Therapeutic Goods Act 1989

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

the risks and benefits of the use of a substance;

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

the toxicity of a substance;

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

the potential for abuse of a substance;

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

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

the Australian Health Ministers’ Advisory Council; and

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

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.

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

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

any person.

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