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:
A total of 9 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:
The responses varied in stance and recommendations, however the majority of respondents from the complementary medicines industry did not support the proposals, with many suggesting rewording or clarification of the warning statement. Concerns were raised about the length and complexity of warning statements, the reference to general liver injury symptoms which can potentially cause confusion among consumers, the lack of clearly established causality between valerian use and liver injury, and lack of similar warning statements in international regulation.
The feedback and recommendations provided by respondents were taken into consideration, and the proposed changes have been finalised. The final changes incorporate variation compared to the original proposals.
The final changes will commence on 1 March 2023. A 12 month transition period will be instated to allow sponsors to ensure product compliance, ending on 1 March 2024.
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
The proposed warning statements for Chelidonium majus, Larrea tridentata, and Valeriana officinalis (valerian) have been altered following consultation feedback. The warning statements were revised to communicate the concern more concisely. The word ‘WARNING’ was also removed, and the word ‘rare’ added to communicate that the risk of liver injury is rare. The warning statements clarify the symptoms of liver injury so consumers can differentiate between general symptoms and ‘unusual’ symptoms which may be indicative of early liver injury and prompt the need to see a doctor.
View submitted responses where consent has been given to publish the response.
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:
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:
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:
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.
All public submissions will be considered after the end of the consultation period.
Final decisions on the proposed changes will be published by Thursday 1 December 2022. 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 Wednesday 1 March 2023. A transition period of 12 months from the 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 Friday 1 March 2024 unless otherwise specified.
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