The UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA) has advised that products containing cannabidiol (CBD) to be used for medical purposes meet the definition of a medicinal product. This means that such products must have been granted a marketing authorisation (MA) before they can be legally sold and supplied or advertised in the UK.
The MHRA had previously advised manufacturers and suppliers of CBD products that they were reviewing the regulatory status of CBD products so this decision shouldn’t come as much of a surprise. The MHRA says that they have written to 18 companies informing them of their opinion.
To obtain an MA (or licence), a company will be required to submit data to demonstrate the quality, safety and efficacy of their product. These data will then be assessed by the regulatory authority to determine whether the licence will be granted. The licensing process usually takes around 12 months and longer in many cases. It is possible to be exempted from holding a UK MA – the product being categorised as a ‘special’. A ‘special’ can only be supplied in order to meet the particular needs of an individual patient and cannot not be advertised.
If you would like help with the regulations on ‘specials’ or applying for an MA, please contact us.
For the MHRA announcement on CBD products, please click here.