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.