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While the consultation is open you can make a submission at our consultation hub.
After the closing date, the submissions will be reviewed and our decision will be published on the same consultation page.
About this consultation
Listed medicines are considered low-risk medicines as they can only use low-risk ingredients and make low-level indications. These medicines are not individually evaluated by the Therapeutic Goods Administration (TGA) before they are released onto the market. Instead, they are automatically included in the Australian Register of Therapeutic Goods (ARTG) following completion of an online application and certification by the sponsor (product owner) that their product meets all applicable Australian legislative requirements in relation to safety, quality and efficacy. These medicines can be identified by an AUST L number on their medicine label.
Since listed medicines are not evaluated prior to being listed, we use a variety of mechanisms to help ensure that they are safe for consumers. One such mechanism is the Therapeutic Goods (Permissible Indications) Determination (currently (No. 1) 2025) (Permissible Indications Determination) which incorporates a list of pre-approved indications and requirements that ensure that only appropriate claims are made for low-risk medicines.
The TGA is seeking public comment on issues and proposed amendments to the Permissible Indications Determination.
The purpose of the consultation is to seek feedback from interested parties on the proposed amendments to the Permissible Indications Determination to address these issues. This information will be taken into consideration when making decisions to amend the Permissible Indications Determination.