MHRA Guide

What is a medicinal product? The Medicines and Healthcare products Regulatory Agency (MHRA) issue guidance on cosmetics, medicines and all products in between. This is updated regularly.

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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.
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If you have any queries or questions about if your product is or is not a medicinal product then simply contact us at consultancy@otcexperts.co.uk we can help you untangle the regulations that surround this area to reduce the chance of receiving a Regulation 165 notice.