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ARGOM Appendix 4: Guidelines on OTC applications for new substances

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

12 October 2012

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This part of the guidance document describes applications and safety data requirements for a new substance intended for use in an over-the-counter (OTC) medicine. It does not describe efficacy requirements, which are described in Appendix 1 Guidelines on the efficacy and safety aspects of OTC application. The Australian Regulatory Guidelines for Over-the-counter Medicines (ARGOM), Chapter 10 Sunscreens contains specific information on the requirements for new active ingredients intended for use in sunscreens.

The Appendix is divided into four (4) sections as follows:

  1. Substances for use in listed OTC medicines
  2. Substances for use in registered OTC medicines
  3. Submission and approval of substance applications
  4. Data requirements

A 'new' substance is one that is not in any product currently on the ARTG for supply in Australia. An excipient which is not included in such products, but had a previous long history of safe use in medicines supplied in Australia, may not be considered as a new excipient provided such use is demonstrated.

A new substance can be included as either a new active or new excipient as part of an application to register a new OTC medicine. Sponsors can also apply to the TGA to determine the suitability of a new substance for use in either Registered OTC medicines or Listed OTC medicines (as specified in Schedule 4 of the Therapeutic Goods Regulations), by submitting a stand-alone 'Substance' application (see 'Section 3 Submission and approval of substance applications').

It is strongly recommended that sponsors consult Schedule 10 of the Therapeutic Goods Regulations 1990 (the 'Regulations') to determine the appropriate route of evaluation for any new substances before applying to the TGA. Information regarding the process for scheduling of new substances in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is available on the TGA website.

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