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Permitted indications for listed medicines guidance

7 March 2018

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Using permitted indications

Selecting permitted indications for your medicine

A searchable database of indications and their requirements is also available on the TGA Business Services website. Instructions on searching this database are provided below.

Searching for indications via the TGA Business Services website.

  1. Select 'Public TGA Information' from the left hand menu.
  2. From the dropdown menu select 'Indications for listed medicines'.
  3. Enter the indication key word/or phrase you are looking for in the 'search field' and ensure that in 'all fields' is selected.
  4. Click 'Go'.

When you apply to list your medicine in the ARTG using the Electronic Listing Facility (ELF), you can select indications for your medicine from a searchable catalogue of permitted indications.

You are able to search the list of permitted indications by:

  • body system or body part (e.g. cardiovascular system, respiratory system)
  • evidence requirement (e.g. scientific or traditional)
  • key word/phrase (e.g. itchy or cough); and
  • the indication's unique computer code (e.g. BDEYDR-G-RE).

For more information on how to include your medicine in the ARTG, please see the Listed medicines application and submission user guide.

Selecting indication qualifiers for your permitted indication

When you enter your medicine in the ELF, you may also choose to select indication qualifiers from drop down lists to make a permitted indication more specific and align with the evidence you hold for your medicine.

You:

  • must include indication qualifiers on your medicine label (or other advertising) if you have entered them in the ARTG
  • must only use the indication qualifiers from the Code Tables accessible via the TGA Business Services website.
  • must not use an indication qualifier on your medicine label (or other advertising) unless you have included the qualifier in your ARTG entry
  • must not use an indication qualifier to modify a selected permitted indication if it infers or implies that the medicine is for the treatment of a serious disease.

The types of indication qualifiers available for selection are described in Table 4.

Figure 2 shows the use of a permitted indication with indication qualifiers.

Figure 2 - Use of permitted indications with indication qualifiers

1. Select a traditional context qualifier (Mandatory for indications with a tradition of use), 2. Select a permitted indication (Mandatory), 3. Select indication qualifier/s (Optional) - Time of use, Population, TCM pattern. Example ARTG entry: Traditional context qualifier: 'Traditionally used in Western herbal medicine to' + Permitted indication: 'relieve digestive discomfort' + Indication qualifiers: Time - after eating; Population - in elderly individuals; TCM patter - none selected (not applicable). Example ARTG indication: 'Traditionally used in Western herbal medicine to relieve digestive discomfort after eating in elderly individuals'

For each permitted indication, you can only select one of each of the four indication qualifier types described in Table 4. If you wish to select multiple qualifiers from within one of the indication qualifier groups (for example: select multiple population qualifiers) for your permitted indication, you will need to enter the indication multiple times in the ARTG.

For example:

A sponsor holds scientific evidence that their medicine is used to relieve dry skin in children and adults. The ARTG indications entered for this medicine could be:

  • ARTG indication1: 'Relieve dry skin in children'
  • ARTG indication2: 'Relieve dry skin in adults'

The indication included on the medicine label could be: 'Relieve dry skin in children and adults'

As a medicine sponsor, you must ensure that the safety of your medicine has been established for the target population (e.g. infant target population) that you choose to add to your permitted indication. Under provisions in the Act, a medicine that not safe for its intended use can be cancelled from the ARTG.

Selecting a traditional context qualifier

Indications that are supported by evidence of traditional use must identify the traditional paradigm in the ARTG entry as well as when used on labels and other advertising material.

If your supporting evidence is based on traditional use:

  • you must include the relevant traditional context qualifier in the medicine's ARTG entry
  • you must include the traditional context qualifier when used on your label and other advertising material.

When selecting a traditional context qualifier for a permitted indication, you must ensure that the indication is consistent and appropriate for the traditional paradigm. For more information refer to Permitted indications must be consistent with the relevant treatment paradigm.

Table 5 provides examples of the use of traditional context qualifiers with indications.
Evidence held by sponsor Mandatory traditional context qualifier Indication
Traditional use in Chinese medicine Traditionally used in Chinese medicine clear/expel stagnant Heat
Traditional use in Ayurvedic medicine Traditionally used in Ayurvedic medicine relieve aggravated Vata
Traditional use in Western herbal medicine Traditionally used in Western herbal medicine nourish the heart
Scientific evidence Not applicable Maintain/support bone mineralisation

If your medicine includes indications supported by evidence of traditional use across different traditional paradigms, you must include the traditional context qualifier for each paradigm in the ARTG, even if the indications refer to the same health benefit. If the indications refer to the same health benefit the indication/s can be combined on your medicine label to form a single indication.

For example:

A sponsor holds evidence of traditional use to relieve nasal congestion in the traditional Chinese and Ayurvedic medicine paradigms. The ARTG indications entered for this medicine could be:

  • ARTG indication1: 'Traditionally used in Chinese medicine to relieve nasal congestion'
  • ARTG indication2: 'Traditionally used in Ayurvedic medicine to relieve nasal congestion'

The indication included on the medicine label could be: 'Traditionally used in Chinese medicine and Ayurvedic medicine to relieve nasal congestion'.

If the different traditional paradigms are used for different health benefits, you will need to include the indications separately in the ARTG entry and on your medicine label.

For example:

A sponsor holds evidence of Australian indigenous use to relieve nasal congestion and evidence of traditional Western herbal medicine use to relieve symptoms of common colds and flu. The ARTG indications entered for this medicine could be:

  • ARTG indication1: 'Traditionally used in Australian indigenous medicine to relieve nasal congestion'
  • ARTG indication2: ''Traditionally used in Western herbal medicine to relieve the symptoms of common colds and flu'

The indications included on the medicine label could be:

'Traditionally used in Australian indigenous medicine to relieve nasal congestion'.

'Traditionally used in Western herbal medicine to relieve the symptoms of common colds'.

See Use of permitted indications on medicine labels for more information on how to ensure your medicine label is compliant with the regulatory requirements.

Selecting TCM pattern qualifiers for your TCM permitted indication

TCM patterns are an optional indication qualifier and can be used by TCM sponsors to make TCM indications more specific and align with the evidence you hold for your medicine. TCM patterns have been included in recognition that traditional terminology is required for persons familiar with these paradigms to use the medicines appropriately.

If you select the traditional context qualifier 'Traditionally used in Chinese medicine' when entering your indication in ELF, you will be able to select traditional permitted indications and TCM specific permitted indications. In addition, you will be able to select a 'TCM pattern' qualifier to add to your permitted indication.

For example:

Traditionally used in Chinese medicine to 'dispel Wind Heat' (TCM indication) in 'externally contracted Wind-Heat pattern' (TCM pattern qualifier)

Sponsors using TCM permitted indications and TCM pattern qualifiers must ensure that the resulting combined indications are consistent with the Chinese medicine paradigm.

Using permitted indications on medicine labels and advertising

To allow sponsors some flexibility in label design you are not required to include permitted indications included in your medicine's ARTG entry 'word for word' on your medicine label and other advertising material unless there is a specific requirement for you to do so. However, the indication entered in the ARTG and medicine label (and other advertising material) must have the same meaning. This means that the indication in the ARTG and on the medicine label and other advertising material must have an equivalent therapeutic action and target.

As a sponsor of a listed medicine, you are responsible for ensuring that the overall presentation of your medicine (including the label and any advertising used by you or provided to any other person for their use) is compliant with the labelling order, the advertising requirements in the Act and the Advertising Code. Particular care is required when modifying the wording of indications to ensure that they remain compliant with the advertising requirements.

A medicine may be cancelled from the ARTG if the sponsor does not comply with the advertising and labelling requirements.

Some product names can imply a therapeutic indication. Where this is the case, the implied therapeutic indication must be included in the ARTG entry as a permitted indication as well as on the product label.

Acceptable variation of permitted indications

You can:

  • change the structure or order of the components of a permitted indication
  • use the therapeutic action terms included in a permitted indication interchangeably (e.g. decrease/reduce).

You must not:

  • modify a selected permitted indication to give it a different, broader or more specific therapeutic target
  • modify a mandatory qualifying term (e.g. 'mild', 'medically diagnosed') on your medicine label or other advertising material
  • modify a selected permitted indication to infer or imply that a medicine is for the treatment of a serious disease
  • modify a selected permitted indication to infer or imply that a medicine is for the prevention or cure of any disease.

For example:

*Note: The following are provided as examples only and are not an endorsement of the use of these indications. The overall presentation of your medicine and the evidence you hold must be considered in determining if indications have the same meaning.

Example 1: ARTG indication: 'Maintain/support gastrointestinal system health'

Label indication – may have same meaning: 'Maintains healthy gut'

Label indication – may have same meaning: 'Gastrointestinal health support'

Label indication – different meaning: 'Maintain healthy intestinal flora'

In this example 'intestinal flora' is a more specific target than the general indication of 'Maintains healthy gut' and therefore the meaning of the indication has changed.

Example 2: ARTG indication: 'Reduce/decrease mild muscle inflammation'

Label indication – may have same meaning: 'Relieves mild inflammation in muscles'

Label indication - different meaning: 'Relieves muscle pain'

In this example 'inflammation' and 'pain' are different targets and therefore the meaning of the indication has changed.

Example 3: ARTG indication: 'Decongestant/relieve nasal congestion

Label indication – may have same meaning: 'Unblocks the nose'

Label indication – may have same meaning: 'Clears the nasal passage'

Label indication – different meaning: 'Unblocks sinuses'

In this example 'sinus' is a different target to 'nose' and 'nasal passage' and therefore the meaning of the indication has changed.

Example 4: ARTG indication: 'Decrease/reduce/relieve symptoms of mild arthritis/mild osteoarthritis'

Label indication – may have same meaning: 'Relieves mild arthritis symptoms'

Label indication – different meaning: 'For the treatment of arthritis symptoms'

In this example, the ARTG indication includes the target qualifier 'mild', which must be included on the medicine label to have the same meaning. In addition, the indication refers to treatment, which is not appropriate for listed medicines.

'May' as a qualifier

In general, the action qualifier 'may' is not appropriate as an action qualifier for permitted indications as it can imply that the sponsor does not hold evidence of sufficient quality to support the use of the indication for their medicine. This is not consistent with the legislative requirement for sponsors to hold evidence for the indications they make for their medicine.

Combining permitted indications on medicine labels

You can enter multiple indications in your ARTG entry and combine these into complete sentences on your medicine label and other advertising (see Table 7 below).

When combining indications you must:

  • comply with all requirements that apply to the individual indications
  • use any mandatory action and target qualifiers such as mild, helps, temporary etc. in relation to the combined indication on the product label
  • ensure that you hold evidence to support the combined indications.

You must not:

  • combine selected permitted indications to give them a different, broader or more specific meaning
  • combine selected permitted indications infer or imply that a medicine is for the treatment of a serious disease
  • combine selected permitted indications to infer or imply that a medicine is for the prevention or cure of any disease.
Table 6 - How to combine indications into sentences
Indications included in the ARTG Indications included on the Medicine label
  • Decrease/reduce/relieve watery eyes/excessive lacrimation
  • Decrease/reduce/relieve eye strain
  • Relieve watery eyes and eye strain
  • Decrease/reduce/relieve gastrointestinal pain
  • Decrease/reduce/relieve abdominal cramping
  • Decrease/reduce/relieve abdominal spasm
  • Relieve gastrointestinal pain, abdominal cramping and spasms.

It is possible to enter multiple indications in a medicine ARTG entry that have different evidence bases, such as evidence of traditional use and scientific evidence. These indications must be entered individually in the ARTG so that the evidence base is clear. When using these indications on labels and other advertising material, particular care is required to ensure that they remain compliant with the advertising requirements and that the combination of indications is not misleading.

Linking indications referring to symptoms with diseases or conditions

Permitted indications contain a single 'target' and do not link general symptoms (e.g. 'relieves runny nose') to related conditions (e.g. 'relieves runny nose associated with common cold'). Instead, you can enter a number of indications referring to general symptoms and an indication referring to a disease or condition in your ARTG entry and combine these on your medicine label. An example is provided in Figure 3 below.[8]

When linking general symptom indications with an indication referring to a disease or condition, you must hold evidence for the selected symptoms for that disease or condition.

These indications can be combined on the product label to form a simple sentence, as shown in the mock-up label in figure 3.


Footnote

  1. Note that indications referring to general symptoms can be included in the ARTG as a standalone indication and are not required to be linked to a named disease or condition.

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