CBD products
In 2016 the UK regulatory agency, The MHRA came to the opinion that products containing cannabidiol (CBD) containing more than 0.01% of THC used for medical purposes are a classified as a medicine. All medicinal products must have a valid product licence (marketing authorisation) before they can be legally sold, supplied or advertised in the UK. All Licensed medicinal products must meet safety, quality and efficacy standards to protect public health.
General rules for marketing CBD containing products in the UK that do not require the MHRAs authorisation are that the labelling should contain no medical claims, must contain the CBD content, full manufacturer details and a full list of ingredients. More importantly; the product must not contain more than 0.01% of THC.
Furthermore, EU member states regulatory authorities now regard any food, drink and food supplements that contain CBD as a “novel food”.
All Novel foods containing CBD will require a marketing authorisation. This means any company aiming to add CBD into food are required to apply to the European Commission before the commencement of marketing the product.
Examples of CBD foods in scope of novel food regulations are any CBD oils, capsules or oral sprays, CBD gummies, mints or other sweets, CBD tea, coffee, alcoholic and non-alcoholic drinks and any CBD containing snacks such as crisps or energy bars.
Pharmareg offer a consulting service to fulfil compliance with all CBD regulations and help you bring your CBD containing products on to the UK/EU market legally.
Get in touch!
We’re proud to offer a range of solutions for regulatory affairs. If you’d like to find out more, please get in touch!