Interaction between substance and cellular consituent within user's body sufficient for 'pharmalogical action'

PHARMACEUTICAL LAW

Interpretation of ‘pharmacological action’ in Pharma Directive on the basis of guidance document.

"27. It follows from the foregoing considerations that Article 1(2)(b) of Directive 2001/83 must be interpreted as meaning that, for the purpose of defining the term ‘pharmacological action’ within the meaning of that provision, account may be taken of the definition of that term in the guidance document on the demarcation between the Cosmetic Products Directive and the Medicinal Products Directive."

Pharmacological action: interaction between substance and cellular constituent within user’s body is sufficient; interaction on molecular level not necessary.

"36. [...] that, for a substance to be regarded as exerting a ‘pharmacological action’ within the meaning of that provision, it is not necessary for there to be an interaction between the molecules of which it consists and a cellular constituent of the user’s body, as an interaction between that substance and any cellular constituent present within the user’s body may be sufficient."

IPPT20120906, CJEU, Kreussler v Sunstar

C-308/11 - ECLI:EU:C:2012:548