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

May 2013

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Appendix 2

Likely impact upon the industry group of each proposed types of changes
Propose changes Likely impact Comments
Inclusion of new advisory/warning statements which are mandated by Listing Notices (in relation to substances that are usually active ingredients in complementary medicines) introduced since 2009 No impact - Unlikely that sponsors will need to change the labelling of their current marketed products The condition for listing of the particular medicine on the ARTG would already require the warning statement to be included on the label.
Inclusion of advisory/warning statements as required by the Australian Regulatory Guideline on Over the Counter Medicines (ARGOM 2003) not previously included in current version of RASML No impact - Unlikely that sponsors will need to change the labelling of their current marketed products The sponsor would already have been required to include the warning statement on the label as part of evaluation of the application for registration of the particular medicine on the ARTG.
Inclusion of new advisory/warning statements required by the Electronic Lodgement Facility (ELF) not previously included in current version of RASML No impact - Unlikely that sponsors will need to change the labelling of their current marketed products The condition for listing of the particular medicine on the ARTG would already require the warning statement to be included on the label.
Inclusion of new or amended advisory statements as recommended by the Advisory Committee of Non prescription medicines (ACNM), Advisory Committee on Complementary Medicines (ACCM) and/or Advisory Committee on Safety of Medicines (ACSOM) as a consequence of medicine safety reviews (e.g. TGA review of cough and cold medicines for use in children) There could be impact on sponsors as there would be a need to change the labelling of current marketed products

Some warning statements introduced to ensure public health safety as a consequence of safety reviews of the medicines would be immediately communicated to the sponsors as a condition of registration under section 28 of the Act. In this case, the subsequent inclusion of the statements in the RASML would only impact new sponsors.

In other cases, there would be a need to amend the existing medicine labels as a consequence of its inclusion in RASML document, with the possibility of significant impact.

New or amended requirements as a consequence of changes to scheduling of the medicines in the Standard Uniform Scheduling of Medicines and Poisons (SUSMP) e.g. butoconazole, pantoprazole, omeprazole, fexofenadine No impact or minimal impact - Sponsors will not need to change the labelling of their current marketed products

Before a medicine can be marketed under the new schedule, new labels must be approved by the TGA.

In some cases, where the product was already in an OTC schedule, the labels are approved via 'self-assessable' applications and there is a possibility that they could be non-compliant. But the number of products affected in this way would be expected to be minimal.

Proposal to remove existing superseded warning statements from the main body of the document to the archival section No impact to the whole industry group Warning statements do not apply to any medicines, hence proposal to remove the warning statements from the main body of the document.

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