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Update on the proposal for the re-scheduling of Codeine products

24 March 2016

See: Update on the proposal for the rescheduling of codeine products, 20 December 2016

The Advisory Committee on Medicines Scheduling (ACMS) met on 15 March 2016 to consider the public submissions received following the release of the interim decision on 1 October 2015 to up-schedule codeine. The consultation on the interim decision attracted a large number of submissions.

They also considered alternative options including the reduction of pack sizes and label advisory statements, which were also provided for public comment on 11 December 2015. The Advisory Committee has considered submissions at their March 2016 meeting, as well as an independent review on the safety and efficacy of low dose codeine containing products, which was commissioned by the TGA to inform discussion.

The Delegate is considering advice from the ACMS, as well as all relevant matters required under the Therapeutic Goods Act 1989, and the input from the public submissions.

More information on the proposal to reschedule codeine will be published after June 2016.

About codeine

Codeine is an opioid pain reliever used to treat mild to moderately severe pain. It is also used, usually in combination with other medications, to reduce coughing. Codeine is not available over-the-counter in the USA, most of Europe, Hong Kong, India, Japan, the Maldives and the United Arab Emirates.

Link: www.tga.gov.au

Media contact: Kay McNiece, 02 6289 7400