Importing therapeutic goods

If you plan to import a therapeutic good, you must meet certain legal requirements set out in the 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.

Importing unapproved therapeutic goods

There are certain circumstances where unapproved therapeutic goods that are not in the ARTG can be legally imported.

• Import/export of unapproved therapeutic goods for experimental purposes
  Guidance and application form for importing unapproved therapeutic goods for clinical trials
• Personal import scheme
  Guidance on the importation of therapeutic goods for personal use

Importing controlled substances

The Office of Drug Control, as part of the Australian Government Department of Health, regulates and provides advice on the import of controlled substances.

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.

To import therapeutic goods that contain a controlled substance you need:

• a licence and/or permit to import 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 requiring a licence and/or permit to import
• contact the Office of Drug Control