Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 10

             (1)  The Minister may, by order published in the Gazette , determine 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 or the British Pharmacopoeia (Veterinary)).

             (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 or the British Pharmacopoeia (Veterinary); 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.

             (4)  The Minister must not determine a standard or amend or revoke a standard unless the Minister has consulted with respect to the proposed action with a committee established by the regulations to advise the Minister on standards.