{"id":"tas:act-2001-097","name":"Therapeutic Goods Act 2001","slug":"therapeutic-goods-act-2001","collection":"act","jurisdiction":"tas","status":"in_force","isInForce":true,"actNumber":"97 of 2001","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":105758,"registerId":"tas-act-2001-097-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Part 1","sectionType":"part","heading":"Preliminary","content":"# Part 1 Preliminary","sortOrder":0},{"sectionNumber":"1","sectionType":"section","heading":"Short title","content":"### 1 Short title\n\n> This Act may be cited as the [Therapeutic Goods Act 2001](/view/html/inforce/2026-04-12/act-2001-097) .","sortOrder":1},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"### 2 Commencement\n\n> This Act commences on a day to be proclaimed.","sortOrder":2},{"sectionNumber":"3","sectionType":"section","heading":"Interpretation","content":"### 3 Interpretation\n\n> In this Act, unless the contrary intention appears –\n> \n> > ***animal*** means any animal (other than a human being), whether vertebrate or invertebrate, and includes but is not limited to –\n> > \n> > > > (a) mammals, birds, bees, reptiles, amphibians, fish, crustaceans and molluscs; and\n> > > \n> > > > (b) the semen, ova or embryo of an animal (other than a human being) or any other substance or thing directly relevant to the reproduction of an animal (other than a human being);\n> \n> > ***applied provisions*** means the Commonwealth therapeutic goods laws that apply as a law of Tasmania because of [section 6](#GS6@EN) ;\n> \n> > ***authority*** means an authority issued and in force for the purposes of this Act or the regulations;\n> \n> > ***automatic machine*** means any machine or mechanical device used or capable of being used for the purpose of supplying goods without the personal manipulation or attention of the supplier or the supplier's employee or other agent at the time of supply;\n> \n> > ***Commonwealth Act*** means the *Therapeutic Goods Act 1989* of the Commonwealth;\n> \n> > ***Commonwealth administrative laws*** means the following Acts and regulations of the Commonwealth:\n> > \n> > > > (a) [*\\[Section 3 Amended by No. 8 of 2025, s. 32, Applied:14 Oct 2024\\]*](/view/html/inforce/2024-10-14/act-2025-008#GS32@EN) the *Administrative Review Tribunal Act 2024*;\n> > > \n> > > > (b) the *Freedom of Information Act 1982*;\n> > > \n> > > > (c) the *Ombudsman Act 1976*;\n> > > \n> > > > (d) the *Privacy Act 1988*;\n> > > \n> > > > (e) the regulations in force under any of those Acts;\n> \n> > ***Commonwealth Department*** means the Department of Human Services and Health or such other Department of the Commonwealth as is the relevant Department for the purposes of the Commonwealth therapeutic goods laws;\n> \n> > ***Commonwealth Secretary*** means the Secretary of the Commonwealth Department;\n> \n> > ***Commonwealth therapeutic goods laws*** means –\n> > \n> > > > (a) the *Therapeutic Goods Act 1989* of the Commonwealth; and\n> > > \n> > > > (b) all regulations, orders and manufacturing principles in force under that Act;\n> \n> > ***exempt goods*** has the same meaning as in the Commonwealth Act;\n> \n> > ***licence*** means a licence issued and in force for the purposes of this Act;\n> \n> > ***listed goods*** has the same meaning as in the Commonwealth Act;\n> \n> > ***occupier***, in relation to premises, includes a person in charge of those premises;\n> \n> > ***Poisons List*** has the same meaning as in the [Poisons Act 1971](/view/html/inforce/2026-04-12/act-1971-081) ;\n> \n> > ***premises*** includes any structure, building, aircraft, vehicle, vessel or place (whether built upon or not), and any part thereof;\n> \n> > ***registered goods*** has the same meaning as in the Commonwealth Act;\n> \n> [*\\[Section 3 Amended by No. 3 of 2010, Sched. 1, Applied:01 Jul 2010\\]*](/view/html/inforce/2010-07-01/act-2010-003#JS1@Ja69@GC1@EN)\n> \n> > ***registered veterinary surgeon*** has the same meaning as in the [Veterinary Surgeons Act 1987](/view/html/inforce/2026-04-12/act-1987-104) ;\n> \n> > ***regulations*** means regulations made under this Act;\n> \n> > ***sell*** includes sell, whether by wholesale or retail, barter and exchange, and also includes dealing in, agreeing to sell, offering or exposing for sale, keeping or having in possession for sale, sending, forwarding, delivering or receiving for sale or on sale, or authorising, directing, causing, suffering, permitting or attempting any such acts or things;\n> \n> > ***supply*** includes –\n> > \n> > > > (a) sell, dispense and distribute; and\n> > > \n> > > > (b) supply, whether free of charge or otherwise, by way of sample or advertisement; and\n> > > \n> > > > (c) supply, whether free of charge or otherwise, in the course of testing for safety or efficacy on persons or animals; and\n> > > \n> > > > (d) agree or offer to sell or distribute; and\n> > > \n> > > > (e) keep or have in possession for sale, dispensing or distribution; and\n> > > \n> > > > (f) send, forward, deliver or receive for sale, dispensing or distribution; and\n> > > \n> > > > (g) authorise, direct, cause, suffer, permit or attempt any act mentioned in [paragraph (a)](#GS3@Nd36867510798611@Hpa@EN) , [(b)](#GS3@Nd36867510798611@Hpb@EN) , [(c)](#GS3@Nd36867510798611@Hpc@EN) , [(d)](#GS3@Nd36867510798611@Hpd@EN) , [(e)](#GS3@Nd36867510798611@Hpe@EN) or [(f)](#GS3@Nd36867510798611@Hpf@EN) ;\n> \n> > ***supply by wholesale***, in relation to goods, means –\n> > \n> > > > (a) supply of the goods for the purposes of resupply; or\n> > > \n> > > > (b) supply of an ingredient for the purposes of incorporation in the goods –\n> > > \n> > > and includes supply of the goods in wholesale quantities for use –\n> > > \n> > > > (c) in a public institution; or\n> > > \n> > > > (d) in connection with the carrying on by persons, in circumstances prescribed by the regulations, of any activity so prescribed;\n> \n> > ***therapeutic device*** has the same meaning as in the Commonwealth Act;\n> \n> > ***therapeutic goods*** has the same meaning as in the Commonwealth Act.","sortOrder":3},{"sectionNumber":"4","sectionType":"section","heading":"Act binds Crown","content":"### 4 Act binds Crown\n\n> This Act binds the Crown in right of Tasmania and, so far as the legislative power of Parliament permits, in all its other capacities.","sortOrder":4},{"sectionNumber":"5","sectionType":"section","heading":"Notes in text","content":"### 5 Notes in text\n\n> Notes in the text of this Act are explanatory notes only and do not form part of this Act.","sortOrder":5},{"sectionNumber":"Part 2","sectionType":"part","heading":"The applied provisions","content":"# Part 2 The applied provisions","sortOrder":6},{"sectionNumber":"6","sectionType":"section","heading":"Application of Commonwealth therapeutic goods laws to Tasmania","content":"### 6 Application of Commonwealth therapeutic goods laws to Tasmania\n\n> > (1)  The Commonwealth therapeutic goods laws, as in force for the time being and as modified by or under this Part, apply as a law of Tasmania.\n> \n> > (2)  Those Commonwealth therapeutic goods laws so apply as if they extended to –\n> > \n> > > > (a) things done or omitted to be done by persons who are not corporations; and\n> > > \n> > > > (b) things done or omitted to be done in the course of trade or commerce within the limits of Tasmania.\n> \n> > (3)  The regulations under this Act may modify the Commonwealth therapeutic goods laws for the purposes of this section.","sortOrder":7},{"sectionNumber":"7","sectionType":"section","heading":"Interpretation of Commonwealth therapeutic goods laws","content":"### 7 Interpretation of Commonwealth therapeutic goods laws\n\n> > (1)  The *Acts Interpretation Act 1901* of the Commonwealth, as in force for the time being, applies as a law of Tasmania in relation to the interpretation of the applied provisions, and so applies as if those provisions were an Act of the Commonwealth or regulations or orders under such an Act, as the case requires.\n> \n> > (2)  The [Acts Interpretation Act 1931](/view/html/inforce/2026-04-12/act-1931-059) does not apply to the applied provisions.","sortOrder":8},{"sectionNumber":"Part 3","sectionType":"part","heading":"Functions and powers under applied provisions","content":"# Part 3 Functions and powers under applied provisions","sortOrder":9},{"sectionNumber":"8","sectionType":"section","heading":"Functions and powers of Commonwealth Minister","content":"### 8 Functions and powers of Commonwealth Minister\n\n> The Commonwealth Minister has the same functions and powers under the applied provisions as that Minister has under the Commonwealth therapeutic goods laws as those laws apply to the Commonwealth.","sortOrder":10},{"sectionNumber":"9","sectionType":"section","heading":"Functions and powers of Commonwealth Secretary","content":"### 9 Functions and powers of Commonwealth Secretary\n\n> > (1)  The Commonwealth Secretary has the same functions and powers under the applied provisions as that Secretary has under the Commonwealth therapeutic goods laws as those laws apply to the Commonwealth.\n> \n> > (2)  Without limiting [subsection (1)](#GS9@Gs1@EN) , the Commonwealth Secretary has the function of including goods in the Australian Register of Therapeutic Goods kept under the applied provisions and is authorised to cancel the inclusion of goods in that Register in accordance with those provisions.","sortOrder":11},{"sectionNumber":"10","sectionType":"section","heading":"Functions and powers of other persons","content":"### 10 Functions and powers of other persons\n\n> An authorised person, authorised officer or official analyst appointed under the Commonwealth therapeutic goods laws has the same functions and powers under the applied provisions as the person, officer or analyst has under those Commonwealth laws as they apply to the Commonwealth.","sortOrder":12},{"sectionNumber":"11","sectionType":"section","heading":"Delegations by Commonwealth Minister or Secretary","content":"### 11 Delegations by Commonwealth Minister or Secretary\n\n> Any delegation by the Commonwealth Minister or the Commonwealth Secretary under section 57 of the Commonwealth Act is taken to extend to, and have effect for the purposes of, the corresponding provision of the applied provisions.","sortOrder":13},{"sectionNumber":"12","sectionType":"section","heading":"Appointments under Commonwealth therapeutic goods laws","content":"### 12 Appointments under Commonwealth therapeutic goods laws\n\n> The appointment of a person to an office or position under a provision of the Commonwealth therapeutic goods laws is taken to extend to, and have effect for the purposes of, the applied provisions.","sortOrder":14},{"sectionNumber":"Part 4","sectionType":"part","heading":"Administrative law matters","content":"# Part 4 Administrative law matters","sortOrder":15},{"sectionNumber":"13","sectionType":"section","heading":"Application of Commonwealth administrative laws to applied provisions","content":"### 13 Application of Commonwealth administrative laws to applied provisions\n\n> > (1)  The Commonwealth administrative laws apply as laws of Tasmania to any matter arising in relation to the applied provisions as if those provisions were a law of the Commonwealth and not a law of Tasmania.\n> \n> > (2)  For the purposes of a law of Tasmania, a matter arising in relation to the applied provisions –\n> > \n> > > > (a) is taken to be a matter arising in relation to laws of the Commonwealth in the same way as it would if those provisions were a law of the Commonwealth; and\n> > > \n> > > > (b) is taken not to be a matter arising in relation to laws of Tasmania.\n> \n> > (3)  [Subsection (2)](#GS13@Gs2@EN) has effect for the purposes of a law of Tasmania except as prescribed by the regulations.\n> \n> > (4)  Any 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.","sortOrder":16},{"sectionNumber":"14","sectionType":"section","heading":"Functions and powers conferred on Commonwealth officers and authorities","content":"### 14 Functions and powers conferred on Commonwealth officers and authorities\n\n> > (1)  A Commonwealth administrative law applying because of [section 13](#GS13@EN) that confers on a Commonwealth officer or authority a function or power also confers on the officer or authority the same function or power in relation to a matter arising in relation to the applied provisions.\n> \n> > (2)  In performing a function, or exercising a power, conferred by this section, the Commonwealth officer or authority must act as nearly as practicable as the officer or authority would act in performing or exercising the same function or power under the Commonwealth administrative law.\n> \n> > (3)  A function or power conferred on a Commonwealth officer or authority because of this section cannot be performed or exercised by an officer or authority of Tasmania.","sortOrder":17},{"sectionNumber":"Part 5","sectionType":"part","heading":"Offences against applied provisions","content":"# Part 5 Offences against applied provisions","sortOrder":18},{"sectionNumber":"15","sectionType":"section","heading":"Application of Commonwealth criminal laws to offences against applied provisions","content":"### 15 Application of Commonwealth criminal laws to offences against applied provisions\n\n> > (1)  The relevant Commonwealth laws apply as laws of Tasmania in relation to an offence against the applied provisions as if those provisions were a law of the Commonwealth and not a law of Tasmania.\n> \n> > (2)  For the purposes of a law of Tasmania, an offence against the applied provisions –\n> > \n> > > > (a) is taken to be an offence against the laws of the Commonwealth, in the same way as if those provisions were a law of the Commonwealth; and\n> > > \n> > > > (b) is taken not to be an offence against the laws of Tasmania.\n> \n> > (3)  [Subsection (2)](#GS15@Gs2@EN) has effect for the purposes of a law of Tasmania except as provided by the regulations.","sortOrder":19},{"sectionNumber":"16","sectionType":"section","heading":"Functions and powers conferred on certain Commonwealth officers and authorities relating to offences","content":"### 16 Functions and powers conferred on certain Commonwealth officers and authorities relating to offences\n\n> > (1)  A provision of the applied provisions applying because of [section 15](#GS15@EN) that confers on a Commonwealth officer or authority a function or power in relation to an offence against the Commonwealth therapeutic goods laws also confers on the officer or authority the same function or power in relation to an offence against the corresponding provision of the applied provisions.\n> \n> > (2)  In performing a function, or exercising a power, conferred by [subsection (1)](#GS16@Gs1@EN) , the Commonwealth officer or authority must act as nearly as practicable as the officer or authority 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 laws.","sortOrder":20},{"sectionNumber":"17","sectionType":"section","heading":"No double jeopardy for offences against applied provisions","content":"### 17 No double jeopardy for offences against applied provisions\n\n> If –\n> \n> > > (a) an act or omission is an offence against both the applied provisions and an offence against the Commonwealth therapeutic goods laws; and\n> > \n> > > (b) the offender has been punished for that offence under those Commonwealth laws –\n> \n> the offender is not liable to be punished for the offence under the applied provisions.","sortOrder":21},{"sectionNumber":"Part 6","sectionType":"part","heading":"Miscellaneous","content":"# Part 6 Miscellaneous","sortOrder":22},{"sectionNumber":"18","sectionType":"section","heading":"Commonwealth may retain fees paid to Commonwealth Secretary","content":"### 18 Commonwealth may retain fees paid to Commonwealth Secretary\n\n> The Commonwealth may retain fees paid to, or recovered by, the Commonwealth Secretary in respect of the performance or exercise of functions or powers conferred on that Secretary by the applied provisions.","sortOrder":23},{"sectionNumber":"19","sectionType":"section","heading":"Hawking of therapeutic goods","content":"### 19 Hawking of therapeutic goods\n\n> > (1)  A person who –\n> > \n> > > > (a) goes from house to house supplying therapeutic goods; or\n> > > \n> > > > (b) while in a public street or other public place, supplies therapeutic goods –\n> > \n> > is guilty of an offence.\n> \n> > (2)  [Subsection (1)](#GS19@Gs1@EN) does not apply to a person or a person of a class of persons, or therapeutic goods or therapeutic goods of a class of therapeutic goods, exempted by an order under [subsection (3)](#GS19@Gs3@EN) .\n> \n> > (3)  The Minister may, by order published in the *Gazette*, exempt any person or class of persons, or any therapeutic goods or class of therapeutic goods, from the operation of [subsection (1)](#GS19@Gs1@EN) .\n> \n> > (4)  An exemption under [subsection (3)](#GS19@Gs3@EN) may be unconditional or subject to conditions.\n> \n> > (5)  In this section –\n> > \n> > > ***house*** means any premises where people reside, whether permanently or not;\n> > \n> > > ***public place*** means any place where members of the public are lawfully entitled, invited or permitted to be present in their capacity as members of the public, whether conditionally or unconditionally, but does not include –\n> > > \n> > > > > (a) a shop; or\n> > > > \n> > > > > (b) [*\\[Section 19 Subsection (5) amended by No. 3 of 2010, Sched. 1, Applied:01 Jul 2010\\]*](/view/html/inforce/2010-07-01/act-2010-003#JS1@Ja69@GC2@EN) premises where a medical practitioner, registered veterinary surgeon or a person registered under the Health Practitioner Regulation National Law (Tasmania) in the dental profession or pharmacy profession carries on the practice of his or her profession.","sortOrder":24},{"sectionNumber":"20","sectionType":"section","heading":"Secretary of Department can obtain information about certain goods","content":"### 20 Secretary of Department can obtain information about certain goods\n\n> > (1)  The Secretary of the Department may, by notice served on a person who manufactures in, imports into or supplies in Tasmania any therapeutic goods, require the person to give to the Secretary, or to such other person as may be identified in the notice, such information about the goods as is specified in the notice.\n> \n> > (2)  A notice –\n> > \n> > > > (a) may specify a period of not less than 14 days within which the requirement of the notice is to be complied with; and\n> > > \n> > > > (b) may be served on a person even though the person has previously given information about the goods specified in the notice.\n> \n> > (3)  A person who, without reasonable excuse, fails to comply with a notice served on the person under this section is guilty of an offence.\n> > \n> > Penalty:  Fine not exceeding 20 penalty units.\n> \n> > (4)  A person who, in purporting to comply with a notice under this section, gives information that the person knows, or ought reasonably to know, is false or misleading in a material respect is guilty of an offence.\n> > \n> > Penalty:  Fine not exceeding 20 penalty units.\n> \n> > (5)  In this section,\n> > \n> > > ***therapeutic goods*** includes any substance that might warrant inclusion in the Poisons List.","sortOrder":25},{"sectionNumber":"21","sectionType":"section","heading":"Delegation by Secretary of Department","content":"### 21 Delegation by Secretary of Department\n\n> The Secretary of the Department may delegate any of his or her functions or powers under this Act (other than this power of delegation).","sortOrder":26},{"sectionNumber":"22","sectionType":"section","heading":"Offence to supply certain goods by automatic machine","content":"### 22 Offence to supply certain goods by automatic machine\n\n> > (1)  A person who, whether in premises under the person's control or elsewhere –\n> > \n> > > > (a) installs an automatic machine for the supply of therapeutic goods; or\n> > > \n> > > > (b) supplies therapeutic goods by means of an automatic machine –\n> > \n> > is guilty of an offence.\n> > \n> > Penalty:  Fine not exceeding 20 penalty units.\n> \n> > (2)  A person who occupies or controls premises is guilty of an offence if –\n> > \n> > > > (a) an automatic machine for the supply of therapeutic goods is installed on the premises; or\n> > > \n> > > > (b) therapeutic goods are stored in an automatic machine that is installed on the premises; or\n> > > \n> > > > (c) therapeutic goods are supplied by means of an automatic machine.\n> > \n> > Penalty:  Fine not exceeding 20 penalty units.\n> \n> > (3)  [Subsections (1)](#GS22@Gs1@EN) and [(2)](#GS22@Gs2@EN) do not apply to a person or a person of a class of persons, or therapeutic goods or therapeutic goods of a class of therapeutic goods, exempted by an order under [subsection (4)](#GS22@Gs4@EN) .\n> \n> > (4)  The Minister may, by order published in the *Gazette*, exempt any person or class of persons, or any therapeutic goods or class of therapeutic goods, from the operation of [subsection (1)](#GS22@Gs1@EN) or [(2)](#GS22@Gs2@EN) .\n> \n> > (5)  An exemption under [subsection (4)](#GS22@Gs4@EN) may be unconditional or subject to conditions.","sortOrder":27},{"sectionNumber":"23","sectionType":"section","heading":"Offence to supply unregistered or unlisted goods","content":"### 23 Offence to supply unregistered or unlisted goods\n\n> > (1)  A person who supplies by retail therapeutic goods to a person is guilty of an offence unless –\n> > \n> > > > (a) the goods are registered goods or listed goods; or\n> > > \n> > > > (b) the goods are exempt goods or are the subject of an approval or authority under section 19 of the Commonwealth Act.\n> > \n> > Penalty:  Fine not exceeding 20 penalty units.\n> \n> > (2)  This section applies to therapeutic goods that are for use in or on humans, but does not apply to –\n> > \n> > > > (a) a supply of therapeutic goods that are listable devices within the meaning of the Commonwealth Act; or\n> > > \n> > > > (b) a supply of therapeutic goods by a person who is a sponsor within the meaning of that Act.\n> > > > \n> > > > | Note. Section 19 of the Commonwealth Act empowers the Commonwealth Secretary to grant approval for the import, export or supply of therapeutic goods for the treatment of a person or for use solely for experimental purposes in humans. |","sortOrder":28},{"sectionNumber":"24","sectionType":"section","heading":"Offence to supply therapeutic goods by retail after expiry date","content":"### 24 Offence to supply therapeutic goods by retail after expiry date\n\n> > (1)  A person who supplies by retail therapeutic goods after the expiry date that is, in accordance with a standard that is applicable to the goods, stated on or in relation to the goods is guilty of an offence.\n> > \n> > Penalty:  Fine not exceeding 20 penalty units.\n> \n> > (2)  A standard is applicable to therapeutic goods if –\n> > \n> > > > (a) a standard specified in an order under section 10 of the Commonwealth Act is applicable to the goods; or\n> > > \n> > > > (b) where no such order is applicable to the goods but the goods are the subject of a monograph in the British Pharmacopoeia in the case of goods for use in or on humans, or the British Pharmacopoeia (Veterinary) in the case of goods for use in or on animals, it is a standard that is constituted by the statements in that monograph.\n> > > > \n> > > > | Note. Section 10 of the Commonwealth Act empowers the Commonwealth Minister to make orders determining standards for therapeutic goods. |","sortOrder":29},{"sectionNumber":"25","sectionType":"section","heading":"Offence to use certain therapeutic devices without licence","content":"### 25 Offence to use certain therapeutic devices without licence\n\n> A person who, in Tasmania, uses a therapeutic device of a kind prescribed by the regulations for the purposes of this section is guilty of an offence, unless the use is under, and is in accordance with the conditions of, a licence issued in accordance with the regulations.\n> \n> Penalty:  Fine not exceeding 50 penalty units.","sortOrder":30},{"sectionNumber":"26","sectionType":"section","heading":"Offences by bodies corporate","content":"### 26 Offences by bodies corporate\n\n> > (1)  If a body corporate contravenes, whether by act or omission, any provision of this Act or the regulations, each person who is a director, or a person concerned in the management, of the body corporate is taken to have contravened the same provision if the person knowingly authorised or permitted the contravention.\n> \n> > (2)  A person may be proceeded against and convicted under a provision under this section whether or not the body corporate has been proceeded against or convicted.\n> \n> > (3)  This section does not affect any liability imposed on a body corporate for an offence committed by the body corporate against this Act or the regulations.","sortOrder":31},{"sectionNumber":"27","sectionType":"section","heading":"Inspectors","content":"### 27 Inspectors\n\n> > (1)  The Secretary of the Department may, in writing, appoint a State Service officer or State Service employee employed in the Department to be an inspector for the purposes of this Act and that officer or employee may hold that office in conjunction with State Service employment.\n> \n> > (2)  The Secretary of the Department, with the consent of another Head of a State Service Agency, may, in writing, appoint a State Service officer or State Service employee employed in that Agency to be an inspector for the purposes of this Act and that officer or employee may hold that office in conjunction with State Service employment.\n> \n> > (3)  The Secretary of the Department may authorise a person who is not a State Service officer or State Service employee to perform the functions and exercise the powers of an inspector for the purposes of this Act.\n> \n> > (4)  An appointment or authorisation under this section may authorise the performance or exercise of all the functions or powers of an inspector under this Act or only specified functions or powers and may authorise the performance or exercise of functions or powers generally or in a particular case.\n> \n> > (5)  The Secretary of the Department must ensure that each person appointed or authorised under this section is issued with an identity card that incorporates a recent photograph of the inspector.\n> \n> > (6)  A person appointed or authorised under this section must, as soon as practicable after ceasing to be appointed or authorised under this section, return the person's identity card as an inspector to the Secretary of the Department.\n> > \n> > Penalty:  Fine not exceeding 2 penalty units.\n> \n> > (7)  A police officer is, by virtue of his or her office, taken to be an inspector for the purposes of this Act.","sortOrder":32},{"sectionNumber":"28","sectionType":"section","heading":"Powers of entry and seizure","content":"### 28 Powers of entry and seizure\n\n> > (1)  This section applies to –\n> > \n> > > > (a) therapeutic goods that are for supply or are (whether or not the goods are to be the subject of further manufacture) intended for supply; or\n> > > \n> > > > (b) goods that an inspector reasonably believes to be therapeutic goods referred to in [paragraph (a)](#GS28@Gs1@Hpa@EN) .\n> \n> > (2)  For the purpose of ascertaining whether the provisions of this Act or the regulations are being complied with, an inspector may do any of the following:\n> > \n> > > > (a) enter any premises that the inspector reasonably believes to be used in or in connection with the manufacture, distribution, conveyance, storage, handling or supply of goods to which this section applies;\n> > > \n> > > > (b) search those premises;\n> > > \n> > > > (c) require the production of stocks of any such goods that are kept on those premises and any record relating to the keeping of, or dealings with, those stocks;\n> > > \n> > > > (d) inspect stocks, and inspect and make copies of a record, or part of a record, produced in accordance with such a requirement or found on the premises;\n> > > \n> > > > (e) open and examine any receptacle, container or package that the inspector reasonably believes may contain any such goods;\n> > > \n> > > > (f) examine any such goods;\n> > > \n> > > > (g) seize and remove for analysis portions or samples of any such goods;\n> > > \n> > > > (h) seize and detain any things found on those premises if the inspector reasonably believes that a contravention of this Act or the regulations has been committed with respect to those things.\n> \n> > (3)  The power conferred by [subsection (2)(g)](#GS28@Gs2@Hpg@EN) or [(h)](#GS28@Gs2@Hph@EN) to seize goods or things includes a power to remove the goods or things from the premises where they were seized.\n> \n> > (4)  An inspector may not enter a part of premises used for residential purposes without the consent of the occupier or unless in accordance with a search warrant issued under [section 29](#GS29@EN) .\n> \n> > (5)  An inspector must not exercise a power conferred by this section unless the inspector –\n> > \n> > > > (a) is in possession of a certificate of identity; and\n> > > \n> > > > (b) gives reasonable notice to the occupier of the premises of intention to exercise the power (unless giving notice would defeat the purpose for which it is intended to exercise the power); and\n> > > \n> > > > (c) exercises the power at a reasonable time (unless it is being exercised in an emergency); and\n> > > \n> > > > (d) produces the certificate of identity if asked to do so by an occupier of the premises; and\n> > > \n> > > > (e) uses no more force than is reasonably necessary to exercise the power.\n> \n> > (6)  A police officer in uniform is not required to comply with [subsection (5)(a)](#GS28@Gs5@Hpa@EN) or [(d)](#GS28@Gs5@Hpd@EN) when exercising the powers of an inspector conferred by this section.\n> \n> > (7)  The owner of the premises is entitled to recover from the Crown as a debt a reasonable amount of compensation for damage caused by an inspector while exercising the power to enter, inspect or search premises.\n> \n> > (8)  A person who –\n> > \n> > > > (a) intentionally delays or obstructs an inspector in the exercise of any of the inspector's powers under this Act; or\n> > > \n> > > > (b) without reasonable excuse, fails to produce any goods or records that the person is required to produce under this Act –\n> > \n> > is guilty of an offence.\n> > \n> > Penalty:  Fine not exceeding 20 penalty units.\n> \n> > (9)  In this section –\n> > \n> > > ***production*** of a record includes, if the record is not in writing or is not written in English or is not decipherable on sight, production of a statement in English that is decipherable on sight and sets out the contents of the record;\n> > \n> > > ***record*** includes any book, account, document, paper or other source of information compiled, recorded or stored in written form, on microfilm, by electronic process or in any other manner or by any other means.","sortOrder":33},{"sectionNumber":"29","sectionType":"section","heading":"Search warrant may be issued in certain cases","content":"### 29 Search warrant may be issued in certain cases\n\n> > (1)  An inspector may apply to a justice of the peace for a search warrant for premises if entry to the premises has been refused, or an attempt to enter has been, or is likely to be, unsuccessful, and –\n> > \n> > > > (a) there are reasonable grounds for believing that an offence under this Act has been, or is being, committed on the premises; or\n> > > \n> > > > (b) the search warrant is sought in order to exercise a power conferred by [section 28(2)](#GS28@Gs2@EN) .\n> \n> > (2)  A justice of the peace to whom an application is made under this section may, if satisfied that there are reasonable grounds for doing so, issue a search warrant authorising a person named in the warrant to enter the premises.\n> \n> > (3)  [Schedule 1](#JS1@EN) applies to a search warrant issued under this section.","sortOrder":34},{"sectionNumber":"30","sectionType":"section","heading":"Proceedings for offences","content":"### 30 Proceedings for offences\n\n> Proceedings for an offence against this Act or the regulations may be started only within 2 years after the offence is alleged to have been committed.","sortOrder":35},{"sectionNumber":"31","sectionType":"section","heading":"Regulations","content":"### 31 Regulations\n\n> > (1)  The Governor may make regulations for the purposes of this Act.\n> \n> > (2)  Without limiting [subsection (1)](#GS31@Gs1@EN) , regulations may be made for or in relation to any of the following:\n> > \n> > > > (a) providing for the issue, renewal, suspension and cancellation of licences by the Secretary of the Department for the purposes of this Act and the conditions subject to which such licences may be issued or renewed for those purposes;\n> > > \n> > > > (b) prohibiting or regulating the advertising of therapeutic goods by persons engaged in the supply of those goods, including the form and content of advertisements and the manner in which advertisements may be published or displayed;\n> > > \n> > > > (c) providing for labelling, sampling, examining, testing and analysing therapeutic goods;\n> > > \n> > > > (d) prescribing conditions to be complied with when preparing, supplying, storing, packing, handling, carrying and delivering therapeutic goods;\n> > > \n> > > > (e) prohibiting or regulating the supply of therapeutic goods of a specified class;\n> > > \n> > > > (f) prescribing fees that are to be paid for matters arising under this Act (including fees for the issue and renewal of licences referred to in [paragraph (a)](#GS31@Gs2@Hpa@EN) );\n> > > \n> > > > (g) requiring persons of a specified class to keep records for the purposes of this Act;\n> > > \n> > > > (h) prohibiting the supply of therapeutic goods by self-service methods specified in the regulations.\n> \n> > (3)  The regulations may also make provision for or with respect to any of the following:\n> > \n> > > > (a) empowering magistrates to order the forfeiture of therapeutic goods and other things seized under this Act and to order payments to be made to meet costs incurred in seizing, storing and disposing of goods or things so seized;\n> > > \n> > > > (b) providing for the storage and release of goods seized under this Act;\n> > > \n> > > > (c) conferring rights of appeal on persons aggrieved by decisions of the Secretary of the Department relating to –\n> > > > \n> > > > > > (i) the issue or renewal of licences, or refusal to issue or renew licences, issued or renewed for the purposes of this Act; or\n> > > > > \n> > > > > > (ii) the suspension, withdrawal or cancellation of licences issued or renewed for those purposes.\n> \n> > (4)  Regulations made under this Act may –\n> > \n> > > > (a) apply generally or be limited in their application by reference to specified exemptions or specified factors; and\n> > > \n> > > > (b) apply differently according to different factors, limitations or restrictions of a specified kind; and\n> > > \n> > > > (c) authorise any matter to be from time to time determined, applied or regulated by the Minister or the Secretary of the Department; and\n> > > \n> > > > (d) apply, adopt or incorporate, with or without modification, any publication as in force from time to time.\n> \n> > (5)  Regulations made under this Act may –\n> > \n> > > > (a) provide that a contravention of, or failure to comply with, any of the regulations is an offence; and\n> > > \n> > > > (b) in respect of any such offence, provide for the imposition of a fine not exceeding 50 penalty units and, in the case of a continuing offence, a further penalty of a fine not exceeding 5 penalty units for each day during which the offence continues.","sortOrder":36},{"sectionNumber":"32","sectionType":"section","heading":"Administration of Act","content":"### 32 Administration of Act\n\n> Until provision is made in relation to this Act by order under [section 4 of the](/view/html/inforce/2026-04-12/act-1990-004#GS4@EN) [Administrative Arrangements Act 1990](/view/html/inforce/2026-04-12/act-1990-004)  –\n> \n> > > (a) the administration of this Act is assigned to the Minister for Health and Human Services; and\n> > \n> > > (b) the department responsible to the Minister for Health and Human Services in relation to the administration of this Act is the Department of Health and Human Services.","sortOrder":37},{"sectionNumber":"33","sectionType":"section","heading":"Therapeutic Goods and Cosmetics Act 1976  repealed","content":"### 33 Therapeutic Goods and Cosmetics Act 1976  repealed\n\n> The [Therapeutic Goods and Cosmetics Act 1976](/view/html/inforce/2026-04-12/act-1976-001) is repealed.","sortOrder":38},{"sectionNumber":"SCHEDULE 1 - Provisions with r","sectionType":"part","heading":"SCHEDULE 1 - Provisions with respect to search warrants","content":"# SCHEDULE 1 - Provisions with r SCHEDULE 1 - Provisions with respect to search warrants\n\n[Section 29(3)](#GS29@Gs3@EN)\n\n> **1.   **Applications for search warrants****\n> \n> > > (1) An application for a search warrant is to be made in writing to a justice of the peace.\n> > \n> > > (2) A justice of the peace is not to issue a search warrant unless –\n> > > \n> > > > > (a) the application for the search warrant sets out the grounds for seeking the search warrant; and\n> > > > \n> > > > > (b) the applicant for the search warrant has given the justice of the peace, either orally or in writing, any further information the justice of the peace requires concerning the grounds for seeking the search warrant; and\n> > > > \n> > > > > (c) the information given by the applicant is verified before the justice of the peace on oath or by affidavit.\n\n> **2.   **Record of proceedings before justice of the peace****\n> \n> > A justice of the peace who issues a search warrant is to cause a record to be made of all relevant particulars of the grounds the justice of the peace has relied on to justify the issue of the search warrant.\n\n> **3.   **Duty to show search warrants****\n> \n> > An inspector executing a search warrant is to produce the search warrant for inspection by an occupier of the premises if requested to do so by that occupier.\n\n> **4.   **Assistance in executing search warrants****\n> \n> > An inspector may execute a search warrant using such assistance as the inspector considers necessary.\n\n> **5.   **Expiry of search warrants****\n> \n> > A search warrant ceases to have effect –\n> > \n> > > > (a) on the date specified in the search warrant as the date on which it ceases to have effect; or\n> > > \n> > > > (b) if it is withdrawn before that date by the justice of the peace who issued the search warrant; or\n> > > \n> > > > (c) after it has been executed; or\n> > > \n> > > > (d) if the person to whom it is issued ceases to be an inspector –\n> > \n> > whichever first occurs.\n\n> **6.   **Reports to justice of the peace on execution of search warrants, &c.****\n> \n> > > (1) The inspector to whom a search warrant is issued is to furnish a report in writing to the justice of the peace who issued the search warrant –\n> > > \n> > > > > (a) stating whether or not the search warrant has been executed; and\n> > > > \n> > > > > (b) if the search warrant has been executed, setting out briefly the result of the execution of the search warrant, including a brief description of anything seized; and\n> > > > \n> > > > > (c) if the search warrant has not been executed, setting out briefly the reasons why the search warrant has not been executed.\n> > \n> > > (2) A report with respect to a search warrant is to be made within the period of 10 days immediately after the execution of the search warrant or the expiry of the search warrant, whichever first occurs.\n\n> **7.   **Death, absence, &c., of justice of the peace who issued search warrant****\n> \n> > If the justice of the peace who issued a search warrant has died, has ceased to be a justice of the peace or is absent, a report required to be furnished to that justice of the peace is to be furnished to another justice of the peace.\n\n> **8.   **Defects in search warrants****\n> \n> > A search warrant is not invalidated by any defect, other than a defect that affects the substance of the search warrant in a material particular.","sortOrder":39}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":6,"scope_assessment":{"changed":false,"description":"The legislation appears to maintain its original purpose of applying Commonwealth therapeutic goods laws to Tasmania. While it includes specific Tasmanian additions (hawking bans, vending machine prohibitions, inspector powers), these are ancillary to the core function of adopting federal standards. The scope has not expanded beyond the regulation of therapeutic goods safety and supply."},"complexity_factors":["Extensive cross-referencing to Commonwealth legislation (Therapeutic Goods Act 1989 and associated regulations) which are not reproduced in the text","Dual application mechanism - the Act applies Commonwealth laws 'as in force for the time being', creating a dynamic incorporation that changes as federal law changes","Complex interaction between state and federal jurisdictions, including specific rules about which administrative laws apply and how offences are treated","Multiple defined terms (approximately 25) including nested definitions that refer back to Commonwealth legislation","Conditional exemptions throughout (sections 19, 22, 23) allowing Ministerial discretion to exempt persons or goods from offences","Specific procedural requirements for inspectors exercising powers (section 28) with multiple conditions and exceptions (e.g., police officers in uniform exempt from certain requirements)","Schedule 1 contains detailed procedural rules for search warrants with multiple sub-conditions and reporting requirements"],"plain_english_summary":"This is a Tasmanian law that adopts the Commonwealth's therapeutic goods laws (medicines, medical devices, etc.) and makes them apply in Tasmania. It essentially 'plugs in' the federal Therapeutic Goods Act 1989 so that it covers individuals and businesses in Tasmania, not just corporations.\n\n**What it does:**\n- **Adopts federal law**: The Commonwealth therapeutic goods laws automatically apply in Tasmania as if they were Tasmanian laws (with some modifications).\n- **Extends coverage**: Normally, federal laws only apply to corporations. This Act extends them to cover individuals and local trade within Tasmania.\n- **Applies federal administrative laws**: Things like freedom of information, privacy, and review tribunal processes from the Commonwealth also apply to decisions made under this Act.\n- **Creates specific Tasmanian offences**: It bans certain practices like:\n  - Door-to-door selling ('hawking') of medicines\n  - Selling medicines through vending machines\n  - Selling expired medicines\n  - Selling unregistered medicines (with some exceptions)\n- **Gives inspectors powers**: Authorised officers can enter premises, inspect records, seize goods, and get search warrants to check if the laws are being followed.\n- **Protects against double punishment**: If someone is punished under the federal law for the same offence, they can't be punished again under this Tasmanian law.\n\n**Who it affects:**\n- Anyone who makes, imports, sells, or distributes medicines and medical devices in Tasmania\n- Pharmacies, doctors, veterinarians, and healthcare businesses\n- Manufacturers and importers of therapeutic goods\n\n**Why it matters:**\nThis ensures that Tasmania has the same safety standards for medicines and medical devices as the rest of Australia, while allowing the state to add extra rules (like banning vending machine sales) that address local concerns. It avoids having two separate regulatory systems running side by side."},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"issue_detection":{"absurdities":[],"contradictions":[]},"summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"Based on the limited metadata available, there is no evidence of scope change from the original 2001 intent. The Act appears to remain focused on its original purpose of regulating therapeutic goods within Tasmania in alignment with the national framework. However, a definitive assessment cannot be made without access to the full text of the Act and its amendments."},"complexity_factors":["Operates within a layered federal-state regulatory framework, requiring understanding of how Tasmanian law interacts with Commonwealth therapeutic goods legislation","Specialist subject matter — therapeutic goods regulation involves medical, pharmaceutical, and scientific concepts","Legislation has been amended multiple times since 2001, creating a need to track changes across versions","The document provided is almost entirely metadata with no substantive provisions, making meaningful analysis impossible from this extract","Scope of 'therapeutic goods' is itself a complex legal definition that can include borderline products like supplements, cosmetics with therapeutic claims, and medical software"],"plain_english_summary":"Tasmania's Therapeutic Goods Act 2001 aligns the state with the Commonwealth's national framework (the TGA) to govern medicines, medical devices and related products within Tasmania. It shapes who may supply, import or sell therapeutic goods and sets safety, labelling and quality expectations to protect consumers.\n\nThe supplied document contains only metadata/version info (current to 14 Oct 2024), so its full substantive provisions, offences and penalties are not available here."},"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":true,"description":"The Act replaces the prior Tasmanian regime (repealing the 1976 Act, s.33) by making the Commonwealth Therapeutic Goods Act and its regulations the operative law in Tasmania (s.6). It extends Commonwealth-style regulation to non-corporate persons and intra‑state trade (s.6(2)), applies Commonwealth administrative and criminal procedures to those matters (ss.13,15), and centralises significant decision-making and fee retention with Commonwealth offices (ss.8–12,18). The change shifts enforcement, licensing and standard-setting toward Commonwealth structures while preserving State roles in appointment of inspectors and local administration (ss.27,32)."},"complexity_factors":["Direct incorporation of an entire Commonwealth regulatory regime into State law (application and modification of Commonwealth therapeutic goods laws) (s.6)","Layering of Commonwealth administrative and criminal laws onto Tasmanian matters, treating applied provisions as Commonwealth law for interpretation and procedure (ss.7,13,15)","Multiple delegations and cross-appointments between Commonwealth and State offices (functions/powers of Commonwealth Minister, Secretary and appointees) (ss.8–12,14,16)","Broad inspection, seizure and search-warrant powers with procedural safeguards and reporting requirements (ss.27–29, Schedule 1)","Wide regulatory discretion for exemptions, licensing, advertising, labelling and offences, including scope for conditions and incorporation of external standards (ss.19,22,25,31)","Offences and penalties that apply to individuals and bodies corporate, plus mechanisms for attributing corporate liability to directors/managers (ss.23,24,26)","Interaction and potential overlap between State inspectors and Commonwealth officers, and limits on State officers exercising certain Commonwealth-conferred powers (ss.13–16)","Administrative burdens on industry: information notices, record-keeping, compliance with applicable standards, and time-limited prosecution windows (ss.20,28,30)"],"plain_english_summary":"This Act makes the Commonwealth therapeutic goods framework operate in Tasmania: registration, listing, approvals, offences and enforcement under the Commonwealth Therapeutic Goods Act apply in the State. It gives inspection, seizure and search-warrant powers, creates retail and vending offences, and allows licensing, exemptions and regulations by Ministers and the Secretary.\n\nManufacturers, importers, suppliers and users of therapeutic goods face Commonwealth-style compliance and penalties; fees may be charged and retained by the Commonwealth (s.18)."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-act-2001","history":"/api/acts/therapeutic-goods-act-2001/history","analysis":"/api/acts/therapeutic-goods-act-2001/analysis","conflicts":"/api/acts/therapeutic-goods-act-2001/conflicts","importantCases":"/api/acts/therapeutic-goods-act-2001/important-cases","documents":"/api/acts/therapeutic-goods-act-2001/documents"}}