Judgment_paragraph 42 · Laboratoires Lyocentre v Lääkealan turvallisuus- ja kehittämiskeskus and Sosiaali- ja terveysalan lupa- ja valvontavirasto (C-109/12)

42Whether a product falls within the definition of a medicinal product by virtue of its function for the purposes of Directive 2001/83 must be determined by the national authorities on a case-by-case basis, acting under the supervision of the courts, taking account of all the characteristics of the product, in particular its composition, its pharmacological, immunological or metabolic properties, to the extent to which they can be established in the present state of scientific knowledge, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail (C-140/07 Hecht-Pharma [2009] ECR I-41, paragraph 39, and C-27/08 BIOS Naturprodukte [2009] ECR I-3785, paragraph 18).