Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2022-23

Closes 15 Sep 2022

Opened 4 Aug 2022

Results expected 1 Dec 2022

Overview

The Therapeutic Goods Administration (TGA) is seeking feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients Determination. The proposed changes address the following issues:

  1. Warning statement requiring healthcare professional supervision for the ingredients Chelidonium majus and Larrea tridentata
  2. Liver injury associated with Valeriana officinalis

To view the details of the proposed changes and respond to this consultation, please click the link under 'View Consultation and Submit Response' at the bottom of this page.

You can respond to any or all of the proposed changes. Responses may be typed into the provided text boxes, or you can upload your response as a single or multiple PDF or Word document/s. 

Privacy and your personal information

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

  1. Contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
  2. Help provide context about your submission (e.g. to determine whether you are an individual or 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 individual whose identity is apparent, or can reasonably be ascertained, 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You may specify whether there is anything in your submission which you would prefer to not be published online (e.g. names, email addresses, proprietary information) by: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 Providing details of content not to be published e.g. “Do not publish pages 3-5”, “Please redact contact details”; or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 and assessed listed medicines.

View Consultation and Submit Response

Audiences

  • Anyone from any background

Interests

  • Legislation
  • Regulatory policy
  • Non-prescription medicines