TGA seeks submissions on codeine options


white pills - look like codeine combination OTCs

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.

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NOTICE: It can sometimes take awhile for comment submissions to go through, please be patient.