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RCMs using active ingredients permitted in listed medicines

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ARGCM Part D: Registered complementary medicines

29 October 2017

A registered medicine can contain active ingredients permitted for use in listed medicines when the indications are at a higher level than those permitted for listed medicines.

The Therapeutic Goods (Permissible Ingredients) Determination provides a comprehensive list of ingredients permitted for use in listed medicine, along with requirements applying to the use of particular ingredients included in listed medicines.

When each active ingredient is in compliance with the requirements stated in the Therapeutic Goods (Permissible Ingredients) Determination, safety data is usually not required.

Conditions

  • No new safety data available beyond what was considered to establish safety for listed medicines
  • No changes to the quality of the active ingredient

Data requirements

  • Module 3 (quality)
  • Module 5 (clinical) - clinical data is required to support all the indications and can be presented as clinical trial study reports or literature based evidence or a mixture of both.

Note: Safety (non-clinical) data is required when the medicine contains excipients (that are not approved for use in listed medicines.