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Permitted indications for listed medicines guidance

7 March 2018

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Applying for new indication qualifiers

You can apply through the ELF to TGA for additional indication qualifiers to be available for selection. Applications must be submitted using the 'Indication and Qualifier application' form. This is available from the 'Applications' drop-down menu after you logged into your sponsor portal via the TGA Business Services website. Proposals for new indication qualifiers can only be for:

  • a traditional context (with a document history of use), for example: 'Traditionally used in Western herbal medicine'
  • a target populations, for example: 'in elderly males', 'in healthy adults'
  • a TCM pattern, for example: 'in/of interior excess pattern', 'in/of Liver Fire pattern'
  • time of use, for example: 'after exercise', 'after eating'. Time of use qualifiers are not intended to be directions for use statements, such as 'when taken twice a day' and are also not intended to imply an additional disease, disorder or condition to what is covered in the selected indication, such as 'when suffering with a cold'.

In principle, indication qualifiers should make an indication more specific and should not broaden the application of the indication.

Indication qualifiers cannot:

  • have the potential to increase the risk of the indication, for example: include a vulnerable target population
  • include or imply an additional therapeutic use by including a condition or symptom, for example: 'in times of anxiety' or 'associated with the common cold'
  • relate to a direction for use, for example: 'when taken daily'
  • refer to claims of efficacy, for example: '25% more effective
  • be marketing claims, for example : '25% more potent formula'.

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