Permitted indications for listed medicines guidance

7 March 2018

Book pagination

Permitted indications for listed medicines

Listed medicines are considered 'low risk' and are not individually evaluated before they are entered in the Australian Register of Therapeutic Goods (ARTG). Upon submission of a listing application, applicants must certify that their medicine is eligible for listing and complies with all applicable regulatory requirements.

As listed medicines are not evaluated, the Therapeutic Goods Administration (TGA) uses a variety of mechanisms to help ensure that they are of high quality and used safely by consumers. One of these mechanisms is that listed medicines must only use indications drawn exclusively from a list of pre-approved 'permitted indications' and must comply with any requirements for the use of these indications in listed medicines.

This guidance provides information for sponsors on:

  • what permitted indications are, including terminology and structure
  • the use of permitted indications for listed medicines; and
  • how to apply for inclusion of new indications on the permitted indications list.

Transition period

The new regulatory requirements for permitted indications commenced on 6 March 2018. There is a three year transition period for existing listed medicines to comply with the new legislative requirements for permitted indications. At the end of the transition period on 6 March 2021, listed medicines that do not meet the legislative requirements for permitted indications, will be cancelled from the ARTG. You cannot supply a medicine that is cancelled from the ARTG in the Australian market.

What are permitted indications?

'Indications' are statements that describe the specific therapeutic use[1] for a medicine. They describe a medicine's claimed purpose or health benefit, for example: 'relieves coughs'. Indications can be specific (e.g. refer to a named non-serious condition); or non-specific (e.g. refer to general health maintenance).

Indications available for use for listed medicines are included in a 'list of permitted indications' which is contained in the Therapeutic Goods (Permissible Indications) Determination (the Permissible Indications Determination). The list of permitted indications is maintained by the TGA and provides a comprehensive list of indications currently accepted for use in listed medicines, provided appropriate evidence is held by the medicine sponsor.

Consistent with their low risk status, listed medicines may only use low level indications that will not lead to their unsafe or inappropriate use. Permitted indications have been assessed against a set of criteria and determined to be appropriate for listed medicines. These criteria are intended to ensure that permitted indications will only cover (and listed medicines will be limited to making) indications relating to:

  • health maintenance
  • health enhancement
  • prevention of a non-serious vitamin or mineral dietary deficiency; or
  • certain non-serious[2], self-limiting diseases, ailments, defects or injuries.

To be consistent with their low risk status, regulatory requirements are placed on the use of certain indications in listed medicines. These are also specified in the Permissible Indications Determination (see Requirements relating to the use of a permitted indication).

Does your product make therapeutic indications, cosmetic or food claims?

Some products are used in a similar way to therapeutic goods but are actually regulated as cosmetics or foods. The list of permitted indications includes a number of indications that could be used for therapeutic goods, cosmetic products or foods, depending on such things as the product's ingredients, presentation and route of administration[3]. Potential examples of such indications could be:

  • 'Maintain/support hair strength' could be used for an oral therapeutic good, such as a vitamin/mineral supplement, while a similar indication might be used for a topical hair product presented as a cosmetic e.g. hair conditioner[4].
  • 'Enhance bone density' could be used for an oral therapeutic good, such as a mineral supplement, while a similar indication might be used for a food[5].
  • 'Decrease/reduce/relieve skin dryness' could be used for an oral therapeutic good, while a similar indication could be used for a topical moisturiser presented as a cosmetic.

Just because an indication is in the list of permitted indications does not mean that the use of that indication makes a product a therapeutic good. Further, inclusion of an indication in the list does not mean that only therapeutic goods can use that indication. Before listing a medicine in the ARTG, the sponsor should satisfy themselves that their product is a therapeutic good. Refer to the Australian Regulatory Guidelines on Complementary Medicines: Complementary medicine interface issues for information to help you determine whether or not your product is a therapeutic good.

Components of a permitted indication

Permitted indications have a consistent structure and terminology to describe the therapeutic uses for listed medicines.

All permitted indications contain a therapeutic action and a therapeutic target. In general, permitted indications form a complete sentence. However, in some circumstances an indication may contain an action and a target in a single word, for example: 'antiemetic' and 'laxative'.

Some indications also include an action or target qualifier to ensure that they are appropriate to be used for low risk listed medicines. Where an indication includes an action or target qualifier, it must be included on your medicine label (see Figure 1 and Table 1).

Figure 1 - Permitted indication structure

Action qualifier e.g 'Helps' + Action e.g 'Reduce occurence of' + Target qualifier e.g. 'symptoms of' +  Target e.g. 'Common cold'
Table 1 - Permitted indication components
Indication component Explanation Use in permitted indications Examples
Action The therapeutic action or effect of a medicine Always included 'Reduce/relieve'
'Reduce occurrence of'
'Maintain/support'
'Enhance/improve'
Target

Either a:

  • physiological / psychological factor or process; or
  • disease, ailment, condition, defect or injury.
Always included 'Bone strength'
'General health'
'Eye health'
'Headache'
'Excess mucous'
Action qualifier Terms that ensure the action is suitable for a low level indication. They often specify the effectiveness of a medicine. Sometimes included 'Temporarily'
'Help'
Target qualifier Terms that ensure the indication is not referring to a restricted representation (that is a serious form of a disease, disorder or condition). Sometimes included 'Mild'
'Symptoms of'
'Healthy'
'Medically diagnosed'

Note that sponsors can modify a selected permitted indication using a set of pre-approved 'permitted indication qualifiers' to align with the supporting evidence they hold for their medicine. In the case of indications for which a sponsor holds evidence of traditional use, the sponsor must select a 'Traditional context qualifier' to identify the traditional paradigm in the ARTG entry and on the medicine label. Please see Selecting permitted indication qualifiers for your permitted indication for more information.

Product statements and claims that are not indications

Statements or claims that do not describe a therapeutic use are not included in the permitted indications list. Some examples are provided below.

  • Marketing statements that are not related to the therapeutic use of the product

For example:

  • 'Contains ingredients of plant origin'
  • '20% more tablets, same price'
  • Claims relating to the effectiveness of the product

For example:

  • 'Improves X by 10%'
  • 'Results in 2 weeks'
  • 'Fast acting formula'
  • 'Water resistant'
  • Directions for use statements

For example:

  • 'When taken three times a day'
  • Structure, function, and/or mechanism of action statements that do not include an action, target or a therapeutic use

For example:

  • 'X is a component of bone'
  • 'X is used in the production of ATP'

While structure, function and mechanism of action statements are generally not therapeutic indications, in some instances they can be considered to imply a therapeutic use. A therapeutic use may be implied where the message conveyed to the consumer suggests a health benefit, that is, that the product is intended to influence, inhibit or modify a physiological process. Where this is the case, an indication of similar intent must be included in the ARTG entry.

Examples of structure, function and mechanism of action statements that imply a therapeutic use and possible permitted indication with similar intent are provided below.

For example:

  • 'Calcium is a natural component of bone' (potential ARTG indication 'Maintain support health').
  • 'X is a component of skin cell membranes' (potential ARTG indication 'Maintain/support healthy skin structure').
  • 'X is a co-factor for mitochondrial function' (potential ARTG indication: 'Maintain/support energy production').

Product statements and claims that are not indications are not required to be included on the ARTG entry for the medicine in order to be used on product labels or other advertising. However, you must hold evidence (and be able to provide this evidence if requested) to support any statement/claim made for your medicine and comply with all relevant advertising requirements including the Therapeutic Goods Advertising Code (the Advertising Code).

Requirements for using permitted indications

To ensure that permitted indications are suitable for listed medicines, the Permissible Indications Determination includes 'requirements' for their use for listed medicines. As a sponsor, you must ensure that you comply with all 'requirements' that apply to the use of the permitted indications you select for your listed medicine. The Therapeutic Goods Act 1989 (the Act) allows for cancellation of a medicine from the ARTG if the requirements are not met.

Evidence requirements

At the time of listing a medicine in the ARTG, sponsors must certify that they hold evidence to support any indications and claims made about their medicine. Information on the types of evidence required to support scientific and traditional indications for listed medicines can be found in the Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines or the Australian regulatory guidelines for sunscreens (ARGS).

The Permissible Indications Determination specifies the type of evidence that must be held by sponsors to support the use of each permitted indication for listed medicines. There are four categories of permitted indications based on the type of evidence required to support their use.

The types of indications and evidence sources are described in Table 2 below.

Table 2 - Evidence requirements
Type of indication Type of evidence
Scientific indications Must be supported by scientific evidence, such as clinical studies or systematic reviews, for example: 'Help maintain/support bone mineralisation'.
Traditional indications Must be supported by evidence of traditional use in a recognised paradigm outside modern conventional medicine. These include indications that can be used across different traditional paradigms, for example: 'Blood cleanser/purifier'.
Traditional Chinese medicine indications Must be supported by evidence of traditional use within traditional Chinese medicine (TCM). These indications use specific terminology used in TCM, for example: 'Traditionally used in Chinese medicine to disseminate Lung Qi'.
Traditional Ayurvedic indication Must be supported by evidence of traditional use within Ayurvedic medicine. These indications use specific terminology used in Ayurvedic medicine, for example: 'Traditionally used in Ayurvedic medicine to relieve aggravated Vata'.

Note that some indications can be supported by scientific evidence or evidence of traditional use, for example: 'Improve/enhance digestion' and 'Traditionally used in Western herbal medicine to improve/enhance digestion'. For these indications the type of evidence is marked as a 'scientific or traditional'.

In preparing the Permitted Indications Determination, the TGA has not considered whether each indication is supported by evidence for each permitted ingredient or combination of ingredients.

As a sponsor of a listed medicine, it is your responsibility to ensure that your product meets all the requirements for listing, including that you hold evidence for all indications made for your medicine.

Other indication requirements

Other requirements included in the Permissible Indications Determination specify circumstances when individual indications can or cannot be used or specify conditions that must be met to use the indication for a listed medicine. For example, requirements may:

  • specify a vulnerable population for which the indication is not suitable, such as children
  • specify an advisory statement that must be included on product labels
  • require that the product presentation does not imply or refer to a serious form of a disease (i.e. a restricted representation); and/or
  • specify that a qualifying term(s) must be used on medicine labels, for example where an indication is qualified to only refer to a 'mild' form of a disease.

For examples of specific indication requirements see Table 3.

Table 3 - Examples of indication requirements
Indication Type of evidence Other requirements
Antipyretic/Antihydrotic /febrifuge/relieve mild fever/reduce body temperature/body cooling Scientific or Traditional

Label statement: If symptoms persist, seek the advice of a healthcare professional

Label statement: Not to be used in children under 5 years

Helps prevent dietary (state vitamin/mineral/nutrient) deficiency Scientific Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not replace a balanced diet
Helps enhance/promote preconception health Scientific or Traditional

Product presentation must not imply or refer to infertility.

Label statement: Advise your doctor of any medicine you take during pregnancy, especially in your first trimester

Balance Yin and Yang Traditional Chinese medicine Label statement: Please seek the advice of a traditional Chinese medicine practitioner to ensure this medicine is right for you.
Trophorestorative/restore organ health Traditional Product presentation must not imply or refer to disease in any body organ.
Decrease/reduce/relieve symptoms of mild arthritis/mild osteoarthritis Scientific or Traditional

Label statement: If symptoms persist, seek the advice of a healthcare professional

Product presentation must only refer to mild joint symptoms.

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis

Requirements relating to using TCM and Ayurvedic permitted indications

TCM and Ayurvedic indications have been included in the list of permitted indications in recognition that traditional terminology is required for persons familiar with the these paradigms to use the medicines appropriately.

However, TCM and Ayurvedic terminology are not likely to be understood by average consumers. Therefore, it is a requirement (in addition to the requirement to include a traditional context qualifier) that medicines using indications with paradigm specific terminology include an advisory statement on their label with words to the effect of:

  • 'Seek advice from a Chinese medicine practitioner if you are unsure if this medicine is right for you'.
  • 'Seek the advice from an Ayurvedic medicine practitioner if you are unsure if this medicine is right for you'.

A sponsor may also choose to include an English version of the TCM or Ayurvedic indication (from the permitted indications list) in the ARTG and on the medicine's label alongside the traditional terminology, if the indication has the same meaning.

For example:

'Traditionally used in Chinese medicine to harmonise the stomach' (TCM) could, if appropriate, be accompanied by an English indication such as: 'Traditionally used in Chinese medicine to help maintain/support stomach health'.


Footnotes

  1. 'Therapeutic use' is defined in section 3 of the Therapeutic Goods Act 1989.
  2. Note that the term 'serious' as used in this document has the same meaning as in the Therapeutic Goods Advertising Code 2015, which defines that term as meaning forms of those diseases, conditions, ailments or defects which are generally accepted either to not be appropriate to be diagnosed or treated without consulting a suitably qualified healthcare professional or to be beyond the average consumer's ability to accurately evaluate and treat safely without regular supervision by a qualified healthcare professional (e.g. cardiovascular diseases, haematological diseases).
  3. E.g, Order that Goods are Therapeutic Goods No. 2 of 1999 declares that products promoted for cosmetic purposes when promoted for oral consumption are, for the purposes of the Act, therapeutic goods.
  4. Please refer to the National Industrial Chemicals Notification and Assessment Scheme for information on the regulation of cosmetics.
  5. Please refer to Food Standards Australia New Zealand for information on health claims for foods.
  6. Listed complementary medicines may only contain low risk ingredients permitted for use in listed medicines as included in the Permissible Ingredients Determination. See Overview of listed complementary medicines for more information.

Book pagination