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Update to listed medicines indications in January 2021

Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021

21 January 2021

Listed medicines indications and requirements for their use have been updated in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021, which commenced on 21 January 2021. This determination replaces the previous instrument, the Therapeutic Goods (Permissible Indications) Determination (No. 2) 2019.

Ensure you are accessing the current version of the instrument through the Therapeutic Goods Determination page.

A total of 16 changes have been made in the updated Determination. A complete list of changes are provided below.

Sponsors are reminded that the transition period for permitted indications is ending soon. For more information, see: Transition for permitted indications for listed medicines ends 5 March 2021.

Changed indications/requirements

Indication/s Change type Change details Required sponsor action for affected medicines

Maintain/support healthy blood capillary health

Remove duplicate indication

This indication is a duplicate of 'maintain/support blood capillary health'. The ARTG entry for existing listed medicines using will be updated to replace 'maintain/support healthy blood capillary health' with 'maintain/support blood capillary health'.

ARTG entries of affected medicines will be updated by the TGA.

No required change to existing medicine labels as the two indications have the same meaning and intent.

Helps maintain/support healthy heart function

Broaden evidence requirement

Expansion of type of evidence allowable from 'traditional' to 'scientific or traditional'.

ARTG entries of affected medicines will be updated by the TGA.

No action required from sponsors

Enhance/promote/increase temporary weight loss

New

New indication with the following requirements for use in listed medicines:

Label statement: For healthy weight maintenance it is recommended to continue a reduced intake of dietary calories and increased physical activity

Label statement: Weight loss may not be maintained for longer than 3 months

Label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

NA

Maintain/support healthy thyroid gland function for pregnancy

New

New indication with the following requirements for use in listed medicines:

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

Label statement: If you are concerned about the health of yourself or your baby, talk to your health practitioner.

Label statement: If you have pre-existing thyroid conditions, seek advice from your medical practitioner before taking this medicine.

Indication can only be used for medicines that contain iodine as a mandatory component of one or more permitted active ingredients and the recommended daily dose of the medicine provides a minimum of 150 micrograms of iodine.

Product presentation must not imply or refer to any thyroid related diseases.

NA

Aid/assist healthy thyroid hormone production for pregnancy

New

New indication with the following requirements for use in listed medicines:

Indication can only be used for medicines that contain iodine as a mandatory component of one or more permitted active ingredients and the recommended daily dose of the medicine provides a minimum of 150 micrograms of iodine.

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

Label statement: If you are concerned about the health of yourself or your baby, talk to your health practitioner.

Label statement: If you have pre-existing thyroid conditions, seek advice from your medical practitioner before taking this medicine.

Product presentation must not imply or refer to any thyroid related diseases.

NA

  1. Vitamin D helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life
  2. A diet deficient in calcium can lead to osteoporosis in later life. Calcium may help prevent osteoporosis when dietary intake is inadequate
  3. Maintain/support (state vitamin/mineral) within normal range
  4. Helps enhance/promote/increase absorption of dietary (state vitamin/mineral/nutrient)
  5. Maintain/support absorption of dietary (state vitamin/mineral/nutrient)
  6. Helps prevent dietary (state vitamin/mineral/nutrient) deficiency
  7. Helps enhance/promote/increase body utilisation of (state mineral/vitamin/nutrient)
  8. Aid/assist/helps metabolism of (state vitamin/mineral/nutrient)
  9. Helps maintain/support cellular uptake of (state vitamin/mineral/nutrient)
  10. Maintain/support (state vitamin/mineral/nutrient) levels in the body
  11. Enhance/improve/promote/increase (state vitamin/mineral/nutrient) levels in the body

Change to wording of required label statement for 11 indications

Change in indication requirement from:

'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' to:

'Label statement: [Vitamins/minerals/nutrients/dietary supplements] can only be of assistance if dietary intake is inadequate OR [Vitamins/minerals/nutrients/dietary supplements] should not replace a balanced diet (or words to that effect)'

This change will enable sponsors to choose a label statement that appropriately reflects the ingredients contained in their medicine formulation.

ARTG entries of affected medicines will be updated by the TGA.

Sponsors of existing medicines are advised to update their medicine label with the appropriate statement for their ingredients included in their medicine formulation at the next label print run.

No changes required for existing medicine labels.