3 Final decisions on proposed amendments to the current Poisons Standard under regulation 42ZCZR
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3.1 Final decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #31, June 2020)
3.1.2 Final decision in relation to eletriptan
Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to confirm the interim decision and amend the current Poisons Standard in relation to eletriptan as follows:
Schedule 4 - Amend Entry
Schedule 3 - New Entry
Appendix H - New Entry
Index - Amend Entry
In making this final decision, the Delegate considered the following material:
The application to amend the current Poisons Standard with respect to eletriptan;
Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health;
Reasons for the final decision (including findings on material questions of fact)
I have made a final decision to confirm my interim decision to amend the current Poisons Standard with respect to eletriptan. My reasons for making the final decision are those set out in the interim decision. In making my final decision, I have taken into account the material detailed in the interim decision and the public submission received before the second closing date in response to the call for further submissions published on 13 October 2020 under regulation 42ZCZP of the Regulations. I note that seven of the eight public submissions were in support of my interim decision.
Date of effect of the decision
1 February 2021
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.