You will require 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. 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); and
- The clinical trials systems (CTX and CTN).
Please consult the Contact Officer for more information.
A licence defines the need to obtain recognition / certification and registration to undertake a certain business activity.
To be eligible for this authority you must be a registered medical practitioner.
Please consult the Contact Officer for more information regarding eligibility requirements.
As specified on the authority.
Please consult the Contact Officer for information on fees to be submitted.
Authority to Supply Unregistered Therapeutic Drugs - Please consult the Contact Officer for information on forms to be submitted.
Department of Health
Therapeutic Goods Administration
Therapeutic Goods Act 1989 (Australian Government)
Therapeutic Goods Regulations 1990 (Australian Government)
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