Permitted indications: what a listed medicine can claim, and the evidence behind it

In short

• A listed (AUST L) medicine can only make therapeutic claims from the TGA's permitted indications, set out in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025.
• Each indication sets the evidence the sponsor must hold, scientific or traditional, and any requirements for using it, such as a label statement. The TGA can ask for the evidence at any time.
• Listed medicines make low-level claims only: "relieves throat irritation", not "reduces high blood pressure".
• Advertising, which includes the label, must not be inconsistent with the indications on the ARTG, and advertising to the public can't use endorsements from health practitioners, health professionals or medical researchers.

What an indication is

In the TGA's words, indications "are statements that describe the specific therapeutic use for a medicine", such as "relieves coughs".

A label can carry other claims, but one that implies a therapeutic use needs a permitted indication of similar intent in the medicine's ARTG entry, supported by evidence.

How the Permissible Indications Determination works

The legal list is the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, in force since 3 April 2025. Its 17 Parts group indications mostly by body system, with separate Parts for traditional Chinese medicine (TCM), traditional Ayurvedic medicine, sunscreens and pregnancy. Each entry gives the wording, the type of evidence needed and any requirements:

• "Maintain/support energy levels": scientific or traditional evidence, and "Product presentation must not imply or refer to chronic fatigue syndrome."
• "Aid/assist in the healing of minor body tissue injuries": scientific or traditional, with the label statement "If symptoms persist, talk to your health professional."
• "Aid/assist/helps connective tissue production/formation": scientific evidence only.

The Determination also limits how the wording can change:

• Rewording. A label can vary the wording, or where appropriate combine indications into simple sentences, without changing the meaning or intent. It must not imply that the medicine treats a serious form of a disease, ailment, defect or injury, or that it prevents or cures any disease, ailment, defect or injury. In a TGA example, "Maintain/support gastrointestinal system health" can read "Maintains healthy gut", but not "Maintain healthy intestinal flora".
• Qualifiers. Only qualifiers from the TGA's code tables can modify an indication, and each must be on the label. Traditional evidence needs a traditional context qualifier; population, time of use and (for TCM evidence) TCM pattern qualifiers are optional. The TGA says the label and the ARTG entry must carry the same qualifiers.
• Pregnancy. Pregnancy indications have their own Part, and can't be combined in a sentence with other indications.

A sponsor can apply to have a new indication considered for the list; the 2026–27 fee is $1,331.

Listed, assessed listed or registered

The TGA only allows listed medicines "low level health claims": a listed medicine may claim it "relieves throat irritation", but not "reduces high blood pressure" or "cures rheumatoid arthritis". An assessed listed medicine, which the TGA assesses for efficacy before sale, might be able to reference a condition like tinnitus. A registered medicine (AUST R) is fully assessed for safety, quality and efficacy before it goes on sale. Our TGA listing guide compares the three tiers.

TGA evidence requirements: what the sponsor must hold

Listed medicines are not individually evaluated by the TGA for quality, safety and efficacy before they are supplied. Instead, the sponsor certifies, when applying to list, that the indications are covered by the Determination and meet its requirements. It also certifies that it holds evidence for every indication and claim.

The sponsor must hold that evidence "at all times while the medicine remains listed", and provide it to the TGA on request.

The TGA's Listed medicines evidence guidelines (version 4.0, June 2022) set out what counts. They aren't mandatory, but show what a TGA delegate considers in a compliance review. Non-specific scientific indications are about general health and wellbeing; specific ones go further.

Basis of the indication	Scientific	Traditional
What it is	Evidence "based on scientific research and quantifiable data", usually including clinical trials in humans	Traditional use "in a recognised paradigm outside modern conventional medicine", for over three generations (75 years)
The guidelines' minimum	Non-specific: two Category B or C sources, such as observational studies or non-systematic reviews. Specific: one Category A source, such as a double-blind randomised controlled trial, or one B and two C	Two sources of evidence of the tradition of use
Not enough, or not allowed	Abstracts alone, or non-clinical studies on their own	Implying efficacy based on scientific evidence, such as "clinically tested"

The guidelines call these minimums "the lowest threshold below which the efficacy of the medicine cannot be reasonably assessed", and say they may not suit every medicine. They also expect a critical appraisal of the evidence, which should weigh whether the benefit is clinically significant: for a listed medicine, "a degree of health benefit that is meaningful to the consumer".

Advertising: the Therapeutic Goods Advertising Code

As the Act defines it, advertising includes any statement intended to promote the use or supply of the goods, including on the label. The rules below come from the Act, its Regulations and the Therapeutic Goods Advertising Code, which doesn't apply to advertising directed only at health professionals and the others named in section 42AA of the Act:

• Consistent with the ARTG. Advertising must not be inconsistent with any indication accepted for the medicine's ARTG entry. It must be accurate, balanced, not misleading and substantiated before publication.
• Required statements. Most medicine ads must include the medicine's name, one or more accepted indications and "ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE". Short-form ads carry "ALWAYS FOLLOW THE DIRECTIONS FOR USE" instead. Neither applies to the label itself.
• Online stores. Where an ad lets people buy without inspecting the product, it must also give the dosage form, quantity and each active ingredient, plus any health warnings or a link to them.
• Endorsements and testimonials. An endorsement must not be given by "a current or former health practitioner, health professional or medical researcher". Testimonials can't come from people engaged in producing, marketing or supplying the goods, which the Code says includes influencers and others who receive valuable consideration for them. The advertiser must verify each one.
• Restricted representations. These refer to a serious form of a disease, condition, ailment or defect, one that requires "a health professional to diagnose, follow-up or treat". They need the TGA's prior approval or permission, unless part of a required health warning.
• Prohibited representations. Listed in the Therapeutic Goods Regulations 1990, these include claims about treating or preventing cancer or mental illness, and can't be applied for. The TGA can permit them in specific ads if necessary for public health or the appropriate use of the goods.

What the TGA checks, and what can follow

• Reviews. The TGA runs random and targeted compliance reviews of listed medicines. Its 2024–25 priorities included advertising indications not on the ARTG and not meeting the Determination, especially restricted or prohibited representations. Another was not holding sufficient evidence to support efficacy.
• Outcomes. If a medicine doesn't comply, the TGA acts according to the risk. It may, for example, require the sponsor to update the label, remove the medicine from the ARTG so it can no longer be lawfully supplied, or recall it.
• Cancellation. Among other grounds, the TGA can cancel a listing if the sponsor's evidence certifications are incorrect, or the medicine's efficacy appears unacceptable. Criminal and civil penalty provisions may apply to a false or misleading statement in a certification.

Food and cosmetic claims work differently

On a food, Standard 1.2.7 of the Food Standards Code says a claim must not refer to the prevention, diagnosis, cure or alleviation of a disease, disorder or condition. In the TGA's example, "Helps skin look firm" is a cosmetic claim, about appearance, while "Improves skin's internal structure for firmer skin" is therapeutic. More on medicine, food or cosmetic? and skincare.

Where we come in

We design the formula inside the TGA's permitted ingredients and indications, with every ingredient, its form and its dose chosen for the claim you want to make. The claims evidence is built alongside the formula, not after it. For a complex herbal capsule, the evidence package covered more than 13 ingredients. More on formulation, or book a call.