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Mandatory requirements for an effective over-the-counter medicines application

Applicable for applications lodged from 1 March 2016

Guidance on submitting an effective application to register an over-the-counter (OTC) medicine.

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This Guidance is directly referenced in legislation and must be presented in its original publication format.

You can contact us at nonprescriptionmedicines@health.gov.au, for any questions relating to this Guidance.

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Show all page updates (3)

Version 1.2 - Addition of footnote to Table 2: Module 3 - Quality.

Version 1.1 - Minor changes to clarify original publication and effective dates.

Version 1.0 - Original publication.

Version 1.2 - Addition of footnote to Table 2: Module 3 - Quality.

Version 1.1 - Minor changes to clarify original publication and effective dates.

Version 1.0 - Original publication.