Therapeutic Goods Act 1989

For the purposes of this Act, registered goods are a reportable medicine if:

the goods are medicine; and

either:

the medicine contains one or more substances included in Schedule 4 or 8 to the current Poisons Standard; or

the medicine is determined in an instrument under subsection (2).

The Minister may, by legislative instrument, determine medicine for the purposes of subparagraph (1)(b)(ii).

The Minister must not determine a medicine unless the Minister is satisfied of either or both of the following:

the medicine is critical to the health of patients in Australia;

the notification to the Secretary of any shortage of the medicine, or of any decision to permanently discontinue the supply of the medicine, in Australia would be in the interests of public health.