To address concerns about the safety and quality of medicinal cannabis products available in Australia, the federal government introduced a suite of new manufacturing, labelling, and packaging requirements last Friday (25 March 2022) that apply to medicinal cannabis products.
These changes are the latest in a series of shifts in the regulation of therapeutic goods containing cannabinoids, as legislators aim to keep up with increasing demand and medical research across the world. The Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Amendment Order 2022 (Amendment Order), which commenced yesterday (28 March 2022) provides greater clarity and certainty to patients, medical practitioners, sponsors and manufacturers.
Here, we take a comprehensive look at how the import, supply, sale, advertising and labelling of these increasingly prevalent products are regulated in Australia (and how the Amendment Order fits into this framework).
1. What is medicinal cannabis?
‘Medicinal cannabis’ is a commonly used umbrella term that includes both psychoactive medicinal cannabis (products containing tetrahydrocannabinol (THC)) and products containing only cannabidiol (CBD).
CBD and THC are cannabinoids derived from the cannabis plant but there is a critical difference: CBD does not have the intoxicating effect of THC. The Amendment Order clarifies that all active ingredients or other cannabinoids in a medicinal cannabis product must be from the cannabis plant and must not be modified or transformed in any way – for example, they must not be synthetically-produced.
A number of products containing CBD and THC are approved for therapeutic use. For example:
- low-dose CBD is used to treat anxiety, insomnia and PTSD; and
- products containing THC are used to treat epilepsy, chronic pain, multiple sclerosis and chemotherapy-induced nausea and vomiting.
It is worth noting that a considerable and growing array of medicinal cannabis products not approved for therapeutic use in Australia are currently marketed and sold in other jurisdictions. These include oils, edible gummies, lozenges, capsules, sprays, dried herbs for vaporisation, patches, and creams containing varying concentrations of THC and/or CBD.
2. How is the supply of medicinal cannabis regulated?
2.1 Poisons Standard
The Commonwealth Poisons Standard (Poisons Standard) classifies medicines and poisons into ten schedules according to the degree of control that is exercised over their availability to the public. Each Australian state and territory has adopted the Poisons Standard and the possession, sale and supply of substances listed in the Poisons Standard, including medicinal cannabis, is regulated by local state and territory legislation.
Medicinal cannabis products are included in different schedules of the Poisons Standard:
- Low-dose CBD (at least 98% CBD concentration and 1% or less THC) is included in Schedule 3 (Pharmacist Only Medicines) and is available for over the counter supply – that is, under pharmacist supervision without a prescription;
- Higher-dose CBD (2% or less THC or other non-CBD cannabinoids) is included in Schedule 4 (Prescription Only Medicines) and can only be supplied on prescription; and
- High-dose therapeutic CBD and THC-dominant (up to 98% of either CBD or THC) is included in Schedule 8 (Controlled Drugs), can only be supplied on prescription and is also subject to additional strict requirements relating to production, storage, supply, distribution, possession, and use.
All other cannabis products are included in Schedule 9 (Prohibited Substances) and are prohibited from supply.
Since February 2021, oral dosage forms that contain 1% or less THC may be supplied as Schedule 3 medicines – that is, by pharmacists without a prescription, provided they are sold in packs with no more than 30 days’ supply (with a recommended daily dose of 150mg of CBD per day).
2.2 Regulation as therapeutic goods
Therapeutic goods, including cannabis and products that contain THC and CBD, are also regulated by the Therapeutic Goods Act 1989 (Cth) (TG Act).
A ‘therapeutic good’ is one that is represented to be, or is likely (because of the way it is presented) to be taken to be, for therapeutic use (or for use as an ingredient in the manufacture of therapeutic goods).
‘Therapeutic use’ includes, relevantly, any use in connection with preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury, or influencing, inhibiting or modifying a physiological process in persons (Therapeutic Use).
It is an offence to import, export, manufacture or supply a therapeutic good for use in humans that is not registered on the Australian Register of Therapeutic Goods (ARTG) (or that is otherwise exempt).
Unless one of the exceptions discussed below applies, medicinal cannabis products must not be supplied or offered for supply as therapeutic products, whether over the counter or by prescription, without an ARTG registration.
As of March 2022, there are no Schedule 3 medicinal cannabis products on the ARTG (other than some export only products) however prescription-only medicinal cannabis products are registered on the ARTG (including for the treatment of multiple sclerosis).
Exceptions for foods and external use
Foods containing cannabis sativa seeds and seed products may be sold as an ingredient for food, however CBD must not be present at a level greater than 75mg/kg. Hemp seed oil can also be used “for purposes other than internal” where they contain 50mg/kg or less of cannabinoids and 20mg/kg or less of THC. Those products must be labelled as either “not for internal use” or “not to be taken”.
Subject to these two exceptions, the non-therapeutic use of cannabis and cannabis products (including seeds, extracts, resins and any part of the plant when packed or prepared) is prohibited by Australian state and territory law.
3. Alternative access pathways
Unapproved medicinal cannabis products can, in some limited circumstances, be supplied via an approved pathway for unregistered therapeutic goods. The approved pathways include the Special Access Scheme (SAS) and the Authorised Prescriber Scheme (APS).
Serious illness, clinical justification and established use: via the Special Access Scheme
Under the SAS, particular health practitioners can access unapproved products for a single patient using one of three possible pathways:
- Category A can be accessed by prescribing medical practitioners for patients who are seriously ill with a condition that is likely to cause death within months or in the absence of early treatment. The prescribing practitioner must notify the TGA following supply of a product under the Category A pathway (but does not need to notify the TGA prior to supply).
- Category B enables health practitioners to access unapproved products where there is demonstrable clinical justification. A Category B application must be approved by the TGA before the product can be supplied to a patient.
- Category C applies to therapeutics goods included on a list of products that have an established history of use. The current Category C list does not include any medicinal cannabis products.
Research purposes, established use of product: via the Authorised Prescriber Scheme
Under the APS, authorised medical practitioners can supply unapproved therapeutic goods directly to patients in particular circumstances under their immediate care without patient specific approval. Authorised prescribers can supply via:
- the standard pathway with approval from a human research ethics committee or endorsement by a specialist college; or
- the established history of use. On 22 November 2021, the regulations were amended to reduce the administrative burden for prescribers and allow flexibility in brand substitution. This pathway now permits the supply of the following medicinal cannabis products where the route of administration is oral (in liquid or capsule form) and the indication is for treatment of refractory chronic pain (all categories) or refractory anxiety in adult patients (categories one and two):
- (category one: CBD medicinal cannabis product) products in which CBD comprises at least 98% of the total cannabinoid content (provided any other cannabinoids are naturally found in cannabis and comprise no more than 2% of the total cannabinoid content);
- (category two: CBD dominant medicinal cannabis product) products in which CBD derived from cannabis comprises at least 60% and less than 98% of the total cannabinoid content (provided any other cannabinoids (including THC) derived from cannabis comprise the remaining cannabinoid content); and
- (category three: balanced medicinal cannabis product) products in which CBD derived from cannabis comprises at least 40% and less than 60% of the total cannabinoid content (provided any other cannabinoids (including THC) derived from cannabis comprise the remaining cannabinoid content).
4. Importation of medicinal cannabis products
The Office of Drug Control regulates the cultivation, production, manufacture and importation of medicinal cannabis in Australia. A number of permits and licences are required, and are subject to stringent checks, certifications and controls.
The importation of medicinal cannabis is prohibited unless the importer holds both an import licence and an import permit issued by the Office of Drug Control. A permit is required for each consignment that is imported, whereas licences are issued annually. Importantly, once ARTG registration is obtained, the process for obtaining a licence and permits to import products containing medicinal cannabis is not onerous.
Regarding production and importation, the Amendment Order imposes new requirements, including that imported medicinal cannabis products must be manufactured in accordance with standards for Good Manufacturing Practice (GMP) or equivalent international standards. The manufacturing sites of imported products must also meet local licensing and certification requirements in the country of manufacture. Previously, only medicinal cannabis products manufactured in Australia were required to be manufactured in accordance with GMP requirements (due to the requirement to hold a manufacturing license under the TG Act). This change levels the playing field for Australian manufacturers.
The importation by patients of unapproved medicinal cannabis products is prohibited. However, medical practitioners licenced under customs legislation may import a specific medicinal cannabis product on behalf of a specific patient under the SAS.
5. Advertising and labelling medicinal cannabis products
5.1 No advertising is permitted
Products containing medicinal cannabis, including pharmacist only medicines, must not be advertised to the public. These products may, however, be advertised to health professionals.
Advertising in relation to therapeutic goods is defined broadly and includes any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods. This includes material posted on the internet (including websites and in social media), articles published in newspapers and magazines, photographs, broadcast material, and displays on posters and notices.
Recently, an individual was fined $18,648 for alleged advertising breaches relating to products containing CBD. The individual was responsible for a website that advertised CBD vaping liquid and other CBD products which had not been entered in the ARTG.
5.2 Strict labelling requirements
Labelling of prescription and non-prescription medicines is regulated by the TGA. State and territory legislation also applies to the labelling of medicines and poisons. In particular, ingredients used in therapeutic goods must be named accurately and consistently.
The Amendment Order introduces additional labelling requirements that apply to medicinal cannabis products. Products that are not extemporaneously compounded or repackaged by a pharmacist must be labelled with information including the product name, sponsor details, storage conditions, batch number, expiry date, the name of each active ingredient (and quantities), dosage form and the quantity of the medicinal cannabis product. The labelling requirements for products that are extemporaneously compounded or repackaged by a pharmacist are less onerous, requiring only the name and the quantity of each active ingredient to be included.
The Amendment Order also now requires medicinal cannabis products to comply with child-resistant packaging requirements set out in the Therapeutic Goods Order No. 95.
6. Where to from here?
Australian manufacturers are likely to welcome the harmonisation of manufacturing standards that apply to imported and domestically produced products. Updated labelling and packaging requirements will also give patients and health practitioners additional information and comfort about the contents and formulations of medicinal cannabis products supplied in Australia.
The new requirements introduced by the Amendment Order relating to manufacturing quality, child resistant packaging and labelling will apply to medical cannabis products released for supply in Australia from 1 July 2023. Sponsors have until 1 July 2023 to ensure that their medicinal cannabis products comply with the new requirements. Manufacturers and sponsors should make the most of this time to review their manufacturing processes and product labels to ensure compliance.
The regulation of medicinal cannabis is an area undergoing regular reform – our team has experience advising on the legal framework applying to medicinal cannabis and can assist clients navigate these complex and frequently changing regulations.
 This includes practitioners who are registered or licensed to practice a health profession.