Regulatory options Substances can either be up-scheduled or down-scheduled on application to the Secretary (or scheduling delegate). Re-scheduling applications may be submitted by the general public, industry or state and territory authorities. An application to up-schedule codeine was made to the Secretary (or the Secretary’s medicines scheduling delegate (the Delegate)) who sought advice on the proposed amendment from the Advisory Committee on Medicines Scheduling (ACMS) and an independent external evaluator. Additionally, the Delegate will also consider all public submissions received regarding how codeine should be made available to the Australian public. Due to the significant health risks associated with OTC codeine-containing medicines (as outlined in the preceding sections as well as in the original scheduling application) and to ensure that public health and safety is protected using best practice regulation, the Department of Health, through the TGA, is currently reviewing OTC access to codeine-containing medicines in Australia. What are the regulatory options and scenarios being considered? The interim decision in October 2015 was to up-schedule all Schedule 2 and Schedule 3 codeine preparations to Schedule 4. In December 2015, the delegate considered other regulatory options such as restricting pack size and labelling. The final proposed options are summarised in Table 1. Table : Summary of regulatory options Option 1 The current scheduling of codeine remains appropriate. The current Schedule 2 entries for codeine in and cold medicine preparations be Option 2 amended to reduce the pack size to not more than 3 days’ supply and include a label warning that codeine can cause addiction. The current Schedule 2 entries for codeine in and cold medicine preparations are Option 3 up-scheduled to Schedule 3, and that the pack size is reduced to not more than 3 days’ supply and include a label warning that codeine can cause addiction. Up-schedule the current Schedule 2 entries for codeine to Schedule 4 and amend the Option 4* current Schedule 4 and 8 entries: this forms part of the interim decision. The current Schedule 3 entries for codeine (including, but not limited to Option 5 analgesics) is amended to reduce the pack size to not more than 3 days’ supply and include a label warning that codeine can cause addiction. Up-schedule the current Schedule 3 entries for codeine to Schedule 4 and amend the Option 6* current Schedule 4 and 8 entries: this forms part of the interim decision. * The current interim decision consists of Option 4 plus Option 6.
Regulatory options Substances can either be up-scheduled or down-scheduled on application to the Secretary (or scheduling delegate). Re-scheduling applications may be submitted by the general public, industry or state and territory authorities. An application to up-schedule codeine was made to the Secretary (or the Secretary’s medicines scheduling delegate (the Delegate)) who sought advice on the proposed amendment from the Advisory Committee on Medicines Scheduling (ACMS) and an independent external evaluator. Additionally, the Delegate will also consider all public submissions received regarding how codeine should be made available to the Australian public. Due to the significant health risks associated with OTC codeine-containing medicines (as outlined in the preceding sections as well as in the original scheduling application) and to ensure that public health and safety is protected using best practice regulation, the Department of Health, through the TGA, is currently reviewing OTC access to codeine-containing medicines in Australia. What are the regulatory options and scenarios being considered? The interim decision in October 2015 was to up-schedule all Schedule 2 and Schedule 3 codeine preparations to Schedule 4. In December 2015, the delegate considered other regulatory options such as restricting pack size and labelling. The final proposed options are summarised in Table 1. Table : Summary of regulatory options Option 1 The current scheduling of codeine remains appropriate. Option 2 The current Schedule 2 entries for codeine in and cold medicine preparations be amended to reduce the pack size to not more than 3 days’ supply and include a label warning that codeine can cause addiction. Option 3 The current Schedule 2 entries for codeine in and cold medicine preparations are up-scheduled to Schedule 3, and that the pack size is reduced to not more than 3 days’ supply and include a label warning that codeine can cause addiction. Option 4* Up-schedule the current Schedule 2 entries for codeine to Schedule 4 and amend the current Schedule 4 and 8 entries: this forms part of the interim decision. Option 5 The current Schedule 3 entries for codeine (including, but not limited to analgesics) is amended to reduce the pack size to not more than 3 days’ supply and include a label warning that codeine can cause addiction. Option 6* Up-schedule the current Schedule 3 entries for codeine to Schedule 4 and amend the current Schedule 4 and 8 entries: this forms part of the interim decision. * The current interim decision consists of Option 4 plus Option 6.
codeine_re-scheduling_ris.docx