7BKits

7B Kits

(1) If a package contains one or more goods, the package and each of the goods in the package together constitute a kit for the purposes of this Act if: (a) the package and each of the goods are for use as a unit; and (b) the package and the goods do not constitute a composite pack; and (c) at least one of the goods is therapeutic goods; and (d) each item of the therapeutic goods consists of goods that are: (i) registered or listed; or (ii) exempt goods in relation to Part 3‑2; or (iii) included in the Register under Part 3‑2A; or (iv) exempt under subsection 32CA(2) or section 32CB. (2) A package and therapeutic goods in the package together constitute a composite pack if: (a) the therapeutic goods are of 2 or more kinds; and (b) the package does not contain any medical devices; and (c) the therapeutic goods are for administration as a single treatment or as a single course of treatment; and (d) it is necessary that the therapeutic goods be combined before administration or that they be administered in a particular sequence. (3) To avoid doubt, it is declared that a kit constitutes therapeutic goods.