The TGA is seeking further advice and submissions from stakeholders in regard to newly proposed options for the future scheduling of OTC codeine-containing preparations.
Last month it deferred its final decision on codeine’s future, to seek further advice including from the ACMS at its March 2016 meeting, prior to making a final decision, which will not be before 23 June 2016.
Should the final decision require an implementation date, it will not be before 2017.
The proposals include:
Schedule 2 (cough and cold medicine preparations)
- Proposal to amend the Schedule 2 entry to reduce the pack size to not more than 3 days’ supply and include a label warning that codeine can cause addiction; OR
- Proposal to up-schedule the Schedule 2 entry to Schedule 3 and reduce the pack size to not more than 3 days’ supply and include a label warning that codeine can cause addiction; OR
- Retain the interim decision to up-schedule to Schedule 4.
Schedule 3 (including, but not limited to codeine containing analgesics):
- Proposal to amend the Schedule 3 entry to reduce the pack size to not more than 3 days’ supply and include a label warning that codeine can cause addiction; OR
- Retain the interim decision to up-schedule to Schedule 4.
Submissions should be sent before close of business, Friday, 29 January, 2016, and feedback will be released following consideration of the submissions.
