MHRA Guidelines Explained

Explaining the Medicines and Healthcare Products Regulatory Agency policy on Cannabidiol.

MHRA Statements

Statements relating to the regulation and legislation directly from the MHRA.

Complete

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.

Did this help you?

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:

  • References to all medical conditions major to minor including colds, headaches, cuts and bruises, spots, smoking addiction, obesity, arthritis, depression, stress and all childhood disorders and serious diseases.
  • References to condition of the mind such as depression, addictions, attention deficit/hyperactivity disorder.
  • References to treatment or alleviation of adverse conditions including decongests, relieves pain.
  • Reduces inflammation, calms, stops itching, cures insomnia, reduces blood pressure, reduces sugar levels.
  • References to the symptoms of disease such as pain, inflammation etc.

What isn't allowed?

  • You are NOT permitted to make any explicit medical claims about your product.
  • You are NOT permitted to offer any advice, nor offer any product to treat any specific condition.
  • You are NOT to have links to organisations that promote “cancer cures” or other medicinally biased sites.
  • You are NOT to publish articles that may imply your products can or have traditionally been used to treat any illness.
  • You MUST NOT suggest they talk to any medical professional whatsoever.
  • You MUST NOT use any imagery or product names that may imply your products are medicines.
  • You MUST NOT make comparison with licensed medicines.
  • You MUST NOT use product names which imply the product is a medicine.
  • You MUST NOT make references to medical and / or clinical research and testing.
  • You MUST NOT make references to the health risks of not taking CBD.
  • You MUST NOT publish editorial medicinal claims.
  • You MUST NOT publish recommendations by Doctors/health professionals.
  • You MUST NOT publish testimonials that include/imply medicinal claims.
  • You MUST NOT use graphics that imply medicinal.
  • You MUST NOT reference to or reproduce "generic" information.

We can appreciate these regulations are incredibly harsh, but they're in place to protect the customer and your business.

Did this help you?

Source: https://www.gov.uk/government/news/mhra-statement-on-products-containing-cannabidiol-cbd

Download the MHRA Guidelines PDF