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.
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.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.