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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 |
| 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. |