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The three-tiered risk-based framework for complementary medicines

27 March 2018

On 19 March 2018 a new pathway to enter a complementary medicine in the Australian Register of Therapeutic Goods (ARTG) will be introduced – the assessed listed medicines pathway. Australia will then have three types of complementary medicines available to consumers: listed medicines, assessed listed medicines and registered complementary medicines. These are categorised on the ingredients they contain, and therapeutic indications (claimed health benefits) they use.

Listed and assessed listed medicines may only use ingredients which are included in the Therapeutic Goods (Permissible Ingredients) Determination. Registered complementary medicines may use any complementary medicine ingredient, provided it is not in Schedules 4, 8 or 9 of the Poisons Standard.

The table below assists sponsors in determining the appropriate risk category of the medicine based on based on the claimed therapeutic indications.

Three-tiered risk-based hierarchy of indications

Low risk Intermediate risk Higher risk

A low level indication may refer to:

  • health enhancement
  • health maintenance
  • prevention of dietary deficiency
  • a disease, ailment, defect or injury other than a serious form of those diseases.

A low level indication must not:

  • refer to, or imply, the prevention, alleviation, or cure of any form of a disease, ailment, defect or injury
  • contain a prohibited representation
  • contain a restricted representation
  • have been specified in any nonpermitted indications list.

Intermediate level indications may refer to:

  • refer to the prevention, cure or alleviation of a non-serious form of a disease, ailment, defect or injury
  • restricted representations (i.e. a serious form of a disease).

An intermediate level indication must not:

  • refer to the prevention, cure or alleviation of a restricted representation (i.e a serious form of a disease)
  • contain a prohibited representation.

High level indications may refer to:

  • prevention, alleviation or cure of a serious form of a disease, ailment, defect or injury (i.e. restricted representations).

A high level indication must not:

  • contain a prohibited representation.

Listed medicines may only use lower risk indications drawn exclusively from the list of permitted indications. Provided they only use permitted indications and ingredients permitted for use in listed medicines, they can be listed in the ARTG without undergoing pre-market assessment by the TGA.

Assessed listed medicines must have at least one intermediate risk indication, and may also include lower risk indications. Due to the slightly higher risk of assessed listed medicines, evidence of efficacy for all indications require successful pre-market assessment by the TGA before listing in the ARTG.

Registered complementary medicines may carry higher risk, intermediate risk and low risk indications. All aspects of registered complementary medicines undergo pre-market assessment.

The table below summarises the key aspects and regulatory requirements for each pathway to enter a complementary medicine in the ARTG.

Regulatory requirements for complementary medicines pathways

Listed medicines
AUST L
Assessed listed medicines
AUST L(A)
Registered medicines
AUST R
Ingredients Must draw exclusively from the permitted ingredients list. Ingredients must not be included in a schedule to the Poisons Standard. Must draw exclusively from the permitted ingredients list. Ingredients must not be included in a schedule to the Poisons Standard. An ingredient from the permitted ingredients list and/or an ingredient in a schedule to the Poisons Standard, other than Schedule, 4, 8 or 9
Indications Low level indications drawn exclusively from the permitted indications list Intermediate level indications that exceed the permitted indications list but are not high level indications, and low level indications High level indications which are not suitable for the listed or assessed listed medicines pathway, and intermediate and low level indications
Application Self-certification that alllegislative requirements are met Self-certification of quality and safety with pre-marketassessment of efficacy Full pre-market assessment
Evidence Evidence held by the sponsor Efficacy evidence must be assessed pre-market by the TGA Safety, quality and efficacy must be assessed pre-market by the TGA
Manufacturing quality Manufactured under GMP Manufactured under GMP Manufactured under GMP
Presentation Presentation cannot state that the product has been assessed by the TGA Sponsor able to use a 'claimer' on the label and other promotional material to indicate that efficacy of the product has been independently assessed Sponsor able to use a 'claimer' on the label and other promotional material to indicate safety, quality and efficacy of the product has been independently assessed
Post-market compliance Products may be selected for random or targeted review to confirm applicant certifications are correct. May include review of evidence to support claims

Products may be selected for random or targeted review to confirm applicant certifications are correct

Efficacy evidence would not be routinely reassessed post‑market

Products may be selected for post-market review; e.g. if there are safety concerns