3 Final decisions on proposed amendments to the current Poisons Standard under regulation 42ZCZR
Note
New text is shown as green, larger font, with a horizontal line above it.
3.1 Final decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #29, March 2020)
Final decision in relation to adapalene
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 adapalene as follows:
Schedule 4 - Amend Entry
ADAPALENE except when included in Schedule 3.
Schedule 3 - New Entry
ADAPALENE in topical preparations containing 0.1 per cent or less of adapalene for the treatment of acne vulgaris in adults and in children over 12 years of age.
Appendix H - New Entry
ADAPALENE
Index - Amend Entry
ADAPALENE
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 adapalene;
- The six public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
- The advice received from the Advisory Committee on Medicines Scheduling (ACMS #29);
- The one public submission received in response to the interim decision consultation under regulation 42ZCZP of the Regulations;
- Section 52E of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purpose for which a substance is to be used and the and extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (e) the potential for abuse of a substance;
- 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 to down-schedule adapalene to Schedule 3 with restrictions on the preparation and indication. 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 10 June 2020 under regulation 42ZCZP of the Regulations. I note the public submission was in support of my interim decision.
Date of effect of the decision
1 June 2021