Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 52E

             (1)  In exercising a power under subsection 52D(2) , the Secretary must take the following matters into account (where relevant):

                     (a)  the risks and benefits of the use of a substance;

                     (b)  the purposes for which a substance is to be used and the extent of use of a substance;

                     (c)  the toxicity of a substance;

                     (d)  the dosage, formulation, labelling, packaging and presentation of a substance;

                     (e)  the potential for abuse of a substance;

                      (f)  any other matters that the Secretary considers necessary to protect public health.

             (2)  In exercising a power under subsection 52D(2) , the Secretary must comply with any guidelines of:

                     (a)  the Australian Health Ministers' Advisory Council; and

                     (b)  the subcommittee of the Council known as the National Coordinating Committee on Therapeutic Goods (or any replacement subcommittee);

notified to the Secretary for the purposes of this section.

             (3)  In exercising a power under subsection 52D(2) , the Secretary must have regard to any recommendations or advice of the Advisory Committee on Medicines Scheduling or the Advisory Committee on Chemicals Scheduling.

             (4)  In exercising a power under subsection 52D(2) , the Secretary may seek advice from either or both of the following:

                     (a)  any committee that the Secretary considers appropriate (whether or not the committee is established under this Act or the regulations);

                     (b)  any person.

             (5)  Subsections (2) to (4) do not limit the information the Secretary may consider in exercising a power under subsection 52D(2).