Medicinal product
A medicinal product is defined in the European Union (cf. Dir 2001/83/EC) as any substance or combination of substances presented for treating or preventing disease in human beings. Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product. For further info see medication and drug.
This definition requires updating as follows because Dir 2001/83/EC was amended by Directive 2004/27/EC as follows:
'Medicinal product:
(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.’
A medicinal product has to be distinguished from medical devices, cosmetics and food products.
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