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Notification of amendments to the Poisons Standard in relation to Delegate-only final decisions and New Chemical Entities (NCEs), January 2022

24 January 2022

Scheduling amendments not referred to expert advisory committee

Subdivision 3D.3 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the procedure to be followed where the Secretary receives an application under section 52EAA of the Therapeutic Goods Act 1989 (the Act) to amend the current Poisons Standard and decides not to refer the proposed amendment to an expert advisory committee. These include, under regulation 42ZCZU, that the Secretary decides to make a final decision in relation to the proposed amendment without an interim decision. If the final decision is to amend the current Poisons Standard, the Secretary must, in doing so, take into account the matters mentioned in subsection 52E(1) of the Act (including, for example, the risks and benefits of the use of a substance, and the potential for abuse of a substance) and the scheduling guidelines as set out in the Scheduling Policy Framework for Medicines and Chemicals.

In accordance with 42ZCZX of the Regulations, the Secretary publishes here the scheduling final decisions, the reasons for those decisions and the date of effect (for decisions to amend the current Poisons Standard, this will be the date when it is expected that the current Poisons Standard will be amended to give effect to the decision).

Delegate-only final decisions and reasons, and NCEs

We aim to provide documents in an accessible format. If you're having problems using this document, please contact medicines.scheduling@health.gov.au (for substances referred to the ACMS or Joint ACCS-ACMS) or chemicals.scheduling@health.gov.au (for substances referred to the ACCS).

Contents

  • 1 Notice of Decisions to amend the current Poisons Standard
  • 2 Amendments to the Poison Standard in relation to New Chemical Entities (NCEs)
    • 2.1 Infigratinib
    • 2.2 Ponesimod
    • 2.3 Selumetinib
    • 2.4 Sotorasib
    • 2.5 Molnupiravir
    • 2.6 Selinexor
    • 2.7 Tepotinib
    • 2.8 Nirmatrelvir
  • 3 Amendments to the Poisons Standard made as delegate-only decisions
    • 3.1 Final decision in relation to gliptins
    • 3.2 Final decision in relation to isotianil
    • 3.3 Final decision in relation to chromium trichloride hexahydrate
    • 3.4 Final decision in relation to metobromuron
    • 3.5 Final decision in relation to kinetin
    • 3.6 Final decision in relation to iron compounds
    • 3.7 Final decision in relation to rescalure
    • 3.8 Final decision in relation to fluoxapiprolin
    • 3.9 Final decision in relation to disodium manganese EDTA
    • 3.10 Final decision in relation to deutetrabenazine