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 31 December 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.
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.
An MHRA spokesperson said:
Update 1 November 2016
An MHRA spokesperson said:
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.
Update 30 December 2016
A Certificate of Analysis can be obtained from the distributor or manufacturer of the CBD product. At a minimum, it should state the:
A Certificate of Analysis will typically be sufficient to determine the quantities of CBD and any specified substances, and to establish whether the definition has been met.
To be considered a ‘CBD product’ under Section 2A of the Misuse of Drugs Act 1975, the tetrahydrocannabinols (THCs) and specified substances within the product must not exceed 2 percent of the total CBD, tetrahydrocannabinol (THC) and other specified substances.
For further information, please refer to the Medsafe guidance on bringing medicines into New Zealand.
Requirements for a Certificate of Analysis
Before you can supply a CBD product you will need to apply to the Medicinal Cannabis Agency for a product assessment to establish it meets the medicinal cannabis minimum quality standard.