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ARGOM Appendix 4: Guidelines on OTC applications for new substances
1. Substances for use in listed OTC medicines
Most common OTC medicines are registrable, but some low-risk OTC medicines, in particular sunscreens, are listable. Where a new substance is proposed for use in a Listed OTC (non-complementary6) medicine, the required safety and chemistry data will need to be submitted as part of a "Substance" application (see 'Section 3 Submission and approval of substance applications'). A "Substance" application is also required where a new route of administration for a Listed OTC medicine is proposed for an existing ingredient, or where an existing excipient ingredient is proposed for use in a Listed OTC medicine as an active ingredient for the first time. If approved, the substance may then be used in Listed medicines without the need for submission of further safety data, provided any conditions or limitations on the use of the substance are met (refer to 'Section 3 Submission and approval of substance applications').
Note: While the efficacy of a new active substance is not assessed in a "Substance" application, when listing a new OTC medicine the sponsor must certify that evidence is held in support of any efficacy claims [see the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) - Part II]. For further information specifically in relation to ingredients for use in sunscreen, refer to the Australian Regulatory Guidelines for Over-the-counter Medicines (ARGOM), Chapter 10 Sunscreens.
- For information regarding requirements for complementary medicine substances, refer to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM).