This web publication constitutes a notice for the purposes of regulation 42ZCZS of the Therapeutic Goods Regulations 1990 (the Regulations). In accordance with regulations 42ZCZS, this notice publishes:
- the decisions made by a delegate of the Secretary of the Department of Health, Disability and Ageing (the Delegate) pursuant to regulation 42ZCZR
- the reasons for those final decisions and
- the date of effect of those decisions.
Defined terms
- In this notice the following defined terms are used in addition to those above:
- the Therapeutic Goods Act 1989 (Cth) (the Act)
- the Scheduling Policy Framework 2018 (the SPF)
- the Scheduling handbook, Guidance for amending the Poisons Standard (the Handbook) and
- the Therapeutic Goods Administration (the TGA).
Note: additional terms are also defined for individual decisions.
Final decisions and reasons
We aim to provide documents in an accessible format. If you're having problems using this document, please contact medicines.scheduling@health.gov.au.
Contents
Notice of final decisions to amend the current Poisons Standard
Final decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #47, June 2025)
- 6-methylnicotine
- somatrogon, lonapegsomatropin and somapacitan
Amendments to the Poison Standard in relation to New Chemical Entities (NCEs)
- bempedoic acid
- efanesoctocog alfa
- eplontersen
- gadoquatrane
- gepotidacin
- olutasidenib
- tapinarof
- teplizumab