4 July 2014

Changes to Required Advisory Statements for Medicine Labels – Regulation Impact Statement – Therapeutic Goods Administration

On 23 May 2014 the National Manager of the Therapeutic Goods Administration (as delegate to the Minister for Health) made the Therapeutic Goods Order 69D, changing the requirements for the advisory statements that must be made on non-prescription medicine labels.

The labels of non-prescription medicines should provide self-medicating consumers with sufficient information to choose the medicines appropriately and to use the medicines safely and effectively. In order to ensure that important safety information is included on non-prescription medicine labels, the Therapeutic Goods Act 1989 mandates the inclusion of advisory statements on some labels. These statements are currently compiled in the “Required Advisory Statements for Medicine Labels” (‘the RASML’).

From time to time it is necessary to review the mandatory advisory statements and to update the RASML to include new/revised statements where appropriate. This is because new medicines requiring new advisory statements may become available to consumers, or because new risks may be identified with existing medicines.

The changes to the RASML will require approximately 70 businesses to change the labels of around 500 different medicines. This will result in a one-off additional cost to these firms of around $2 million to $5 million. There will be an 18 month implementation period for the changes to allow firms to bring their products in line with the updated RASML. As a result of the changes, consumers will be better informed of the appropriate use of the affected medicines.

A Regulation Impact Statement (RIS) was prepared and certified by the Therapeutic Goods Administration under the June 2010 RIS requirements. It was assessed as adequate by the Office of Best Practice Regulation.

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