As listed medicines are not evaluated, the Therapeutic Goods Administration (TGA) uses a variety of mechanisms to help ensure that they are of high quality and used safely by consumers. One of these mechanisms is that listed medicines must only use indications drawn exclusively from a list of pre-approved 'permitted indications' and must comply with any requirements for the use of these indications in listed medicines.
This guidance provides information for sponsors on:
what permitted indications are, including terminology and structure
the use of permitted indications for listed medicines; and
how to apply for inclusion of new indications on the permitted indications list.
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.