3 Final decisions on proposed amendments to the current Poisons Standard under regulation 42ZCZR
Note
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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
Final decision
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
ELETRIPTAN except when included in Schedule 3.
Schedule 3 - New Entry
ELETRIPTAN for oral use in tablets containing 40 mg or less per tablet and when in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have a stable, well-established pattern of symptoms.
Appendix H - New Entry
ELETRIPTAN
Index - Amend Entry
ELETRIPTAN
Schedule 4
Schedule 3
Appendix H
Materials considered
In making this final decision, the Delegate considered the following material:
- The application to amend the current Poisons Standard with respect to eletriptan;
- The two public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
- The advice received from the Meeting of the Advisory Committee on Medicines Scheduling (ACMS #31);
- The eight public submissions received, in response to the interim decision consultation under regulation 42ZCZP of the Regulations;
- 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;
- The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
- The Scheduling handbook: Guidance for amending the Poisons Standard.
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