The Personal Importation Scheme (PIS) operates under the Therapeutic Goods Act 1989 (Cth) and associated TGA guidance. It allows individuals to bring therapeutic goods into Australia , including certain medicines, vitamins, and medical devices , for their own personal use or for the use of an immediate family member travelling with them. The scheme does not extend to commercial supply or distribution.
Quantity limits apply strictly. For most medicines, the allowable amount is a three-month supply. Goods that exceed this threshold, or that fall outside the scheme's eligibility criteria, require a separate import permit or must be accompanied by documentation such as a prescription or a letter from a treating practitioner. The TGA retains authority to seize or destroy goods that do not meet the scheme's conditions at the Australian border.
The PIS does not override scheduling obligations under the Poisons Standard (the Standard for the Uniform Scheduling of Medicines and Poisons). Substances listed as Schedule 8 (controlled drugs) or Schedule 9 (prohibited substances) are not eligible for personal importation under ordinary PIS provisions, and importing them without specific authorisation may constitute a criminal offence under Commonwealth or state and territory law. Certain Schedule 4 (prescription-only) medicines may be imported under the scheme provided conditions are met, but this does not constitute a prescription or authorisation to obtain such medicines domestically.
It is a common misconception that the PIS functions as a regulatory loophole for unapproved therapeutic goods. The TGA has stated clearly that unapproved goods imported under the scheme carry no guarantee of safety, quality, or efficacy, and that importing unapproved goods remains the individual's legal responsibility. The scheme offers no protection against prosecution where scheduled or prohibited substances are involved.
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