A guide to Australia’s TGA approval process

Entering the Australian market confidently

If your product makes a health claim, it must be approved by Australia’s Therapeutic Goods Administration (TGA) and entered on the Australian Therapeutic Goods Register before it can be imported into and sold in Australia.

This guide covers:

  • The types of products that require TGA approval
  • What does it mean if your product needs TGA approval
  • Who can be an Australian sponsor?
  • The power of the sponsor
  • Sponsorship options:
    • Your distributor sponsors your product with the TGA
    • You establish an Australian subsidiary as the sponsor
    • You use an established registration-holding company as the sponsor

Entering the Australian market confidently

If you’re considering entering the Australian market and would like to learn more, please provide your details below, and we’ll email you a copy of the guide.

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    Please note, this document gives you a general view of the legal landscape at a point in time. That landscape will always be extensive and could change at any time. You should not, therefore, rely on this document as specific to your situation, current or exhaustive.

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