Can U Bring CBD Oil Into Australia

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You’ve probably met its mate, delta-9-tetrahydrocannabinol (aka THC aka the one that makes you high) but what about CBD? Can you travel to Australia with lawfully prescribed medical marijuana? It depends on which government department you ask. To address concerns about the safety and quality of medicinal cannabis products available in Australia, the federal government introduced a suite of…

What’s the deal with getting and using CBD oil in Australia?

What you and your mates potentially know as CBD oil is actually cannabidiol, a compound found in cannabis/word you’ll probably have to try pronounce at least twice.

You’ve probably met its mate, delta-9-tetrahydrocannabinol (aka THC aka the one that makes you ≋h≋i≋g≋h≋) but CBD will not get you stoned. (Unless you’ve got it from somewhere slightly dodgy and you’re not 100% sure about the THC content).

So to be clear, CBD is used for medical reasons and NOT Reefer Madness. What kind of medical reasons? According to Dr Iain McGregor, Professor of Psychopharmacology, “It’s more a case of what it doesn’t do rather than what it does.”

What’s CBD good for?

It was first discovered in the 50s and 60s (in modern times) and was basically thought to be useless, says the Doc. That was, until the 70s, when we rediscovered its antiepileptic effects. But it really wasn’t until the past four or five years that there’s been a real increase in awareness and research.

“It’s become this almost universal panacea,” says Dr Iain. Depending on who you ask, CBD oil is good for what ails you, whether that be anxiety, anorexia, insomnia, PTSD, chemotherapy-induced nausea and vomiting, depression, migraines, or feeling chronically unchill.

Neuropharmacologist, University of Wollongong lecturer and Associate Investigator with ACRE, Dr Katrina Green, also notes that after 12,000 years of interaction between humans and cannabis, our understanding of this plant is still very much in its infancy.

“CBD is obviously pretty important. Its anti-inflammatory capacity and its ability to protect the brain is evident in almost every study that you pick up.”

She finds these anti-inflammatory effects, even in low doses of cannabidiol, especially exciting since inflammation kind of underlies everything. “Low levels of inflammation are involved in body weight gain, if you pull a muscle. there’s such wide ranging benefits to anti-inflammatories.”

“There’s evidence, particularly in illnesses of the brain, that it does work,” she says. So depression, anxiety, ADHD, tourettes, PTSD, different aspects of psychosis — for those type of things the evidence consistently shows that there’s benefits. CBD is not as great with pain, she says, because you kind of need THC to get any pain benefits.

But CBD research takes money, something which scientists are notoriously short on. And ideally they’d be able to grow their own products here to research but that would take less regulation, something which governments are notoriously fond of.

So, what’s legally available in Australia?

As of 2015 CBD oil is legal in Australia, as long as it contains at least 98% cannabidiol and 2% or less of other cannabinoids found in cannabis. When compared to a lot of other countries, like the US, Canada, Japan, Germany, Switzerland, UK, Netherlands, we’re quite behind.

“Surprisingly the government — particularly the Therapeutic Goods Administration (TGA), which regulates how drugs are marketed and available to consumers — seem to be listening,” says Dr Iain.

CBD has recently changed from Schedule 4 (prescription only) to Schedule 3, which means you should be able to get low dose CBD (max.150 mg daily dose) over the counter at your local pharmacy.

However, there are currently no TGA approved products on the Australian Register of Therapeutic Goods (ARTG) that meet the Schedule 3 criteria. And that process of approval could take years.

How do you actually get CBD oil?

“CBD got caught up in the whole medical cannabis legalisation thing that happened from late 2016,” Dr Iain explains. As part of that, there was a “torturous process” set up for Australians to access CBD, whereby you had to go through a doctor, hope said doctor is educated about CBD and is in favour of its use, then persuade them that CBD is right for you, then they would need to write a complicated application and send that off to Canberra to the TGA who would then decide either way.

The difference now is that Authorised Prescribers (AP) don’t need to apply to the TGA via the Special Access Scheme (SAS), they can write you a prescription on the spot. These APs can be either specialists or a GP, but there’s no full list right now, so your best bet is to start making some enquiries.

Of course, if you do go that route, there’s the issue of cost, which is prohibitive for a lot of people. Sitting at about $10-$15 a day, “you’d probably find it’s cheaper to grow your own (and a lot of people do).”

As of 2020, out of the approvals issued in total in over three years, Dr Iain estimated that about 20,000 patients gained access legally (when you take into account the prescription renewals throughout that time). “And there’s probably 10 times more people — certainly from our surveys — that are accessing illicit cannabis and self-medicating.”

So yeah, the government and researchers are well aware that a lot of people in Australia are opting to bypass the current system and spend their money offshore, buying online from places like Canada and the US. But there are signs that prices will go down, since obviously there’s an increasingly competitive market for it.

Already there’s countless overseas companies taking an interest in selling to Aussies. “They see it as perhaps the fastest growing market in the world, even though it’s a small population the numbers add up,” says Dr Iain.

“The main thing we need is a really vibrant domestic market. It grows particularly well in Australia — the stuff just jumps out of the ground!”

The good news in all of this, agree both experts, is that that strict regime tends to ensure high quality control of the product. “By being careful and quite well regulated the Australian scheme is probably going to give rise to very good products that will have a lot of export potential,” says Dr Iain. “The unfortunate thing is, Australian consumers are having to wait a very long time to get these products and at a reasonable price.”

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On top of that, your average over the counter product that’ll be available here will have relatively low concentrations of CBD. So, if you’re getting an oil that has maybe 30 milligrams per mil, your average daily dose is probably less than 100 milligrams of CBD. However, clinical trials and research suggest that effective doses for things like anxiety and psychosis tend to be a lot higher, they tend to be up around 500-1000 milligrams, which causes Dr Iain beg the question: “Even if we get the over the counter products available in Australia, will they actually be any good?”

Should you believe the hype?

Dr Iain says to “watch the hype.” He points to when cocaine was first invented, when they thought it would be a great cure for opium addiction and you could just chuck it in any old fizzy drink. “You always get this huge hype [around new drugs] and you do have to let research run its course. Big clinical trials take several years so complete; five years from now we’ll know a lot more about CBD and it’s potentials and limitations.”

There’s also the placebo effect to consider, so after weeks of use the shine may wear off and the expenditure may seem less worth it.

“The hype is almost certainly wrong. The idea that it’s just a placebo is almost certainly wrong, as well. So the truth is somewhere in between. What we have to do as scientists is work out what that truth actually is.”

As a neuroscientist, Dr Katrina is particularly interested in the developing brain and the short term and long term effects of cannabidiol use on it. “A lot of people say that CBD is non-psychoactive but psychoactive is defined as something that interacts with the brain and changes behaviour. Now that applies to THC, alcohol, heroin, whatever. CBD is absolutely psychoactive, it’s just psychoactive in a good way.”

“What is concerning. as CBD becomes more available companies will inevitably jump on board to try and make a dollar out of it. This is the hype that I’m concerned about,” she says.

Especially when it comes to younger brains and an increasingly casual use of cannabis products, Dr Katrina advises: “Just remember cannabidiol is a medicine.”

“We’re saying that it’s beneficial for all of these illnesses, it’s not just a wellness substance like a vitamin C.” She recommends only taking it if you actually need to for genuine dysfunction or illness, not as a supplement, and to exercise “a little bit of caution when ordering things from overseas or using as a daily tonic”

Can You Travel to Australia With Medical Cannabis?

If you live in one of the 28 American states that have legalized medical cannabis and are planning a trip Down Under to celebrate, you might be wondering about the state of Australia’s cannabis laws. Medical marijuana, as you may have heard, is federally legal in Australia now, albeit in a restricted scope. But can you travel to Australia with lawfully prescribed medical marijuana? It might depend on which Australian government department you ask.

According to Australia’s Department of Immigration and Border Protection, you do not need a permit to bring in most prescription medicines even if they contain a controlled substance—although you should carry your prescription. The department’s advice indicates some exceptions to that rule, including steroids and thalidomide, but doesn’t mention medical cannabis. Elsewhere, however, DIBP explicitly states that “marijuana and cannabis” are prohibited substances which cannot be brought into Australia.

The Office of Drug Control has a different view: Despite cannabis being prohibited, “travellers with Sativex and CBD oil should email [email protected] to clarify whether they can travel with their medication,” the office advises. Sativex is the brand name of a cannabis extract, one of the only cannabis-based medicines registered in Australia. CBD oil refers to oil containing cannabidiol, a cannabinoid extracted from cannabis.

So if you have a prescription for Sativex or a doctor’s recommendation for CBD oil, can you bring that in? Leafly asked Australia’s Department of Health, which oversees the Office of Drug Control, to clarify. We received a response from a spokesperson of yet another government department, the Therapeutic Goods Administration.

A Therapeutic Goods Administration spokesperson said travelers to Australia (including Australian residents) with a valid prescription may carry up to a three-month supply of a CBD product into Australia. But beware trying to bring THC. The spokesperson was emphatic that “Cannabis plant material (e.g. flowers, leaves) or products containing THC are not permitted entry with travellers to Australia.”

In other words, the only kind of cannabis you can safely bring into Australia (after politely emailing the government to let them know) is CBD oil. Bringing in unprocessed cannabis with any THC, even if you have a lawful prescription—and even though medical cannabis is “legal” in Australia—will likely land you in hot water at the airport. You’d probably have better luck bringing in an invasive species of cane toad.

For Australian border control, there’s no distinction between cannabis legally prescribed by an American doctor for pain and cannabis smuggled in for black-market sale. That view seems like a bit of a double standard given that other prescription drugs with street market value are not treated with the same aggressive approach.

Prescription drug abuse was declared a national emergency by the Australian Medical Association last year, yet the government still seems to be more concerned with travelers bringing small amounts of lawful, prescribed cannabis into the country. If Australia wants to genuinely recognize cannabis as a medicine, it’s still got a long way to go.

Another important factor to consider when traveling with medical cannabis is where you’re your plane might stop. Flying into Australia may mean a stopover in a country like Singapore, for example, which has some of the harshest drug penalties in the world. The narcotics officers who patrol Changi airport can require anyone they reasonably suspect of drug use to submit to a urine test. A positive test could lead to prosecution in a country that has reversed the burden of proof for many drug offenses—and where some cannabis crimes even carry a death penalty.

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How are rules for medicinal cannabis and CBD products in Australia changing?

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[1] 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.
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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):
    1. (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);
    2. (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
    3. (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.

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