Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 7B

             (1)  A package and therapeutic goods in the package together constitute a kit for the purposes of this Act if:

                     (a)  the package and the therapeutic goods are for use as a unit; and

                     (b)  each item of the therapeutic goods consists of goods that are registered or listed or are exempt goods in relation to Part 3‑2; and

                     (c)  the package and therapeutic goods do not constitute a composite pack or a system or procedure pack.

             (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 or therapeutic 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.