The status of borderline medicinal products is mostly determined in accordance with statutory determination procedures laid down in Part 9 of the Human Medicines Regulations 2012. In some cases, the MHRA may deem it appropriate to issue a determination without following the statutory procedure. These determinations are made under Regulation 165. This list has been updated from 2016 to 2019. There is a trend in new products (CBD) being referred to MHRA.
Summary of Regulation 165 notices
Within this link is a summary of the activities of the borderline section - the 165 notices. A quick read shows that CBD products start to make an appearance as the trend for this food supplement grows in this sector.
If you have any queries or questions about if your product is or is not a medicinal product then simply contact us at firstname.lastname@example.org we can help you untangle the regulations that surround this area to reduce the chance of receiving a Regulation 165 notice.