If you walk into a modern medical cannabis cultivation facility in the UK, the first thing that strikes you isn’t the plants themselves. It’s the precision. Stainless steel. Climate-controlled rooms. Full PPE. Every part of the process is logged, monitored, and inspected under the watchful eye of EU GMP, the pharmaceutical gold standard for manufacturing medicines.
On the surface, it looks exactly like the production line for any other prescription medicine. And yet, there’s a paradox. Despite the rigorous controls and the EU GMP stamp of approval, medical cannabis in the UK remains what regulators call an unlicensed medicine.
This is where things get complicated… and often misunderstood.
EU GMP, after all, is about how an Active Pharmaceutical Ingredient/medicine is made; the cleanliness of the facility, the precision of the processes, the consistency of the product from one batch to the next. It tells patients and doctors that what’s in the jar is safe and of appropriate quality. What it doesn’t do is say anything about the medical or therapeutic effects. Medical claims can only be stated when the medical product has been through the full clinical trials process needed for a marketing authorisation, the licence that allows a pharmaceutical company to promote a medicine as safe and effective for a specific condition.
Cannabis-based medicinal products (CBPMs) largely haven’t gone through that full process yet in the UK, aside from a few examples like Sativex, Epidiolex and Nabilone (synthetic). That’s why CBPMs sit in this unusual regulatory space; manufactured to pharmaceutical standards, prescribed legally by doctors under certain conditions, but officially classed as unlicensed.
But here’s the thing many people don’t realise… this isn’t unique to cannabis.
Across the NHS, clinicians routinely use unlicensed or off-label medicines where it’s in a patient’s best interest; particularly in paediatrics, psychiatry and palliative care. Hospital pharmacies often supply “specials” (made-to-order formulations), for example liquid medicines for children when no suitable licensed liquid exists. During the first phase of COVID-19, remdesivir reached patients via the Early Access to Medicines Scheme ahead of full licensing. Melatonin shows how nuanced this can be: a prolonged-release brand (Slenyto) is licensed for insomnia in 2–18-year-olds with autism/Smith–Magenis syndrome; outside those products or indications, melatonin use is off-label or unlicensed.
Off-label prescribing is also common more broadly. Semaglutide (Ozempic) was widely sought for weight loss before Wegovy gained NICE-backed approval, and amitriptyline (licensed for depression) is routinely used at low doses for neuropathic pain. In each case, doctors balance the evidence, guidance and governance to meet clinical need when licensed options don’t fit. PMC+6GMC UK+6SPS – Specialist Pharmacy Service+6
Some medicines do have full marketing authorisation, but only for one specific condition, even though doctors may prescribe them for others.
For patients, these distinctions can feel like technicalities. But for companies and doctors, they change almost everything.
Because these medicines are unlicensed, they can’t be marketed the way licensed medicines can. There are no glossy adverts. No promotional campaigns saying “this product treats this condition”. Instead, companies focus on education, funding real-world evidence studies, running training sessions for clinicians and providing an environment where clinicians can share their own clinical experiences and knowledge with colleagues, to further expand their understanding of medical cannabis treatments. The line between information and promotion is carefully drawn, and crossing it carries real regulatory risk.
The prescribing side is just as complex. Because cannabis is unlicensed, GPs rarely prescribe it. Instead, it falls to specialist consultants who must be satisfied that no licensed alternative meets the patient’s needs. Each prescription requires clinical justification, and with it comes a degree of professional responsibility that goes beyond writing a script for a licensed medicine.
So we end up in this curious situation; pharmaceutical-grade production on one side, but limited awareness and access on the other. Patients often ask, “If it’s made to the same standard as other medicines, why can’t my doctor just prescribe it?” The answer lies in this gap between manufacturing approval and licensing, between making a medicine safely and proving, through the highest levels of evidence, that it works for a specific condition in a specific way.
“If it’s made to the same standard as other medicines, why can’t my doctor just prescribe it?”
That’s changing, slowly. More real-world evidence is emerging. Clinical trials are starting to build the data regulators need to feel confident granting full marketing authorisation. Until then, medical cannabis in the UK will remain in this unusual middle ground; tightly controlled, legally prescribable, but still carrying that label, “unlicensed”.
For companies, doctors, and patients alike, understanding that distinction is key. It shapes everything from the tone of medical education to the types of doctors willing to prescribe, right through to how quickly patients can access treatment.
As the evidence base grows, the hope is that the regulatory framework will evolve with it so that one day, these carefully cultivated plants, grown under the strictest pharmaceutical conditions, can move from unlicensed to fully licensed, bringing clarity where, for now, there’s still confusion.
Disclaimer:
The information provided in this blog is for educational purposes only and is intended for healthcare professionals involved in the prescribing and administration of cannabis-based medicinal products (CBMPs). It does not constitute medical advice, diagnosis, or treatment recommendations. While every effort has been made to ensure accuracy, regulatory guidelines and clinical best practices may evolve. Prescribers should refer to the latest guidance from the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), and other relevant bodies when making treatment decisions. Dalgety does not endorse any specific product or treatment pathway and encourages healthcare professionals to exercise their clinical judgement in patient care.
