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ARGOM Appendix 4: Guidelines on OTC applications for new substances

Version 1.0

12 October 2012

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3. Submission and approval of substance applications

Sponsors can apply to have a new substance evaluated by the TGA by completing the "Substance" form in the OTC medicines portal in electronic Business Services (eBS). The TGA requires that sponsors establish the correct regulatory route of evaluation (under Schedule 10 of the Regulations) prior to submitting an application.

Sponsors should use Australian Approved Name (AAN) terminology. For those ingredients without an AAN, an Application form for proposing a chemical name, available from the TGA website, should be completed and either included with the application or submitted separately to the TGA (to the attention of the 'The Secretariat, Australian Approved Names Committee').

Note: Where the form has been submitted separately, it is recommended that the application letter include a statement alerting the evaluator to this fact or a copy of the AAN application form also be included in the substance application.

A new substance may be approved with conditions for use by a specific route of administration, and up to a maximum concentration, consistent with the data provided with the application. Further data and approval will be required if the substance is proposed for use by a different route of administration or at higher concentrations than have been previously approved.

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