As a stakeholder that may be impacted by the proposed change, health care professionals are invited to provide feedback on the proposal through the public consultation that is now open.
Proposed change
The proposed scheduling amendments under consideration would create a new entry in Schedule 10 of the Poisons Standard for products that contain over 15 per cent of the substance. Concentrations below 15 per cent would still in in their current schedules, including being unscheduled for less than 0.5 per cent, in therapeutic goods or when used in aerosols.
Medicines and chemicals scheduling
By way of background, scheduling is a national classification system that controls how medicines and chemicals are made available to the public. Medicines and chemicals are classified into Schedules in the Poisons Standard according to the risk of harm and the level of access control required to protect public health and safety. Scheduling decisions are made by a senior medical officer at the TGA acting as a Delegate of the Secretary of the Commonwealth Department of Health (the Delegate).
Following the current consultation process, the proposed amendments will be referred for advice to the upcoming meeting of the Advisory Committees on Medicines and Chemicals Scheduling (Joint ACMS/ACCS #28) to be held on 22-24 June 2021.
When a substance is referred to an advisory committee on scheduling, there are two periods of public consultation; the first at the pre-meeting stage, and the second in response to the Delegate’s interim decision. The Delegate’s interim decision is made following consideration of the committee’s advice and the public submissions received during the first consultation. After the public consultation on the interim decision, the Delegate makes the final decision, which is published on the TGA website. Scheduling decisions come into effect on the implementation date given in the Delegate’s final decision. Further information about the scheduling process and timeframes is available on the TGA website at: www.tga.gov.au/scheduling-medicines-poisons
The first of the public consultations for these proposals has now opened on the TGA website and the TGA are seeking your comment. This consultation closes on Thursday 27 May 2021.
How to provide feedback
If you would like to provide feedback on the proposed changes, please submit your comments through TGA's consultation hub. To view the pre-meeting notices, which contain more information about the proposed change, please see the Scheduling notification webpage.
If you require any further information on the Scheduling proposals, please contact the Secretariat by email at Medicines.Scheduling@health.gov.au
