ARGOM Appendix 5: Guidelines on OTC applications for specific substances

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Australian regulatory guidelines for over-the-counter medicines (ARGOM)

12 October 2012

This guidance document is intended to assist sponsors in submitting acceptable applications for registration of over-the-counter (OTC) medicines.

Products are assessed according to the best clinical and scientific information at the time of evaluation. If a sponsor believes that a particular application warrants a departure from the guidelines, a justification should be submitted with the application.

Sponsors of products that were approved before the introduction of a new guideline should bring the product into compliance with the guideline at the earliest opportunity, for example, when any changes are proposed to the product labelling.

Sponsors should also refer to the Required Advisory Statements for Medicine Labels (RASML).

Note: This guidance document contains references to warning statements that are being included in the current updating of the RASML document. Warning statements marked with an (*) which are included in the updated version of the RASML document will be removed from this guidance document once the updated RASML is implemented.

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