Is the TGA or the ODC responsible for medicinal cannabis?

Both, for different things. The TGA regulates the medicine itself: quality standards, access approvals, advertising and the ARTG. The ODC licenses cultivation, production and manufacture under the Narcotic Drugs Act 1967 and controls imports and exports. State health departments and Ahpra also play roles.

Is medicinal cannabis TGA approved?

Only two medicinal cannabis products are registered on the ARTG. Most prescribed products are unapproved, meaning the TGA has not evaluated them. Prescribers access them through the Special Access Scheme or as Authorised Prescribers, and the products must meet the TGO 93 quality standard.

Do I need a state permit to get medicinal cannabis?

You do not apply yourself; your prescriber handles approvals. Depending on where you live, the prescriber may need state approval for all Schedule 8 products, as in Tasmania and the ACT, or only for higher-risk patients, as in Victoria and Western Australia.

Who do I complain to about a medicinal cannabis doctor?

Raise concerns about a doctor or nurse practitioner with Ahpra on 1300 361 041. In NSW, contact the Health Care Complaints Commission, and in Queensland the Office of the Health Ombudsman. Report suspected unlawful advertising of medicinal cannabis to the TGA.

Can the ODC give me a licence to grow my own medicine?

No. ODC licences are for businesses and researchers that meet strict requirements. The Narcotic Drugs Act 1967 does not support cultivation of medicinal cannabis for personal use, even if you are a patient with a valid prescription.

What is the difference between SAS-B and an Authorised Prescriber?

Under SAS-B, a prescriber applies to the TGA for one patient at a time. An Authorised Prescriber holds approval, for up to five years, to prescribe specified unapproved products to a class of patients in their care, and reports to the TGA every six months.

Where do I report a side effect from medicinal cannabis?

Tell your prescriber or pharmacist first. You can also report suspected side effects directly to the TGA through its online adverse event reporting page. Reports help the TGA monitor the safety of medicines, including unapproved medicinal cannabis products.

TGA vs ODC: Who Regulates Medicinal Cannabis in Australia?

By Medicated TV · by the patient, for the patients · Reviewed 28 September 2026

Quick answerThe Therapeutic Goods Administration (TGA) regulates medicinal cannabis as a medicine: quality, access approvals, advertising and product registration. The Office of Drug Control (ODC) licenses cultivation, production, manufacture, import and export under the Narcotic Drugs Act 1967. States set prescribing rules, and national boards oversee practitioners.

Medicinal cannabis sits under more regulators than most medicines. The Therapeutic Goods Administration (TGA) and the Office of Drug Control (ODC) are both federal, but they do very different jobs, and state health departments and professional boards add further rules. This guide maps who does what, as at 28 September 2026.

From the patient side (Medicated TV founder Irish Wick pitched a Medicinal Cannabis Access Portal, or MCAP, which became Medicated TV), this is the map we wish every new patient had on day one.

Who regulates medicinal cannabis in Australia?

Four groups share the job. The TGA regulates the medicine. The ODC controls growing, making, importing and exporting. State and territory health departments set Schedule 8 prescribing rules. The Australian Health Practitioner Regulation Agency (Ahpra) and national boards oversee the doctors, nurse practitioners and pharmacists involved.

The TGA and ODC both sit within the Australian Government Department of Health, Disability and Ageing. They work closely together but use different laws: the Therapeutic Goods Act 1989 for the TGA, and the Narcotic Drugs Act 1967 plus customs regulations for the ODC.

What does the TGA do for medicinal cannabis?

The TGA regulates medicinal cannabis products as therapeutic goods under the Therapeutic Goods Act 1989. It keeps the Australian Register of Therapeutic Goods (ARTG), approves access to unapproved products, oversees quality standards, enforces the advertising ban, collects side-effect reports and publishes the national Poisons Standard.

The ARTG: only two medicinal cannabis products are registered: a nabiximols mouth spray and a cannabidiol (CBD) oral solution. Registration means the TGA has evaluated the product for specific uses.
Unapproved products: almost everything else prescribed is "unapproved". The TGA has not evaluated these products, so a prescriber needs a TGA approval or notification to supply them.
Quality: unapproved products must meet Therapeutic Goods Order 93 (TGO 93), the Standard for Medicinal Cannabis.
Advertising: advertising medicinal cannabis to the public is prohibited, with significant civil and criminal penalties.
Safety: patients and health professionals can report side effects to the TGA.
Poisons Standard: the TGA publishes the national Poisons Standard, and states and territories give it legal effect through their own laws.

What are SAS-A, SAS-B and Authorised Prescribers?

They are the TGA pathways prescribers use for unapproved medicinal cannabis. Special Access Scheme Category B (SAS-B) is an application for an individual patient. SAS Category A (SAS-A) is a notification for seriously ill patients. An Authorised Prescriber (AP) is approved to prescribe certain products to a class of patients.

SAS-A: a notification pathway, limited to patients who are seriously ill.
SAS-B: the prescriber applies with a clinical justification, including why registered options are unsuitable.
AP: approval lasts up to five years, with six-monthly reports instead of an application for each patient.
Clinical trials: products can also be supplied within an approved trial.

Since 22 November 2021, TGA approvals have been based on product categories, defined by cannabinoid content, rather than individual trade names.

What does the Office of Drug Control do?

The ODC administers the Narcotic Drugs Act 1967, which gives effect to Australia's obligations under the Single Convention on Narcotic Drugs 1961. It grants licences and permits to cultivate, produce and manufacture medicinal cannabis, and it controls imports and exports. Patients rarely deal with the ODC directly.

Licences: 2016 amendments allowed cultivation for medicinal and scientific purposes. Since 24 December 2021, one licence can cover cultivation, production, manufacture and research, and most commercial licences no longer expire, though they can be suspended or revoked.
Permits: permits sit under a licence and set what can be grown or produced, using approved supply categories.
Import and export: the ODC grants permission under regulation 5 of the Customs (Prohibited Imports) Regulations 1956 and regulation 10 and related provisions of the Customs (Prohibited Exports) Regulations 1958.
No home growing: the Act does not support cultivation for personal use, even by patients.
Coming up: the Narcotic Drugs Regulation 2016 and its licence charges regulation sunset on 1 April 2027. After consultation from 22 June to 19 July 2026, the Department said it plans to remake them with only minor or necessary changes.

What do state and territory health departments control?

States and territories control who may prescribe and dispense Schedule 8 (S8) medicines, which covers most tetrahydrocannabinol (THC) products. Rules differ. Some need a state approval for every S8 cannabis patient, others only for higher-risk patients, and several require prescribers to check a real-time prescription monitoring system first.

In plain English: Schedule 8 means a controlled drug (THC products), Schedule 4 (S4) means prescription-only (products that are at least 98% CBD), and Schedule 3 means pharmacist-only (low-dose CBD). NSW Health's 2025 guidance noted that no Schedule 3 CBD product had been registered on the ARTG.

State or territory	State approval for S8 medicinal cannabis?	Notes
New South Wales	Only in some cases	NSW Health authority needed in specified cases, such as drug-dependent patients. None needed for S4 CBD.
Victoria	Only for drug-dependent patients	Since 28 February 2022. SafeScript must be checked before every S8 script.
Queensland	No	QScript must be checked before prescribing S8 products.
Western Australia	Not usually	Since 12 December 2024, needed only for under-18s or patients recorded as drug dependent or oversupplied.
South Australia	Sometimes	Needed for drug-dependent patients and generally once S8 treatment passes two months (some exemptions).
Tasmania	Yes	State authorisation for S8 products. Interstate scripts can be dispensed since 16 February 2026.
Australian Capital Territory	Yes	ACT Chief Health Officer approval, as well as any TGA approval.
Northern Territory	No extra NT approval	Usual S8 monitoring, prescription and storage rules apply.

Who oversees doctors and pharmacists?

Ahpra and the national boards, including the Medical Board of Australia and Pharmacy Board of Australia, regulate practitioners' conduct. In 2025 they issued medicinal cannabis guidance on safe prescribing, telehealth, conflicts of interest and dispensing. In NSW and Queensland, complaints go through state co-regulatory bodies.

Prescribers (9 July 2025): the guidance expects thorough assessment, including mental health and substance use history, informed consent that says when a product is unapproved, good records, real-time telehealth, and careful management of conflicts of interest. The boards expect S8 cannabis to be managed as carefully as opioids.
Pharmacists (23 September 2025): the Pharmacy Board's guidance covers conflicts of interest, checking prescriptions and medication history, counselling and independent judgement, including when supply happens without in-person contact.
Proactive checks: Ahpra has said it will investigate practitioners with high prescribing rates for scheduled medicines, even without a complaint.

How do the pieces fit together?

Think of it as a chain. The ODC licenses the grower, maker or importer. The TGA sets product standards and approves the prescriber's access. The state sets S8 prescribing rules. Ahpra and the boards hold the prescriber and pharmacist to professional standards, and the pharmacy dispenses your medicine.

Regulator	What it does	What it does not do	When patients deal with it
TGA	ARTG registration; SAS and AP approvals; quality standards; advertising enforcement; side-effect reports; Poisons Standard	License growers or discipline practitioners	Side effects, advertising concerns, product questions
ODC	Licences and permits for cultivation, production, manufacture and research; import and export permissions	Approve prescriptions or register products	Rarely
State or territory health department	S8 approvals; prescribing, dispensing and storage rules; monitoring systems	Register products	Questions about state S8 rules
Ahpra and national boards	Registration and conduct of doctors, nurse practitioners and pharmacists	Regulate products	Concerns about a practitioner (outside NSW and Queensland)
Your pharmacy	Dispenses and counsels	Approve access	Everyday medicine questions

What changed in 2025 and 2026?

TGA review: the TGA consulted on the safety and oversight of unapproved medicinal cannabis from 11 August to 7 October 2025 and received 786 submissions. Its published feedback reported broad agreement that the current access framework is not fit for purpose. It has committed to education for practitioners and consumers; no specific regulatory changes had been announced in that response.
States: WA removed routine state authorisation for most S8 medicinal cannabis on 12 December 2024, and Tasmania began dispensing interstate prescriptions on 16 February 2026.
ODC: the narcotic drugs regulations are due to be remade before 1 April 2027.

Where do patients go with complaints or questions?

Start with your prescriber or pharmacist. Report side effects or suspected advertising breaches to the TGA. Raise concerns about a practitioner with Ahpra, or with the Health Care Complaints Commission in NSW or the Office of the Health Ombudsman in Queensland. Ask your state health department about S8 rules.

A question about your medicine or dose: your prescriber or pharmacist.
A side effect or product problem: tell your prescriber, then report it to the TGA online.
An ad promoting medicinal cannabis: report it to the TGA.
Unsafe or unprofessional care: Ahpra on 1300 361 041. In NSW, the Health Care Complaints Commission (1800 043 159); in Queensland, the Office of the Health Ombudsman (133 646).
State approval or S8 rules: your state or territory health department's medicines and poisons unit.

What do patients often get wrong?

"TGA approved" on a script usually means your prescriber had approval to prescribe an unapproved product, not that the product is registered.
The ODC does not handle patient complaints. Go to the TGA, Ahpra or your state body instead.
A cultivation licence is for businesses, not patients.
Not on the Pharmaceutical Benefits Scheme (PBS): most products are not subsidised, so expect to pay the full cost.

This guide is general information only, not medical or legal advice. Talk to your doctor or pharmacist about your treatment, and to a lawyer if you need legal advice.

Sources

General information only, not medical or legal advice. Medicinal cannabis is a prescription medicine in Australia — talk to your doctor or pharmacist about your own situation.