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