MHRA publishes opinion on regulatory status of CBD products
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Following a review the Medicines and Healthcare products Regulatory Agency has published an opinion on the regulatory status of products containing cannabidiol (CBD).
It has determined that products containing cannabidiol (CBD) used for medical purposes are medicines. If a company markets a CBD containing product that makes a medicinal claim it will be considered to fall within the definition of a medical product contained in The Human Medicines Regulations 2012.
It is for companies to consider whether they wish to market products that fall outside the definition of a medical product and which are subject to regulation elsewhere (eg. under food law), says the MHRA.
However, the Agency says it can give no assurance that a product, including those under development, will not subsequently be classified as a medicinal product. “Should companies wish to provide us with evidence that demonstrates that their products fall outside the definition of a medicinal product, then we are happy to consider this,” it says.
The Food Standards Agency (FSA) confirmed the novel food status of CBD in January 2019. CBD food products require authorisation before they can be sold legally in the UK.