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Regulatory impact statement (RIS) - update to the Required Advisory Statements for Medicine Labels (RASML)

May 2013

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1. Executive summary

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'), which was published in September 2008.

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.

The need for new advisory statements can arise when new medicines are evaluated and approved by the TGA for supply to the Australian market. Some of these new medicines have risks that require new advisory statements. Additional risks may subsequently be identified via post-market pharmacovigilance and regulatory activities, or publication of new scientific or clinical information. New risks may also arise from a change to the level of scheduling of a medicine that results in greater consumer access.

The TGA proposes to update the current version of the RASML to incorporate a number of new advisory statements.

Stakeholders were consulted throughout the RASML update process over the past 3 years. Stakeholders generally supported adoption of the proposed updated RASML. Specific issues raised by stakeholders in relation to individual statements were considered by the TGA, and acted on where appropriate.

If the proposal to update the RASML is accepted, industry will be advised and the document will be finalised and published on the Federal Register of Legislative Instruments (FRLI). Supportive information and a link to the FRLI will be published by the TGA on its website to ensure that sponsors and manufacturers are fully informed of the new and amended requirements. The proposed date of commencement of the updated RASML will allow time for sponsors and manufacturers to comply with the new requirements.

The new (updated) RASML will result in one-off costs to industry associated with the amendment of labels that are impacted by the changes. However, these costs will be minimised by the proposed phase-in period allowed for implementation of the changes. Relevant stakeholders are already aware of the proposed changes and the possible costs as a result of the consultation process already undertaken with regard to the RASML update. In the long term there should be benefits to all stakeholders from the increased transparency of the TGA's requirements.

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