Module 18 - Drug Device Combinations and Other Technologies

What is a medicinal product?

a)

Any substance or combination of substances presented as having properties of preventing or treating disease in human beings ; or Any substance or combination of substances that may be used by or administered to human beings with a view to – i. restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or ii. making a medical diagnosis .

b)

- The Human Medicines Regulations 2012 (S.I. 2012/1916)

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Borderlines with Medicinal Products

Most (if not all) medical devices will ‘fit’ the definition of a medicinal product at least under the first part.

Thus determining whether a product is a medical device or a medicinal product can be a complex process.

Key areas:

• Mode of action (pharmacological, immunological, metabolic or physical?) • The intended purpose for the product • The claims being made for the product • The ingredients contained in the product

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