Personal Importation Scheme for Unapproved Therapeutic Goods – TGA Rules

Overview

The Personal Importation Scheme permits Australian residents (or visitors) to bring small quantities of unapproved therapeutic goods (mainly prescription medicines) into Australia for their own personal use or for a family member/immediate companion when strict criteria are met.

Eligible Goods and Quantity Limits

• Prescription medicines:
  • Maximum 3 months' supply at the maximum dose recommended by the manufacturer.
  • Must be prescribed by a medical practitioner for the importer or immediate family/companion.
• Non-prescription medicines:
  • Reasonable personal quantity (typically up to 3 months).
• Medical devices:
  • Limited to personal use quantities; most must comply with ARTG inclusion unless exempt.
• Prohibited or restricted goods:
  • Controlled substances (e.g., narcotics) generally not allowed under this scheme.
  • Certain biologicals or high-risk devices may require additional approval.

Key Conditions

• Personal use only: No resale, supply to others, or commercial purpose.
• Prescription requirement (for prescription medicines):
  • Valid prescription from Australian-registered practitioner or equivalent overseas practitioner (recognized in some cases).
  • Prescription must be current and for the condition being treated.
• Declaration:
  • Declare goods to Australian Border Force upon arrival.
  • Provide prescription and evidence of personal use if requested.
• Source:
  • Goods should come from reputable sources to avoid counterfeits.
• No advertising:
  • Importer must not advertise or promote the goods.

Risks and Enforcement

• Non-compliant imports may be seized and destroyed.
• Penalties apply for false declarations or commercial importation.
• Health risks from unapproved, counterfeit, or improperly stored products.
• TGA and ABF may inspect or request further information.

Alternatives to Personal Importation

• Use TGA-approved products available in Australia.
• Apply via Special Access Scheme (SAS) Category B for unapproved medicines.
• Clinical trial supply under CTN/CTA for investigational goods.

Detailed eligibility criteria, quantity calculations, prescription validity rules, declaration procedures, prohibited items list, and consumer warnings are outlined in the TGA guidance on the Personal Importation Scheme for unapproved therapeutic goods. Source: Personal importation scheme - TGA

This scheme provides limited access to necessary treatments while protecting public health from unregulated products.