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This Act may be cited as the Therapeutic Goods Act 1989.
This Act commences on the day after the day on which a House of the Parliament approves regulations made under this Act in the same form as approved by the other House, provided that:
not more than 90 days have elapsed; and
the places of Senators have not become vacant under section 13 of the Constitution; and
a dissolution or expiration of the House of Representatives has not occurred;
between the approval of one House and the approval of the other House.
Homoeopathic preparation
For the purposes of this Act, a homoeopathic preparation is a preparation:
manufactured from a mother substance; and
manufactured in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia.
Homoeopathic standard
For the purposes of this Act, if:
there are therapeutic goods that are a homoeopathic preparation; and
the goods are the subject of one or more monographs (other than a monograph exempt under subsection (4)) in the homoeopathic pharmacopoeia describing the manufacturing procedure that the preparation was manufactured in accordance with;
then there is a homoeopathic standard, in relation to the goods, that is constituted by the statements (other than statements exempt under subsection (5)) in those monographs, as interpreted in accordance with any interpretation sections of that homoeopathic pharmacopoeia.
Specifying publications
The Minister may, by legislative instrument, specify either or both of the following for the purposes of the definition of homoeopathic pharmacopoeia in subsection 3(1):
publications;
parts of publications.
Exempting entire monographs
The Minister may, by legislative instrument, determine that specified monographs in a specified homoeopathic pharmacopoeia are exempt for the purposes of paragraph (2)(b).
For specification by class, see subsection 13(3) of the Legislation Act 2003.
Exempting parts of monographs
The Minister may, by legislative instrument, determine that specified statements in specified monographs in a specified homoeopathic pharmacopoeia are exempt for the purposes of subsection (2).
Anthroposophic preparation
For the purposes of this Act, an anthroposophic preparation is a preparation:
manufactured from a mother substance; and
manufactured in accordance with a manufacturing procedure described in an anthroposophic pharmacopoeia.
Anthroposophic standard
For the purposes of this Act, if:
there are therapeutic goods that are an anthroposophic preparation; and
the goods are the subject of one or more monographs (other than a monograph exempt under subsection (4)) in the anthroposophic pharmacopoeia describing the manufacturing procedure that the preparation was manufactured in accordance with;
then there is an anthroposophic standard, in relation to the goods, that is constituted by the statements (other than statements exempt under subsection (5)) in those monographs, as interpreted in accordance with any interpretation sections of that anthroposophic pharmacopoeia.
Specifying publications
The Minister may, by legislative instrument, specify either or both of the following for the purposes of the definition of anthroposophic pharmacopoeia in subsection 3(1):
publications;
parts of publications.
Exempting entire monographs
The Minister may, by legislative instrument, determine that specified monographs in a specified anthroposophic pharmacopoeia are exempt for the purposes of paragraph (2)(b).
For specification by class, see subsection 13(3) of the Legislation Act 2003.
Exempting parts of monographs
The Minister may, by legislative instrument, determine that specified statements in specified monographs in a specified anthroposophic pharmacopoeia are exempt for the purposes of subsection (2).
The Minister may declare, in writing, that a country specified in the declaration is a member of:
the European Community; or
the European Free Trade Association.
A declaration under subsection (1) must be published in the Gazette or on the Department’s website.
The Minister may declare, in writing, that a country specified in the declaration is covered by the non‑EC/EFTA MRA specified in the declaration.
A declaration under subsection (1) must be published in the Gazette or on the Department’s website.
Exempting entire monographs
The Minister may, by legislative instrument, determine that specified monographs in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary are exempt in relation to specified therapeutic goods for the purposes of paragraph (b), (c) or (d) of the definition of standard in subsection 3(1). The determination applies to those monographs as in force from time to time.
For specification by class, see subsection 13(3) of the Legislation Act 2003.
Exempting parts of monographs
The Minister may, by legislative instrument, determine that specified statements in specified monographs in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary are exempt in relation to specified therapeutic goods for the purposes of paragraph (b), (c) or (d) of the definition of standard in subsection 3(1). The determination applies to those statements and monographs as in force from time to time.
Incorporation of other instruments
Despite subsection 14(2) of the Legislation Act 2003, a determination under subsection (1) or (2) of this section may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time.
The objects of this Act are to do the following, so far as the Constitution permits:
provide for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are:
used in Australia, whether produced in Australia or elsewhere; or
exported from Australia;
to provide a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and ensure the safe handling, of poisons in Australia;
provide for a scheme allowing pharmacists to substitute certain medicine for other medicine if the Minister has declared there is a serious scarcity of the other medicine;
provide for the establishment and maintenance of a national system of controls relating to the regulation of vaping goods that are:
imported into Australia; or
manufactured in Australia; or
supplied in Australia, whether manufactured in Australia or elsewhere; or
exported from Australia.
The reference in paragraph (1)(a) to the efficacy of therapeutic goods is a reference, if the goods are medical devices, to the performance of the devices as the manufacturer intended.
This Act is therefore not intended to apply to the exclusion of a law of a State, of the Australian Capital Territory or of the Northern Territory to the extent that the law is capable of operating concurrently with this Act.
This Act binds the Crown in right of the Commonwealth, of each of the States, of the Australian Capital Territory and of the Northern Territory, but nothing in this Act renders the Crown liable to be prosecuted for an offence or to be subject to civil proceedings for a contravention of a civil penalty provision.
Section 15.2 of the Criminal Code (extended geographical jurisdiction—category B) applies to offences against subsections 21A(1), (4) and (4A), sections 22A, 32DO and 41FE, subsections 42DZD(1) and (2) and sections 42DZG, 42DZL, 42E and 42T.
This Act (other than Part 4‑8A or Part 6‑1A) applies to:
things done by corporations; and
things done by natural persons or corporations in so far as those things are done:
in the course of, or in preparation for, trade or commerce between Australia and a place outside Australia, among the States, between a State and a Territory or between 2 Territories; or
under a law of the Commonwealth relating to the provision of pharmaceutical or repatriation benefits; or
in relation to the Commonwealth or in relation to an authority of the Commonwealth.
Part 4‑8A is about mandatory reporting, by healthcare facilities, of adverse events involving medical devices.
Without limiting the effect of this Act apart from this subsection, this Act also has the effect it would have if the reference in paragraph (1)(a) to things done by corporations were confined to things done by trading corporations for the purposes of their trading activities.
A corresponding State law may confer functions or powers, or impose duties, on:
a Commonwealth officer; or
a Commonwealth authority.
Subsection (1) does not authorise the conferral of a function or power, or the imposition of a duty, by a corresponding State law to the extent to which:
the conferral or imposition, or the authorisation, would contravene any constitutional doctrines restricting the duties that may be imposed on Commonwealth officers or Commonwealth authorities; or
the authorisation would otherwise exceed the legislative power of the Commonwealth.
Subsection (1) does not extend to a function, power or duty of a kind specified in regulations made for the purposes of this subsection.
This Act is not intended to exclude or limit the operation of a corresponding State law that confers any functions or powers, or imposes any duties, on a Commonwealth officer or Commonwealth authority to the extent to which that law:
is consistent with subsections (1) to (3); and
is capable of operating concurrently with this Act.