Regulation Impact Statement Updates

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

Clearer labels for medicines

Aust Gov
19th August 2016

Regulation Impact Statement – Department of Health

On 9 August 2016, the Therapeutic Goods Administration (TGA), part of the Department of Health, announced new requirements for the presentation of information on medicine labels. The new requirements aim to make Australian medicine labels clearer and more consistent and consequently help to avoid medication errors.

The new medicine labelling standards, among other things, require greater prominence and consistent location of information on active ingredients, and specify new allergens to be declared on medicine labels. A four year transition period is provided to allow industry to adopt the label changes with minimal compliance costs.

A Regulation Impact Statement (RIS) was prepared and certified by the TGA under the Australian Government best practice regulation requirements, and has been assessed as compliant and consistent with best practice by the Office of Best Practice Regulation (OBPR).

The RIS estimates the average annual regulatory cost to be $1.1 million a year, and identifies offsets. The OBPR has agreed to the regulatory cost and offset estimates.

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