Proposal for the re-scheduling of Codeine products

1 October 2015

Subsequent to this announcement the delegate sought further comment and advice from the public and also the Advisory Committee on Medicines Scheduling at its March 2016 meeting. Given this, and noting that a final decision has yet to be made, the announcement on an implementation date is no longer applicable.

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

This interim decision recommends that all over-the-counter medicines containing codeine be rescheduled to become prescription-only medicines.

The interim decision 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 15 October.

Following a review of those submissions, a final decision will be made in late November 2015.

The earliest possible implementation for any final decision is from 1 June 2016 so the availability of any over-the-counter products containing codeine will not change before then. This will allow time for industry, consumers, pharmacists and doctors to manage any change.

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