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
(Case C-618/23, SALUS)
Language of the case: German
Referring court
Oberlandesgericht Düsseldorf
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
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’).
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?
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’?
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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).
1 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).
1 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).