The public submissions that were made in response to the delegate's interim decision regarding proposed amendments to the Poisons Standard will be published on the TGA website no later than 11 September 2020.
1 Notice of final decisions to amend (or not amend) the current Poisons Standard
This web publication constitutes a notice for the purposes of regulation 42ZCZS and regulation 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations). In accordance with regulations 42ZCZS and 42ZCZX, this notice publishes:
- the decisions made by a delegate of the Secretary pursuant to regulations 42ZCZR and 42ZCZU;
- the reasons for those final decisions; and
- the date of effect of those decisions.
2 Deferral of the final decision in relation to melatonin
The delegate has made a decision to defer their final decision on melatonin. In accordance with regulations 42ZCZP of the Therapeutic Goods Regulations 1990 (Cth) (Regulations) the delegate made a call for further submission specifically in relation to the 1 October 2020 implementation date set out in their interim decision. The closing date for submissions is 28 August 2020.
3 Final decisions on proposed amendments to the current Poisons Standard under regulation 42ZCZR
- 3.1 Final decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #29, March 2020)
- Final decision in relation to rizatriptan
- Final decision in relation to ondansetron
- Final decision in relation to adapalene
- Final decision in relation to Selective Serotonin Reuptake Inhibitors (SSRI)
- Final decision in relation to ranitidine
- Final decision in relation to fexofenadine
- Final decision in relation to flurbiprofen
- 3.2 Final decisions on proposed amendments referred to the Advisory Committee on Chemicals Scheduling (ACCS #27, March 2020)
- 3.3 Final decisions on proposed amendments referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #24, March 2020)
4 Final decisions on proposed amendments to the current Poisons Standard under regulation 42ZCZU
In my capacity as a delegate of the Secretary for the purpose of regulation 42ZCZU of the Therapeutic Goods REgulations 1990 (Regulations), I have made final decisions to amend the current Poisons Standard in the manner set out in the application under regulation 42ZCZU with respect to the following substances: