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9 min read
Sarah Sinclair
A number of different bodies are involved in the oversight of medical cannabis, from the manufacturing and production, to the clinics and specialists who prescribe them to patients.
In this article we will examine the regulatory framework for medical cannabis in the UK and how this aims to protect patients from harm, ensuring the medicines you receive are of the highest quality and safety.
Let’s start from the beginning.
Under the Misuse of Drugs Act 1971, cannabis remains a controlled drug, making it illegal for people to possess, supply, produce, or import/export.
However, in November 2018, the rescheduling of cannabis under the Misuse of Drugs Regulations 2001, allowed CBPMs to be prescribed under certain circumstances.
CBPMs fall into two categories: licensed and unlicensed.
The majority of products prescribed in the UK are unlicensed, meaning they have not yet received market authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA).
Unlicensed cannabis medicines must meet a number of strict requirements — and only those which get the green light are permitted to be prescribed in the UK. This is where other regulatory bodies come in.
When a doctor chooses to prescribe an unlicensed medicine, they accept full responsibility and would not be protected by their NHS trust or health provider should anything go wrong.
Only three CBPMs have a marketing authorisation (known as a ‘licence’) in the UK. These are Sativex, Epidyolex and Nabilone. Licensed CBPMs can be prescribed through the NHS and are largely treated the same as other medications.
Any individual or organisation intending to cultivate cannabis for medicinal use in the UK must obtain a Controlled Drug Licence from the Home Office. This is necessary to legally cultivate, produce, possess, and supply cannabis plants and products containing cannabis.
As the products being manufactured are intended for medicinal use, the organisation must also secure a licence from the MHRA, which is responsible for regulating medicinal products in the UK and for overseeing their safety, quality, and efficacy. All CBMPs must comply with MHRA regulations, including Good Manufacturing Practice (GMP) standards, to ensure quality and consistency.
Cultivation facilities intending to produce CBPMs must adhere to GMP guidelines for the manufacturing of medicinal products. GMP certification ensures that the production processes meet the necessary quality standards to ensure the safety and quality of the end products.
Securing these licences and building a production facility to meet these standards is an expensive and complex process. As a result, at the moment, very few CBPMs prescribed in the UK are manufactured here. The majority of products are imported for other countries, which are subject to a different process.
Once a doctor has written a prescription for an unlicensed cannabis medicine, they must apply to the MHRA for a licence to import the product into the UK.
The import licence application includes detailed information about the patient, the medical condition being treated, the proposed treatment plan, and the specific product being requested. The doctor must provide what is known as a letter of demand to support the use of the product and demonstrate that there are no suitable licensed alternatives available.
The MHRA will review the application to ensure compliance with regulatory requirements, such as GMP, and assess the risks and benefits of the proposed treatment. Once approved, the product can be legally imported into the UK, following customs clearance procedures.
Under the new Misuse of Drugs Regulations, only doctors on the General Medical Council (GMC) specialist register—consultants or ‘specialists’ such as neurologists, psychiatrists, and rheumatologists — are permitted to prescribe CBPMs.
A specialist can prescribe CBPMs for any condition if they deem it to be in the best interests of the patient, but prescribing criteria generally requires a patient to have severe, long-term clinical needs which haven’t been met by existing treatments.
The National Institute for Health and Care Excellence (NICE) guidelines make recommendations around which medicines should be prescribed on the NHS based on cost, and the available evidence for safety and efficacy.
Currently, NICE only recommends the prescription of licensed CBPMs on the NHS: Sativex, for use in the treatment of spasticity in Multiple Sclerosis; Epidyolex, for use in the treatment of seizures in children with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex; and Nabilone as a treatment for chemotherapy-induced nausea and vomiting in adults.
However, it has made recommendations that more research is carried out on the use of CBPMs in chronic neuropathic pain.
The CQC is an independent regulator of health and social care services in England.
Any service provider that carries out a regulated activity listed in the Health and Social Care Act 2008 (Regulated Activities Regulations) Regulations 2010 must register with CQC.
The Act describes a regulated activity as “an activity involving, or connected with, the provision of health or social care”. This includes private medical cannabis clinics.
The CQC carries out regular inspections to monitor services to ensure they are safe, effective, compassionate, and of high quality.
Following an inspection, officers will provide clinics with a rating (from ‘inadequate’ to ‘outstanding’) based on a variety of factors. If it identifies areas of concern, it may take action to protect those who use the services.
Any doctors prescribing medical cannabis in the UK must adhere to the same guidelines as with any other medicine, such as those set out by the GMC.
Doctors must be registered with the GMC to legally practise medicine in the UK. Its primary role is to protect, promote, and maintain the health and safety of the public by ensuring that doctors meet the necessary standards of competence, conduct, and ethical behaviour.
The GMC sets standards around clinical competence, professionalism, ethics, communication skills and patient safety, and has the authority to investigate concerns about the fitness to practice of registered doctors.
In the UK, the advertising of medicines is regulated primarily by the MHRA, but also potentially by the ASA (Advertising Standards Authority).
All CBPMs (licensed and unlicensed) are prescription only medicines (POM), meaning they cannot be advertised to consumers in the UK.
According to the MHRA Blue Guide licensed medicines can be advertised to doctors and healthcare professionals. Section 4.2 of the Blue Guide makes it clear that unlicensed CBPMs cannot be advertised at all, even to prescribing doctors, although information can be provided in response to unsolicited requests.
Clinics that offer cannabis-based medicines are able to advertise their services provided that the main focus is not on the medicine, but on other treatments or aspects of their service.
Consumer CBD products in the UK are regulated differently to prescribed CBPMs.
The Home Office states that only CBD products which contain less than 0/2% levels of THC can be legally sold as food supplements in the UK.
In January 2019 it was determined that CBD should be classed as a Novel Food under the Novel Food Regulations (NFR) and as a result, it is now overseen by the Food Standards Agency (FSA), the body responsible for regulating the UK food market.
The FSA is responsible for authorising CBD products for sale in the UK.
In February 2020, the FSA stated that all CBD products must have a valid Novel Food application in order to continue being sold.
The FSA also publishes guidance on the safe use of CBD products, including the recommended maximum daily intake of CBD. In October 2023, this was reduced from 70 mg to 10mg.
Consumer CBD products, such as tinctures, gummies, and cosmetics, can be marketed directly to consumers. But as they are not licensed medicines, companies cannot make medicinal claims about their products in their marketing.
The advertising of CBD and what is defined as a ‘medicinal claim’ is determined both by Advertising Standards Agency (ASA) / the Committee on Advertising Practice (CAP) rules, and ultimately by MHRA.
It is important to seek medical advice before starting any new treatments. The patient advisors at Releaf are available to provide expert advice and support. Alternatively, click here to book a consultation with one of our specialist doctors.
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Am I eligible?Sarah, a distinguished journalist with over a decade in publishing and communications, now excels in cannabis health and policy journalism in the UK, advocating for informed health decisions through her award-winning work.
All of our articles are written by medical cannabis experts, guided by strict sourcing guidelines, and reference peer-reviewed studies and credible academic research. Our expert clinical team and compliance specialists provide valuable insights to ensure accuracy when required. Learn more in our editorial policy.
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