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.
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.