62023CJ0589_SUM
Case C‑589/23
Cassella-med GmbH & Co.KG and MCM Klosterfrau Vertriebsgesellschaft mbH
v
Verband Sozialer Wettbewerb eV
(Request for a preliminary ruling from the Bundesgerichtshof)
Judgment of the Court (Fifth Chamber) of 13 March 2025
(Reference for a preliminary ruling – Medicinal products for human use – Directive 2001/83/EC – Article 1(2)(b) – Concept of ‘medicinal product by function’ – Concept of ‘pharmacological action’ – Binding of a substance, in a reversible manner, to bacteria to prevent them from adhering to human cells – Article 2(2) – Applicable legal framework – Classification as a ‘medical device’ or as a ‘medicinal product’ – Medical devices – Directive 93/42/EEC – Article 1(2)(a) – Concept of ‘medical device’)
Approximation of laws – Medicinal products for human use – Directive 2001/83 – Classification of a product as a medicinal product by function – Concept of ‘pharmacological action’ – Reversible binding of a substance to bacteria to prevent them from adhering to human cells – Included
(European Parliament and Council Directive 2001/83, as amended by Directive 2004/27/EC, Arts 1(2)(b) and 2(2); Council Directive 93/42, as amended by Directive 2007/47, Art. 1(2)(a))
(see paragraphs 37-60, operative part)
See the text of the decision.