Explaining the Medicines and Healthcare Products Regulatory Agency policy on Cannabidiol.
Statements relating to the regulation and legislation directly from the MHRA.
An MHRA Spokesman said on: 13th October 2016
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.
UPDATED: 1st November 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 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.
UPDATED: 30th December 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.
The main focus of the MHRA is the customers health. Due to CBD not being officially regulated to protect the consumer the MHRA have set a series of guidelines.
These guidelines are an official list of what CBD companies in the United Kingdom have to adhere to at the time of writing.
Making any reference to any medical condition or implying that your product could have medicinal benefits would be considered a medical claim.
When making a determinations into borderline products the MHRA considers the following examples to be medical claims:
What isn't allowed?
We can appreciate these regulations are incredibly harsh, but they're in place to protect the customer and your business.
Download the MHRA Guidelines PDF