Getting a US-approved medicine in Australia: the legal route, documents and timing
A sourced guide for patients, families and doctors in Australia, checked against TGA rules on 17 October 2026.
Reviewed by the Reserve Meds clinical operations team on 17 October 2026. Sources accessed 17 October 2026.
The short answer
In Australia, an unapproved medicine is usually accessed through the TGA's Special Access Scheme, case by case for one patient, or through the Authorised Prescriber scheme. Category A is a notification for seriously ill patients, Category B needs TGA approval first, and Category C covers goods with an established history of use. A health practitioner applies, not the patient.
- Regulator: Therapeutic Goods Administration (TGA).
- Main route: Special Access Scheme (SAS) categories A, B and C, or the Authorised Prescriber scheme.
- Who applies: The treating medical or health practitioner.
- Price: Quote on request.
Who regulates medicines in Australia
Medicines in Australia are regulated by the Therapeutic Goods Administration under the Therapeutic Goods Act 1989. Section 19 of the Act provides for approvals or authorities for certain uses, which is the legal basis for supplying a therapeutic good that is not approved for general supply.[1]
The TGA is also one of the partner agencies in the US FDA's Project Orbis, which lets some cancer medicines be reviewed at the same time in several countries. That can shorten the wait for local approval, but it does not help a patient who needs a medicine before it is approved in Australia.[2]
The legal route for a medicine that is not registered in Australia
The Special Access Scheme allows the import and supply of an unapproved therapeutic good for a single patient, on a case by case basis. There are three pathways, used by health practitioners:[3]
- Category A is a notification pathway that only medical practitioners can use, for patients who are seriously ill with a condition from which death is reasonably likely within months, or from which premature death is reasonably likely without early treatment.[3]
- Category B is an application pathway for patients who do not fit Category A, where the good does not have an established history of use. An approval letter from the TGA is needed before the good can be accessed.[3]
- Category C is a notification pathway for goods the TGA has listed as having an established history of use, which practitioners can supply without prior approval.[3]
A doctor who expects to treat several patients with the same unapproved medicine can apply to become an Authorised Prescriber. The application must be endorsed by an ethics committee, except for medicines on the TGA's list of goods with an established history of use. Hospitals may still require their own ethics or governance approval.[3]
Documents you will usually need
The TGA forms ask the practitioner for clinical information. Our checklist for the treating team:[3]
- The diagnosis and the clinical reason the unapproved medicine is needed
- Why approved alternatives in Australia are not suitable
- Details of the product, its dose and its approval status overseas, such as the US FDA approval and label
- For Category B, the TGA approval letter before supply
Timing, quantities and fees
We could not open the TGA's own pages from our systems on 17 October 2026, so we do not quote TGA processing times. The treating practitioner sees the current timeframes when submitting through the TGA's online system. Category A and C are notifications, so supply can follow without waiting for an approval letter; Category B waits for the TGA's decision.[3]
How a US-approved medicine reaches a patient in Australia
First, confirm the medicine is approved in the US. FDA's Drugs@FDA database lists approved prescription medicines and links to the approved label.[4]
In Australia the practitioner, usually through the hospital pharmacy, makes the SAS submission. A sponsor or importer then brings the medicine in for that patient. We work with the treating team and the importer, and supply from the US through our wholesale partner once the TGA notification or approval is in place.
Once the local permission is in place, the medicine is bought from the US supply chain, packed for the temperature the label requires, and shipped to the named hospital, clinic or importer with the documents customs will ask for. Cold-chain medicines need a validated shipper and a temperature record for the whole journey.
If the medicine is a cell or gene therapy, the rules are different: these are usually given only at qualified treatment centers chosen by the manufacturer, so the realistic route is often treatment at a center abroad rather than import.[5]
Practical checks before you start
- Ask the treating specialist whether a registered alternative already exists in Australia. Most special routes only apply when it does not.
- Check whether the medicine is a controlled drug. Controlled medicines need extra permits in almost every country.
- Ask the hospital pharmacy whether it has handled this route before and who signs the application.
- Keep copies of every document and approval. Customs and the hospital will ask for them again at delivery.
How Reserve Meds helps
Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help families and treating doctors understand the route, prepare the documents the regulator or hospital asks for, arrange supply from the US once approval is in place, and keep everyone updated. We do not diagnose, prescribe or decide what a regulator approves.
We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them. Your coordination fee is quoted in writing for your case before you commit. No hidden charges. We give you a written timeline estimate for your case before you commit.
Ask us about a medicine for a patient in Australia
Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.
Frequently asked questions
Can a patient in Australia get a medicine that the TGA has not approved?
Yes, through the Special Access Scheme for a single patient, or through a doctor who is an Authorised Prescriber. The route depends on how ill the patient is and whether the medicine has an established history of use.
What is the difference between SAS Category A and Category B?
Category A is a notification that only medical practitioners can use for seriously ill patients. Category B is an application: the TGA must approve it before the medicine can be supplied.
Can the patient apply to the TGA directly?
No. The Special Access Scheme is used by health practitioners. The patient's doctor makes the notification or application.
Does Reserve Meds apply to the regulator for us?
No. The application is made by the person or institution the rules name, usually the treating doctor or hospital. We help prepare the paperwork, confirm the US approval and arrange supply from the US once permission is granted.
How much does it cost?
Quote on request. The total depends on the medicine, the dose, shipping, import steps and coordination. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.
Sources for these answers: [3]
Sources
All sources were opened and checked on 17 October 2026. Rules and labels change, so the treating hospital or regulator confirms the current position before anything is filed.
- Federal Register of Legislation: Therapeutic Goods Act 1989 (section 19, approvals for certain uses) (accessed 17 October 2026)
- US FDA Oncology Center of Excellence: Project Orbis (accessed 17 October 2026)
- NSW Health, Sydney Local Health District (RPA): Authorised Prescriber and Special Access Scheme (accessed 17 October 2026)
- US FDA: How do I find out if a drug is approved? (accessed 17 October 2026)
- US FDA: Approved Cellular and Gene Therapy Products (accessed 17 October 2026)
Related
- All country guides
- Named-patient access, explained
- US expanded access (compassionate use)
- Answers to common access questions
- How cold-chain medicines are shipped
This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.