CBD has been a prescription-only medicine in Australia since 2015. The main steps since then were the registration of the first CBD-only medicine in 2020, the creation of a pharmacist-only category that remains empty, and a period of tighter oversight in 2025 and 2026.12 This page lists the key dates and flags what is still pending as of November 2026.
What happened before 2020?
| Date | Event |
|---|---|
| 2012 | Sativex (nabiximols), a spray containing THC and CBD, registered for spasticity in multiple sclerosis.3 |
| 2015 | CBD first listed in Schedule 4 (prescription only) of the Poisons Standard.1 |
| 2016 | Schedule 8 (controlled drug) entries created for cannabis and THC.1 |
| 2017 | The quality standard for medicinal cannabis, TGO 93, made.2 |
| 12 November 2017 | Low-THC hemp seed foods became legal to sell.4 |
| 2018 | Schedule 4 CBD entry clarified to its current wording: CBD must be 98% or more of total cannabinoids, with other cannabinoids 2% or less.1 |
| 2018 | Department of Veterans’ Affairs began funding medicinal cannabis case by case.5 |
| 15 May 2018 | Office of Drug Control warned consumers that CBD and hemp oil imports “will be seized at the border”.6 |
| Late 2019 to April 2020 | TGA safety review of low-dose CBD.7 |
What happened in 2020 and 2021?
| Date | Event |
|---|---|
| 31 January 2020 | ACT personal cannabis law commenced, allowing adults to possess and grow small amounts.8 |
| 18 to 21 September 2020 | TGA approved Epidyolex, a CBD oral solution, and entered it on the national register.9 |
| 15 December 2020 | TGA announced its final decision to create a Schedule 3 (pharmacist only) entry for low-dose CBD. The daily limit was raised from 60 mg in the interim decision to 150 mg.10 |
| December 2020 | TGA issued 4 infringement notices totalling $10,656 to a man in Western Australia for alleged unlawful advertising of CBD.11 |
| 2021 | Schedule 3 CBD entry took effect.1 |
| 2021 | Applications for unapproved products changed to be made by active-ingredient category, not brand.2 |
| 5 July 2021 | Australian Border Force warned of “a marked increase” in interceptions of CBD and hemp products.12 |
| 28 July 2021 | TGA issued 4 infringement notices totalling $10,656 to a Sydney-based individual for alleged unlawful advertising of CBD oil, including a claim about “cancerous tumours”.13 |
The TGA papers we read give only the year, 2021, for the Schedule 3 entry taking effect, so we have not stated a day. For why this change put nothing on pharmacy shelves, see over-the-counter CBD.
What happened from 2022 to 2024?
| Date | Event |
|---|---|
| March 2022 | TGO 93 amended to add manufacturing, packaging and labelling requirements.2 |
| 2023 | Good Manufacturing Practice made mandatory for both domestic and overseas manufacturers.2 |
| 1 June 2023 | Epidyolex listed on the PBS for Lennox-Gastaut syndrome.14 |
| 10 August 2023 | Legalising Cannabis Bill 2023 introduced in the Senate.15 |
| December 2023 | TGA published advertising guidance for medicinal cannabis businesses.16 |
| 4 December 2023 | TGA began Federal Court proceedings against CDA Clinics QLD and its former director for alleged unlawful advertising of medicinal cannabis.17 |
| 18 April 2024 | TGA began Federal Court proceedings against Montu Group, Alternaleaf and their director for alleged unlawful advertising. Not decided as of November 2026.18 |
| May 2024 | Senate committee recommended “that the Senate not pass” the Legalising Cannabis Bill. Its status is “Not Proceeding”.15 |
| 26 June 2024 | 35 infringement notices totalling $627,252 issued to 6 businesses and 2 individuals for alleged unlawful advertising.19 |
| 9 July 2024 | A news publisher, News Life Media, issued 3 infringement notices totalling $56,340 for alleged unlawful advertising in an article.20 |
Special Access Scheme approvals for medicinal cannabis grew from 57,711 in 2020 to 177,762 in 2024.2
What happened in 2025?
| Date | Event |
|---|---|
| 1 March 2025 | Victoria: courts gained discretion not to cancel the licence of a prescribed medicinal cannabis patient who tests positive for THC. It remains an offence.21 |
| 20 June 2025 | TGA began Federal Court proceedings against AG Therapeutics (trading as Atlus) and its director, two media companies (Mamamia and News Life Media) and a PR firm for alleged unlawful advertising. Not decided as of November 2026.22 |
| 20 June 2025 | NSW upper house inquiry tabled its final report on cannabis regulation.23 |
| 9 July 2025 | Ahpra and the Medical and Nursing and Midwifery Boards published medicinal cannabis prescribing guidance.24 |
| July 2025 | PBAC recommended easing the PBS rules for Epidyolex in Lennox-Gastaut syndrome.14 |
| 11 August to 7 October 2025 | TGA consultation on the safety and oversight of unapproved medicinal cannabis products.25 |
| September 2025 | Pharmacy Board published guidance on supplying medicinal cannabis.26 |
| 22 September 2025 | Dispensed Pty Ltd issued 6 infringement notices totalling $118,800, and a direction notice, for alleged unlawful advertising.27 |
What happened in 2026?
| Date | Event |
|---|---|
| 1 January 2026 | PBS general co-payment cut from $31.60 to $25.00, which applies to Epidyolex.28 |
| 16 February 2026 | Department of Veterans’ Affairs tightened its medicinal cannabis funding framework.29 |
| 20 February 2026 | TGA published its response to the consultation, according to a law firm summary.30 |
| 18 March 2026 | TGA told its scheduling committee that reform options “may include a review of the current scheduling of cannabis, CBD and THC”.1 |
| March 2026 | PBAC recommended easing the PBS rules for Epidyolex in Dravet syndrome.31 |
| Mid-2026 | TGA published general guidance on advertising prescription medicines to the public.32 |
| 1 July 2026 | Commonwealth penalty unit rose to $364.33 |
| 30 July 2026 | Senate inquiry into a hemp industry reported, with 14 recommendations.34 |
| 4 August 2026 | TGA began Federal Court proceedings against Better Leaf, Better Life Aussie and their director for alleged unlawful advertising. Not decided as of November 2026.35 |
| 10 September 2026 | The World Anti-Doping Agency approved its 2027 Prohibited List, as reported by national anti-doping agencies. From 1 January 2027 natural cannabinoids such as CBN and CBG are no longer prohibited. CBD remains permitted and THC remains prohibited.36 |
| 17 September 2026 | NSW Parliament passed a medicinal cannabis driving registration scheme, according to news reports. Not yet in force.3738 |
| 17 September 2026 | Queensland passed higher drug-driving penalties, effective 1 December 2026.39 |
| 1 October 2026 | Poisons Standard October 2026 commenced. The CBD entries were unchanged in substance.40 |
| 30 October 2026 | TGA announced that the Federal Court had ordered CDA Clinics QLD to pay $6.5 million and its former director $450,000 ($6.95 million in total) for unlawful advertising of medicinal cannabis.17 |
What is pending as of November 2026?
These matters were unresolved, or passed but not yet in force, when this page was updated.
- Over-the-counter CBD. Still no Schedule 3 product on the national register.1
- TGA reform. No reform had been decided in the latest TGA documents we found (mid-2026).41 We could not confirm whether anything was announced between July and November 2026.
- NSW driving scheme. The Act commences on proclamation. The existing rules apply until then.38 See CBD in New South Wales.
- Queensland penalties. Higher drug-driving penalties take effect on 1 December 2026.39 See CBD in Queensland.
- Epidyolex on the PBS. The November 2026 PBAC meeting was to consider a listing for tuberous sclerosis complex and a larger maximum quantity. Outcomes had not been published as of 13 November 2026.42
- Montu and Alternaleaf case. Argued in the Federal Court in October 2026, according to legal media. We found no judgment as of 13 November 2026. The TGA’s claims remain allegations.43
- ACT driving bill. A bill to add a lawful-use defence for medicinal cannabis patients was before the Assembly and had not been voted on.44 An Assembly committee reported on 11 November 2026, recommending that the bill not be passed in its current form, according to local news reports.45 See CBD in the ACT.
- Sport. The 2027 anti-doping list takes effect on 1 January 2027.36 See CBD and sport.
Driving law is covered in full on CBD and driving.
Footnotes
-
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 ↩3 ↩4 ↩5 ↩6 ↩7
-
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 ↩6
-
MS Australia. Disappointing outcomes for PBS inclusion. https://www.msaustralia.org.au/news/disappointing-outcomes-for-pbs-inclusion/ ↩
-
Food Standards Australia New Zealand. Australia New Zealand Food Standards Code, Standard 1.4.4, compilation of 12 November 2017. https://www.legislation.gov.au/F2015L00416/2017-11-12/2017-11-12/text/original/epub/OEBPS/document_1/document_1.html ↩
-
Department of Veterans’ Affairs. FOI disclosure 82360, 2026. https://www.dva.gov.au/sites/default/files/2026-06/82360-foi-disclosure-log.pdf ↩
-
Office of Drug Control. Consumer warning on CBD and hemp oil imports, 15 May 2018. https://www.odc.gov.au/node/1328 ↩
-
Therapeutic Goods Administration. Review on the safety of low dose cannabidiol, 2020. https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/review-safety-low-dose-cannabidiol ↩
-
ACT Government. Drugs of Dependence (Personal Cannabis Use) Amendment Act 2019. https://www.legislation.act.gov.au/a/2019-34/ ↩
-
Therapeutic Goods Administration. Australian public assessment report for cannabidiol, January 2021. https://www.tga.gov.au/sites/default/files/auspar-cannabidiol-210115.pdf ↩
-
Therapeutic Goods Administration. Over-the-counter access to low dose cannabidiol, media release, 15 December 2020. https://www.tga.gov.au/news/media-releases/over-counter-access-low-dose-cannabidiol ↩
-
Therapeutic Goods Administration. Reminder: supply and advertising controls on medicinal cannabis, 3 May 2021. https://www.tga.gov.au/news/news-articles/reminder-supply-and-advertising-controls-medicinal-cannabis ↩
-
Australian Border Force. Increase in seizures prompts warning, media release republished by Mirage News, 5 July 2021. https://www.miragenews.com/increase-in-seizures-prompts-warning-to-590129/ ↩
-
Therapeutic Goods Administration. Sydney-based individual fined $10,656 for alleged unlawful advertising of medicinal cannabis, media release, 28 July 2021. https://www.tga.gov.au/news/media-releases/sydney-based-individual-fined-10656-alleged-unlawful-advertising-medicinal-cannabis ↩
-
Pharmaceutical Benefits Scheme. Medicine status: cannabidiol for Lennox-Gastaut syndrome. https://www.pbs.gov.au/medicinestatus/document/898.html ↩ ↩2
-
Parliament of Australia. Senate Legal and Constitutional Affairs Legislation Committee, Legalising Cannabis Bill 2023 report. https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Legal_and_Constitutional_Affairs/LegalisingCannabis/Report ↩ ↩2
-
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 ↩
-
Therapeutic Goods Administration. Court orders CDA Clinics QLD and its former director to pay $6.95 million for unlawful advertising of medicinal cannabis, media release, 30 October 2026. https://www.tga.gov.au/news/media-releases/court-orders-cda-clinics-qld-and-its-former-director-pay-695-million-unlawful-advertising-medicinal-cannabis ↩ ↩2
-
Therapeutic Goods Administration. Court proceedings initiated against Montu Group Pty Ltd, Alternaleaf Pty Ltd and an individual for alleged unlawful advertising of medicinal cannabis, media release, 18 April 2024. https://www.tga.gov.au/news/media-releases/court-proceedings-initiated-against-montu-group-pty-ltd-alternaleaf-pty-ltd-and-individual-alleged-unlawful-advertising-medicinal-cannabis ↩
-
Therapeutic Goods Administration. More than $600,000 in fines issued for alleged unlawful medicinal cannabis advertising, media release, 26 June 2024. https://www.tga.gov.au/news/media-releases/more-600000-fines-issued-alleged-unlawful-medicinal-cannabis-advertising ↩
-
Therapeutic Goods Administration. News Life Media fined for alleged unlawful advertising of medicinal cannabis, media release, 9 July 2024. https://www.tga.gov.au/news/media-releases/news-life-media-fined-alleged-unlawful-advertising-medicinal-cannabis ↩
-
Parliament of Victoria. Roads and Road Safety Legislation Amendment Bill 2024, amendment schedule. https://legislation.vic.gov.au/sites/default/files/2024-11/LC-Amendment-schedule-Roads-and-Road-Safety-Legislation-Amendment-Bill-2024.pdf ↩
-
Therapeutic Goods Administration. Atlus, Mamamia and News Life Media face court for alleged unlawful advertising of medicinal cannabis, media release, 20 June 2025. https://www.tga.gov.au/news/media-releases/atlus-mamamia-and-news-life-media-face-court-alleged-unlawful-advertising-medicinal-cannabis ↩
-
Parliament of NSW. Report 66: impact of the regulatory framework for cannabis in New South Wales, 20 June 2025. https://www.parliament.nsw.gov.au/lcdocs/inquiries/3043/Report%2066%20-%20Impact%20of%20the%20regulatory%20framework%20for%20cannabis%20in%20NSW%20-%2020%20June%202025.pdf ↩
-
Ahpra. Medicinal cannabis guidance, news release, 9 July 2025. https://www.ahpra.gov.au/News/2025-07-09-Medicinal-cannabis-guidance.aspx ↩
-
Therapeutic Goods Administration. Consultation hub: reviewing the safety and regulatory oversight of unapproved medicinal cannabis products. https://consultations.tga.gov.au/medicines-regulation-division/test-soms/ ↩
-
Ahpra and Pharmacy Board of Australia. Medicinal cannabis supply guidance. https://www.ahpra.gov.au/Resources/Medical-cannabis-supply ↩
-
Therapeutic Goods Administration. Dispensed Pty Ltd issued infringement notices and directed to cease alleged unlawful advertising of medicinal cannabis, media release, 22 September 2025. https://www.tga.gov.au/news/media-releases/dispensed-pty-ltd-issued-infringement-notices-and-directed-cease-alleged-unlawful-advertising-medicinal-cannabis ↩
-
Pharmaceutical Benefits Scheme. Fees, patient contributions and safety net thresholds. https://www.pbs.gov.au/info/healthpro/explanatory-notes/front/fee ↩
-
Department of Veterans’ Affairs. Updated medicinal cannabis framework supports safe and effective prescribing practices. https://www.dva.gov.au/providers/provider-news/updated-medicinal-cannabis-framework-supports-safe-and-effective-prescribing-practices ↩
-
King and Wood Mallesons. The TGA’s medicinal cannabis products review: what stakeholders said and what comes next, 2026. https://pulse.mallesons.com/global/the-tgas-medicinal-cannabis-products-review-what-stakeholders-said-and-what-comes-next/ ↩
-
Pharmaceutical Benefits Advisory Committee. Cannabidiol public summary document, March 2026. https://www.pbs.gov.au/industry/pbac/psd/2026/03/cannabidiol-psd-march-2026-a1155.pdf?variant=3 ↩
-
Therapeutic Goods Administration. Complying with the restrictions on advertising prescription medicines to the public, 2026. https://www.tga.gov.au/resources/guidance/complying-restrictions-advertising-prescription-medicines-public ↩
-
Australian Securities and Investments Commission. Fines and penalties (value of a Commonwealth penalty unit). https://asic.gov.au/about-asic/asic-investigations-and-enforcement/fines-and-penalties/ ↩
-
Parliament of Australia. Senate Rural and Regional Affairs and Transport References Committee, Opportunities for the development of a hemp industry in Australia, report, 30 July 2026. https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Rural_and_Regional_Affairs_and_Transport/Hempindustry_48/Report ↩
-
Therapeutic Goods Administration. TGA sues Better Leaf and Better Life Aussie for alleged unlawful advertising of medicinal cannabis, media release, 4 August 2026. https://www.tga.gov.au/news/media-releases/tga-sues-better-leaf-and-better-life-aussie-alleged-unlawful-advertising-medicinal-cannabis ↩
-
UK Anti-Doping. 2027 Prohibited List: summary of changes. https://www.ukad.org.uk/news/2027-prohibited-list-summary-changes ↩ ↩2
-
The Canberra Times. State sets agenda on medicinal cannabis drivers, 2026. https://www.canberratimes.com.au/story/9352659/state-sets-agenda-on-medicinal-cannabis-drivers/ ↩
-
Parliament of NSW. Road Transport Legislation Amendment (Medical Cannabis and Driving Offences) Bill 2026, as passed by both Houses. https://files.parliament.nsw.gov.au/fileapi/ParlFiles/GetArtifact?serverRelativeUrl=%2Fbill%2Ffiles%2F18920%2FPassed+by+both+Houses.pdf ↩ ↩2
-
Queensland Government. Transport and Other Legislation Amendment Act 2026. https://www.legislation.qld.gov.au/view/whole/html/asmade/act-2026-023 ↩ ↩2
-
Australian Government. Therapeutic Goods (Poisons Standard, October 2026) Instrument 2026. https://www.legislation.gov.au/F2026L01327/asmade/2026-09-30/text/original/pdf ↩
-
Therapeutic Goods Administration. Update to the sector on the medicinal cannabis review, July 2026. https://www.tga.gov.au/sites/default/files/2026-07/update-tga-sector.pdf ↩
-
Pharmaceutical Benefits Advisory Committee. November 2026 meeting agenda. https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/agenda/pdf/2026/November-2026-PBAC-Meeting-Web-Agenda-v6.pdf ↩
-
Law360 Australia. Montu says cannabis posts had no advertising intent, 29 October 2026. https://www.law360.com/au/articles/2542706 ↩
-
ACT Legislative Assembly. Road Transport (Alcohol and Drugs) Amendment Bill 2026, explanatory statement. https://www.legislation.act.gov.au/DownloadFile/es/db_74553/current/PDF/db_74553.PDF ↩
-
Region Canberra. Report advises against roadside test carve-out for Canberra’s medicinal cannabis users, for now, November 2026. https://region.com.au/report-advises-against-roadside-test-carve-out-for-canberras-medicinal-cannabis-users-for-now/1014429/ ↩
Common questions
When did CBD become legal in Australia?
CBD was first listed in Schedule 4 of the Poisons Standard, as a prescription-only medicine, in 2015. As a Schedule 4 medicine it can be supplied only on prescription.
When did CBD become available over the counter?
It has not, in practice. The TGA announced a pharmacist-only category for low-dose CBD on 15 December 2020, and it took effect in 2021. As of November 2026 no product has been approved for sale under it.
What changed for CBD in 2026?
The scheduling of CBD did not change. The main developments were a TGA response to its medicinal cannabis review, tighter veterans' funding rules, new guidance on advertising prescription medicines, and a $6.95 million Federal Court penalty for unlawful advertising.
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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