Australian proposal for the re-scheduling of codeine products

Australia's medicines regulator, the Therapeutic Goods Administration, has today published an interim decision on a proposal to up-schedule codeine-containing medicines.

This interim decision recommends that all over-the-counter medicines containing codeine be rescheduled to become prescription-only medicines. This is based on the assessment on many issues including risk of dependence and adverse events compared to safer products also available over-the-counter.

The decision was made after an application, public submissions and advice from the Advisory Committee on Medicines Scheduling (ACMS). Stakeholders may make submissions on this interim decision up to October 15. Following a review of those submissions, a final decision will be made in late November 2015.