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

Closed 29 Sep 2021

Opened 4 Aug 2021

Contact

Complementary Medicines Evaluation Section

listed.medicines@health.gov.au

Feedback updated 15 Dec 2021

We asked

The TGA sought feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients Determination. The proposed changes were intended to 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.

You said

A total of 20 submissions were received in response to this consultation. All submissions that gave permission to be published on the TGA website are available through the ‘View submitted responses’ link below.

The TGA received:

  • 6 responses to the proposed mollusc warning statement,
  • 15 responses to the proposed changes for vitamin B6 ingredients,
  • 5 responses to the proposed changes to benzalkonium, and
  • 8 responses to the proposed warning statement for artemisinin-containing ingredients.

There was general agreement for the proposed mollusc label statement and changes to benzalkonium for use in nasal sprays, whereas the submissions concerning vitamin B6 and artemisinin varied in stance and recommendations.

We did

The feedback and recommendations provided by respondents were taken into consideration, and the proposed changes have been finalised. The final changes incorporate some variation compared to the original proposals.

The final changes will commence on 1 March 2022. A 1 year transition period will be instated to allow sponsors to ensure product compliance, ending on 1 March 2023.

Results updated 15 Dec 2021

The TGA thanks all those who participated in this consultation.

Please see the Final Decisions Document for specific details of the finalised changes identified below, and the reasoning given for these final decisions which were made in consideration of the consultation responses received.

Overview of final decisions

  1. The proposed allergen warning statement for mollusc-derived ingredients has been accepted with no further alterations.
  2. The proposed changes to vitamin B6 ingredient requirements are accepted with an alteration to the maximum recommended daily dose. This will now be 100 mg pyridoxine for adults instead of 50 mg as proposed.
  3. The proposed requirements for benzalkonium chloride have been accepted with an additional restriction implemented on benzalkonium chloride concentration in nasal sprays.
  4. The proposed pregnancy warning statement for artemisinin-containing ingredients has been accepted with alterations. The warning statement will not be required when the ingredient is for excipient use and is a steam-distilled essential oil used in proprietary ingredient formulations (including flavours and fragrances). The davana oil requirements will not be changed.

Published responses

View submitted responses where consent has been given to publish the response.

Overview

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 please click the 'Consultation document' link 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.

What happens next

All public submissions will be considered after the end of the consultation period.

Final decisions on the proposed changes will be published by Wednesday 15 December 2021. Public submissions received as part of the consultation may be published if consent was given.

Finalised changes will be included in an update to the Permissible Ingredients Determination on Tuesday 1 March 2022. A transition period of 12 months from commencement of the new Determination will be provided to allow sponsors of existing listed and assessed listed medicines to bring their products into compliance. The transition period will end on Wednesday 1 March 2023 unless otherwise specified.

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