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 or the United States Pharmacopeia‑National Formulary).

Note:          Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.

             (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 or the United States Pharmacopeia‑National Formulary; 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 the Standards Australia International Limited; 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 Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.

             (4)  The Minister must not make an order under subsection (1), or vary or revoke an order made under subsection (1), unless the Minister has consulted with respect to the proposed action with a committee established by the regulations to advise the Minister on standards.