This guidance is for medical practitioners, Human Research Ethics Committees (HRECs), specialist colleges and sponsors of 'unapproved' therapeutic goods and provides information about the:
Authorised Prescriber scheme
roles and responsibilities of HRECs, specialist colleges, Authorised Prescribers, sponsors and TGA in relation to the Authorised Prescriber scheme
legal basis for supply of 'unapproved' therapeutic goods
This guidance also provides details about relevant amendments to the Therapeutic Goods Regulations 1990 to streamline the application process for medicines considered to have an established history of use.
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.