Regulation Impact Statement Updates

Official website for publishing regulatory impact analysis information for regulatory decisions announced by the Australian Government, COAG and COAG Councils.

Codeine Re-scheduling

Aust Gov
13th February 2017

Regulation Impact Statement – Department of Health

On 20 December 2016, the Therapeutic Goods Administration (TGA) within the Department of Health announced that products containing codeine will be available by prescription only. The change will commence on 1 February 2018.

The change in scheduling of products containing codeine from over-the-counter medicines (Schedule 2 and Schedule 3) to prescription medicines (Schedule 4) will mean that people who wish to use painkiller medicines or cough and cold products containing codeine will have to obtain a prescription from their health care provider or use an alternative over-the-counter product. The TGA notes that there are a number of alternative over-the-counter medicines available.

The Office of Best Practice Regulation assessed the Regulation Impact Statement (RIS) prepared by the TGA as compliant with the Government’s requirements but not best practice. Although a significant amount of work was undertaken, a more informative analysis of all costs and benefits of all the options was required for the RIS to achieve best practice.

The RIS estimates the average annual regulatory cost of the proposal to be $10.24 million. The OBPR has agreed to the regulatory costs.

Back to all Updates