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Is my CBD oil "TGA approved"?

Almost certainly not. Only two cannabis medicines are registered in Australia. Other prescribed CBD products are unapproved, though they must meet a quality standard.

Facts checked 13 November 20262 min readHow we research

Almost certainly not, unless it is Epidyolex. Only two cannabis medicines are registered in Australia, Epidyolex and Sativex, and every other prescribed CBD product is an “unapproved” medicine.1 The Therapeutic Goods Administration (TGA) says unapproved products “have not been assessed by us for safety, quality or effectiveness”.2

What is the difference?

Registered (approved) medicine Unapproved product
Assessed by the TGA for safety and effectiveness Yes, for a stated use No
Must meet the quality standard TGO 93 Yes Yes
Number of cannabis products Two More than 1,000 supplied

Sources: TGA.13 More than 99% of medicinal cannabis products prescribed in Australia are unapproved.3

Why does my prescriber have a “TGA approval”?

Because the prescriber needed permission to supply an unapproved product, through the Special Access Scheme or the Authorised Prescriber scheme.2 That approval is permission to prescribe. It is not a finding that the product works or is safe. Prescribers must tell patients that the product “is unapproved and not included in the ARTG”.4

What does the quality standard cover?

All medicinal cannabis lawfully supplied in Australia must comply with TGO 93. It covers cannabinoid content, pesticides, microbes, mould toxins, adulteration and plant identity. Since 2023, Good Manufacturing Practice has been mandatory.3 The TGA does not test every product. It samples on a risk basis.3 When the TGA tested products supplied through the Special Access Scheme, most were close to the label, and a later survey found 20 of 21 met requirements.5

What if a label or website says “TGA approved”?

Treat it as a warning sign. The TGA’s advertising guidance treats statements implying TGA approval or endorsement as prohibited.6 Advertising prescription medicines to the public is also prohibited. A seller making health claims is already ignoring one rule.

Is there an approved over-the-counter CBD?

No. A pharmacist-only (Schedule 3) category exists in law, but a product must be registered to use it, and none has been as of November 2026.73

Read the full guide: quality standards for Australian CBD products and Epidyolex and Sativex.

Footnotes

  1. Therapeutic Goods Administration. Paper to the scheduling advisory committee, 18 March 2026, released as FOI 26-2886. https://www.tga.gov.au/sites/default/files/2026-06/FOI%2026-2886.PDF ↩ ↩2

  2. Therapeutic Goods Administration. Medicinal cannabis access pathways. https://www.tga.gov.au/products/unapproved-therapeutic-goods/medicinal-cannabis/access-pathways ↩ ↩2

  3. Therapeutic Goods Administration. Consultation paper: reviewing the safety and regulatory oversight of unapproved medicinal cannabis products, August 2025. https://consultations.tga.gov.au/medicines-regulation-division/test-soms/user_uploads/final---consultation-paper---medicinal-cannabis-review---august-2025.pdf ↩ ↩2 ↩3 ↩4 ↩5

  4. Therapeutic Goods Administration. Do your patients know the risks of unapproved medicinal cannabis products?, 2 June 2026. https://www.tga.gov.au/news/blog/do-your-patients-know-risks-unapproved-medicinal-cannabis-products ↩

  5. Therapeutic Goods Administration. Testing of medicinal cannabis products being supplied through the SAS in Australia. https://www.tga.gov.au/resources/publication/tga-laboratory-testing-reports/testing-medicinal-cannabis-products-being-supplied-sas-australia ↩

  6. Therapeutic Goods Administration. Advertising guidance for businesses involved with medicinal cannabis products, December 2023. https://www.tga.gov.au/sites/default/files/2023-12/advertising-guidance-businesses-medicinal-cannabis-products.docx ↩

  7. Australian Government. Therapeutic Goods (Poisons Standard, October 2026) Instrument 2026. https://www.legislation.gov.au/F2026L01327/asmade/2026-09-30/text/original/pdf ↩

This page is general information, not medical or legal advice. Laws and evidence change; we show the date we last checked the facts at the top of every page. Talk to your doctor or pharmacist before starting, stopping or changing any medicine.

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