Notice and invitation to comment on an interim decision to amend the current Poisons Standard in relation to nicotine
On 23 September 2020 an interim decision was announced which would make certain nicotine products a prescription only medicine. Public submissions on the proposed changes are invited before any final decision is made. The closing date for submissions is 12 November 2020.
From 1 October 2021, nicotine e-cigarette access by import is made the same as access domestically. Find out more.
We have changed the way to make submissions.
Submissions now should be provided through our consultation hub
This invitation is only about the interim decision of the Secretary’s delegate on nicotine. It is not concerned with the proposed prohibition on importing e-cigarettes containing vaporiser nicotine which is the subject of a completely separate process.
This consultation closes on 12 November 2020.
This web publication constitutes a notice for the purposes of regulation 42ZCZP of the Therapeutic Goods Regulations 1990 (the Regulations). In accordance with regulation 42ZCZP, this notice sets out:
- an interim decision made by a delegate of the Secretary under regulation 42ZCZN in relation to a proposed amendment to the current Poisons Standard, which was referred to an expert advisory committee under Division 3D.2 of the Regulations in June 2020; and
- the proposed date of effect of the proposed amendment (in circumstances where the interim decision proposes an amendment to the current Poisons Standard).
In accordance with regulation 42ZCZP, interested persons (including the applicant requesting the amendment) are invited to make submissions to the Secretary in relation to this interim decision on or before 12 November 2020.
Please note that in accordance with subregulation 42ZCZQ(4) of the Regulations, the Secretary must publish all relevant submissions received, unless the Secretary considers the information to be confidential information.
How to respond
Go to our consultation hub to make a submission on the interim decision.
If you have difficulty accessing the consultation hub or uploading your submission, contact email@example.com and include 'Interim decision public submission (nicotine)' in the subject line of your email.
What will happen
The delegate will take into account all relevant submissions received on or before the closing date of 12 November 2020 before making a final decision. Expecting the final decision in mid December.
To keep up to date with scheduling announcements, including final decisions of the delegate, please subscribe to the scheduling email list.
All public submissions will be published on the TGA website at Public submissions on scheduling matters, unless marked confidential or indicated otherwise in the submission (see Privacy and your Personal information).
Privacy and your personal information
- Under the Regulations, for certain scheduling applications or proposals, the TGA is required to call for and publish any public submissions. These submissions may contain personal information of the individual making submissions and others. However, the TGA is not required to publish any confidential information including any personal information TGA collects from you.
- The TGA collects your personal information as part of its regulatory functions in this submission and may use your personal information in order to:
- contact you if the TGA wants to seek clarification of issues raised in your submission;
- check whether or not 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 a director of a company or representing an interest group where you consent to the publication of this information).
- The TGA will only disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name.
- 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 do not include personal information about other individuals in the body of your submission. The TGA will not publish submissions which contain information about other individuals. 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.
- Please note that the TGA will not publish personal information about you/others without your/their consent unless authorised or required by law.
Any questions should be directed by email to firstname.lastname@example.org.