Cannabis based product for medicinal use: What changed in UK law on 1 November 2018

Written By As Prescribed

On 1 November 2018 the law changed so that specialist doctors in the UK could prescribe cannabis as a medicine. This is an overview of what happened, and what it did and did not change.

It is often called the day cannabis was legalised. It was not. Cannabis remains a controlled drug, and possessing it without a prescription is still a criminal offence.

In short

  • Cannabis is now recognised as having a medical use. A defined category of product — a cannabis-based product for medicinal use in humans, or CBPM — can be lawfully prescribed, possessed and supplied, under the same kind of controls that apply to morphine.

  • Without a prescription, cannabis is still an illegal drug. It remains a Class B controlled drug under the Misuse of Drugs Act 1971, and possession is a criminal offence. The 2018 change did nothing to that.

  • Nobody gained a right to be prescribed it. The change made prescribing possible, not automatic.

  • Only a specialist can start a prescription — a consultant on the Specialist Register held by the GMC (the General Medical Council, the regulator for doctors), not a GP.

  • Almost every product is unlicensed, so the prescriber carries more of the responsibility personally. That is an ordinary, long-established mechanism used across medicine.

  • NHS prescribing is very small. Almost all UK prescribing happens privately.

  • Smoking a CBPM is prohibited by name in the regulations. Vaporising is allowed, and a health minister confirmed so in Parliament in December 2025.

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The law that changed

On 1 November 2018, cannabis went from a drug that could not lawfully be used as a medicine in the UK at all, to one a doctor could prescribe.

Before that date it sat in Schedule 1 — the list for substances with no recognised medical use. Nothing in Schedule 1 can be prescribed, and even researching it requires a Home Office licence.

The change was a narrow one. A new set of regulations created a category — a "cannabis-based product for medicinal use in humans", usually shortened to CBPM — and moved products meeting that definition into Schedule 2, alongside morphine and other controlled medicines that doctors prescribe every day. ‍

Those regulations were the Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018 — SI 2018/1055 — made on 9 October 2018, laid before Parliament on 11 October, and in force from 1 November. Northern Ireland was dealt with by a separate instrument on the same timetable.

To count as a CBPM, a product has to meet three requirements. The Home Secretary set them out in his statement to Parliament:

"It needs to be a preparation or product which contains cannabis, cannabis resin, cannabinol or a cannabinol derivative; It is produced for medicinal use in humans and; Is a medicinal product, or a substance or preparation for use as an ingredient of, or in the production of an ingredient of, a medicinal product"

So what turns cannabis into a medicine is not the plant itself. The first requirement is met by any cannabis at all. It is the second and third that do the work: what the product is made for, and whether it meets the legal test of a medicinal product.

That test lives in a different set of rules — the Human Medicines Regulations 2012 — which define a medicinal product as either:

"any substance or combination of substances presented as having properties of preventing or treating disease in human beings"

or

"any substance or combination of substances that may be used by or administered to human beings with a view to — restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or making a medical diagnosis"‍ ‍

Both limbs are about purpose and presentation, not composition. Cannabis grown for the illicit market and cannabis grown for a prescription can be the same plant, with the same chemistry. What separates them in law is that one is produced for medicinal use and presented and supplied as a medicine, and the other is not.

Anything failing the definition, as the statement puts it, "will remain a Schedule 1 drug and only be available under a Home Office licence."

The Home Office circular sets out that definition and the controls that come with Schedule 2. It says nothing about how a CBPM must be manufactured, or to what quality standard.

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What did not change

Cannabis was not legalised. It was not decriminalised. Possessing cannabis without a prescription remained, and remains, a criminal offence. What changed is that a specific category of product, prescribed by a specific kind of doctor, became lawful to possess and use.

The change also didn't create any right to be prescribed. It made prescribing possible, not automatic.

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How the law actually works

Two separate bodies of law apply to a medicine made from cannabis. Most of the confusion around this subject comes from mixing them up.

Drug control law decides what is criminal. The Misuse of Drugs Act 1971 makes it an offence to possess, supply or produce a controlled drug, and sorts those drugs into Classes A, B and C, which set the penalties. Cannabis is Class B, and has been since the Act came in.

The same Act then provides its own way out. Section 7 lets the government make regulations excepting drugs from those offences, and requires those regulations to make it lawful for a doctor to prescribe, and a pharmacist to supply, a controlled drug when acting in that capacity. The regulations doing that job are the Misuse of Drugs Regulations 2001, and they sort the same drugs into five schedules, numbered 1 to 5, by how tightly access should be controlled. Schedule 1 is the most restricted; Schedule 5 the least. The number is not a measure of how dangerous a drug is.

So the class sets the penalty. The schedule sets whether a doctor can reach it at all. ‍

Medicines law decides what can be sold and prescribed as a medicine. That is the territory of the Medicines and Healthcare products Regulatory Agency — the MHRA — the body that licenses medicines in the UK, and it runs on licensing. A manufacturer submits trial data, and a licence — a marketing authorisation — sets out what the medicine treats, at what dose, and for whom. A product with no licence can still be prescribed, through a long-established route, but more of the responsibility then sits with the prescriber.

The 2018 change was made in the first system so that cannabis could enter the second.

Schedule 2 is where controlled drugs that do have a recognised medical use sit. It permits a drug to be lawfully imported, exported, produced, possessed, supplied and administered — none of which is possible in Schedule 1. The Home Office circular issued alongside the change lists the controls that come with it — "Safety Custody", "Prescription requirements", "Marking bottles", "Mandatory requisition forms", "Record keeping" and "Destruction" — and states that cannabis-based products for medicinal use "remain subject to the strict requirements of Schedule 2 to the 2001 Regulations."

The word "Schedule 2" does double duty here. Cannabis is a Class B drug, and Class B is Part II of Schedule 2 to the Misuse of Drugs Act 1971 — the Act's list of controlled drugs, divided up by class, which is what sets the penalties. That is a different thing entirely from Schedule 2 of the Misuse of Drugs Regulations 2001, which governs what may be prescribed and under what controls. Cannabis sits in the Act's Schedule 2 as a Class B drug. CBPMs sit in the Regulations' Schedule 2 as a prescribable medicine.

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How it came about

Two families are usually credited with forcing the issue, and both involved children with severe, treatment-resistant epilepsy.

Alfie Dingley was six years old and had been having frequent seizures. His family had moved to the Netherlands to access a cannabis-based treatment, and on returning to the UK campaigned to be allowed to continue it.

Billy Caldwell was twelve. In June 2018 his mother, Charlotte Caldwell, travelled to Canada to obtain cannabis oil for him and it was confiscated on arrival at Heathrow. Billy was subsequently admitted to hospital.

Both were resolved the same way — an individual Home Office licence, issued case by case. Billy's came on 16 June 2018, announced by the Home Secretary, Sajid Javid:

"This morning, I've used an exceptional power as Home Secretary to urgently issue a licence to allow Billy Caldwell to be treated with cannabis oil."

Three days later he went considerably further. On 19 June 2018 he made a statement to the House of Commons. In it he confirmed a licence for Alfie as well — "the Policing Minister also spoke to Alfie Dingley's mum Hannah Deacon, and informed her that we will issue a licence for Alfie later today" — and announced a review.‍ ‍

Granting licences one child at a time had answered two emergencies; it could not answer the question underneath them, which was whether cannabis should be capable of being prescribed at all. His reason was blunt:

"the position that we find ourselves in currently is not satisfactory. It's not satisfactory for the parents, it's not satisfactory for the doctors, and it's not satisfactory for me."

He was equally clear about what it was not:

"this step is in no way a first step to the legalisation of cannabis for recreational use. This government has absolutely no plans to legalise cannabis and the penalties for unauthorised supply and possession will remain unchanged."

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The review

The review came in two parts, and both recommended the same thing.

Part one was carried out by Professor Dame Sally Davies, then Chief Medical Officer, and reported in June 2018. She found "conclusive evidence of the therapeutic benefit of cannabis based medicinal products for certain medical conditions", and "reasonable evidence of therapeutic benefit in several other medical conditions". Her recommendation was that "cannabis based medicinal products are moved out of Schedule 1 of the Misuse of Drugs Regulations 2001". Leaving them there, given the evidence, was in her words "very difficult to defend".

Part two was carried out by the Advisory Council on the Misuse of Drugs — a statutory body set up under the Misuse of Drugs Act 1971 to advise government on the control of drugs. It advises; ministers decide. Its chair, Dr Owen Bowden-Jones, wrote to the Home Secretary on 19 July 2018. The ACMD agreed the products should move to Schedule 2 — but attached a condition that shaped everything that followed. Nobody had yet defined what a cannabis-derived medicinal product actually was. They asked the Department of Health and the MHRA to "promptly develop a clear definition", and advised that "only products meeting this definition be moved into Schedule 2 of the MDR pending our further advice." They also asked for frameworks and clinical guidance providing "checks and balances" to keep prescribing safe.

Meanwhile there was an immediate problem. The review would take months, and until it concluded cannabis was still in Schedule 1 — so nothing could be prescribed to anyone. The only lawful route was an individual Home Office licence, granted case by case, which is what Alfie Dingley and Billy Caldwell had been given.

So on 27 June 2018 the government opened an expert panel of clinicians, chaired by Dr Michael McBride, Chief Medical Officer for Northern Ireland. Senior doctors could apply to it on behalf of a named patient, and the panel would recommend whether a licence should be granted, with ministers deciding within two to four weeks. It was explicitly "an interim measure while the review is ongoing", and it was wound up once the regulations came into force and licences were no longer the only way in.

The formal announcement of the change came in a written ministerial statement on 11 October 2018.

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Who can prescribe

Unlicensed cannabis-based medicines may only be prescribed by a doctor on the General Medical Council's Specialist Register. In practice that means a consultant, not a GP.

A GP can be involved after that first prescription. The regulations refer to the prescription or direction of a specialist medical practitioner, and guidance published in 2019 by NICE, the National Institute for Health and Care Excellence, allows subsequent prescriptions to be issued by another prescriber under a shared care arrangement. So the consultant makes the initial decision, and a GP can carry it on from there — though in practice this is uncommon.

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Why almost everything is "unlicensed"

"Unlicensed" sounds like a warning. It is the mechanism that makes prescribing possible at all.

A licensed medicine is one the MHRA has assessed and approved for a particular use, based on clinical trial data submitted by the manufacturer. The licence sets out what it treats, at what dose, for whom.

There are two ways a doctor can go beyond that, and they're often confused.

Off-label is using a licensed medicine outside the terms of its licence. The MHRA describes it as "use of a licensed medicine outside the terms defined by the licence (eg, outside defined indications, doses, routes of administration, or contrary to listed warnings)". The medicine itself has been approved — it's just being used for something else.

Unlicensed is different and goes further. The product has no marketing authorisation — the formal approval that makes something a licensed medicine in the UK. It has never been submitted to the MHRA, assessed, and approved for treating anything. These are prescribed through what the MHRA calls the "specials" regime, used "when no licensed suitable alternative is available".‍ ‍

Most cannabis-based medicines in the UK are unlicensed, not off-label. They have not been through the approval process, so there is no licence to be outside of.

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This is ordinary, not exceptional

Prescribing unlicensed and off-label medicines is a normal, long-established part of medical practice with its own regulatory framework. It is routine in paediatrics, in palliative care, and in rare conditions — anywhere a licensed product doesn't exist or doesn't fit the patient in front of the doctor. The GMC has published standards for it, the MHRA has published guidance on it, and pharmacies dispense against it every day.

What is notable about cannabis is not that an unusual mechanism was invented for it. It's that this ordinary mechanism is what allows it to be prescribed at all — because so few cannabis-based products have been through licensing.

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What it means for the prescriber

The trade-off is responsibility. With a licensed medicine, the manufacturer has done the trials and the regulator has approved the use. With an unlicensed one, the prescriber carries more of that weight personally. ‍

The GMC's standards say that a doctor proposing, prescribing or providing an unlicensed medicine must:

"be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy"‍ ‍

"take responsibility for prescribing the medicine ... and for overseeing the patient's care, monitoring and any follow up treatment (or make sure that arrangements are in place for another suitable medical professional to do so)"

"make a clear, accurate and legible record of all medicines prescribed and, where you are not following common practice, your reasons for prescribing an unlicensed medicine."

That is part of why prescribing is restricted to specialists, and part of why it can feel harder to obtain than an ordinary prescription.

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The three that are licensed

‍ Three cannabis-related medicines are licensed in the UK.

Sativex is a mouth spray for spasticity in multiple sclerosis, approved by the MHRA on 16 June 2010. Its licence is narrower than it is usually described. It covers adults with moderate to severe MS spasticity "who have not responded adequately to other anti-spasticity medication" and who show a clear improvement during an initial trial of it.

Epidyolex is an oral solution of purified cannabidiol, for certain rare and severe epilepsies. It was approved by the European Commission on 19 September 2019, at a point when EU authorisations still took effect in the UK.

Nabilone is synthetic rather than made from the plant. It is licensed for nausea and vomiting caused by cancer chemotherapy, in patients "who have failed to respond adequately to conventional antiemetic treatments".‍ ‍

The first two are written into the regulations, and taken out of the CBPM category. The definition of a CBPM excludes any product "to which paragraph 5 of part 1 of Schedule 4, or paragraph 10 of Schedule 5, applies" — and those two paragraphs describe Sativex and Epidyolex without naming either. They do it by formulation, concentration and approval date: paragraph 5 covers a mouth spray "approved for marketing by the Medicines and Healthcare Products Regulatory Agency on 16th June 2010", and paragraph 10 an oral solution "approved for marketing by the European Commission on 19th September 2019". Nabilone is listed separately, by name, in Schedule 2.

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The NHS position

NICE decides what the NHS should use. It does not license medicines — that is the MHRA's job — and it does not make law. It weighs the evidence for a treatment and recommends whether the NHS should offer it, and that judgement includes what it costs. NICE describes its own purpose as helping "practitioners and commissioners get the best care to patients, fast, while ensuring value for the taxpayer." So a decision not to recommend something can rest on weak evidence, on cost, or on both.

NICE published guidance on cannabis-based medicinal products in November 2019. It recommended them for a small number of specific situations, and did not recommend them for chronic pain, citing insufficient evidence.

NICE guidance is advisory, even inside the NHS. NICE describe their clinical guidelines as "advisory rather than compulsory, but should be taken into account by healthcare and other professionals when planning care for individual patients", and say the guidance "does not override the responsibility of healthcare professionals and others to make decisions appropriate to the circumstances of each patient."

The harder constraint is money, and it turns on which kind of guidance this is. Where NICE issues a technology appraisal, the NHS is "legally obliged to fund and resource" the treatment, and must make it available "within 3 months". The 2019 cannabis guidance is not a technology appraisal. It is a NICE guideline — NG144 — and no funding duty attaches to it. So an NHS clinician is not forbidden from prescribing; what is absent is any obligation on the NHS to pay for it, and that decision is made locally.

‍And none of it binds private practice. A private prescriber is not making an NHS commissioning decision, so a NICE recommendation against NHS use does not stop a private prescription being written. They remain bound by the law and by GMC standards — but not by NICE's view of what the NHS should fund. It is why a condition NICE did not recommend for NHS use can still be treated privately.

The result is that NHS prescribing of unlicensed cannabis medicines is very small, and almost all UK medical cannabis prescribing happens privately. The sector operates, in Prohibition Partners' description, "almost entirely outside the NHS through a network of more than 40 private online clinics".

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How many patients are there

You'll see very different figures quoted — 60,000 in one place, 140,000 in another.

Prescriptions are counted. Patients are not. Almost all of this prescribing is private, but the NHS still sees it. Private prescriptions for Schedule 1, 2 and 3 controlled drugs are written on a dedicated form — the FP10PCD — and pharmacies must send them to the NHS Business Services Authority every month, "no later than the fifth day of the month following which they were supplied." That is where the dispensing figures below come from, even though the NHS neither prescribed nor paid for any of it.

What that does not produce is a headcount. It records items dispensed, not people, and one patient may receive several products across several appointments in a year. As the Cannabis Industry Council put it in May 2026, "there is currently no official UK-wide patient count published by government". Every patient figure below is an estimate built on top of the dispensing data.

The lower figure. Research published on 15 May 2026 by Plantz and Cannavec.ai, built on NHSBSA dispensing data alongside estimates from the Medical Cannabis Clinicians Society, the Cannabis Industry Council, Prohibition Partners and Cannamonitor, estimates:

  • 60,000–75,000 active patients as of mid-2026

  • 75,000–90,000 peoplewho received a prescription at some point during 2025

  • around 95,000 people prescribed cumulatively since legalisation in November 2018

They publish their full methodology, and they deliberately give ranges rather than a single number "to reflect the limitations of the available data and avoid overstating precision".

The higher figure. Prohibition Partners, in their UK Medical Cannabis Market Update 2026, estimate that more than 140,000 people will be prescribed medical cannabis during 2026, up from around 100,000 the year before.

Most of that gap is definition. One is a snapshot of people on treatment at a given moment; the other counts everyone prescribed at any point across a whole year, which will always be the larger number.

The growth is not in doubt, whichever count you prefer. NHSBSA records show private cannabis items rising from negligible levels in 2019 to 282,920 in 2023 and 659,293 in 2024, and past a million a year by 2025. Imports roughly doubled in a year, from 14,992 kg in 2024 to 30,061 kg in 2025, and the number of cannabis-based medicines available to UK patients went from 374 to 818 over the same period.

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One rule about how it may be taken, and why

S‍moking cannabis with a prescription is banned. The regulations include a specific provision, at regulation 16A(3) of the Misuse of Drugs Regulations 2001:

"A person shall not self-administer a cannabis-based product for medicinal use in humans by the smoking of the product (other than for research purposes in accordance with regulation 13)."

‍What Parliament was told. The only statement made to Parliament about the smoking prohibition was in the Home Secretary's written ministerial statement of 11 October 2018:

"I have been consistently clear that I have no intention of legalising the recreational use of cannabis. To take account of the particular risk of misuse of cannabis by smoking and the operational impacts on enforcement agencies, the 2018 Regulations continue to prohibit smoking of cannabis, including of cannabis-based products for medicinal use in humans."

‍The reasons given are the risk of misuse and the practical effect on enforcement.

What clinicians were told. Three weeks later, on 31 October 2018, a joint letter went out to clinicians from Professor Dame Sally Davies, the Chief Medical Officer, together with Professor Stephen Powis, National Medical Director of NHS England, and Dr Keith Ridge, Chief Pharmaceutical Officer. It said:

"The health harms of smoking are clear, therefore the regulations prohibit both the prescription and self-administration of a cannabis-based product for medicinal use in humans by way of smoking other than for research purposes, and patients should be informed of the health risks associated with such use."

‍Where it came from. The recommendation originated with the Advisory Council on the Misuse of Drugs, in a letter of 11 September 2018: "The ACMD does not anticipate that smoking will be a permissible route of administration of a CDMP as there is evidence of harms associated with smoking Cannabis." The evidence cited for that sentence was a single footnote: Lee, M. and Hancox, R. J. (2011), 'Effects of smoking cannabis on lung function', Expert Review of Respiratory Medicine, 5:4, pp 537–547. One paper, on lung function, about smoking.

The explanatory memorandum published alongside the regulations gives both reasons together, adding: "There was also a concern that permitting smoking of cannabis-based products for medicinal use would make it significantly more difficult to enforce existing offences on the recreational use of cannabis."

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What the documents say about vaporising

‍The prohibition in regulation 16A(3) applies to smoking. Official documents distinguish vaporising from it.

‍A health minister, Dr Zubir Ahmed, confirmed the position in a written answer on 1 December 2025. He was asked by James MacCleary MP whether prescribed medical cannabis might be used within NHS buildings, and replied:

"The law was amended in 2018 to permit specialist doctors to prescribe unlicensed cannabis-based products for medicinal use. While smoking these medicines is banned, vaping and other forms of administration are not prohibited."

In practice, vaporising is the normal route for a dried flower prescription, and it is what UK clinics recommend to their patients.

One point of process about the regulations, for anyone reading the regulations themselves. They were made under the negative resolution procedure, which means they were not debated in Parliament. The explanatory memorandum records, at paragraph 10.3, that "A full public consultation was not undertaken due to the need to ensure access to these products was made possible at the earliest opportunity." What consultation there was, the memorandum says, was with the Chief Medical Adviser, the ACMD and the MHRA.

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What happens next

‍The Advisory Council on the Misuse of Drugs was asked in June 2025 to review whether the 2018 change has had its intended effect. Its call for evidence ran from 17 September to 17 October 2025 and is now closed.

There is no published date for the report. Asked in Parliament on 25 November 2025 when the review would be completed and published, the Home Office minister Sarah Jones said the ACMD "is an independent scientific advisory body and determines its own procedures", while noting that "the three-year Ministerial commission for 2025 – 2028 flagged the CBPM commission as a priority". She confirmed the government's response "will be published on gov.uk".

The same answer sets out what the ACMD has been asked to do: "review the evidence on CBPMs and assess whether the legislative change in 2018 has had the desired effect and whether there have been any unintended consequences."

We will update this page when it reports.

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Who's who

The bodies named on this page, and what each actually does:

The MHRA— the Medicines and Healthcare products Regulatory Agency. It regulates "medicines, medical devices and blood components for transfusion in the UK", and its job includes ensuring they "meet applicable standards of safety, quality and efficacy". This is the body that licenses a medicine, and it sits within government.

NICE— the National Institute for Health and Care Excellence. It assesses evidence and produces guidance on what treatments work and represent value, describing its purpose as "to help practitioners and commissioners get the best care to patients, fast, while ensuring value for the taxpayer." NICE does not license medicines and does not make law. It advises on what should be used, and NHS bodies are expected to take its guidance into account.

The GMC — the General Medical Council. The regulator for doctors. It keeps the registers of who is licensed to practise, sets professional standards, and can remove a doctor's licence.

The ACMD — the Advisory Council on the Misuse of Drugs. A statutory body established under the Misuse of Drugs Act 1971 to advise government on the control of drugs. It advises; ministers decide.

NHS England — responsible for how the NHS in England commissions and delivers care. Its guidance shapes NHS prescribing, not private prescribing.

In one line: the MHRA licenses, NICE advises on use, the GMC regulates doctors, the ACMD advises on drug law, and Parliament makes the law itself.

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Sources

The law itself

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What was said, and when

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Patient numbers

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The three licensed medicines

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Guidance and standards

On the ACMD's single reference: Lee, M. and Hancox, R. J. (2011), 'Effects of smoking cannabis on lung function', Expert Review of Respiratory Medicine, 5:4, pp 537–547.

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General information, not medical or legal advice

As Prescribed sells equipment. We are not a pharmacy, a clinic or a prescriber, and nothing here is medical advice. Nor is it legal advice. This article is general information about how the law changed and what it says.

For anything about your medication, your dose or your condition, speak to your prescribing clinician or your dispensing pharmacy. For anything about your own legal position, take proper advice.

We set out what we know so you can weigh it up, check it against your own sources, and decide for yourself what suits you.

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