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Case C-618/23, SALUS: Judgment of the Court (Fifth Chamber) of 26 June 2025 (request for a preliminary ruling from the Oberlandesgericht Düsseldorf – Germany) – SALUS Haus Dr. med. Otto Greither Nachf. GmbH & Co. KG v Astrid Twardy GmbH (Reference for a preliminary ruling – Medicinal products for human use – Directive 2001/83/EC – Article 1(29) – Article 16a – Traditional herbal medicinal products – Article 62 – Information which is useful to the patient – Regulation (EU) 2018/848 – Article 2(1) – Scope – Indications on the outer packaging of a medicinal herbal tea – Use of terms referring to organic production)
ECLI:EU:UNKNOWN:62023CA0618
62023CA0618
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Official Journal of the European Union
C series
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C/2025/4430
(Case C-618/23,
(SALUS)
(Reference for a preliminary ruling - Medicinal products for human use - Directive 2001/83/EC - Article 1(29) - Article 16a - Traditional herbal medicinal products - Article 62 - Information which is useful to the patient - Regulation (EU) 2018/848 - Article 2(1) - Scope - Indications on the outer packaging of a medicinal herbal tea - Use of terms referring to organic production)
(C/2025/4430)
Language of the case: German
Referring court
Parties to the main proceedings
Applicant: SALUS Haus Dr. med. Otto Greither Nachf. GmbH & Co. KG
Defendant: Astrid Twardy GmbH
Operative part of the judgment
Article 1(29) and Article 16a 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/EU of the European Parliament and of the Council of 31 March 2004,
must be interpreted as meaning that products classified as ‘traditional herbal medicinal products’ within the meaning of those provisions, which come within the scope of Directive 2001/83, as amended, by virtue of Article 2 thereof, may not be regarded simultaneously as ‘plant-based traditional herbal preparations’ within the meaning of Annex I to Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007, coming within the scope of Regulation 2018/848 pursuant to Article 2(1) thereof.
Article 62 of Directive 2001/83, as amended by Directive 2004/27,
must be interpreted as meaning that information relating to the organic production of the active substances of traditional herbal medicinal products within the meaning of Article 1(29) and Article 16a of Directive 2001/83, as amended, cannot be regarded as ‘useful to the patient’ and as not being ‘of a promotional nature’.
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(1) OJ C, C/2024/710.
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ELI: http://data.europa.eu/eli/C/2025/4430/oj
ISSN 1977-091X (electronic edition)
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