Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2021-22

Closes 29 Sep 2021

Opened 4 Aug 2021

Results expected 15 Dec 2021


ATTENTION: Due to difficulties many of our stakeholders are experiencing in lockdown, the closing date for submissions to this consultation has been extended until Wednesday 29th September 2021. The outcomes of the consultation will now be anticipated for publication on Wednesday 15th December 2021.

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. Allergen statement for mollusc-derived ingredients.
  2. Peripheral neuropathy associated with lower dose vitamin B6.
  3. Risk to infants from nasal use of benzalkonium chloride.
  4. Artemisinin and pregnancy risk.

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:

  • 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.
  • 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).

The TGA may disclose your name and (if applicable) your designation/work title on the Internet (i.e. make this information publicly available) if you consent to the publication of your name. 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. Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE' and highlighted in grey.

Please note that the TGA will not publish personal information about you/others without your/their consent unless authorised or required by law.

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


  • Anyone from any background


  • Legislation
  • Non-prescription medicines
  • Strategic Policy
  • Policy Development