(1) The Minister may, by legislative instrument, determine that, for the purposes of this Act, specified goods (other than goods declared not to be therapeutic goods under an order in force under section 7 and goods covered by a determination under subsection 7AA(1) or (2) (excluded goods)):
(a) are therapeutic goods; or
(b) when used, advertised, or presented for supply in a particular way, are therapeutic goods.
(2) Before making a determination under subsection (1), the Minister:
(a) must have regard to the following matters:
(i) whether it is likely that the specified goods, if not regulated under this Act, might harm the health of members of the public;
(ii) whether it is appropriate in all the circumstances to apply the national system of controls relating to the quality, safety, efficacy and performance of therapeutic goods established by this Act to regulate the specified goods;
(iii) whether the kinds of risks from the specified goods to which members of the public might be exposed could be more appropriately dealt with under another regulatory scheme; and
(b) may have regard to any other relevant matter.