A product is a medicinal product if it restores, corrects or modifies physiological functions

PHARMACEUTICAL LAW

No medicinal product by function

"29. Consequently, the answer to the first part of the first question is that Article 2(2) of Directive 2001/83 must be interpreted as meaning that that directive does not apply to a product in respect of which it has not been scientifically established that it is a medicinal product by function, without its being possible to ex-clude that possibility."

Concept of ‘medicinal product by function’

"37. The answer to the third question is therefore that Article 1(2)(b) of Directive 2001/83 must be inter-preted as meaning that the characteristics of the manner in which a product is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail are still relevant to determining whether that product falls within the definition of a medicinal prod-uct by function."

Account taken of the content in active substances: A product cannot be regarded as a medicinal product where, it is incapable of appreciably restoring, correcting or modifying physiological functions.

"45. That Article 1(2)(b) of Directive 2001/83 must be in-terpreted as meaning that, apart from the case of substances or combinations of substances intended for the purpose of making a medical diagnosis, a product cannot be regarded as a medicinal product within the meaning of that provision where, having regard to its composition – including its content in active substances – and if used as intended, it is incapable of appreciably restoring, correcting or modifying physiological func-tions by exerting a pharmacological, immunological or metabolic action"

IPPT20090115, ECJ, Hecht-Pharma v Bezirksregierung Luneburg

C140/07 - ECLI:EU:C:2009:5