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Listed medicines

Lower risk medicines containing pre-approved, low-risk ingredients and that make limited claims can be listed on the Australian Register of Therapeutic Goods. Listed medicines can only contain low risk ingredients and use low level indications. 

An overview of listed medicines

Start here to get an overview of how your product is regulated and helpful information to support your journey.

Regulation of listed medicines

Know your obligations at each point along your product’s regulatory journey.

Latest alerts

  • Homart Pharmaceuticals Pty Ltd is recalling specific batches of its product, SpringLeaf Fat Clear, due to two identified compliance problems.
  • Well Herb is recalling batch numbers: DB0014M & DB0015M with expiry Date 11/12/2027 supplied in Australia of Xinyi Biyan Pills due to the medicine having unacceptable amounts of lead above the permitted daily dose.

Articles

  • We initiated targeted compliance reviews of selected listed medicines containing Vitamin D to verify whether sponsors had appropriate evidence to support their bone strength claims.
  • In 2025, the Therapeutic Goods (Exempt Monographs) Amendment Determination was introduced under the Therapeutic Goods Act 1989. This amendment updates the 2021 determination to exempt specific labelling requirements in certain pharmacopoeial monographs.

Latest publications