The MHRA have issued new guidance on Cannabidiol. This week sees a new issue of the very useful MHRA’s ‘Guide to what is a Medicinal Product’. This is a primary document for products that fall within the borderline area. It sets out what the MHRA is thinking based on new legislation/cases they have assessed. The MHRA will never say if a category is or is not legal, as they always assess each product on a case by case basis. Cannabidiol is one such category that attracts much debate. Indeed, anyone attending the Pharmacy Show this month would have seen many vendors with non-medicinal hemp products.
In this October 2018 revised guide, the reader needs stamina as the changes are presented in Appendix 10, page 67. This appendix covers the MHRA position/guidance for Cannabidiol containing products, covering:
- CBD products for non-medical purposes
- Compliance with other regulatory frameworks
- CBD products for medical purposes
- Supply of an unlicensed medicine (a ‘Special’)
- Obtaining a licence to supply a licensed medicine
This guidance sets out MHRA’s current position in respect of the classification of CBD products. It also briefly covers the supply of CBD products as medicines. Companies need to be mindful of MHRA’s remit and ensure that they have obtained advice from all relevant regulators prior to placing products on the market.
OTCexperts have previous blogged about CBD and claims – click here to read more
OTCexperts look to maintain or revitalise brands or launch new products in borderline areas to assist companies to be compliant with claims and presentation. Please contact us on consultancy@otcexperts.co.uk
