Therapeutic Goods Act 2001

Therapeutic Goods Act 2001

This Act may be cited as the Therapeutic Goods Act 2001.

This Act commences on a day to be proclaimed.

In this Act, unless the contrary intention appears –

animal means any animal (other than a human being), whether vertebrate or invertebrate, and includes but is not limited to – mammals, birds, bees, reptiles, amphibians, fish, crustaceans and molluscs; and 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);

applied provisions means the Commonwealth therapeutic goods laws that apply as a law of Tasmania because of section 6;

authority means an authority issued and in force for the purposes of this Act or the regulations;

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;

Commonwealth Act means the Therapeutic Goods Act 1989 of the Commonwealth;

Commonwealth administrative laws means the following Acts and regulations of the Commonwealth:the Administrative Review Tribunal Act 2024; the Freedom of Information Act 1982; the Ombudsman Act 1976; the Privacy Act 1988; the regulations in force under any of those Acts;

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;

Commonwealth Secretary means the Secretary of the Commonwealth Department;

Commonwealth therapeutic goods laws means – the Therapeutic Goods Act 1989 of the Commonwealth; and all regulations, orders and manufacturing principles in force under that Act;

exempt goods has the same meaning as in the Commonwealth Act;

licence means a licence issued and in force for the purposes of this Act;

listed goods has the same meaning as in the Commonwealth Act;

occupier, in relation to premises, includes a person in charge of those premises;

Poisons List has the same meaning as in the Poisons Act 1971;

premises includes any structure, building, aircraft, vehicle, vessel or place (whether built upon or not), and any part thereof;

registered goods has the same meaning as in the Commonwealth Act;

registered veterinary surgeon has the same meaning as in the Veterinary Surgeons Act 1987;

regulations means regulations made under this Act;

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;

supply includes – sell, dispense and distribute; and supply, whether free of charge or otherwise, by way of sample or advertisement; and supply, whether free of charge or otherwise, in the course of testing for safety or efficacy on persons or animals; and agree or offer to sell or distribute; and keep or have in possession for sale, dispensing or distribution; and send, forward, deliver or receive for sale, dispensing or distribution; and authorise, direct, cause, suffer, permit or attempt any act mentioned in paragraph (a), (b), (c), (d), (e) or (f);

supply by wholesale, in relation to goods, means – supply of the goods for the purposes of resupply; or supply of an ingredient for the purposes of incorporation in the goods – and includes supply of the goods in wholesale quantities for use – in a public institution; or in connection with the carrying on by persons, in circumstances prescribed by the regulations, of any activity so prescribed;

therapeutic device has the same meaning as in the Commonwealth Act;

therapeutic goods has the same meaning as in the Commonwealth Act.

This Act binds the Crown in right of Tasmania and, so far as the legislative power of Parliament permits, in all its other capacities.

Notes in the text of this Act are explanatory notes only and do not form part of this Act.

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.

Those Commonwealth therapeutic goods laws so apply as if they extended to – things done or omitted to be done by persons who are not corporations; and things done or omitted to be done in the course of trade or commerce within the limits of Tasmania.

The regulations under this Act may modify the Commonwealth therapeutic goods laws for the purposes of this section.

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.

The Acts Interpretation Act 1931 does not apply to the applied provisions.

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.

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.

Without limiting subsection (1), 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.

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.

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.