Notice of final decision to amend (or not amend) the current Poisons Standard - ACMS #40, ACCS #34, Joint ACMS-ACCS #32

This web publication constitutes a notice for the purposes of regulations 42ZCZS and 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations). In accordance with regulations 42ZCZS and 42ZCZX, this notice publishes the:

• A decision made by a delegate of the Secretary pursuant to regulations 42ZCZR and 42ZCZU;
• reasons for that final decision; and
• date of effect of the decision.

Final decision in relation to paracetamol - correction

The amendments to the Schedule 2 entry for paracetamol that were depicted in the final decision notice incorrectly showed under clause g) iii) (A) the retention of the existing wording ‘or in a container with a child-resistant closure’. However, as reflected in the reasons, the correct decision is that these words are to be removed, to require tablet and capsule preparations on general sale to be in blister packaging. From 1 February 2025, the Poisons Standard will be amended so that general sale and Schedule 2 paracetamol tablets and capsules will be required to be in blister packaging.

Final decision and reasons

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Contents

• 1 Notice of final decisions to amend (or not amend) the current Poisons Standard
• 2 Final decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #40, November 2022)
  • 2.1 Final decision in relation to paracetamol
  • 2.2 Final decision in relation to ivermectin
  • 2.3 Final decision in relation to brimonidine
  • 2.4 Final decision in relation to fexofenadine
  • 2.5 Final decision in relation to ibuprofen
  • 2.6 Final decision in relation to melatonin
• 3 Final decisions on proposed amendments referred to the Advisory Committee on Medicines and Chemicals Scheduling (ACMS-ACCS #32, November 2022)
• 4 Final decisions on proposed amendments referred to the Advisory Committee on Chemicals Scheduling (ACCS #35, November 2022)
  • 4.1 Final decision in relation to ethalfluralin
  • 4.2 Final decision in relation to tigolaner
• 5 Amendments to the Poisons Standard made as delegate-only decisions
  • 5.1 Final decision in relation to spiromesifen
• 6 Amendments to the Poison Standard in relation to New Chemical Entities (NCEs)
  • 6.1 Andexanet alfa
  • 6.2 Avatrombopag
  • 6.3 Difelikefalin
  • 6.4 Ivosidenib
  • 6.5 Pralsetinib