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Scheduling delegate's final decisions, March 2016

Scheduling medicines and poisons

17 March 2016

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2.3 Paracetamol/ibuprofen

Part A - Final decisions on matters referred to an expert advisory committee

2. Scheduling proposals referred to the November 2015 meeting of the Advisory Committee on Medicines Scheduling (ACMS#16)

2.3 Paracetamol/ibuprofen

Scheduling proposal

The medicines scheduling delegate has referred the following scheduling proposal for consideration by the Advisory Committee on Medicines Scheduling (ACMS):

  • To amend the Schedule 2 entry for paracetamol to include paracetamol when combined with ibuprofen in pack sizes of 12 dosage units or less.
Delegate's interim decision

The delegate's interim decision is available at Reasons for scheduling delegate's interim decision and invitation for further comment for the ACCS and ACMS meetings, November 2015

Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACMS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors18;
  • Other relevant information.
Public submissions on the interim decision

Four public submissions were received. All supported the delegate's interim decision to amend the S2 entry, however 2 submissions requested an amendment to part (a) of the proposed entry into the Poisons Standard as follows:

PARACETAMOL for therapeutic use:

  1. when combined with ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing 12 dosage units or less.
Delegate's decision

The delegate has deferred making a final decision at this time regarding the scheduling of paracetamol when combined with ibuprofen. This is due to a late submission received during the most recent consultation period, and allows the submission to be given due consideration before the delegate makes a final decision. The final decision will be made before the end of April.


Footnotes

  1. Scheduling Policy Framework for Medicines and Chemicals (SPF, 2015)

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