Importing Medicines or Medical Devices into Australia – TGA Consumer Guide

General Rules for Personal Importation

• Medicines and medical devices must generally be included in the Australian Register of Therapeutic Goods (ARTG) to be lawfully imported and used in Australia.
• Personal importation is allowed only for genuine personal use (not for resale or commercial purposes).
• Importation without proper authorisation may result in seizure by the Australian Border Force and potential fines.

Medicines – Key Requirements

• Prescription medicines:
  • Must have a valid Australian prescription from a registered practitioner.
  • Maximum 3 months' supply (or the standard treatment course if longer).
• Over-the-counter (OTC) medicines:
  • May be imported in reasonable personal quantities (typically up to 3 months).
  • Must be for personal use and not controlled substances.
• Controlled substances (Schedule 8 or 4 with restrictions):
  • Strict limits apply; often require TGA approval via Special Access Scheme or Authorised Prescriber.
• Unapproved medicines:
  • Generally prohibited unless under SAS Category B or clinical trial.

Medical Devices – Key Requirements

• Most devices:
  • Must be included in the ARTG.
  • Personal quantities allowed if for own use (e.g., one device plus spares).
• High-risk devices (Class IIb, III, AIMD):
  • Stricter controls; importation usually requires ARTG inclusion or exemption.
• Custom-made devices:
  • May be imported for specific patient use under certain conditions.

Practical Steps for Safe Importation

• Check if the product is in the ARTG using the TGA website search.
• Obtain a valid Australian prescription if required.
• Limit quantity to personal needs (typically 3 months).
• Declare all items to Australian Border Force upon arrival.
• Keep documentation (prescription, invoice, proof of personal use).
• Avoid importing from unknown sources to prevent counterfeit or substandard products.

Risks of Non-Compliance

• Goods may be seized and destroyed.
• Importer may face fines or prosecution.
• Health risks from unapproved, counterfeit, or substandard products.

Detailed rules on quantities, prescription requirements, prohibited substances, ARTG search instructions, customs declaration process, special access options, and consumer warnings are provided in the TGA consumer guide on importing medicine or medical devices. Source: Importing medicine or medical devices - TGA

This guidance helps individuals import safely while protecting public health from unregulated products.