business.gov.au

Authority to Supply Unregistered Therapeutic Drugs - Australian Government

Description

You will need this authority if you are a registered medical practitioner and you intend to provide therapeutic drugs that are not registered or listed on the Australian Register of Therapeutic Goods (ARTG). There are some legal exemptions to the requirement for a prescription medicine to be registered on the ARTG.

These are implemented through:

  • the Special Access Scheme (SAS)
  • the clinical trials systems (CTA and CTN).

Service type

Licence

A licence defines the need to obtain recognition / certification and registration to undertake a certain business activity.

Eligibility requirements

To be eligible for this authority you must be a registered medical practitioner.

Duration

As specified

Fees

Fees Details for this service in table format.

Task Type Business Structure Description
Apply Application All

Fees are listed on the attached document.

Forms

Other resources

Task Business Structure Resources
Comply All Fees and Charges Summary from 1 July 2023 - PDF (Opens in new window)

Act(s) name

Therapeutic Goods Act 1989 Australian Government

Regulation(s) name

Therapeutic Goods Regulations 1990 Australian Government

Administering agency

Department of Health and Aged Care

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.