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Case C-589/23, Cassella-med and MCM Klosterfrau: Judgment of the Court (Fifth Chamber) of 13 March 2025 (request for a preliminary ruling from the Bundesgerichtshof – Germany) – Cassella-med GmbH & Co. KG, MCM Klosterfrau Vertriebsgesellschaft mbH v Verband Sozialer Wettbewerb eV (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)
ECLI:EU:UNKNOWN:62023CA0589
62023CA0589
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Official Journal of the European Union
C series
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C/2025/2497
12.5.2025
(Case C-589/23,
(1)
Cassella-med and MCM Klosterfrau)
(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’)
(C/2025/2497)
Language of the case: German
Referring court
Parties to the main proceedings
Applicants: Cassella-med GmbH & Co. KG, MCM Klosterfrau Vertriebsgesellschaft mbH
Defendant: Verband Sozialer Wettbewerb eV
Operative part of the judgment
Article 1(2)(b) 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 a substance which, by means of a reversible binding to bacteria, prevents the bacteria from adhering to human cells must be regarded as exerting a ‘pharmacological action’ within the meaning of that provision.
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(1) OJ C C/2024/706.
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ELI: http://data.europa.eu/eli/C/2025/2497/oj
ISSN 1977-091X (electronic edition)
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