The Personal Importation Scheme allows individuals to import therapeutic goods not entered in the Australian Register of Therapeutic Goods (ARTG), provided certain conditions are met.
These products are typically shipped via mail or courier from overseas and must only be for use by that individual or their immediate family members, they cannot be sold or supplied to any other person.
Counterfeit (fake) medicines and medical devices are prohibited from being imported under any circumstances.
This applies even if you have a prescription for the medication and were unaware that you purchased a counterfeit product.
Known counterfeit products will be seized at the border, resulting in the loss of both the items and the money you spent on them.
Conditions of the Personal Importation Scheme
For an import to be covered by the scheme, all the following conditions must be met.
- The products must be for your personal use or for the use of an immediate family member – they cannot be sold, supplied or given away to others.
- Immediate family is limited to the individual’s parents, grandparents, spouse, de facto spouse, child or ward of that person.
- If the medicine is prescription-only in Australia, you must hold a valid Australian prescription or written authority at the time of importation.
- The import cannot be more than a 3-month supply at the maximum prescribed dose (prescription-only medicines) or dose recommended by the manufacturer (non-prescription medicine). The total quantity imported within any 12-month period must not exceed a 15-month supply.
- If you wish to import more than a 3-month supply in a single order, an Australian-registered doctor must apply to the TGA for Special Access Scheme approval on your behalf.
The import must not:
- include any vaping products, such as disposable vapes, vaping substances, accessories, vaping kits, or items within a therapeutic vaping pack
- contain a controlled substance
- be prohibited under Australian Customs or quarantine rules.
If your import does not meet these conditions the products may be seized resulting in the loss of both the items and the money spent on them.
Where possible, keep your medicines or medical devices in their original packaging with any dispensing labels intact.
It is difficult for us to assess medicines when they are not clearly labelled or are stored in containers that do not match the product, which may result in them not being released.
When we receive mislabelled products or those with no labels at all, we cannot release them as we cannot confirm their identity.
Even if this is out of your control, such as when ordering online, if the labels are not intact, you will not receive the products.
If family or friends are sending the items, please ensure that they keep labels and original packaging intact.
Written authority requirements
A valid written authority, such as an Australian prescription must:
- be issued by an Australian registered medical practitioner and include the prescribers:
- name
- address
- telephone number
- Australian prescriber number
- signature
- match the quantity of products being imported
- contain the following details:
- the date of the written authority
- the patient’s name and address
- the item, dosage form, strength, quantity and usage instructions
- the number of times the medicine can be supplied under the written authority.
To avoid having your items seized by Australian Border Force (ABF), only order what your doctor has prescribed and provide the seller a copy of your written authority to include it in your package.
This helps demonstrate to the ABF that you have a valid written authority for the medicine being imported. You can also email a copy of your written authority directly to us at PIS.writtenauthority@health.gov.au.
We can’t facilitate partial releases if the import doesn’t match the written authority.
Additionally, if you obtain a written authority after the import has been held then you have not complied with the requirements of the scheme.
Additional documentation, such as a Customs declaration, may also be required.
Electronic prescriptions (eScripts)
Electronic prescriptions (eScripts) cannot be accepted as valid written authority for importation because they often lack the necessary details.
Additionally, the TGA does not have access to the clinical information system software required to verify and process eScripts.
These systems are typically used within specific healthcare settings and are not integrated with the ABF or TGA’s processes.
This lack of integration prevents the TGA from verifying the details of eScripts. As such they cannot be accepted for importation.
If you cannot produce a valid written authority, the products will be seized at the border.
Health risks and precautions for importing therapeutic goods
Products imported under the Personal Importation Scheme are not evaluated by us, meaning their safety, quality and efficacy cannot be guaranteed.
They may not adhere to Australian standards and could pose significant risks, they may be counterfeit products or contain prohibited substances.
Using such products could result in ineffective treatment, harmful side effects or other safety concerns.
To minimise risks, avoid ordering medicines - including dietary supplements and herbal preparations – online unless you:
- are fully aware of the product’s ingredients, contents and preparation
- have verified the legal requirements for importing and using such goods in Australia
- have ordered only what your health practitioner has recommended or prescribed.
Always discuss the use of any ‘unapproved’ medicine imported from overseas with your treating health practitioner to ensure it is safe and suitable for you.
Risks and consequences of unlawful importation
Importing therapeutic goods into Australia without the relevant approval or exemption can have serious consequences.
If you cannot provide valid evidence that your importation complies with legal requirements, your products may be seized and destroyed.
You may also face significant fines, or civil or criminal proceedings.
Certain medicines are either prohibited from importation or may only be imported by a medical professional on behalf of a patient.
Attempting to import these medicines without the necessary permissions can result in the ABF seizing and destroying the package.
This would result in the loss of both the product and the funds spent, along with potential legal repercussions.
Customs
Each country has its own controls regarding the import of specific substances.
While countries that are signatories to international drug treaties usually have consistent requirements for narcotic and psychotropic substances, regulations for anabolic and androgenic steroids can vary significantly.
The substances listed below are not controlled substances in some countries, such as the USA where they are included in dietary supplements:
- DHEA (Dehydroepiandrosterone)
- Norandrostenedione
- Ephedra (ma huang)
- Ephedrine.
However, under Australian Customs legislation, these substances are classified as either anabolic steroids or precursors.
They are prohibited imports unless an import permit has been obtained.
To confirm whether your medicine is subject to Customs controls, you need to know what ingredients are in the product.
You can check whether these ingredients are Controlled substances that require import licences or permits.
Anyone ordering herbal or dietary supplements from overseas should verify that the product does not contain any controlled substances.
If Customs identifies these as prohibited imports, they will be seized.
Import permits cannot be issued retrospectively and the products may be destroyed by Customs.
Quarantine
Quarantine clearance may be necessary before importing any materials of biological origin, including human, animal, plant or bacterial ingredients.
Contact the Department of Agriculture, Fisheries and Forestry to determine if an import permit is required.
For importing or exporting substances containing parts of animals and plants listed as endangered species, you will need a permit issued under the Environment Protection and Biodiversity Conservation Act 1999 (EPBC Act).
Further information can be obtained from the Department of Climate Change, Energy, the Environment and Water.
Case studies
The following worked examples are provided to help consumers understand the Personal Importation Scheme.
These are not the only situations where issues may arise however, they are commonly observed.
Unlawful import – No prescription held at the time of import
A member of the public purchases a prescription-only medicine from an overseas online supplier without a valid Australian prescription or written authority.
The package is stopped by Customs and assessed by the TGA.
Reason for non-compliance with the Personal Importation Scheme
A valid Australian prescription or written authority was not held at the time of importation, the import does not meet the conditions of the Personal Importation Scheme.
It is considered unlawful and seized by Customs.
No compensation is provided to the importer.
Unlawful import – Counterfeit goods
A member of the public holds a valid Australian prescription or written authority and purchases a prescription-only medicine from an overseas online supplier.
The package is stopped by Customs and assessed by the TGA.
The TGA has previously tested these medicines and discovered they contain undeclared substances and are considered counterfeit (fake).
Reason for non-compliance with the Personal Importation Scheme
It is prohibited to import counterfeit products under any circumstances.
The individual having a prescription for the medicine does not affect the prohibition.
This import cannot meet the conditions of the Personal Importation Scheme and is considered unlawful and seized by Customs.
No compensation is provided to the importer.
Lawful Import – Australian prescription held, 3-month supply
After consultation with their doctor, an individual is prescribed a particular prescription medicine and decides to purchase a 3-month supply of the medicine from an overseas online supplier.
The individual requests the supplier include a copy of their prescription in the package.
Upon arrival in Australia, the package is stopped by Customs and assessed by the TGA.
Reason for compliance with the Personal Importation Scheme
A valid Australian prescription or written authority was held at the time of importation.
The total quantity is within a 3-month supply, matches the written authority and is not a controlled substance.
The import meets the conditions of the Personal Importation Scheme.
The importation is lawful and is released to the individual.