Queensland law in relation to offences against the applied provisions (s 11).
It sets treatment for prosecutions and double jeopardy. Offences against the applied provisions are to be treated as if they were offences against Commonwealth law, and a person punished under the Commonwealth Therapeutic Goods Laws is not liable to be punished again under the applied provisions (s 11(2)-(3); s 13).
It addresses fees, delegations and register entries. The Secretary (as defined in s 5) may include or cancel therapeutic goods from the register maintained under the Commonwealth Act for the applied provisions (s 8(2)-(3)), and the Commonwealth may keep fees paid to or recovered by the Secretary for exercise of any functions conferred under the applied provisions (s 14).
It provides a limited transitional immunity for certain individuals dealing with goods that become therapeutic goods on commencement: where it was lawful to deal immediately before commencement, the individual may continue to deal with the goods as before for two years and will not be liable for prosecution or civil proceedings for contravention of an applied offence provision to that limited extent (s 16(1)-(4)).
The Act therefore shifts legal status, decision‑making and enforcement for therapeutic goods in Queensland from a purely state framework to one dominated by the Commonwealth Therapeutic Goods Laws, while preserving scope for regulations to modify how those Commonwealth laws operate as Queensland law (see s 6(3), s 7(2), s 9(3) and s 11(4)). The State remains bound by the Act but the Act expressly provides that nothing in it makes the State liable to be prosecuted for an offence (s 3).
Main concepts
The Act rests on a small set of recurring structural concepts that determine legal operation and institutional control. Those concepts are defined in or follow directly from the text.
Applied therapeutic goods provisions. Defined by operation rather than an independent schedule. Section 7 makes Commonwealth Therapeutic Goods Laws apply as Queensland laws, subject to any regulatory modification, and labels them the applied therapeutic goods provisions (s 7(3)). Every legal consequence in the Act flows from provisions being “applied” in that sense.
Commonwealth Therapeutic Goods Laws. Section 5 defines this as the Therapeutic Goods Act 1989 (Cwlth) together with the regulations, orders and manufacturing principles under that Act. The Act repeatedly refers to definitions, powers and functions in those Commonwealth instruments (s 5(1)-(2)).
Importation of Commonwealth interpretive and administrative regimes. The Act declares that the Commonwealth Acts Interpretation Act 1901 applies to interpretation of any applied law as if it were a Commonwealth law (s 6(2)). It then makes a selected set of Commonwealth administrative statutes apply as laws of Queensland to matters arising out of the applied provisions (s 9(1)), and provides that, for the purposes of applying Queensland law, a matter arising in relation to the applied provisions is to be treated as a matter arising in relation to a Commonwealth law and not as a Queensland matter (s 9(2)).
Transfer or alignment of functions and powers to Commonwealth entities. Several provisions make a Commonwealth entity that has a function or power under the Commonwealth laws be taken to have the same function or power for the applied provisions (s 8(1)-(2); s 10(1)-(2); s 12(1)-(2)). Those entities must, to the extent practicable, act as if performing the functions or powers under the Commonwealth laws (s 8(3); s 10(3); s 12(3)). Delegations and appointments made under Commonwealth law are declared to have effect for the applied provisions (s 8(4)).
Criminal and administrative carriage under Commonwealth regimes. Section 11 explicitly imports Commonwealth criminal laws relevant to offences against the Commonwealth Therapeutic Goods Laws and declares they apply as Queensland law for offences against the applied provisions (s 11(1)-(2)). The list of subject matters in s 11(1) is broad and expressly includes investigation and prosecution, arrest and custody, sentencing and fines, forfeiture of proceeds, and spent convictions.
Secretary and register powers. The Secretary of the Commonwealth department that administers the Commonwealth Therapeutic Goods Laws is given practical powers under the applied provisions, including power to include or remove therapeutic goods in the register maintained under the Commonwealth Act (s 8(2)). Section 14 then provides that fees paid to or recovered by the Secretary in exercising any functions under the applied provisions may be kept by the Commonwealth.
Transitional carve‑outs. Section 16 creates a time‑limited exception for particular individuals who lawfully dealt with goods immediately before commencement that become therapeutic goods on commencement. The exception lasts two years, is limited to individuals (not corporations by express operation of the definition of “deal with goods”), and does not prevent voluntary compliance before the two years expire (s 16(1)-(4)).
These concepts operate in a network. For example, the fact that Commonwealth administrative laws apply to matters arising under the applied provisions (s 9) directly affects who may review administrative decisions (Administrative Review Tribunal Act 2024 (Cwlth)), how FOI requests are processed, and how privacy complaints are handled. The importation of Commonwealth criminal laws (s 11) affects arrest, prosecution and sentencing procedures for offences that arise from the applied provisions. The Secretary’s register power (s 8) interacts with the Commonwealth register regime under the Commonwealth Act, and the Act’s definition clauses (s 5) tie interpretive meaning back to Commonwealth statutory language. Finally, a regulation-making power that can modify the application of Commonwealth laws as Queensland law appears repeatedly (s 6(3), s 7(2), s 9(3), s 11(4)), leaving scope for tailored calibration of the applied regime.
Who it affects
The Act explicitly binds “all persons, including the State” (s 3(1)), and applies to dealings by non‑corporate entities and trade or commerce within Queensland that are otherwise outside Commonwealth reach (s 7(1)). Those textual statements describe the universe of affected parties and identify several distinct groups.
Individuals who import, export, manufacture, supply or otherwise use goods in Queensland. The Act uses the phrase “deal with goods” and defines it to include import, export, manufacture, supply or otherwise use the goods (s 16(4)). Those activities, when applied therapeutic goods provisions define certain goods as therapeutic, will bring individuals within the applied Commonwealth regime.
Businesses, commercial traders and non‑corporate entities. Section 7(1) expressly extends the Commonwealth Therapeutic Goods Laws, as applied, to things done by entities that are not corporations and to things done in the course of trade and commerce within Queensland. That wording brings sole traders, partnerships, individuals and other non‑corporate actors into the regulatory ambit where they engage in the relevant activities.
Commonwealth entities and officers. The Act directly impacts Commonwealth entities that exercise functions under the Commonwealth Therapeutic Goods Laws by making them the primary decision makers for applied provisions in Queensland (s 8(1)-(3), s 10(1)-(3), s 12(1)-(3)). Those entities must act, to the extent practicable, as if acting under Commonwealth law when exercising functions in relation to the applied provisions.
The Queensland Government and its agencies. The Act binds the State (s 3(1)) but includes a specific limitation that the Act does not make the State liable to be prosecuted for an offence (s 3(2)). That means state bodies are within the statutory reach, but the Act removes criminal exposure for the State itself.
Regulators, review bodies and oversight agencies. The Administrative Review Tribunal, Ombudsman, FOI and Privacy frameworks specified in s 9 are made applicable to matters arising under the applied provisions. Those Commonwealth oversight bodies, and any Commonwealth bodies charged with administering the Therapeutic Goods Act, will be responsible for many administrative interactions arising from the applied provisions.
The Secretary of the Commonwealth department that administers the Commonwealth Therapeutic Goods Laws. Section 5 defines “Secretary” and s 8 gives the Secretary specific operative powers, including the power to include or cancel therapeutic goods in the Commonwealth register for the applied provisions.
Persons subject to criminal investigation or enforcement. Section 11 imports Commonwealth criminal laws relevant to offences against the Commonwealth Therapeutic Goods Laws and applies them as Queensland law, which affects persons who may be investigated, arrested, charged, prosecuted, convicted, sentenced or punished for contraventions of the applied provisions.
Fee payers. The Act provides that the Commonwealth may retain fees paid to or recovered by the Secretary for functions under the applied provisions (s 14). Any person required to pay fees under the applied provisions will therefore be paying fees that the Commonwealth can retain.
Two further features affect scope and incidence. First, the Act’s provisions for modification by regulation (s 6(3), s 7(2), s 9(3), s 11(4)) mean that the particulars of who is affected may be adjusted by subordinate instruments. Second, the transitional provision (s 16) gives a temporary, limited non‑liability to particular individuals who were lawfully dealing with goods immediately before commencement and who would otherwise be exposed to applied offence provisions; the protection is personal to individuals and lasts two years (s 16(2)).
In practical terms, regulated businesses and advisers must determine whether goods they import, make or supply fall within the Commonwealth definitions once the applied therapeutic goods provisions commence and how Commonwealth administrative, FOI, privacy and criminal processes will now govern their interactions with regulators.
Key duties and rights
The Act itself is primarily a vehicle for applying elsewhere‑created duties and rights: it does not create a new, independent regulatory code for therapeutic goods in Queensland. Its most important legal effects relevant to duties and rights are the following.
Adoption of Commonwealth duties and prohibitions. By applying the Commonwealth Therapeutic Goods Laws as laws of Queensland (s 7), duties and prohibitions contained in the Therapeutic Goods Act 1989 (Cwlth) and its subordinate instruments now operate in Queensland as if they were Queensland laws. Those applied duties include registration and listing obligations, manufacturing and advertising controls, and other obligations that are set out in the Commonwealth Act and subordinate instruments. The Act expressly links the applied offence provisions to Chapter 3, Part 3‑2 of the Commonwealth Act in the definition used for the transitional provision (s 16(4)), which confirms that offences and civil penalties relating to registration or listing of imported, exported, manufactured or supplied therapeutic goods will be applied.
Rights to administrative review and oversight under Commonwealth law. Section 9(1) extends specified Commonwealth administrative laws to matters arising under the applied provisions. This means that affected persons will, where those Commonwealth statutes apply, have rights under the Administrative Review Tribunal Act 2024 (Cwlth) (for merits review where applicable), the Freedom of Information Act 1982 (Cwlth) (to request access to documents held by Commonwealth agencies), the Ombudsman Act 1976 (Cwlth) (for complaints about administrative action) and the Privacy Act 1988 (Cwlth) (for privacy rights). The Act declares that for application of Queensland law, such matters are to be treated as matters arising in relation to Commonwealth law and not Queensland law (s 9(2)), which affects avenues for challenge, remedies and procedural rights.
Procedural and interpretive rights under Commonwealth Acts Interpretation Act. Section 6(2) requires that where an applied law is being interpreted, the Acts Interpretation Act 1901 (Cwlth) will apply as if the applied law were a Commonwealth law. That shifts interpretive rules and presumptions to the Commonwealth framework to the extent engaged.
Rights and obligations vis‑à‑vis Commonwealth entities. A Commonwealth entity is taken to have the same functions and powers for the applied provisions (s 8(1)-(2), s 10(1)-(2), s 12(1)-(2)), and those entities must, to the extent practicable, act as if they were performing their functions under the Commonwealth law (s 8(3), s 10(3), s 12(3)). A person regulated under the applied provisions therefore acquires rights to engage with Commonwealth decision makers and to seek remedies under the Commonwealth administrative frameworks noted above.
Secretary’s register powers, which affect market access. The Secretary may include or cancel the inclusion of therapeutic goods in the register maintained under the Commonwealth Act, section 9A, for the applied provisions (s 8(2)). Inclusion or removal from the register is consequential for the legal ability to import, manufacture, supply or advertise goods, and so the Secretary’s exercise of that power determines access to market.
Criminal procedural rights and obligations under Commonwealth law. By importing Commonwealth criminal laws relevant to offences (s 11(1)-(2)), the Act subjects accused persons to arrest, custody, bail, trial and conviction processes governed by Commonwealth criminal law provisions as applied in Queensland. Rights associated with criminal procedure, sentencing and appeals will therefore follow the Commonwealth model for applied offences.
Fee obligations and fee receipts. Section 14 gives the Commonwealth an explicit entitlement to keep fees paid to or recovered by the Secretary for exercise of functions under the applied provisions. The duty to pay relevant fees arises from the applied Commonwealth laws; the Act clarifies the destination of those payments.
Transitional limited immunity for certain individuals. Section 16 provides a specific right for individuals who were lawfully dealing with goods immediately before commencement to continue dealing for two years and to be protected from prosecution or civil proceedings for contravention of applied offence provisions to the extent they continue to deal as they did immediately before commencement. The section expressly does not prevent individuals from complying with the applied offence provisions if they choose to do so before the two‑year period ends (s 16(3)).
The Act therefore primarily confers the rights and duties that exist under the Commonwealth Therapeutic Goods Laws, re‑assigns who exercises enforcement and administrative powers (Commonwealth entities), and clarifies certain procedural and financial arrangements (Secretary’s register power and fee retention). Because the Act imports definitions and machinery from the Commonwealth statute and subordinate instruments (s 5), many specific duties and rights will be located in those external instruments rather than in this Act.
Penalties and enforcement
The Act reassigns enforcement of therapeutic goods obligations in Queensland into the Commonwealth legal framework and brings the Commonwealth criminal and administrative enforcement architecture to bear. It does so by treating offences under the applied therapeutic goods provisions as offences against Commonwealth laws, and by importing Commonwealth criminal laws relevant to those offences.
Treatment of offences as Commonwealth offences. Section 4(2)(b) states that the purpose of the Act is achieved by applying relevant Commonwealth laws in Queensland in a way that allows offences against the applied laws to be treated as if they were offences against Commonwealth laws. Section 11 then formalises this by applying Commonwealth law relevant to offences against the Commonwealth Therapeutic Goods Laws as laws of Queensland in relation to an offence against the applied provisions, and by declaring that for applying Queensland law an offence against the applied provisions is to be taken to be an offence against a Commonwealth law and not to be an offence against a Queensland law (s 11(2)-(3)).
Scope of criminal procedures imported. Section 11(1) lists example subject matters that the Commonwealth criminal laws may cover as applied in Queensland, including investigation and prosecution of offences; arrest, custody, bail, trial and conviction; sentencing, punishment and release; fines and penalties; proceeds from or forfeitures in relation to commission of offences; spent convictions; and proceedings, appeals and reviews relating to those matters. Each of these subject areas is therefore governed by the relevant Commonwealth law when applied to offences under the applied provisions.
Powers and functions of Commonwealth entities in criminal matters. Section 12 takes a Commonwealth entity that has a function or power under a Commonwealth law mentioned in s 11(1) and treats it as having the same function or power in relation to an offence against the applied provisions. The entity must, to the extent practicable, act as if performing its function under the Commonwealth law (s 12(2)-(3)). This transfers investigative, prosecutorial and enforcement functions to Commonwealth bodies.
No double punishment. Section 13 provides that if an act or omission constitutes an offence against both the applied provisions and the Commonwealth Therapeutic Goods Laws, and a person has been punished under the Commonwealth Therapeutic Goods Laws, then the person is not liable to be punished under the applied provisions. The section therefore prevents double jeopardy arising from overlapping applications of the same Commonwealth laws and their application as Queensland law.
Fee‑related enforcement consequences. Section 14 provides the Commonwealth may retain fees paid to or recovered by the Secretary for the exercise of functions under the applied provisions. While the Act does not itself set fee amounts, it specifies the destination of fee income; fees required by the applied Commonwealth regime may form part of enforcement and licensing economics.
Regulation‑driven modification of enforcement. Multiple provisions allow regulations to modify how Commonwealth laws apply as Queensland laws (s 6(3), s 7(2), s 9(3), s 11(4)). That power creates a mechanism by which specific enforcement processes, evidentiary rules or other procedural elements could be adapted, subject to the scope of the regulation‑making power.
Transitional non‑liability for particular individuals. Section 16 removes liability for prosecution or civil proceeding for two years for individuals who were lawfully dealing with goods immediately before commencement and whose goods become therapeutic on commencement, to the extent they continue to deal with the goods as before. The section does not prevent them from complying earlier with applied offence provisions if they choose.
The Act therefore shifts enforcement in Queensland from state-based criminal and administrative machinery to the Commonwealth suite of criminal and administrative laws, and places the responsibility for investigation, prosecution and other enforcement actions on Commonwealth entities. The Act also preserves protection against double punishment and allows for regulatory tailoring of how Commonwealth enforcement law applies in the Queensland context.
How it interacts with other laws
This Act is an application statute: it principally operates by importing Commonwealth statutes and instruments into Queensland law and by importing Commonwealth administrative and criminal laws into the Queensland context. The key interaction rules are textual and prescriptive.
Importation and displacement of interpretive regimes. Section 6 makes the Acts Interpretation Act 1901 (Cwlth) apply for the interpretation of any applied law as if the applied law were a Commonwealth law, and accordingly, to the extent s 6(2) applies, the Acts Interpretation Act 1954 (Queensland) and the Statutory Instruments Act 1992 (Queensland) do not apply in relation to the interpretation of the applied law (s 6(2)-(3)). That reassigns rules about interpretation, commencement, expiry, and instrument making to the Commonwealth framework for those applied laws.
Applied Commonwealth laws supersede or supplement state law to the extent those controls do not otherwise apply. Section 4 sets the purpose in terms of applying Commonwealth regulatory controls in Queensland “to the extent those controls do not otherwise apply”. The Act therefore operates where Commonwealth therapeutic goods controls are absent at a state level or where the applied Commonwealth laws are made to operate in Queensland by the Act. The Act does not, on its face, extinguish all Queensland regulatory power in relation to therapeutic goods, but the Act’s repeated declarations that applied laws are to be treated as Commonwealth laws (s 9(2), s 11(3)) mean that for matters covered by the applied provisions the practical legal locus will be Commonwealth law and institutions.
Administrative overlay. Section 9 makes specified Commonwealth administrative statutes apply as laws of Queensland for matters arising under the applied provisions, and provides that for applying Queensland law, such matters are taken to be matters arising in relation to a Commonwealth law and not to be matters arising in relation to a Queensland law (s 9(1)-(2)). This changes the procedural framework for requests for documents, review rights and privacy complaints. It therefore interacts with existing Queensland administrative and oversight regimes by displacing them for those matters to the extent the Commonwealth statutes apply.
Criminal law interaction: Commonwealth criminal laws apply to offences under the applied provisions. Section 11 brings in Commonwealth laws relevant to investigation, prosecution, trial and sentencing where an offence arises under the applied provisions, and declares that for applying Queensland law, such offences are to be treated as offences against Commonwealth law (s 11(2)-(3)). That has the effect of transferring the criminal procedural and sentencing rules applicable to these matters into the Commonwealth domain.
Delegations and appointments. The Act declares that delegations and appointments made by a Commonwealth entity in the performance of functions or exercise of powers under Commonwealth Therapeutic Goods Laws have effect for the applied provisions (s 8(4)). That means that the administrative architecture established under Commonwealth law , including delegations to agency officers , will operate to administer the applied provisions in Queensland.
Interaction with regulatory modification power. The Act repeatedly permits a regulation to modify how a Commonwealth law applies as a Queensland law (s 6(3), s 7(2), s 9(3), s 11(4)). That creates express scope for subordinate instruments to tailor interactions with Queensland law. The statutory text therefore anticipates that the default application of Commonwealth laws may be varied for policy or practical reasons, subject to the limits of the regulation‑making power.
Fees and fiscal connections. Section 14 gives the Commonwealth custody of fees paid to or recovered by the Secretary for functions under the applied provisions. That fiscal routing interacts with any existing Queensland fee arrangements because the Commonwealth will be the recipient of fees arising under the applied Commonwealth regime.
Transitional interaction with pre‑existing lawful dealings. Section 16 recognises existing lawful state activities by giving individuals who lawfully dealt with goods immediately before commencement a two‑year period in which they may continue dealing without liability for applied offence provisions. The section explicitly identifies the relevant applied offence provisions in Chapter 3, Part 3‑2 of the Commonwealth Act (s 16(4)). That transitional ratchet therefore tempers immediate conflict between state practice and the new applied Commonwealth regime.
Taken together, the Act is designed to create legal coherence by moving therapeutic goods regulation in Queensland into the Commonwealth architecture. The interaction points are heavily procedural and institutional , interpretation, administrative review, criminal procedure, delegation and fee collection , and those points determine which statutory rules govern disputes, enforcement, review and fees in relation to therapeutic goods activity in Queensland.
Amendment history
The text supplied contains one explicit amendment notation and otherwise shows the Act in its enacted form with a commencement provision left to proclamation.
Commencement. Section 2 provides that the Act commences on a day to be fixed by proclamation. That means the Act has a commencement mechanism requiring proclamation rather than an automatic date written into the Act (s 2).
Amendment notation attached to s 9. The text includes an amendment annotation, “s 9 amd 2024 No. 47 s 78 sch 2”, immediately above the repeated subsection text for s 9, which indicates that section 9 has been amended by a later instrument (labelled No. 47 of 2024, s 78 schedule 2) in the compilation from which the supplied text is drawn. The presence of that notation in the supplied text is the only explicit signal of amendment history contained within the material provided.
No other amendment annotations present in the supplied text. None of the other sections carry amendment annotations in the excerpt provided. The Act therefore appears in enacted form for the other sections in the supplied material.
Transitional provision dated and time‑limited. Section 16 imposes a two‑year transitional period for particular individuals after the Act’s commencement. The effect of the two‑year period will depend on the proclamation date chosen under s 2 and therefore may be staggered in time relative to other reforms.
Regulation‑making power and future modification. Multiple sections expressly permit regulations to modify the application of Commonwealth laws as Queensland law (s 6(3), s 7(2), s 9(3), s 11(4)). Those provisions create a live pathway for future subordinate legislation to modify the Act’s operation without amending the primary Act itself. As a practical matter, significant operational change to how Commonwealth laws apply in Queensland can be achieved by regulation where authorised.
No schedules in the supplied extract. The supplied text does not include subordinate instrument texts, the Commonwealth Therapeutic Goods Laws being applied, or any later amending Acts beyond the amendment notation for s 9. To understand the full amendment history and the current form of the Commonwealth provisions as applied, readers must consult the Commonwealth Therapeutic Goods Act 1989 (Cwlth) and its own amendment history, as well as any regulations made under this Act.
In short, the supplied Act is structured to allow regulatory modification by subordinate instruments and to operate from proclamation. The embedded amendment notation indicates at least one subsequent amendment affecting s 9 has been made in the statutory compilation supplied, but the full record of amendments to the Commonwealth laws applied by this Act is necessarily external to the Act’s text and must be checked in the Commonwealth statute book.
Litigation history
The supplied text contains no judicial decisions, citations to cases or any litigation record relating to the Act. The Act is primarily an application statute; litigation arising from it will therefore tend to engage:
Challenges to the scope of application. Disputes could arise over whether particular conduct or goods fall within the Commonwealth Therapeutic Goods Laws as applied in Queensland, or whether the Commonwealth controls “otherwise apply” in particular circumstances (see s 4(1)). Litigation may involve statutory interpretation questions calling for application of the Acts Interpretation Act 1901 (Cwlth) as required by s 6(2).
Review of administrative decisions made by Commonwealth entities. Because s 9 brings Commonwealth administrative statutes to bear, affected persons may seek merits review where available, or judicial review in appropriate courts, of decisions by Commonwealth entities exercising powers in relation to applied provisions. The Administrative Review Tribunal Act 2024 (Cwlth) is made applicable by s 9(1), which will create administrative pathways under Commonwealth law.
Criminal prosecutions and procedural disputes. Section 11 imports Commonwealth criminal laws relevant to offences under the applied provisions. Litigation may therefore include criminal prosecutions, appeals and sentencing proceedings governed by Commonwealth law as applied to Queensland. Section 13’s double jeopardy protection may be raised where there is an overlapping Commonwealth prosecution and subsequent proceedings under the applied provisions.
Challenges to delegation and exercise of powers by Commonwealth entities. Section 8(4) declares that delegations or appointments made by a Commonwealth entity under Commonwealth Therapeutic Goods Laws are taken to have effect for the applied provisions. Disputes could concern the validity of delegations, their scope, or the way Commonwealth entities exercise powers when administering applied provisions.
FOI, Ombudsman and privacy complaints. Because s 9(1) imports the FOI Act, Ombudsman Act and Privacy Act, litigation or complaint processes in those spheres may produce decisions involving the Act’s operation, particularly in relation to disclosure of documents or complaints about administrative action.
At present, the supplied text does not report outcomes of any of these types of litigation. Users must consult subsequent case law databases and the Commonwealth registries for any judicial treatment of the operation of the applied therapeutic goods provisions in Queensland. The Act’s repeated delegation to Commonwealth interpretive and administrative regimes suggests that litigation will frequently turn on Commonwealth statutory construction and administrative law principles as established in the relevant Commonwealth courts and tribunals.
Gotchas
The Act contains multiple drafting features and transitional arrangements that create practical traps for regulators, advisers and regulated persons. The following are concrete points to watch, grounded in the statute text.
Applied Commonwealth definitions and interpretive apparatus. Section 5 imports Commonwealth meanings “to the extent the context permits” and s 6 requires the Acts Interpretation Act 1901 (Cwlth) to apply. Practitioners must not assume Queensland statutory definitions or interpretive rules apply. The risk is that a term that has a different meaning under Queensland law will, for applied provisions, take its Commonwealth meaning. The phrase “to the extent the context permits” in s 5 introduces a context‑sensitivity that can generate disputes.
Regulatory modification powers create uncertainty. Sections 6(3), 7(2), 9(3) and 11(4) each allow a regulation to modify how a Commonwealth law applies as a law of Queensland. That means that the default application set out in the Act can be changed by subordinate instruments. Reliance solely on the primary Act without monitoring regulations may result in missing material qualifications or exceptions that alter regulatory duties or rights.
Who decides matters. Multiple provisions make Commonwealth entities the decision makers for applied provisions and for related administrative and criminal matters (s 8, s 10, s 12). That shifts practical contact points for applicants and respondents from Queensland agencies to Commonwealth agencies. Advisers should not assume that a Queensland regulator will handle an application or enforcement action once the Act commences.
Fees accrue to the Commonwealth. Section 14 gives the Commonwealth the right to keep fees paid to or recovered by the Secretary for exercise of any functions under the applied provisions. Entities used to paying Queensland fees need to confirm fee payee and mechanism, and budget accordingly. The Act does not specify fee quantum; fee obligations originate from the applied Commonwealth laws.
State bound but not prosecutable. Section 3(1) says the Act binds all persons, including the State, and s 3(2) says nothing in the Act makes the State liable to be prosecuted for an offence. This can create asymmetries where state activities fall under applied provisions but the State has a protection from prosecution. Advisers should recognise that “binding” in s 3(1) does not imply equivalent exposure to criminal liability.
Transitional protection is limited and personal. Section 16 provides a two‑year, personal protection for individuals who were lawfully dealing with goods immediately before commencement. The protection applies only to individuals (not corporations) and only to dealing to the same extent as before commencement. It is a temporal, limited carve‑out and does not immunise new dealings or expansions of dealing. Moreover, the section does not prevent individuals from electing to comply with the applied offence provisions before the two years elapse.
Double jeopardy protection applies only where punished under Commonwealth law. Section 13 prevents punishment under the applied provisions if a person has been punished for the offence under the Commonwealth Therapeutic Goods Laws. That protection is therefore contingent on the person already having been punished under Commonwealth law; it does not preclude a Commonwealth prosecution following a Queensland‑applied proceeding unless the Commonwealth has already imposed punishment.
Administrative and criminal processes are routed through Commonwealth frameworks. Sections 9 and 11 declare that, for matters arising under the applied provisions, specified Commonwealth statutes apply and the matter is to be taken to be a matter arising in relation to a Commonwealth law and not a Queensland law (s 9(2); s 11(3)). Practitioners must therefore anticipate Commonwealth timeframes, remedies and procedures (for example FOI timeframes under the FOI Act) rather than Queensland equivalents.
Register status and market access are governed by the Secretary. Section 8(2) authorises the Secretary to include or cancel therapeutic goods in the register maintained under the Commonwealth Act for the applied provisions. A product’s legal marketability in Queensland may therefore hinge on a Commonwealth register decision rather than a Queensland administrative decision.
Delegations continue to operate across jurisdictions. Section 8(4) confirms that delegations or appointments made by a Commonwealth entity for Commonwealth Therapeutic Goods Laws are taken to have effect for the applied provisions. Challenges to delegated decisions should therefore be founded on Commonwealth delegation instruments and the administrative law applicable to those instruments.
Multiple layers of statutory reference. Section 15 says that, for sections 9 and 11, a reference in a Commonwealth law to a provision of that law or another Commonwealth law is to be read as a reference to that provision as applying because of those sections. That complicates textual cross‑referencing and means that a provision in a Commonwealth statute may be operating in Queensland in a modified way because of its application under this Act.
In practice these “gotchas” require regulated entities and their advisers to run a two‑track compliance review: examine the applied Commonwealth Therapeutic Goods Laws together with this Act and monitor any Queensland regulations that may modify the application. Failure to monitor the Secretary’s register decisions, Commonwealth fee notices and subordinate regulations carries practical and legal risk.
How to comply
Compliance with the regime created by the Act requires aligning operational practice in Queensland with the substantive and procedural requirements of the Commonwealth Therapeutic Goods Laws as applied. The Act itself does not restate the full body of duties; it imports them. The following practical compliance checklist is derived from obligations and mechanisms established by the Act.
Determine whether your goods fall within the Commonwealth definition of therapeutic goods. Section 5 imports Commonwealth definitions “to the extent the context permits”. Compliance begins with consulting the Therapeutic Goods Act 1989 (Cwlth) and its regulations, orders and manufacturing principles to determine whether the goods you import, export, manufacture, supply or use are captured by the Commonwealth regime as applied in Queensland under s 7. Do not rely on Queensland statutory definitions.
Identify the legal actor status. The Act extends the Commonwealth laws to things done by entities that are not corporations and to things done in the course of trade and commerce within Queensland (s 7(1)). Ensure the legal form under which activities are carried on , individual, partnership, trust, company , is identified because the transitional protection in s 16 applies only to individuals and because corporate actors may be treated differently under the Commonwealth offences and civil penalty regimes.
Review registration and listing obligations against the Commonwealth register. Section 8(2) authorises the Secretary to include or cancel goods in the Commonwealth register under section 9A of the Commonwealth Act for the applied provisions. Confirm whether a product requires inclusion in the register, whether current register status permits your activities, and whether any planned products will need an application to the Secretary. Monitor register entries and cancellation notices.
Budget and pay applicable fees to the Commonwealth. The Commonwealth may keep fees paid to or recovered by the Secretary for the exercise of functions under the applied provisions (s 14). Identify all fees imposed under the Commonwealth Therapeutic Goods Laws and ensure payment mechanisms and accounts are established for payment to Commonwealth agencies rather than Queensland entities.
Comply with Commonwealth regulatory instruments and manufacturing principles. The applied Commonwealth Therapeutic Goods Laws include not only the principal Act but also regulations, orders and manufacturing principles (s 5). Ensure manufacturing and quality systems adhere to the Commonwealth manufacturing principles that are applied.
Prepare for administrative processes under Commonwealth statutes. Section 9 makes certain Commonwealth administrative statutes applicable. Practitioners should plan for FOI obligations and opportunities (FOI Act 1982), potential Ombudsman inquiries (Ombudsman Act 1976), privacy obligations (Privacy Act 1988), and administrative review avenues (Administrative Review Tribunal Act 2024). Records, document management and complaints handling need alignment with Commonwealth requirements.
Anticipate Commonwealth criminal procedures for enforcement. Section 11 brings relevant Commonwealth criminal laws into play for offences under the applied provisions. Ensure internal compliance programs, incident response and cooperation policies are consistent with facing Commonwealth investigation, arrest, custodial processes, bail, trial and sentencing regimes. Legal counsel should be prepared to handle Commonwealth criminal procedure rather than Queensland criminal practice.
Use the transitional relief, but cautiously. If you are an individual who lawfully dealt with goods immediately before the Act’s commencement and those goods become therapeutic goods on commencement, s 16 provides a two‑year window during which you may continue dealing and not be liable for prosecution or civil proceeding to the extent you continue to deal as before. However, the protection is limited to the dealing extent existing immediately before commencement. Consider whether voluntary compliance or seeking registration earlier is preferable to preserve market access after the two years.
Track and respond to regulations that modify application. Multiple sections allow regulations to modify how the Commonwealth laws apply as Queensland law (s 6(3), s 7(2), s 9(3), s 11(4)). Establish a regulatory watch to capture any subordinate instruments that alter duties, procedural routes, exemptions or other material rules affecting compliance.
Structure challenges and reviews with Commonwealth processes in mind. Because the Act routes review and enforcement into Commonwealth law and institutions, prepare challenge strategies anchored in Commonwealth administrative law and review mechanisms. Delegations and appointments by Commonwealth entities are declared to have effect for the applied provisions (s 8(4)), so review and merits appeals will usually engage Commonwealth statutory instruments and Commonwealth tribunal or court processes.
Ensure contractual and supply‑chain alignment. Because the Act changes legal responsibilities in Queensland, revise contracts, supply‑chain warranties and indemnities to reflect the new regulatory governance and the destination of fees to the Commonwealth. Buyers and sellers need clarity on who will meet the costs and legal obligations of registration, testing, labelling and compliance.
Engage with the Secretary and Commonwealth entities early. The Secretary has active powers in relation to register entries and the exercise of functions for the applied provisions (s 8). Early engagement can clarify the Secretary’s expectations, timing for approvals or cancellations, and fee notices.
Keep governance and compliance documentation in Commonwealth‑compatible form. Given the FOI and Privacy Act overlay (s 9(1)), recordkeeping should be designed to survive Commonwealth records requests and privacy scrutiny. Maintain traceable decision logs and documented compliance measures that will support administrative review if required.
Seek specialist advice on interpretation and cross‑jurisdictional issues. Because s 6 places the Acts Interpretation Act 1901 (Cwlth) at the centre of statutory interpretation for applied laws, specialist advice that understands Commonwealth statutory construction, Commonwealth instrument validity, and the applicable Commonwealth criminal and administrative frameworks will be necessary.
In short, the compliance regime requires moving operational, administrative and legal focus from a Queensland centre to a Commonwealth centre for therapeutic goods matters. That shift affects who to approach for approvals, the procedural frameworks for disputes, the regime governing fees, and the duration and nature of transitional relief. Establishing a monitored action plan that covers definition, registration, fees, administrative review and criminal exposure will materially reduce regulatory risk following commencement.
(b) the regulations, orders and manufacturing principles under the Therapeutic Goods Act 1989 (Cwlth) .
sec.6 Interpretation of applied laws
sec.6 Interpretation of applied laws
This section applies to a Commonwealth law (an applied law ) applied as a law of Queensland under this Act.
The Acts Interpretation Act 1901 (Cwlth) applies in relation to the interpretation of an applied law as if the applied law were a Commonwealth law and not a Queensland law.
To the extent subsection (2) applies, the Acts Interpretation Act 1954 and Statutory Instruments Act 1992 do not apply in relation to the interpretation of the applied law.
(sec.6-ssec.1) This section applies to a Commonwealth law (an applied law ) applied as a law of Queensland under this Act.
(sec.6-ssec.2) The Acts Interpretation Act 1901 (Cwlth) applies in relation to the interpretation of an applied law as if the applied law were a Commonwealth law and not a Queensland law.
(sec.6-ssec.3) To the extent subsection (2) applies, the Acts Interpretation Act 1954 and Statutory Instruments Act 1992 do not apply in relation to the interpretation of the applied law.
pt.2 Applied therapeutic goods provisions
Applied therapeutic goods provisions
sec.7 Application of Commonwealth Therapeutic Goods Laws
sec.7 Application of Commonwealth Therapeutic Goods Laws
The Commonwealth Therapeutic Goods Laws apply as laws of Queensland as if the Commonwealth Therapeutic Goods Laws extended to—
things done or omitted to be done by entities that are not corporations; and
things done or omitted to be done in the course of trade and commerce within the limits of Queensland.
For the meaning of corporation, see section 5 (2) and the Therapeutic Goods Act 1989 (Cwlth) , section 3 .
A regulation may modify the application, as a law of Queensland, of the Commonwealth Therapeutic Goods Laws.
The Commonwealth Therapeutic Goods Laws, as applied and modified under this section, are the applied therapeutic goods provisions .
(sec.7-ssec.1) The Commonwealth Therapeutic Goods Laws apply as laws of Queensland as if the Commonwealth Therapeutic Goods Laws extended to— things done or omitted to be done by entities that are not corporations; and things done or omitted to be done in the course of trade and commerce within the limits of Queensland. For the meaning of corporation, see section 5 (2) and the Therapeutic Goods Act 1989 (Cwlth) , section 3 .
(sec.7-ssec.2) A regulation may modify the application, as a law of Queensland, of the Commonwealth Therapeutic Goods Laws.
(sec.7-ssec.3) The Commonwealth Therapeutic Goods Laws, as applied and modified under this section, are the applied therapeutic goods provisions .
(a) things done or omitted to be done by entities that are not corporations; and
(b) things done or omitted to be done in the course of trade and commerce within the limits of Queensland. Note— For the meaning of corporation, see section 5 (2) and the Therapeutic Goods Act 1989 (Cwlth) , section 3 .
sec.8 Functions and powers of Commonwealth entities
sec.8 Functions and powers of Commonwealth entities
This section applies to a Commonwealth entity that has a function or power under the Commonwealth Therapeutic Goods Laws.
The Commonwealth entity is taken to have the same function or power for the applied therapeutic goods provisions.
The Secretary may include, or cancel the inclusion of, therapeutic goods in the register maintained under the Therapeutic Goods Act 1989 (Cwlth) , section 9A for the applied therapeutic goods provisions.
When performing the function or exercising the power for the applied therapeutic goods provisions, the Commonwealth entity must, to the extent practicable, act as if the entity were performing the function or exercising the power under the Commonwealth Therapeutic Goods Laws.
To remove any doubt, it is declared that a delegation, or the appointment of a person, made by a Commonwealth entity in the performance of a function or exercise of a power under the Commonwealth Therapeutic Goods Laws is taken to have effect for the applied therapeutic goods provisions.
(sec.8-ssec.1) This section applies to a Commonwealth entity that has a function or power under the Commonwealth Therapeutic Goods Laws.
(sec.8-ssec.2) The Commonwealth entity is taken to have the same function or power for the applied therapeutic goods provisions. The Secretary may include, or cancel the inclusion of, therapeutic goods in the register maintained under the Therapeutic Goods Act 1989 (Cwlth) , section 9A for the applied therapeutic goods provisions.
(sec.8-ssec.3) When performing the function or exercising the power for the applied therapeutic goods provisions, the Commonwealth entity must, to the extent practicable, act as if the entity were performing the function or exercising the power under the Commonwealth Therapeutic Goods Laws.
(sec.8-ssec.4) To remove any doubt, it is declared that a delegation, or the appointment of a person, made by a Commonwealth entity in the performance of a function or exercise of a power under the Commonwealth Therapeutic Goods Laws is taken to have effect for the applied therapeutic goods provisions.
pt.3 Administrative matters
Administrative matters
sec.9 Application of Commonwealth administrative laws
sec.9 Application of Commonwealth administrative laws
The following laws apply as laws of Queensland to a matter arising in relation to the applied therapeutic goods provisions as if the provisions were Commonwealth laws and not Queensland laws—
the Administrative Review Tribunal Act 2024 (Cwlth) ;
the Freedom of Information Act 1982 (Cwlth) ;
the Ombudsman Act 1976 (Cwlth) ;
the Privacy Act 1988 (Cwlth) ;
a regulation under a Commonwealth Act mentioned in paragraphs (a) to (d) .
For applying a Queensland law, a matter arising in relation to the applied therapeutic goods provisions is taken—
to be a matter arising in relation to a Commonwealth law; and
not to be a matter arising in relation to a Queensland law.
A regulation may modify the application, as a law of Queensland, of a Commonwealth law mentioned in subsection (1) .
s 9 amd 2024 No. 47 s 78 sch 2
(sec.9-ssec.1) The following laws apply as laws of Queensland to a matter arising in relation to the applied therapeutic goods provisions as if the provisions were Commonwealth laws and not Queensland laws— the Administrative Review Tribunal Act 2024 (Cwlth) ; the Freedom of Information Act 1982 (Cwlth) ; the Ombudsman Act 1976 (Cwlth) ; the Privacy Act 1988 (Cwlth) ; a regulation under a Commonwealth Act mentioned in paragraphs (a) to (d) .
(sec.9-ssec.2) For applying a Queensland law, a matter arising in relation to the applied therapeutic goods provisions is taken— to be a matter arising in relation to a Commonwealth law; and not to be a matter arising in relation to a Queensland law.
(sec.9-ssec.3) A regulation may modify the application, as a law of Queensland, of a Commonwealth law mentioned in subsection (1) .
(a) the Administrative Review Tribunal Act 2024 (Cwlth) ;
(b) the Freedom of Information Act 1982 (Cwlth) ;
(c) the Ombudsman Act 1976 (Cwlth) ;
(d) the Privacy Act 1988 (Cwlth) ;
(e) a regulation under a Commonwealth Act mentioned in paragraphs (a) to (d) .
(a) to be a matter arising in relation to a Commonwealth law; and
(b) not to be a matter arising in relation to a Queensland law.
sec.10 Functions and powers of Commonwealth entities for administrative matters
sec.10 Functions and powers of Commonwealth entities for administrative matters
This section applies to a Commonwealth entity that has a function or power under a Commonwealth law mentioned in section 9 (1) .
The Commonwealth entity is taken to have the same function or power in relation to a matter arising under the applied therapeutic goods provisions.
When performing the function or exercising the power for the applied therapeutic goods provisions, the Commonwealth entity must, to the extent practicable, act as if the entity were performing the function or exercising the power under the Commonwealth law.
(sec.10-ssec.1) This section applies to a Commonwealth entity that has a function or power under a Commonwealth law mentioned in section 9 (1) .
(sec.10-ssec.2) The Commonwealth entity is taken to have the same function or power in relation to a matter arising under the applied therapeutic goods provisions.
(sec.10-ssec.3) When performing the function or exercising the power for the applied therapeutic goods provisions, the Commonwealth entity must, to the extent practicable, act as if the entity were performing the function or exercising the power under the Commonwealth law.
pt.4 Criminal matters
Criminal matters
sec.11 Application of Commonwealth criminal laws
sec.11 Application of Commonwealth criminal laws
This section applies to a Commonwealth law relevant to an offence against the Commonwealth Therapeutic Goods Laws, including, for example, a Commonwealth law about any of the following matters—
the investigation and prosecution of offences;
the arrest, custody, bail, trial and conviction of persons charged with offences;
the sentencing, punishment and release of persons convicted of offences;
fines and penalties for offences;
the proceeds from, or forfeitures in relation to, the commission of offences;
spent convictions;
proceedings, appeals and reviews relating to matters mentioned in paragraphs (a) to (f) .
The Commonwealth law applies as a law of Queensland in relation to an offence against the applied therapeutic goods provisions as if the provisions were Commonwealth laws and not Queensland laws.
For applying a Queensland law, an offence against the applied therapeutic goods provisions is taken—
to be an offence against a Commonwealth law; and
not to be an offence against a Queensland law.
A regulation may modify the application, as a law of Queensland, of the Commonwealth law.
(sec.11-ssec.1) This section applies to a Commonwealth law relevant to an offence against the Commonwealth Therapeutic Goods Laws, including, for example, a Commonwealth law about any of the following matters— the investigation and prosecution of offences; the arrest, custody, bail, trial and conviction of persons charged with offences; the sentencing, punishment and release of persons convicted of offences; fines and penalties for offences; the proceeds from, or forfeitures in relation to, the commission of offences; spent convictions; proceedings, appeals and reviews relating to matters mentioned in paragraphs (a) to (f) .
(sec.11-ssec.2) The Commonwealth law applies as a law of Queensland in relation to an offence against the applied therapeutic goods provisions as if the provisions were Commonwealth laws and not Queensland laws.
(sec.11-ssec.3) For applying a Queensland law, an offence against the applied therapeutic goods provisions is taken— to be an offence against a Commonwealth law; and not to be an offence against a Queensland law.
(sec.11-ssec.4) A regulation may modify the application, as a law of Queensland, of the Commonwealth law.
(a) the investigation and prosecution of offences;
(b) the arrest, custody, bail, trial and conviction of persons charged with offences;
(c) the sentencing, punishment and release of persons convicted of offences;
(d) fines and penalties for offences;
(e) the proceeds from, or forfeitures in relation to, the commission of offences;
(f) spent convictions;
(g) proceedings, appeals and reviews relating to matters mentioned in paragraphs (a) to (f) .
(a) to be an offence against a Commonwealth law; and
(b) not to be an offence against a Queensland law.
sec.12 Functions and powers of Commonwealth entities for criminal matters
sec.12 Functions and powers of Commonwealth entities for criminal matters
This section applies to a Commonwealth entity that has a function or power under a Commonwealth law mentioned in section 11 (1) .
The Commonwealth entity is taken to have the same function or power in relation to an offence against the applied therapeutic
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