Proposed changes to the Permissible Indications Determination

Overview

Proposed changes to the Permissible Indications Determination

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 issues include:

1. Omission of the word mild from an indication referring to eczema.
2. Inconsistent/incorrect requirements for indications relating to the thyroid.
3. Lack of flexibility to use alternative label statements for an indication including the term antipyretic.
4. Missing label statement requirement for an indication referring to neural tube defects.
5. Missing label statement requirement for an indication referring to inducing sleep.

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.

The proposed changes are detailed in the Consultation document.

To respond to this consultation please click the 'Online Survey' link below.

You can respond to any or all of the proposed changes. Responses can be entered directly into the text boxes provided, or submitted as a single PDF or Word document upload. 

Privacy and your personal information

The TGA collects your personal information in this submission in order to:

1. Clarify any issues raised in your submission or to confirm whether you consent to certain information being made publicly available.
2. Help provide context about your submission. For example, whether you are responding as an individual, a director of a company or representing an interest group.

Please do not include personal information about other individuals in the body of your submission. Personal information in this context means, information or an opinion about an identified individual, or an individual who is reasonably identifiable, from the information or opinion. The TGA will not publish personal information about you/others without your/their consent unless authorised or required by law.

Online publication of submissions

The TGA may disclose your full name, work title, company/organisation and submission on the Internet (i.e. make this information publicly available) with your consent.

You may specify whether there is anything in your submission which you would prefer to not be published online (e.g. names, email addresses, proprietary information) by:

1. Providing an additional, redacted copy of your submission; or
2. Providing details of content not to be published e.g. “Do not publish pages 3-5”, “Please redact contact details”; or
3. Identifying any text within your submission to remain confidential by having it clearly marked 'IN CONFIDENCE' and highlighted in grey.

Why your views matter

The TGA is requesting feedback to help ensure that the proposed changes are appropriate and support the safety and quality of listed medicines.