Keywords
Summary

Keywords

Approximation of laws — Medicinal products for human use — Directive 2001/83 — Classification of a product as a medicinal product by function — Criteria — Whether the product is such as to have any beneficial effects, either immediately or in the long term, on human health

(European Parliament and Council Directive 2001/83, as amended by Directive 2004/27, Arts 1, point 2, and 4(4))

Summary

Article 1(2)(b) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27, must be interpreted as not covering substances, such as those at issue in the main proceedings, which produce effects that merely modify physiological functions but which are not such as to have any beneficial effects, either immediately or in the long term, on human health, are consumed solely to induce a state of intoxication and are, as such, harmful to human health.

(see para. 50, operative part)