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

May 2013

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9. Implementation and review

If the proposal to update the RASML is accepted, the RASML document will be finalised and industry will be advised (including through the TGA website and letters to industry associations).

The finalised RASML will be published on the Federal Register of Legislative Instruments (FRLI).

The date of commencement of the new Legislative Instrument will allow 18 months for sponsors and manufacturers to bring their products into line with the updated RASML.

The TGA website will include a link to the RASML on the FRLI, as well as extensive advice and information for stakeholders. In line with the current situation, the TGA website will also include an application form that any interested party can use to propose amendments to the RASML.

It is intended that the Legislative Instrument will be reviewed on a regular (preferably annual) basis after it is adopted. Each review will involve public consultation. The ongoing process of review of advisory statements that would be a part of this ongoing update process should lead to regular improvement in the content of the document.

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