Notice under Regulation 42ZCZP of the Therapeutic Goods Regulations 1990 of a call for further submissions on an interim decision to amend the current Poisons Standard in relation to melatonin
This web publication constitutes a notice for the purposes of regulation 42ZCZP of the Therapeutic Goods Regulations 1990 (the Regulations).
Call for further submissions
The Delegate of the Secretary's interim decision to down-schedule modified release melatonin formulations from Schedule 4 to Schedule 3 of the Poisons Standard, with restrictions on age and pack size, was published on 10 June 2020 with a proposed date of effect of the proposed down-scheduling of 1 October 2020. At that time, interested persons were invited to make submissions on the interim decision by 9 July 2020, being the closing date for submissions. The notice is available on the TGA website.
In the Delegate's review of the public submissions received by the aforementioned closing date, none have addressed the matter of the proposed date of effect of the proposed down-scheduling of 1 October 2020. Therefore, the Delegate has decided to exercise the power under 42ZCZP of the Regulations to publish a second notice for public submissions inviting interested persons to make submissions in relation to the 10 June 2020 interim decision's proposed date of effect of 1 October 2020.
Accordingly, the Delegate now invites interested persons (including the applicant requesting the amendment) to make further submissions specifically in relation to the proposed implementation date of 1 October 2020 in the interim decision on melatonin published on 10 June 2020. The closing date for submissions on the proposed date of effect of the proposed down scheduling is 28 August 2020.
Persons making submissions are strongly encouraged to lodge submissions in an electronic format (word or unsecured PDF preferred) using the public submission coversheet available on the TGA's website. As noted above, submissions must be received on or before 28 August 2020 and should be sent to:
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.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.