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

May 2013

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5. Options

There are three options: A - maintain the status quo, B - proceed with the proposed RASML update and update the Labelling Order to refer to the updated RASML document, or C - implement the proposed RASML update as a legislative instrument, and update the Labelling Order to refer to this instrument.

5.1 Option A - Maintain the status quo

If the status quo is maintained, then the Labelling Order will continue to refer to the current (September 2008) version of the RASML that is published on the TGA website.

5.2 Option B - Update the RASML document to include new labelling requirements

Under this option, the RASML document will be updated to include the additional labelling requirements that are recommended by the TGA, and the Labelling Order will be updated to refer to the new document.

5.3 Option C - Update the RASML document to include new labelling requirements and enable the updated RASML as a legislative instrument

Under this option, the RASML document will be updated to include the additional labelling requirements that are recommended by the TGA, and the updated RASML will be made a legislative instrument in its own right. The Labelling Order will then be amended to refer to the Legislative Instrument.

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