Australia · Cosmetics

Australia Cosmetic and Therapeutic Goods Classification

A practical guide to Australia Cosmetic and Therapeutic Goods Classification for cosmetics sold in Australia: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it
Products marketed as cosmetics or therapeutic goods in Australia; Brands and importers of skincare, sunscreen, and personal care
Authority
Therapeutic Goods Administration (TGA)
Legal basis
Therapeutic Goods Act 1989; Poisons Standard
Local representative
An Australian sponsor is required for therapeutic goods
Timeline
Before import or supply; listing timelines vary
Cost
TGA listing fees apply to therapeutic goods; cosmetic compliance costs vary
If you do not comply
Recall, fines, and supply prohibition

Who needs this

Documents you need

Compliance checklist

Tick each item as you collect it. Saved in this browser only.

How to comply

  1. Determine whether the product is a cosmetic or a therapeutic good
  2. Check ingredients against the Poisons Standard
  3. Register or list therapeutic goods where required
  4. Label according to Australian requirements

Brief for your lab or agent

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Request: Australia Cosmetic and Therapeutic Goods Classification — Australia
Product category: Cosmetics
Authority: Therapeutic Goods Administration (TGA)
Legal basis: Therapeutic Goods Act 1989; Poisons Standard

Documents we already have:
  1. Ingredient assessment against the Poisons Standard
  2. Product classification rationale
  3. Australian label artwork
  4. Evidence for any therapeutic claim

Questions:
  1. Does our product fall under Australia Cosmetic and Therapeutic Goods Classification in Australia?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

Before import or supply; listing timelines vary.

TGA listing fees apply to therapeutic goods; cosmetic compliance costs vary.

Common rejection reasons

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.

Official sources

FAQ

Is sunscreen a cosmetic?

Primary sunscreens are generally therapeutic goods and require TGA listing; secondary sunscreens may be cosmetics.

Do cosmetics need registration?

No. True cosmetics are not registered, but they must comply with ingredient and labelling rules.

How long does Australia Cosmetic and Therapeutic Goods Classification take?

Before import or supply; listing timelines vary.

How much does Australia Cosmetic and Therapeutic Goods Classification cost?

TGA listing fees apply to therapeutic goods; cosmetic compliance costs vary.

What happens if I sell without it?

Recall, fines, and supply prohibition.

Who regulates Australia Cosmetic and Therapeutic Goods Classification in Australia?

Therapeutic Goods Administration (TGA).

Related requirements

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