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MHRA Guidance Note 8 - GOV.UK

1 A guide to what is a medicinal product MHRA Guidance Note 8 March 2020 2 A guide to what is a medicinal product Crown Copyright 2020 MHRA 10 South Colonnade Canary Wharf, London E14 4PU Published by MHRA 2020 (Certain Appendices may have been updated at different times) Applications for reproduction should be made in writing to: The Copyright Unit Her Majesty s Stationery Office St Clements House 2-16 ColegateNorwich NR3 1BQ This MHRA Guidance Note should not be taken as a complete or definitive statement of the law. It is not intended as a substitute for legal or other professional advice. The MHRA accepts no liability for any loss or damage caused, arising directly, or indirectly, in connection with reliance on the contents of this Guidance Note. 3 Contents Page Introduction 5 1. What are Borderline Products?

medicines or not and clarifies the MHRA’s position on traditional herbal medicinal products. 2. MHRA policy and practice European Community legislation on medicinal products is not fully harmonised and products are classified under national regulations. For this reason, it is possible that a product classified as a

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  Product, Medicinal, Herbal, Medicinal products, Herbal medicinal products

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