Article 2(2) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, must be interpreted as meaning that Directive 2001/83, as amended by Directive 2004/27, 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 exclude that possibility.

Article 1(2)(b) of Directive 2001/83, as amended by Directive 2004/27, must be interpreted 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 product by function.

Article 1(2)(b) of Directive 2001/83, as amended by Directive 2004/27, must be interpreted 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 functions by exerting a pharmacological, immunological or metabolic action.