The official statement of the MHRA over the regulatory status of products containing CBD
Legal guidelines on cannabidiol in the UK were set in 2016, under the guidance of the government’s Medicines and Healthcare products Regulatory Agency (MHRA).
Following months of research and analysis, the agency declared that cannabidiol products be officially classed as a medicine.
It issued (with dated updates) the following statement:
“We have come to the opinion that products containing cannabidiol (CBD) used for medical purposes are a medicine. Medicinal products must have a product licence (marketing authorisation) before they can be legally sold, supplied or advertised in the UK, unless exempt. Licensed medicinal products have to meet safety, quality and efficacy standards to protect public health.
“If you use CBD and if you have any questions, speak to your GP or other healthcare professional.
We have written to UK CBD stockists and manufacturers to inform them of our view. We can provide regulatory guidance to any company who may wish to apply for a licence.”
Update November 1 2016
“While MHRA has given its opinion that products containing cannabidiol (CBD) used for medical purposes are medicines, we have also carefully considered the needs of individuals using CBD products to treat or manage the symptoms of medical conditions.
“Our primary concern is patient safety. In order to ensure that products remain available until individuals have the opportunity to discuss their treatment with their doctor, companies now have until December 31 2016 to voluntarily operate within the law, by withdrawing their existing products from the market, or working with MHRA to satisfy the legal requirements of the Human Medicines Regulations 2012.
“We have today written to the manufacturers of CBD to make them aware of the timeline for engagement.
“It is vital that medicines meet safety, quality and efficacy standards to protect public health.”
Update December 30 2016
“Our primary concern is patient safety and we wish to reiterate that individuals using cannabidiol (CBD) products to treat or manage the symptoms of medical conditions should discuss their treatment with their doctor.
“MHRA will now work with individual companies and trade bodies in relation to making sure products containing CBD, used for a medical purpose, which can be classified as medicines, satisfy the legal requirements of the Human Medicines Regulations 2012.”
Background
- This opinion is restricted to products containing cannabidiol (CBD).
- MHRA advised manufacturers and suppliers of CBD products that we were reviewing the regulatory status of CBD products prior to this opinion being issued.
- The assessment of whether a product is classified as a ‘medicinal product’ is carried out in accordance with the definition of a medicinal product and is not based on whether the product is a risk to consumers. Once a valid application is made the product will be assessed in terms of its safety quality and efficacy in the medical claims made.
- Unless exempt, medicines must have a product licence (marketing authorisation) before being placed on the market. Exempt products may be supplied as ‘specials’ by an appropriate prescriber. A ‘special’ can only be supplied in order to meet the special needs of an individual patient and may not be advertised. More information about the ‘specials’ process is available on our website.
- MHRA have written to 18 companies to advise them of our opinion.
- MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The Agency is an executive agency of the Department of Health. www.mhra.gov.uk
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