Therapeutic Goods Act 1989

The Minister may, by legislative instrument, make an order determining that matters specified in the order constitute a standard for therapeutic goods or a class of therapeutic goods identified in the order (whether or not those goods are the subject of a monograph in the British Pharmacopoeia, the European Pharmacopoeia, the United States Pharmacopeia‑National Formulary, a homoeopathic pharmacopoeia or an anthroposophic pharmacopoeia).

Section 12 of the Legislation Act 2003 deals with when a legislative instrument commences.

Without limiting the generality of subsection (1), an order establishing a standard for therapeutic goods may:

be specified by reference to:

the quality of the goods; or

the quantity of the goods when contained in specified containers; or

procedures to be carried out in the manufacture of the goods; or

a monograph in the British Pharmacopoeia, the European Pharmacopoeia, the United States Pharmacopeia‑National Formulary, a homoeopathic pharmacopoeia or an anthroposophic pharmacopoeia; or

a monograph in another publication approved by the Minister for the purposes of this subsection; or

such a monograph as modified in a manner specified in the order establishing the standard; or

a standard published by Standards Australia; or

such other matters as the Minister thinks fit; or

require that a matter relating to the standard be determined in accordance with a particular test; or

require that therapeutic goods or a class of therapeutic goods identified in the order be labelled or packaged in a manner, or kept in containers that comply with requirements, specified in the order.

Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard, direct that there be set out, in a manner specified in the order, on:

therapeutic goods or a class of therapeutic goods identified in the order; or

a container or package containing therapeutic goods or a class of therapeutic goods identified in the order; or

a label of therapeutic goods or a class of therapeutic goods identified in the order;

The Minister may, by legislative instrument, vary or revoke an order made under subsection (1).

Section 12 of the Legislation Act 2003 deals with when a legislative instrument commences.

Despite subsection 14(2) of the Legislation Act 2003, an order under subsection (1) of this section, or a variation of such an order, 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.