Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 10

  (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.