Regulatory Focus™ > News Articles > UK’s MHRA: Products Containing Cannabis Extract are Medicines

UK’s MHRA: Products Containing Cannabis Extract are Medicines

Posted 12 October 2016 | By Zachary Brennan 

UK’s MHRA: Products Containing Cannabis Extract are Medicines

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has recently come to the decision that products containing cannabidiol (CBD) are a medicine, following a regulatory review of such products.

“We have come to the opinion that products containing cannabidiol (CBD) are a medicine. Products for therapeutic use must have a medicines’ licence before they can be legally sold, supplied or advertised in the UK. Products will have to meet safety, quality and effectiveness standards to protect public health,” MHRA spokesman James Rose told Focus.

As has been reported earlier this month, MHRA called for the stoppage of all sales, supplies, promotional advertisement or process orders for CBD products within 28 days.

MHRA said it has written to 18 companies to advise them of the new decision, though the names of the companies have not been publicly released.

“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,” Rose said.

At least one supplier has said it will continue supplying CBD products to the rest of the EU and plans to release a new cannabinoid product in the next few weeks which will be legal in the UK and won’t contain CBD (though at least one other claims that “CBD is not medicinal nor is it intended to treat or cure any ailments”).

The shift in policy comes as GW Pharmaceuticals recently released the results of its latest Phase III trial for its CBD treatment Epidiolex (cannabidiol) for seizures associated with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. GW expects to submit a New Drug Application to the US Food and Drug Administration (FDA) in the first half of 2017. GW has commercialized another CBD product, known as Sativex, which is approved treat Multiple Sclerosis spasticity in 23 countries, including 17 countries in the EU.

And the decision by MHRA to classify CBD products as medicines should not come as a surprise to the industry as MHRA made clear from the outset that they were reviewing the regulatory status of CBD products. 


Categories: Regulatory News

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