The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
If you plan to import a therapeutic good, you must comply with therapeutic goods legislation.
Generally, therapeutic goods must be entered in the Australian Register of Therapeutic Goods (ARTG) before you can legally import them into Australia (unless they are exempt from being entered in the ARTG).
Every ARTG entry belongs to a 'sponsor' who is responsible for applying for and maintaining the ARTG entry.
Unapproved therapeutic goods
There are certain circumstances where unapproved therapeutic goods that are not in the ARTG can be legally imported.
Please click on the links below to find out more.
- Import/export of unapproved therapeutic goods for experimental purposes - guidance and application form for importing unapproved therapeutic goods for clinical trials.
- Personal importation scheme - guidance on the importation of therapeutic goods for personal use.
Importing controlled substances
The Office of Drug Control - external site, as part of the Australian Government Department of Health, regulates and provides advice on the import of controlled substances - external site.
Controlled substances (such as narcotic, psychotropic and precursor substances) are prohibited for import without a licence and/or permit under the Customs (Prohibited Imports) Regulations 1956 - external site.
To import therapeutic goods that contain a controlled substance you need:
- a licence and/or permit to import - external site from the Office of Drug Control
If you are unsure if the good you are importing contains a controlled substance, you should:
- check the list of controlled substances - external site requiring a licence and/or permit to import
- contact the Office of Drug Control - external site.