THERAPEUTIC GOODS ACT 1989 - SECT 7B Kits

THERAPEUTIC GOODS ACT 1989 - SECT 7B

  (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.