10Determination of standards

10 Determination of standards

(1) 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).

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

(2) Without limiting the generality of subsection (1), an order establishing a standard for therapeutic goods may: (a) be specified by reference to: (i) the quality of the goods; or (ii) the quantity of the goods when contained in specified containers; or (iii) procedures to be carried out in the manufacture of the goods; or (iv) a monograph in the British Pharmacopoeia, the European Pharmacopoeia, the United States Pharmacopeia‑National Formulary, a homoeopathic pharmacopoeia or an anthroposophic pharmacopoeia; or (v) a monograph in another publication approved by the Minister for the purposes of this subsection; or (vi) such a monograph as modified in a manner specified in the order establishing the standard; or (vii) a standard published by Standards Australia; or (viii) such other matters as the Minister thinks fit; or (b) require that a matter relating to the standard be determined in accordance with a particular test; or (c) 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. (3) 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: (a) therapeutic goods or a class of therapeutic goods identified in the order; or (b) a container or package containing therapeutic goods or a class of therapeutic goods identified in the order; or (c) a label of therapeutic goods or a class of therapeutic goods identified in the order; such particulars as are required by the order. (3A) The Minister may, by legislative instrument, vary or revoke an order made under subsection (1).

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

(4) 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.