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Access unapproved products (consumers)
You can access unapproved therapeutic goods that are not included in the Australian Register of Therapeutic Goods (ARTG) in limited circumstances. You must speak to a health practitioner first.
You may be able to access:
- medicinal cannabis products
- vapes for smoking cessation or the management of nicotine dependence
- MDMA and psilocybin
These are examples of unapproved products.
You must speak to a health practitioner to access unapproved products.
What an unapproved product is
Generally, therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG).
Products not included in the ARTG are referred to as unapproved therapeutic goods.
Unapproved therapeutic goods haven't been evaluated by us. We haven't assessed their quality, safety or effectiveness.
How to apply
Certain health practitioners can apply to prescribe unapproved products for patients. You can't apply by yourself.
Whether the unapproved good is prescribed to you is a clinical decision made by your health practitioner. Discuss your circumstances with them.
Once you have a prescription, go to your pharmacist. The pharmacist will order the product for you. This could take a few days.
How much it costs
Unapproved products are generally not covered by the Pharmaceutical Benefits Scheme (PBS).
You will need to pay full price for products not covered by the PBS.
We have no control over the price charged for unapproved products supplied by companies in the private market.
Speak to your treating health practitioner or pharmacist about the cost of a product.
Why we allow access to unapproved products
We encourage the use of medicines which have been approved in Australia and included in the ARTG.
There are times when approved and available products may not meet the needs of all patients and clinical situations.
If a health practitioner decides an unapproved product is appropriate for their patient, they can apply to prescribe it.
How unapproved products are accessed
There are several ways health practitioners and patients can access unapproved products.
Special Access Scheme (SAS) and Authorised Prescriber (AP)
Some registered health practitioners can access products not included in the ARTG.
They can access these unapproved products through the SAS and AP pathways.
To find out if this is suitable for you, speak to your health practitioner.
Your doctor can advise if a clinical trial for an unapproved product might be suitable for you.
Personal Importation Scheme
In some circumstances you can import a 3-month supply of unapproved medicines into Australia for personal use. This is under the Personal Importation Scheme.
You may need a permit or licence to import unapproved medicines. Read the Office of Drug Control information for importers.
If your medicine is in short supply, talk to your health practitioner or pharmacist.
Read more about how to access medicines during a shortage.
Report a problem or side effect
If you have an issue with an unapproved therapeutic good, report an adverse event or problem (consumers).
You can make a report to the Australian Health Practitioner Regulation Agency (AHPRA) if you are concerned about a health practitioner.
To report a service provider such as a hospital or clinic, contact your state or territory complains organisation. See the AHPRA list of other health complaints organisations.