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Complementary medicines presented as composite packs or kits

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ARGCM Part A: General guidance on complementary medicine regulation in Australia

29 October 2017

Some medicines are put together and presented as a kit or composite pack. The definitions of these as per 7B of the Act are provided below:

  1. A package and therapeutic goods in the package together constitute a kit for the purposes of this Act if:
    1. the package and the therapeutic goods are for use as a unit
    2. each item of the therapeutic goods consists of goods that are registered or listed, are exempt goods in relation to Part 3 2, are included in the Register under Part 3 2A or are exempt under subsection 32CA(2) or section 32CB
    3. 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:
    1. the therapeutic goods are of 2 or more kinds
    2. the package does not contain any medical devices or therapeutic devices
    3. the therapeutic goods are for administration as a single treatment or as a single course of treatment
    4. 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.

Medicines presented as kits

Kits are where two or more (listed, registered or exempt) goods are supplied in a single package, usually share a common therapeutic use and are intended for use as a unit. However, the individual goods can be used independently and do not need to be combined or administered in a sequence for the product's therapeutic purpose, for example: a sunscreen lotion and lip balm presented in a single package or a first aid kit.

Individual therapeutic goods in a kit must be listed (or registered) on the ARTG separately (unless the individual good in question is exempt from this requirement) and the packaged kit must also be listed on the ARTG and have its own AUST L number. As the components of a kit are already on the ARTG with a separate AUST L or AUST R, they are also regulated individually. Where a kit contains a device and a medicine (for example: hair lice kits with a comb) it is regulated as a device.

Medicines presented as composite packs

In a composite pack it is necessary for the therapeutic goods to be combined or used in a particular sequence, for a single treatment or course of treatment.

An example of this sort of product is 'night and day cold medication', which consists of tablets that are required to be taken in a particular order. A composite pack is required to be listed (or registered) on the ARTG, but the individual components do not require individual listing or (registering) on the ARTG. The primary pack must comply with all of the labelling requirements for containers/primary packs in the Therapeutic goods labelling Order as current and in force.