TGA Updates Permitted Ingredient List for Listed Medicines, June 2024

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On June 06, 2024, the Therapeutic Goods Administration (TGA) published an update to the list of ingredients permitted in listed medicines. Listed medicines are low-risk medicines that do not require a prescription and include most Complementary Medicines, some sunscreens, and some over-the-counter medicines. This update is part of a routine revision process aimed at maintaining the list of approved substances.

Key Updates:

  • New Ingredients Added: The update includes the addition of new ingredients that can be used in listed medicines, subject to specific conditions and restrictions to ensure safe use.
  • Re-evaluation of Existing Ingredients: Some ingredients previously allowed in listed medicines have been re-evaluated. Based on new evidence, their use conditions have been revised or, in some cases, the ingredients have been removed from the list of approved ingredients.
  • Stricter Labeling Requirements: The TGA has introduced stricter labeling requirements for certain ingredients to provide clearer information to consumers and healthcare professionals, enhancing the safe use of listed medicines.
  • Updated Permissible Levels: Changes also encompass updates to the permissible levels of certain ingredients in listed medicines, reflecting the latest safety data.
  • Transition Period: The announcement specifies a transition period starting from June 14, 2024, for manufacturers to comply with the new requirements, ensuring a smooth adjustment process without disrupting the availability of listed medicines on the market.

These updates by the TGA are crucial in ensuring that listed medicines remain safe and effective for consumers. Manufacturers are encouraged to review the updated ingredient list and make necessary adjustments to comply with the new regulations.

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