Applying for new indications
If you want to use an indication for your medicine that is not currently approved for use in listed medicines, you can apply for new indications to be added to the list of permitted indications. Applications must be submitted using the 'Indication and Qualifier application' form via the TGA Business Services website. An application fee applies.
The TGA will not evaluate evidence to support the use of a new proposed indication for a listed medicine at the time of application and in general there will be no requirement to submit supporting information. However, the TGA will assess whether the indication meets the Criteria for permitted indications described below.
The Permitted indication assessment tool has been developed to help you determine if a proposed indication is suitable to be included in the permitted indication list. This tool also shows what we will consider when making a decision to accept or refuse an application for a new indication. We recommend that you use the tool to self-assess whether your indication is suitable for inclusion in the permitted indications list before submitting it to us.
A decision by the Secretary (or a delegate) in relation to an application to add a new indication to the list of permitted indications is a reviewable decision. More information about requesting reconsideration of a reviewable decision can be found at Guidance for requesting reconsideration of an initial decision.
Criteria for permitted indications in listed medicines
The TGA will assess proposed indications against the following criteria to confirm that they are appropriate for use in low risk listed medicines. The indication must be:
- a 'low level' indication
- consistent with a treatment paradigm (for example, based on scientific or evidence of traditional use)
- capable of complying with the advertising requirements, including the Act and the Advertising Code when included on product labels and within promotional materials
- not included in a non-permitted indication list (if such a list is made).
Permitted indications must be 'low level'
Low level indications are those indications that are appropriate for medicines that are not assessed pre-market and will not lead to unsafe or inappropriate use of a medicine.
The eligibility requirements for permitted indications are based on a risk based approach to regulation. The risk factors relevant to therapeutic indications include, for example:
- whether the indications refer to a healthy person, or persons suffering from a disease, condition, ailment, defect or injury
- whether the indication relates to use in a vulnerable target population such as pregnant women, neonates or infants or the elderly
- whether the indication relates to a disease or condition that is potentially serious and as a result is inappropriate for self-diagnosis or self-management and/or the use of the medicine may delay consumers seeking medical treatment.
Products making low level indications pose a lower risk to consumers and it is appropriate that medicines with such indications are not individually evaluated by TGA before the medicine is included in the ARTG. Consistent with the risk-based framework, low level indications include indications for general health and wellbeing and self-diagnosable; self-manageable conditions; where a delay in medical treatment is unlikely to be detrimental to the consumer.
In certain circumstances an 'action qualifier' and/or a 'target qualifier' or specific indication requirement may be included in a proposed new permitted indication to ensure that the indication is low level.
What permitted indications can refer to
A proposed new indication may only refer to the following:
- Health maintenance
The indication can refer to the physiological effects of substances on normal growth, development or other functions of the body.
- 'Maintain/support intestinal good/beneficial/friendly flora
- 'Maintain/support eye health'
- 'Maintain/support heart health'
- Health enhancement
The indication can refer to 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.
- 'Enhance/promote healthy digestion'
- 'Helps enhance/promote healthy liver function'
- Prevention of a dietary deficiency
The indication can refer to the prevention of vitamin or mineral dietary deficiency (not the prevention of diseases resulting from a physiological deficiency e.g. anaemia).
- Helps prevent dietary (state vitamin/mineral/nutrient) deficiency'
- A non-serious form of a disease, ailment, defect or injury
The indication can refer to a disease, condition, ailment, defect or injury that is self-diagnosable and/or self-manageable, where a delay in medical treatment will not be detrimental to the consumer. These indications may relate to:
- reduction in risk, frequency, duration or severity of a non-serious form of a disease, condition, ailment, defect or injury
- relief of symptoms, without implying resolution or cure of the non-serious form of disease, condition, ailment, defect or injury.
- 'Relieve digestive discomfort'
- 'Relieve symptoms of mild upper respiratory tract infections'
- 'Reduce duration of symptoms of mild tonsillitis'
What permitted indications cannot refer to
A proposed new indication must not refer to any of the following:
- Prevention, cure or alleviation of any form of a disease, ailment, defect or injury
- 'Cures eczema'
- 'treats dehydration'
- 'Prevents cold sores'
In certain circumstances, it may be possible to include an action qualifier to make an indication less definitive and meet the low-risk criteria, for example; 'Helps reduce occurrence of muscle cramp'. The qualifying term 'helps reduce the occurrence of' is less definitive than 'prevention' and is considered appropriate for use in the permitted indications list for certain indications.
Qualifying terms can only be used where the disease, ailment, defect or injury is considered non-serious and the consumer can self-diagnose, self-manage and self-assess the effectiveness of the medicine.
- A prohibited representation
The indication must not refer to a prohibited representation. Prohibited representations are defined in the Advertising Code.
As an exception to this criterion, the list of permitted indications includes indications covered by the prohibited representation exemption for broad spectrum sunscreens with SPF of 30 or higher (in relation to prevention of skin cancer).
- A restricted representation
The indication must not include any reference or implication to a restricted representation. A restricted representation is a 'serious form' of a disease, condition, ailment or defect specified in the Advertising Code.
As an exception to this criterion, the list of permitted indications includes the indications covered by the substance-based restricted representation exemptions linked to vitamin D and calcium (referring to osteoporosis) and folic acid (referring to neural tube defects) on the basis of their public health importance, safe history of use and well-established evidence base.
All other indications that refer to a restricted representation will require assessment and approval through a pre-market assessment pathway.
Use of 'action qualifiers' and 'target qualifiers' to ensure that proposed indications are low level
In some cases, the TGA will accept a proposed new permitted indication that makes a reference to what could considered a serious form of a disease, condition, ailment or defect if it is appropriately modified with an 'action qualifier' and/or a 'target qualifier' so that it meets the criteria for a low level indication.
These 'qualifying terms' can only be used to modify an indication where it is possible for a consumer to self-diagnose and self-manage the symptoms of the condition.
Note that despite the general principles outlined below, conditions that require ongoing supervision by a medical practitioner are not suitable for listed medicines.
Examples of 'action qualifiers' and 'target qualifiers' are provided in Table 8 and Table 9 below.
The action qualifier 'helps' must be included in a permitted indication where:
|'Temporary'||The action qualifier 'temporary' may be included in a permitted indication to ensure that an indication remains low risk and will not delay a consumer seeking medical attention if their symptoms persist.|
|References to 'mild' forms of conditions|| |
The target qualifier 'mild' may be used to qualify an indication to make it clear that the indication is only referring to a non-serious form of a disease, condition, ailment or defect, for example: 'mild arthritis', 'mild eczema'.
Note that the use of the target qualifier 'mild' cannot be used for conditions that require ongoing medical management, for example: benign prostatic hyperplasia, rheumatoid arthritis.
|References to 'medically diagnosed' conditions|| |
For a limited number of conditions, it may be appropriate for a person to self-assess and/or self-manage the symptoms of their condition after an initial diagnosis has been made by a medical practitioner (including where other more serious diseases and conditions have been ruled out), for example: irritable bowel syndrome, shingles, cystitis. In these circumstances, the indication target (that is, the disease, condition, ailment or defect) may be qualified with 'medically diagnosed'. A required label statement will be 'If symptoms persist or worsen, consult your doctor'.
Serious diseases, conditions, ailments or defects that require ongoing supervision by a medical practitioner cannot be qualified by 'medically diagnosed' as they are not suitable for listed medicines. E.g.: asthma, benign prostate hyperplasia.
Permitted indications must be consistent with the relevant treatment paradigm
The indication must be consistent with a recognised treatment paradigm and the evidence base (scientific or traditional use) required to support its use.
Your scientific indication must not:
- use traditional medicine terminology, such as: 'alterative' or 'cholagogue'.
Your traditional indication must not:
- refer to diagnostic findings or anatomical, physiological or pharmacological effects that are not envisaged within the specified paradigm, for example: 'raise haemoglobin levels'
- use specialist terminology that belongs to a different paradigm or mainstream medical terminology, for example: 'damp heat' is a specific Chinese medicine term and would be inappropriate for an Ayurvedic medicine. Reference to blood glucose would be inappropriate for either paradigm
- include indications or use terminology that requires scientific substantiation, for example: 'assists to increase bone density by 10%'
- refer to conditions that cannot be diagnosed within the specified paradigm, for example: 'Traditionally used in Chinese medicine to increase bone mineral density' is inappropriate as increased bone mineral density cannot be monitored or determined without conventional medical intervention.
Permitted indications must be capable of complying with the advertising requirements and the Therapeutic Goods Advertising Code
The indication must be capable of complying with the advertising requirements set out in Part 5-1 of the Act and the Advertising Code when included on the product label or in promotional materials.
For example, an indication when linked to ingredients or product formulation must not:
- mislead, or be likely to mislead consumers
- contain any implication that the medicine is infallible, unfailing, magical, miraculous, or that it is a certain, or guaranteed cure
- contain any claim, statement or implication that it is effective in all cases of the condition.
To not be considered misleading, the indication must be able to be supported by currently available scientific knowledge or a documented tradition of use. The indication cannot be impossible to be proven true, for example: 'Improves the IQ of your unborn child'.
An indication must not:
- imply definitive efficacy
- infer superiority over an evaluated product, for example: an assessed listed medicine, a registered complementary medicine, OTC or prescription medicine.
Public health and safety policies or principles
Public health messages are an investment by the Government in the promotion of public health and safety. Because listed medicines are not assessed by the TGA pre-market, indications that conflict with current public health policies will not be accepted for inclusion in the permitted indications list. The Government's priorities in public health messaging change, depending on trends and needs within the community. As such, it is not possible to provide an exhaustive list of indications that are unacceptable due to a conflict with public health messaging. However, some examples include:
- substance abuse, such as alcohol or narcotics
Inappropriate use of medicines
Consideration will also be given to whether an indication encourages inappropriate behaviour or inappropriate use of medicines. For example: emetics, which pose a significant hazard if used incorrectly and also pose significant potential for misuse e.g. bulimia.
Note that where there is a public health need or to ensure that listed medicines are used safely, a mandatory requirement will apply to the use of certain indications that products and promotional material cannot be directed to certain vulnerable population subgroups. See Requirements relating to the use of a permitted indication for more information.