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Case C-618/23, SALUS: Request for a preliminary ruling from the Oberlandesgericht Düsseldorf (Germany) lodged on 6 October 2023 — SALUS Haus Dr. med Otto Greither Nachf. GmbH & Co. KG v Astrid Twardy GmbH

ECLI:EU:UNKNOWN:62023CN0618

62023CN0618

October 6, 2023
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Official Journal of the European Union

EN

Series C

C/2024/710

22.1.2024

(Case C-618/23, SALUS)

(C/2024/710)

Language of the case: German

Referring court

Parties to the main proceedings

Defendant and appellant: SALUS Haus Dr. med Otto Greither Nachf. GmbH & Co. KG

Applicant and respondent: Astrid Twardy GmbH

Questions referred

1.Are herbal medicinal teas which are to be classified as ‘traditional herbal medicinal products’ within the meaning of point 29 of Article 1 and Article 16a of Directive 2001/83/EC, (1) inserted by points (1) and (2) of Article 1 of Directive 2004/24/EC, (2) (‘the Community code’) to be regarded as ‘plant-based traditional herbal preparations’ within the meaning of Article 2(1) of, in conjunction with Annex I to, Regulation (EU) 2018/848 (3) (‘the Regulation on organic production’ or ‘the Regulation’).

2.If the first question is answered in the affirmative: Can the labelling provided for in Chapter IV of the Regulation, in particular the official organic production logo of the European Union (Article 33 of, in conjunction with Annex V to, the Regulation), the company’s own organic production logo (Article 33(5) of the Regulation), the code number of the control body (Article 32(1)(a) of the Regulation), the place of production ‘EU Agriculture’ or ‘non-EU Agriculture’ (Article 32(2) of the Regulation), the term ‘bio’ (Article 30(2) of the Regulation), and the reference ‘from organic production’ (Article 30(1) of the Regulation), be affixed on the outer packaging of a medicinal product without the conditions of Article 62 of the Community code having to be fulfilled?

3.If the first or second question is answered in the negative: Is the labelling that is specified in the second question labelling that is ‘useful for the patient’ and is not ‘of a promotional nature’?

(1)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 (OJ 2001 L 311, p. 67).

(2)Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ 2004 L 136, p. 85).

(3)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 (OJ 2018 L 150, p. 1).

ELI: http://data.europa.eu/eli/C/2024/710/oj

ISSN 1977-091X (electronic edition)

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