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ARGOM Appendix 4: Guidelines on OTC applications for new substances

Version 1.0

12 October 2012

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2. Substances for use in registered OTC medicines

Where a new substance is proposed for use in a Registered medicine, data relating to the new substance are usually provided and assessed as part of the product application, which includes provision and assessment of quality, safety and efficacy data. However, the TGA is also willing to accept an application for 'approval' of a substance in isolation from a product without clinical efficacy data. In these circumstances, the safety of the substance per se will be assessed and the sponsor will be advised of its acceptability or otherwise for use in Registered medicines and of any conditions or limitations that might apply. Future applications to register non-prescription medicines containing the substance will not usually need to include non-clinical data to establish the safety of the approved substance (provided any conditions or limitations on the use of the substance are met - see 'Section 3 Submission and approval of substance applications').

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