Pocket Ritual Partners / Markets / Australia

AU · TGA

Australia: your supplement is a medicine.

Australia has no supplement category. Vitamins, minerals, herbs and nutraceuticals are complementary medicines on the Australian Register of Therapeutic Goods — listed fast by self-certification, but against closed lists and with an evidence obligation that is tested after the fact.

The regime in brief

RegulatorTherapeutic Goods Administration (TGA) under the Therapeutic Goods Act 1989.
TiersAUST L (listed, self-certified), AUST L(A) (assessed listed, stronger claims), AUST R (registered, full evaluation). Most supplements are AUST L.
IngredientsEvery active and excipient on the Permissible Ingredients Determination, within its limits.
ClaimsOnly from the Permissible Indications Determination — a closed list of roughly 1,300 pre-worded indications, including traditional-use paradigms.
Sponsor & GMPAn Australian-resident sponsor; overseas manufacturers need TGA GMP Clearance — usually the critical path.
LifecyclePost-market reviews request the evidence file on demand; variations can trigger re-certification; GMP clearances expire.

How we work here

We screen formulas against both Determinations before listing, start GMP Clearance first because it is the long pole, and build the evidence file before TGA asks for it.

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Regulatory content on this site is a learning framework and an indication of how we work, not regulatory or legal advice. Requirements change; every engagement verifies them against current primary sources.

Free company assessment

Tell us where your product is. We'll tell you what comes next.

Fifteen minutes, the same six dimensions we use inside every engagement, read against your company's stage, capabilities and target markets.

Take the free assessment

or write to pan@pocketritual.com