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

May 2013

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8. Conclusion and preferred option

Option C (update the RASML to include new labelling requirements and adopt the updated RASML as a Legislative Instrument) is the preferred option, as it best meets the safety and public health objectives of the TGA, as well as providing certainty and clarity for the pharmaceutical industry.

The initial compliance cost benefit for industry from maintaining the status quo (Option A) does not outweigh the long-term benefits to all stakeholders (including public health benefits) that will result from the update (Options B and C).

The adoption of the RASML as a legislative instrument should ensure a further reduced regulatory burden for those affected by required advisory statements in the future, as future updates will be incorporated and published promptly, rather than being delayed by the process of recognition of the updated RASML in the Labelling Order.

The proposal to update the RASML to include the labelling requirements that are recommended by the TGA will assist consumers in using medicines more safely and effectively, and will provide up-to-date, concise and transparent regulatory requirements for medicines labelling, which should lead to a long-term reduction in compliance costs for industry.

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