Indication requirements for non-prescription medicines
Using indications for non-prescription medicines.
Indications are statements that describe a therapeutic use for a medicine. The Therapeutic Goods Act 1989 defines a 'therapeutic use' as any 'use in, or in connection with, influencing, inhibiting or modifying a physiological process in persons'. They must also:
be included in the ARTG entry for the medicine
be supported by evidence.
Claims do not convey a specific therapeutic benefit (for example, ‘25% more’ or ‘new formula’). Claims:
do not need to be included in the ARTG
must be supported by evidence.
Indications must comply with the Therapeutic Goods Advertising Code
Indications must comply with the Therapeutic Goods Advertising Code when included on the product label or promotional materials.
For example, to comply with the Advertising Code, an indication must not:
- Mislead, or be likely to mislead consumers. (e.g. 'Improves the IQ of your unborn child')
- Imply that the medicine is infallible, unfailing, magical, miraculous, or that it is a certain, or guaranteed cure. (e.g. 'Cures eczema')
- Contain any claim, statement or implication that it is effective in all cases of the condition (e.g. 'Prevents headaches 24/7')
Indications have a risk hierarchy
The TGA has a risk hierarchy of indications for non-prescription medicines.
This takes into account:
- the health status and potential vulnerability of the target population
- the seriousness of any conditions mentioned
- the probability that a consumer may delay seeking medical treatment based on an indication.
Listed medicines (lowest-risk indications)
Listed medicines can only use low-risk indications from the Permissible indications determination and included in the ARTG entry.
Indications permitted for use in listed medicines can relate to diseases, disorders or conditions that are normally of a benign or self-limiting nature that the average consumer can be expected to evaluate or diagnose accurately.
Low risk indications may refer to:
- Health maintenance: The normal physiological effects of substances on growth, development and normal functions of the body. (e.g. 'Supports healthy liver function')
- Health enhancement: The beneficial effects of substances on the physiological and/or psychological state of the body above and beyond normal growth, development and functions of the body. (e.g. 'Stimulates digestive function')
- Prevention or alleviation of a non-serious vitamin or mineral dietary deficiency (e.g. 'Helps prevent dietary vitamin D deficiency')
- Non-serious form of a disease, condition, ailment or defect: Indications can refer to self-diagnosable, self-manageable conditions, where a delay in medical treatment would not be detrimental to the consumer. Indications may relate to reduction in risk, frequency, duration or relief without resolution of the underlying non-serious disease, ailment, defect or injury. (e.g. 'Helps reduce occurrence of eczema/dermatitis')
Low-risk indications cannot refer or imply to a prohibited representation or a restricted representation except for in the prevention of skin cancer through the use of sunscreens.
Listed therapeutic sunscreens are only permitted to carry indications that are specified in the Permissible indications determination. In principle, indications that are considered appropriate for listed therapeutic sunscreens are those that can be applied to products that can be used safely and effectively without the intervention of a healthcare practitioner.
Assessed listed medicines (intermediate risk)
The indications and presentation of assessed listed medicines will be pre-market assessed by the TGA.
The only indications that can be used on the label are those that are assessed by the TGA and included in the ARTG entry.
Registered non-prescription medicines (higher risk)
Registered non-prescription medicines like over the counter (OTC) and registered complementary medicines include higher risk ingredients or make health claims about more serious conditions. These are assessed pre-market by the TGA.
Indications need evidence
Indications must be consistent with the relevant treatment paradigm and the evidence base supporting its use (i.e. scientific evidence or a history of traditional use).
For example, indications based on a 'tradition of use' must not use terminology that would require a scientific procedure or investigation to verify, such as: 'increase bone density'.
It is possible for a medicine to include both scientific and traditional indications where the sponsor has the evidence to support both.
If you do not have your own supportive data, but have published scientific literature you consider to be supportive of an application, you may opt for a literature based submission (LBS).
Listed medicines and sunscreens
The Permissible indications determination specifies the type of evidence (traditional or scientific) that must be held by sponsors to support the use of each permitted indication for listed medicines.
Assessed listed medicines
All indications for assessed listed medicines must be supported by scientific evidence of efficacy of the product.
Efficacy refers to the potential of a medicine to produce a beneficial therapeutic effect in tightly controlled circumstances relative to a placebo or other interventions. Efficacy studies focus on demonstrating statistically significant differences between intervention groups in clinical settings.
Registered non-prescription medicines
The TGA fully evaluates the medicine (including its ingredients and the indications displayed on the label and other advertising) before it is available to buy on the market.
Guidance and resources
- GuidanceThis guidance applies to 'assessed listed medicines' that are eligible for evaluation by the TGA's Complementary and Over-the-counter Medicines Branch (COMB)
- GuidanceThis guidance describes the safety and efficacy data you will need for CTD Module 4 and Module 5 to support applications to either register an OTC medicine in the ARTG or vary the safety and/or efficacy aspects of a registered OTC medicine