Using permitted indications

This fact sheet provides guidance on how to select and use permitted indications for your listed medicine.

On this page: Selecting indications in the Electronic Listing Facility (ELF) | Requirements relating to indications | Linking symptoms to a condition | How to include indications on your medicine label

Selecting indications in the Electronic Listing Facility (ELF)

When entering your medicine into ELF, you will be able search through the list of permitted indications using a key word, body part / system or evidence type (for example, tradition of use).

How to select evidence qualifiers to align with evidence you hold

You may select optional evidence qualifiers to make a permitted indication more specific and align with the evidence you hold for your medicine. If a qualifier is included on the medicine label, it must be included in the ARTG entry and vice versa. The evidence qualifiers include:

	Traditional context	This is a mandatory qualifier for indications supported by evidence of a tradition of use, for example: 'Traditionally used in Western herbal medicine'.
	Population	This is an optional qualifier and specifies the target population, for example: 'in healthy individuals'.
	Traditional Chinese Medicine pattern	This is an optional qualifier for TCMs and specifies the underlying pattern that causes rise to the symptoms included in the indication, for example: 'Qi Deficiency pattern'.
	Time of use	This is an optional qualifier and indicates the time of use, for example: 'after exercise'.

Requirements relating to indications

You must comply with any requirements applicable to the use of your selected indication, such as required label advisory statements.

Linking symptoms to a condition

In your ARTG application, you can select specific primary indications referring to the symptoms of a condition and then link general symptom indications to that primary indication. For example:

Helps decrease/ reduce/ relieve symptoms of common cold	Helps decrease/reduce/relieve cough Helps decrease/reduce/relieve watery/itchy eyes Helps decrease/reduce/relieve runny nose		These symptoms are linked to 'symptoms of common cold'

These indications can be combined on the product label to form a simple sentence, for example: 'Relieve symptoms of common cold such as cough, runny nose and itchy eyes.'

How to include indications on your medicine label

You will not be required to include the permitted indication in your medicine's ARTG entry 'word for word' on your medicine label. However, the indication on the ARTG and on the medicine label must have the same intent and meaning.

For example, if the indication 'Enhance/promote your immune system' was included in a medicine's ARTG entry:

• 'Boost your immune system' would be considered to have the same meaning; but
• 'Increase your resistance to common colds' would be considered to have a different meaning.

Where a permitted indication includes a qualifying term 'mild' e.g. 'mild arthritis' this will be included as a requirement for use of the indication and therefore must also be included on the medicine's label. For more information on the terminology used in developing the list, please see our Principles for terminology used in permitted indications factsheet.