ASMI Media Release – ACMS to consider MR Paracetamol up-schedule

ACMS to consider MR Paracetamol up-schedule
31 August 2018

Late yesterday, the TGA requested that the Advisory Committee on Medicines Scheduling (ACMS) consider up-scheduling modified-release (MR) paracetamol from S2 to S3.

The TGA’s proposal will not affect consumer access to immediate-release paracetamol products which are currently available for self-selection in grocery and pharmacy.

Scheduling decisions, and the review of scheduling decisions, are vital in ensuring consumers have appropriate access to medicines and the Australian Self Medication Industry (ASMI) will participate in the public consultation period that currently closes on 31 October 2018.

The TGA has indicated that this item will be considered at the March 2019 ACMS meeting. The published closing date for public submissions for that meeting is 21 January 2019. It is unclear why the TGA has departed from its own published processes and set a “first closing date” of 31 October for this specific consultation.ASMIhas asked the TGA to clarify the reasons behind this decision.

While ASMI will have more to say when making a submission on this issue to the ACMS, we do note that the New Zealand equivalent body, MedSafe’s Medicines Classification Committee (MCC), is also currently reviewing the same issue. Having consistent scheduling arrangements between Australia and New Zealand assists industry in efficiently providing products to both markets. We are therefore watching that process closely andencourage the TGA/ACMS to delay consideration of this issueby the ACMS until all the relevant information from New Zealand has been made public and can subsequently be used to inform the Australian submissions and the eventual decision.

The MCC is holding their next meeting on 2 November 2018 and we anticipate that the meeting minutes would be publicly available by the end of this year or early next year. Sufficient time should be then allowed to review the MCC meeting outcomes and data prior to the ACMS meeting.

The TGA notice also refers to a “review of the safety of modified-release (MR) paracetamol.

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