Classification of medicinal products
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Classification determines whether a product is to be considered a medicinal product, meaning that requirements for quality, safety, and efficacy must be met.
It can be difficult to distinguish between medicinal products and borderline products such as food supplements, medical devices, cosmetics, feed, biocides, and similar. To determine whether a product or substance falls under the medicines legislation, several aspects of the product must be assessed.
How to classify?
Classification of a product as a medicinal product is based on an overall assessment of the product in question. Classification as a medicinal product may be made either on the basis of function and/or on the basis of presentation.
The definition of a medicinal product in the Medicines Regulation:
"any substance, crude drug, or preparation which is presented as being suitable for preventing, curing, or alleviating disease, disease symptoms, or pain, or for affecting physiological functions in humans or animals; or which may be used or administered to humans or animals to restore, modify, or influence physiological functions through a pharmacological, immunological, or metabolic effect, or to detect disease."
Classification is a national decision, and it may therefore vary from country to country how a product is regulated. A product may therefore be considered a medicinal product in one country but not in another.
See Norwegian version of this page for more information.