The Medicines and Healthcare products Regulatory Agency (MHRA) last week published a statement on their website announcing their decision to class cannabidiol (CBD) as a medicine. This decision means that companies will require a licence in order to sell products containing CBD. This could, for a period of time, cut off supply for those parents who treat their children’s epilepsy with CBD.
The statement confirmed what was said in a letter sent to 18 businesses trading CBD-based products in the UK informing them that they needed to cease trading these products within 28 days, a letter which sparked concern amongst those in the industry. VolteFace contacted the MHRA for clarification on a number of points.
When asked what sanctions would be imposed on companies that did not comply to these new regulations, the agency told VolteFace:
“The MHRA assess the status of borderline products and once it has come to an opinion that a product is a medicine will work with companies as required to facilitate voluntary compliance.”
When asked what prompted this change in classification they said:
“The MHRA were made aware of the sale of products containing CBD where the companies were making overt medicinal claims. MHRA also advised the companies that it was reviewing the mode of action of CBD and this may lead to products being classified as medicinal products and requiring a marketing authorisation before they can be sold”.
When asked what the criteria would be for a licence to sell CBD products, the MHRA said:
“In order to get a marketing authorisation, they must demonstrate that the product is of satisfactory quality, safety and efficacy in the claims made and that it has a positive balance of risk and benefit.”
They were then asked whether, if clinical approval was granted for a specific CBD formula which had undergone clinical trials (such as Epidiolex), other very similar CBD-based products would be able to rely on the result of those trials to obtain a marketing authorisation. The MHRA responded:
“If a product obtains a medicines marketing authorisation on the basis of original clinical trials it is likely that data generated will be subject to a period of protection. During that period other products would not be able to rely on that data. Following the period of data protection products would need to demonstrate that they are sufficiently similar in order to rely on data from that trial.”
The MHRA urged any companies that have not yet been contacted to “contact the MHRA and we will provide a letter that relates to the products that they are selling”.
Words by Abbie Llewelyn. Tweets @Abbiemunch