Provisional text
JUDGMENT OF THE COURT (Fifth Chamber)
26 June 2025 (*)
( Reference for a preliminary ruling – Medicinal products for human use – Directive 2001/83/EC – Article 1(29) – Article 16a – Traditional herbal medicinal products – Articles 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 )
In Case C‑618/23,
REQUEST for a preliminary ruling under Article 267 TFEU from the Oberlandesgericht Düsseldorf (Higher Regional Court, Düsseldorf, Germany), made by decision of 28 September 2023, received at the Court on 6 October 2023, in the proceedings
SALUS Haus Dr. med. Otto Greither Nachf. GmbH & Co. KG
v
Astrid Twardy GmbH,
THE COURT (Fifth Chamber),
composed of M.L. Arastey Sahún, President of the Chamber, D. Gratsias, E. Regan, J. Passer (Rapporteur) and B. Smulders, Judges,
Advocate General: M. Campos Sánchez-Bordona,
Registrar: G. Chiapponi, Administrator,
having regard to the written procedure and further to the hearing on 27 November 2024,
after considering the observations submitted on behalf of:
–        SALUS Haus Dr. med. Otto Greither Nachf. GmbH & Co.
KG, by M. Fuderer and C. Tillmanns, Rechtsanwälte,
–        Astrid Twardy GmbH, by M. Weidner, Rechtsanwalt,
–        the French Government, by G. Bain, P. Chansou, B. Fodda and M. Guiresse, acting as Agents,
–        the Italian Government, by G. Palmieri, acting as Agent, and by G. Natale, avvocato dello Stato,
–        the European Commission, by A. Dawes,
B. Hofstötter, E. Mathieu and A. Spina, acting as Agents,
after hearing the Opinion of the Advocate General at the sitting on 30 January 2025,
gives the following
Judgment
1        This request for a preliminary ruling concerns the interpretation of Article 62 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 (OJ 2001 L 311, p. 67), as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 (OJ 2004 L 136, p. 34) (‘Directive 2001/83’), and of Articles 30 and 32 and Article 33(5) of 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).
2        The reference has been made in proceedings between SALUS Haus Dr. med Otto Greither Nachf. GmbH & Co. KG (‘SALUS’), an undertaking which markets, inter alia, herbal medicinal products, and Astrid Twardy GmbH (‘Twardy’), an undertaking which also markets such medicinal products, concerning the indications appearing on the outer packaging of medicinal herbal teas which SALUS markets or intends to market.
Legal context
European Union law
Directive 2001/83
3        Recitals 2 and 40 of Directive 2001/83 state:
‘(2)      The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health.
…
(40)      The provisions governing the information supplied to users should provide a high degree of consumer protection, in order that medicinal products may be used correctly on the basis of full and comprehensible information.’
4        Appearing under Title I of that directive, entitled ‘Definitions’, Article 1 of Directive 2001/83 provides:
‘For the purposes of this Directive, the following terms shall bear the following meanings:
…
2.      Medicinal product:
(a)      Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b)      Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
…
25.      Labelling:
Information on the immediate or outer packaging.
…
29.      Traditional herbal medicinal product:
A herbal medicinal product that fulfils the conditions laid down in Article 16a(1).
…’
5        Appearing under Title II of that directive, entitled ‘Scope’, Article 2 of Directive 2001/83 provides:
‘1.      This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.
2.      In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a “medicinal product” and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply.
…’
6        Title III of Directive 2001/83 contains the provisions thereof relating to the placing on the market of medicinal products.
7        Appearing in Chapter 1 of that Title III, entitled ‘Marketing authorisation’, Article 11 of that directive reads as follows:
‘The summary of the product characteristics shall contain, in the order indicated below, the following information:
1.      name of the medicinal product followed by the strength and the pharmaceutical form.
2.      qualitative and quantitative composition in terms of the active substances and constituents of the excipient, knowledge of which is essential for proper administration of the medicinal product. The usual common name or chemical description shall be used.
3.      pharmaceutical form.
4.      clinical particulars …
…’
8        Appearing in Chapter 2a of that Title III, entitled ‘Specific provisions applicable to traditional herbal medicinal products’, Article 16a provides:
‘1.      A simplified registration procedure (hereinafter “traditional-use registration”) is hereby established for herbal medicinal products which fulfil all of the following criteria:
(a)      they have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment;
(b)      they are exclusively for administration in accordance with a specified strength and posology;
(c)      they are an oral, external and/or inhalation preparation;
(d)      the period of traditional use as laid down in Article 16c(1)(c) has elapsed;
(e)      the data on the traditional use of the medicinal product are sufficient; in particular the product proves not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-standing use and experience.
…’
9        Title
V of Directive 2001/83, entitled ‘Labelling and package leaflet’, includes, inter alia, Articles 54, 59, 61 and 62 of that directive.
10      Article 54 of that directive provides:
‘The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging:
…
(b)      a statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names;
…
(e)      the method of administration and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated;
…
(k)      the name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder to represent him;
(l)      the number of the authorisation for placing the medicinal product on the market;
…’
11      Article 59(1) of that directive reads as follows:
‘The package leaflet shall be drawn up in accordance with the summary of the product characteristics; it shall include, in the following order:
(a)      for the identification of the medicinal product:
(i)      the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, [who] it is intended for …
…
(b)      the therapeutic indications;
(c)      a list of information which is necessary before the medicinal product is taken …
(d)      the necessary and usual instructions for proper use …
…’
12      Article 61 of that directive provides:
‘1.      One or more mock-ups of the outer packaging and the immediate packaging of a medicinal product, together with the draft package leaflet, shall be submitted to the authorities competent for authorising marketing when the marketing authorisation is requested. …
2.      The competent authority shall refuse the marketing authorisation if the labelling or the package leaflet do not comply with the provisions of this Title or if they are not in accordance with the particulars listed in the summary of product characteristics.
…’
13      Article 62 of Directive 2001/83 provides:
‘The outer packaging and the package leaflet may include symbols or pictograms designed to clarify certain information mentioned in Articles 54 and 59(1) and other information compatible with the summary of the product characteristics which is useful for the patient, to the exclusion of any element of a promotional nature.’
Regulation 2018/848
14      Recitals 10 and 16 of Regulation 2018/848 state:
‘(10)      Experience gained so far with the application of Regulation (EC) No 834/2007 [on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (OJ 2007 L 189, p. 1)] shows the need to make clear to which products this Regulation applies. Primarily, it should cover products originating from agriculture, including aquaculture and beekeeping, as listed in Annex I to the Treaty [FEU]. Moreover, it should cover processed agricultural products for use as food or feed because the placing of such products on the market as organic products provides a major outlet for agricultural products and ensures that the organic nature of the agricultural products from which they are processed is visible to the consumer. Likewise, this Regulation should cover certain other products which are linked to agricultural products in a similarly close way as processed agricultural products for use as food and feed because those other products either constitute a major outlet for agricultural products or form an integral part of the production process. … For reasons of clarity, such other products not listed in Annex I to the TFEU should be listed in an Annex to this Regulation.
…
(16)      This Regulation should apply without prejudice to related legislation, in particular in the fields of safety of the food chain, animal health and welfare, plant health, plant reproductive material, labelling and the environment.’
15      Article 2 of that regulation, headed ‘Scope’, provides:
‘1.      This Regulation applies to the following products originating from agriculture, including aquaculture and beekeeping, as listed in Annex I to the TFEU and to products originating from those products, where such products are, or are intended to be, produced, prepared, labelled, distributed, placed on the market, imported into or exported from the [European] Union:
(a)      live or unprocessed agricultural products, including seeds and other plant reproductive material;
(b)      processed agricultural products for use as food;
(c)      feed.
This Regulation also applies to certain other products closely linked to agriculture listed in Annex I to this Regulation, where they are, or are intended to be, produced, prepared, labelled, distributed, placed on the market, imported into or exported from the Union.
…
4.      Except where otherwise provided, this Regulation applies without prejudice to related Union legislation, in particular, legislation in the fields of safety of the food chain, animal health and welfare, plant health and plant reproductive material.
5.      This Regulation applies without prejudice to other specific Union law relating to the placing of products on the market and, in particular, to Regulation (EU) No 1308/2013 of the European Parliament and of the Council [of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ 2013 L 347, p. 671)] and to Regulation (EU) No 1169/2011
[of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ 2011 L 304, p. 18)].
…’
16      Appearing in Chapter IV of Regulation 2018/848, entitled ‘Labelling’, Article 30 of that regulation, itself headed ‘Use of terms referring to organic production’, reads as follows:
‘1.      For the purposes of this Regulation, a product shall be regarded as bearing terms referring to organic production where, in the labelling, advertising material or commercial documents, such a product, its ingredients or feed materials used for its production are described in terms suggesting to the purchaser that the product, ingredients or feed materials have been produced in accordance with this Regulation. In particular, the terms listed in Annex IV and their derivatives and diminutives, such as “bio” and “eco”, whether alone or in combination, may be used throughout the Union and in any language listed in that Annex for the labelling and advertising of products referred to in Article 2(1) which comply with this Regulation.
2.      For the products referred to in Article 2(1), the terms referred to in paragraph 1 of this Article shall not be used anywhere in the Union, in any language listed in Annex IV, for the labelling, advertising material or commercial documents of a product which does not comply with this Regulation.
Furthermore, no terms, including terms used in trademarks or company names, or practices shall be used in labelling or advertising if they are liable to mislead the consumer or user by suggesting that a product or its ingredients comply with this Regulation.
…’
17      Appearing in the same Chapter IV, Article 32 of that regulation, headed ‘Compulsory indications’, provides:
‘1.      Where products bear terms as referred to in Article 30(1), including products labelled as in-conversion products in accordance with Article 30(3):
(a)      the code number of the control authority or control body to which the operator that carried out the last production or preparation operation is subject shall also appear in the labelling; and
(b)      in the case of prepacked food, the organic production logo of the European Union referred to in Article 33 shall also appear on the packaging, except in cases referred to in Article 30(3) and points (b) and (c) of Article 30(5).
2.      Where the organic production logo of the European Union is used, an indication of the place where the agricultural raw materials of which the product is composed have been farmed shall appear in the same visual field as the logo and shall take one of the following forms, …
…’
18      Article 33 of that regulation, headed ‘Organic production logo of the European Union’, provides:
‘1.      The organic production logo of the European Union may be used in the labelling, presentation and advertising of products which comply with this Regulation.
…
5.      National logos and private logos may be used in the labelling, presentation and advertising of products which comply with this Regulation.
…’
19      Among the products listed in Annex I of Regulation 2018/848, entitled ‘Other products referred to in Article 2(1), is ‘plant-based traditional herbal preparations’.
20      Annex V of that regulation sets out the rules on the use of the organic production logo of the European Union.
German law
21      The fifth sentence of Paragraph 10(1) of the Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz – AMG) (Law on the marketing of medicinal products) of 24 August 1976 (BGB1. 1976 I, p. 2445), in the version applicable to the dispute in the main proceedings (‘the AMG’), which transposes Article 62 of Directive 2001/83, is worded as follows:
‘Additional information which is not provided for in a regulation of the European Community or European Union or which is not already permitted pursuant to such a regulation shall be permitted in so far as it is related to the use of the medicinal product, is useful for the patient’s health education and does not conflict with the information referred to in Paragraph 11a.’
The dispute in the main proceedings and the questions referred for a preliminary ruling
22      SALUS and Twardy, two undertakings incorporated under German law, market, inter alia, traditional herbal medicinal products.
23      The products offered for sale by SALUS include ‘Salus medicinal herbal tea – sage leaves’, on the outer packaging of which appear the official organic production logo of the European Union, the code number of the control body and the indication ‘Non-EU Agriculture’. That company also plans to market, first, an ‘organic nerve-calming’ herbal tea, the outer packaging of which is to bear the official organic production logo of the European Union, SALUS’s organic production logo, the code number of the control body and the statement ‘from organic production’ and, second, an ‘alchemilla’ tea, the outer packaging of which would bear the official organic production logo of the European Union, the code number of the control body and the indication ‘EU Farming’.
24      Being of the view that the inclusion by SALUS of indications relating to the organic production of those products on the outer packaging of those products constitutes an infringement of the fifth sentence of Article 10(1) of the AMG, Twardy brought an action before the Landgericht Düsseldorf (Regional Court, Düsseldorf, Germany) seeking an order requiring SALUS to refrain from marketing medicinal herbal teas the outer packaging of which bears indications of the organic origin of those plants.
25      By judgment of 7 June 2023, the Landgericht Düsseldorf (Regional Court, Düsseldorf) upheld that action and, inter alia, ordered SALUS, in essence, to refrain, in the course of trade, from distributing or having distributed those products if they bear that information on their outer packaging. According to that court, such indications are prohibited under the fifth sentence of Article 10(1) of the AMG.
26      SALUS brought an appeal against that judgment before the Oberlandesgericht Düsseldorf (Higher Regional Court, Düsseldorf, Germany), which is the referring court. That company submits that the scope of Regulation 2018/848 is broader than that of Regulation No 834/2007 and that Regulation 2018/848 is applicable to ‘other products closely linked to agriculture’, such as the medicinal herbal teas at issue in the main proceedings, which are ‘plant-based traditional herbal preparations’. In its view, the labelling provisions of Regulation 2018/848 and Directive 2001/83 apply concurrently. In any event, Article 62 of Directive 2001/83 should be interpreted as meaning that the labelling elements authorised by Regulation 2018/848 are ‘useful to the patient’ within the meaning of that Article 62.
27      Twardy contended that that appeal should be dismissed, arguing that, even if the ‘plant-based traditional herbal preparations’ which are to be classified as medicinal products were to be regarded as coming within the material scope of Regulation 2018/848, Article 62 of Directive 2001/83 and the fifth sentence of Article 10(1) of the AMG should prevail. Indeed, in order to protect the patient from excessive information and advertising on the labelling of medicinal products, Article 62 of Directive 2001/83 must be interpreted strictly, especially since there is no obligation to indicate the organic origin of the plants used in the production of medicinal herbal teas.
28      The referring court observes, first, that the outcome of the dispute in the main proceedings depends, first of all, on whether the concept of ‘plant-based traditional herbal preparations’, within the meaning of Article 2(1) of Regulation 2018/848 in conjunction with Annex I to that regulation, includes preparations, such as the medicinal herbal teas at issue in the main proceedings, which also come within the concept of ‘medicinal products’, within the meaning of Directive 2001/83. That court points out that the category of ‘plant-based traditional herbal preparations’ was introduced by the EU legislature into Regulation 2018/848 and has no equivalent in Regulation No 834/2007.
29      In that regard, the referring court observes that, according to recital 10 of Regulation 2018/848, the EU legislature intended to include in the scope of that regulation products other than food or feed, without, however, providing a more precise definition of those products, which could include medicinal products.
30      Second, the referring court is uncertain as to the relationship between the rules on labelling laid down in Regulation 2018/848 and those resulting from Directive 2001/83. While the latter contains a generally exhaustive list of the indications which may appear on the outer packaging of medicinal products, Regulation 2018/848 authorises, in Articles 30 and 32 thereof, a large number of indications, some of which are compulsory if the labelling of the product includes terms referring to organic production. Article 33(5) of that regulation also permits a large number of other labelling elements.
31      In that regard, that court states that, under Article 2(4) of Regulation 2018/848, the latter applies, except where otherwise provided, ‘without prejudice to related
Union legislation, in particular, legislation in the fields of safety of the food chain, animal health …’. Reference is not, however, specifically made to Directive 2001/83. Furthermore, the fact that that directive governs both the risks and the specific requirements regarding the information appearing on the outer packaging of those products, and carries out the necessary balancing of the requirements in question, supports an interpretation to the effect that the provisions of that directive prevail over that of Regulation 2018/848.
32      Third, the referring court observes that if the labelling provisions of Directive 2001/83 were to prevail, the question would arise as to whether the information referred to in Article 62 of that directive includes information on the method of production of medicinal products, in particular the fact that the herbal substances used in that production come from organic farming. Such information could be regarded as ‘useful to the patient’ within the meaning of that Article 62.
33      In that regard, the referring court states that certain indications are authorised by the fifth sentence of Article 10(1) of the AMG where EU regulations authorise them. That provision applies however only to EU regulations relating to medicinal products, which do not include Regulation 2018/848. Moreover, the wording of the fifth sentence of Paragraph 10(1) of the AMG is closer to the original version of Article 62 of Directive 2001/83, according to which only information ‘which is useful for health education’ was permitted, whereas the new version allows any and all information ‘which is useful to the patient’.
34      Against that background, the German courts’ interpretation to the effect that only information that is directly useful for the health of the patient – which does not include information on the method of manufacture – constitutes information which is useful to the patient may prove to be too narrow. However, given the importance that EU law attaches, through the revision of Regulation No 834/2007, to organic origin, such information could also be ‘useful to the patient’.
35      In those circumstances the Oberlandesgericht Düsseldorf (Higher Regional Court, Düsseldorf) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:
‘(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], inserted by points (1) and (2) of Article 1 of 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)], to be regarded as ‘plant-based traditional herbal preparations’ within the meaning of Article 2(1) of, in conjunction with Annex I to, [Regulation 2018/848]?
(2)      If the first question is answered in the affirmative:
Can the labelling provided for in Chapter IV of [Regulation 2018/848], in particular
–        the official organic production logo of the European Union (Article 33 of, in conjunction with Annex V to, [Regulation 2018/848]),
–        the company’s own organic production logo (Article 33(5) of [Regulation 2018/848]),
–        the code number of the control body (Article 32(1)(a) of [Regulation 2018/848]),
–        the place [where the agricultural raw materials were produced:] “EU Agriculture” or “non-EU Agriculture” (Article 32(2) of [Regulation 2018/848]),
–        the term “bio” (Article 30(2) of [Regulation 2018/848]), and
–        the reference “from organic production” (Article 30(1) of [Regulation 2018/848]),
be affixed on the outer packaging of a medicinal product without the conditions of Article 62 of [Directive 2001/83] 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 [to] the patient” and is not “of a promotional nature”[, within the meaning of Article 62 of Directive 2001/83]?’
Consideration of the questions referred
The first question
36      By its first question, the referring court asks, in essence, whether Article 1(29) and Article 16a of Directive 2001/83 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 that directive by virtue of Article 2 thereof, may be regarded simultaneously as ‘plant-based traditional herbal preparations’, within the meaning of Annex I to Regulation 2018/848, coming within the scope of that regulation pursuant to Article 2(1) thereof.
37      As a preliminary point, it should be noted that, under Article 2(1) of Directive 2001/83, which defines its scope, that directive applies to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process. Article 2(2) specifies that in cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a ‘medicinal product’ and within the definition of a product covered by other EU legislation the provisions of Directive 2001/83 are to apply.
38      In the present case, it is apparent from the information provided by the referring court that the medicinal herbal teas at issue in the main proceedings satisfy the conditions listed in Article 16a(1) of Directive 2001/83, with the result that those herbal teas must be regarded as being medicinal products, within the meaning of Article 1(2) of that directive, which come within the scope of that directive, as defined by Article 2(1) thereof.
39      The referring court points out, however, that, as stated in recital 10 of Regulation 2018/848, the material scope of that regulation is broader than that of Regulation No 834/2007, which had been applicable until then, in that Regulation 2018/848 also covers products closely linked to agricultural products, such as plant-based traditional herbal preparations, referred to in Annex I to that regulation. In so far as, according to the applicant in the main proceedings, the medicinal herbal teas at issue in the main proceedings also come within the scope of Regulation 2018/848, pursuant to Article 2(1) thereof, that court seeks to ascertain whether, as regards the labelling of those products, the provisions of Regulation 2018/848 and those of Directive 2001/83 may be applied concurrently.
40      In that regard, the Court has already held that, in the event of doubt as to the correct classification of the products in question, Article 2(2) of Directive 2001/83 gives priority to the application of EU law relating to medicinal products, which, by reason of the higher requirements deriving from the law relating to medicinal products for the placing of products on the market, is also consistent with the objective of a high level of protection of human health pursued by Article 168 TFEU (judgment of 2 March 2023, Kwizda Pharma, C‑760/21, EU:C:2023:143, paragraph 34).
41      Therefore, according to settled case-law, only the provisions of EU law specific to medicinal products apply to a product which satisfies equally well the conditions for classification as a ‘foodstuff’ and the conditions for classification as a ‘medicinal product’ (see, to that effect, judgment of 9 June 2005, HLH Warenvertrieb and Orthica, C‑211/03, C‑299/03 and C‑316/03 to C‑318/03, EU:C:2005:370, paragraph 43 and the case-law cited).
42      Furthermore, as the Advocate General stated, in essence, in points 42 and 43 of his Opinion, EU legislation in the field of medicinal products for human use tends to preclude the possibility of products classified as ‘medicinal products’ within the meaning of Directive 2001/83 being covered by other legal regimes which might be applicable in that area. In that regard, the term ‘plant-based traditional herbal preparations’, appearing in Annex I to Regulation 2018/848, is certainly generic in nature. Nevertheless, in the absence of an express derogation from the exclusive regime established by that directive, the intention of the EU legislature, set out in recital 10 of that regulation, to include within its scope, by means of a broad and non-targeted formulation, products other than foodstuffs cannot be interpreted as constituting an intention to include in the regime provided for by that regulation products which are covered by the concept of ‘medicinal products’ within the meaning of Article 1(2) of that directive.
43      It is apparent, first, from Article 2(4) of Regulation 2018/848, read in conjunction with recital 16 of that regulation, that that regulation applies ‘without prejudice to related Union legislation, in particular, legislation in the fields of safety of the food chain, animal health …’. Second, Article 2(5) provides that that regulation is to apply without prejudice to ‘other specific Union law relating to the placing of products on the market and, in particular, to [Regulation No 1308/2013] and [Regulation No 1169/2011]’. As is apparent from the use in that provision of the term ‘in particular’, the list of those specific provisions is not exhaustive.
44      It follows that, even though Directive 2001/83 is not expressly mentioned in Article 2(5) of Regulation 2018/848, that directive comes within the scope of related EU legislation and falls within the category of ‘other specific Union law relating to the placing of products on the market’, in that it governs the placing on the market of medicinal products, including traditional herbal medicinal products.
45      In those circumstances, in view of the exclusive nature of the provisions of Directive 2001/83, a product which is to be regarded as a traditional herbal medicinal product within the meaning of that directive must satisfy all the requirements laid down in that directive and cannot at the same time come within the scope of other legislation that is not specific to medicinal products, such as that resulting from Regulation 2018/848. Consequently, medicinal herbal teas, such as those at issue in the main proceedings, which are covered by the concept of ‘medicinal products’ within the meaning of that directive, are excluded from the scope of Regulation 2018/848.
46      It should also be noted that, although it is indeed for economic operators to decide under which classification they wish to market certain products, they must nevertheless fulfil the relevant obligations laid down by the applicable EU legislation. If a product is covered by the concept of ‘medicinal product’ within the meaning of Directive 2001/83, it will not be open to an economic operator to market it under a different classification. Indeed, EU law does not guarantee that an economic operator will be allowed to market its products using any terms it finds to be most advantageous for promoting them (see, by analogy, judgment of 5 November 2014, Herbaria Kräuterparadies, C‑137/13, EU:C:2014:2335, paragraph 46).
47      In the light of the foregoing considerations, the answer to the first question is that Article 1(29) and Article 16a of Directive 2001/83 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 that directive 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 2018/848, coming within the scope of that regulation pursuant to Article 2(1) thereof.
The third question
48      By its third question, which it is appropriate to examine in the second place, the referring court asks, in essence, whether Article 62 of Directive 2001/83 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 that directive, may be regarded as ‘useful to the patient’ and as not being ‘of a promotional nature’.
49      It must be borne in mind that, under Article 1(25) of Directive 2001/83, ‘labelling’ means ‘information on the immediate or outer packaging’.
50      Article 62 of that directive provides, moreover, that the outer packaging and the package leaflet may include symbols or pictograms that clarify certain information mentioned in Articles 54 and 59(1) of that directive and other information compatible with the summary of the product characteristics which is useful to the patient, to the exclusion of any element of a promotional nature.
51      Since that Article 62 does not make any reference to national laws, the concepts of information ‘which is useful to the patient’ and of ‘element of a promotional nature’ must be regarded as autonomous concepts of EU law, which must be interpreted in a uniform manner throughout the territory of the European Union taking into consideration not only the wording of that provision, but also the context in which it occurs and the objectives pursued by the rules of which it is part (judgments of 18 January 1984, Ekro, 327/82, EU:C:1984:11, paragraph 11, and of 22 December 2022, EUROAPTIEKA, C‑530/20, EU:C:2022:1014, paragraph 31 and the case-law cited).
52      As regards, in the first place, the wording of Article 62 of Directive 2001/83, it is apparent from the wording of that provision that the outer packaging of a medicinal product may contain information other than that referred to in Article 54 and Article 59(1) of that directive, provided that three conditions are met. First, it must be possible to reconcile that information with the summary of the product characteristics which, under Article 11 of that directive, is to contain precise information about that medicinal product in a given order. Second, that information must be useful to the patient. Third, the information must not contain any element of a promotional nature. The concept of ‘information which is useful to the patient’ in that second condition means that that information is capable of procuring an advantage for the patient, and the concept of ‘element of a promotional nature’ in that third condition refers to an element which participates in a form of advertising for that medicinal product.
53      As regards, in the second place, the context of Article 62 of Directive 2001/83, it must be noted that that Article 62 is among the provisions of Title V of that directive, entitled ‘Labelling and package leaflet’, which seek, inter alia, as stated in recital 40 of that directive, to provide a high degree of consumer protection, in order that medicinal products may be used correctly on the basis of full and comprehensible information and to eliminate as far as possible the health risks associated with their incorrect administration.
54      Indeed, the very particular nature of medicinal products, the therapeutic effects of which distinguish them substantially from other goods, must be emphasised. Those therapeutic effects have the consequence that, if medicinal products are consumed unnecessarily or incorrectly, they may cause serious harm to health, without the patient being in a position to realise that when they are administered (see, to that effect, judgment of 22 December 2022, EUROAPTIEKA, C‑530/20, EU:C:2022:1014, paragraph 41 and the case-law cited).
55      In that regard, Article 61 of Directive 2001/83 provides that all the information appearing on the packaging and the package leaflet of a medicinal product must have been submitted to the competent authorities when the marketing authorisation was requested and approved by them. Thus, this is information which is not only objective, and without any danger a priori to the consumer, but also approved, and the appearance of which on the outer packaging and the package leaflet is even obligatory in accordance with Articles 54 and 59 of that directive (judgment of 5 May 2011, MSD Sharp & Dohme, C‑316/09, EU:C:2011:275, paragraph 41).
56      It follows that Article 62 of Directive 2001/83, which allows certain optional information to be added on condition that it is ‘useful to the patient’ while excluding ‘any element of a promotional nature’ must be interpreted strictly, excluding any information which was not submitted to the competent authorities at the time when the marketing authorisation was requested and was not approved by them. In any event, it must be stated that, in accordance with Article 16a of Directive 2001/83, traditional herbal medicinal products are covered, not by that procedure, but by the simplified registration procedure.
57      That conclusion is, however, without prejudice to the possibility for a producer of such medicinal products to choose to use, where appropriate, the marketing authorisation procedure for a medicinal product, following which the competent authority may find that active substances with therapeutic or preventive properties resulting from organic production have a beneficial effect on the therapeutic characteristics of a medicinal product and, therefore, may approve such a statement on the outer packaging of that medicinal product.
58      In the third place, the interpretation set out in paragraph 56 of the present judgment is supported by the interest of safeguarding public health, which is, as stated in recital 2 of Directive 2001/83, the essential aim of any rules governing the production, distribution and use of medicinal products (judgment of 23 April 2020, DHU Arzneimittel, C‑101/19 and C‑102/19, EU:C:2020:304, paragraph 44).
59      Indeed, by taking the view that the information ‘which is useful to the patient, to the exclusion of any element of a promotional nature’ within the meaning of Article 62 of Directive 2001/83 must be information which serves to inform patients as to the correct use of medicinal products, that information contributes to the protection of public health. That information thus makes it possible to safeguard the patient from an excess of irrelevant information and marketing in the labelling of medicinal products, while promoting the proper use of those medicinal products.
60      Such an objective could be jeopardised if it were open to an economic operator that markets products covered by the concept of ‘traditional herbal medicinal products’, within the meaning of Article 1(29) and Article 16a of Directive 2001/83, with a view to promoting the sale or consumption of those products, to choose the additional information which may appear on their outer packaging, including information on the method of production of the plants used in their manufacture.
61      In those circumstances, it must be held, as the Advocate General stated in point 85 of his Opinion, that including on the packaging of a traditional herbal medicinal product labelling elements provided for in Chapter IV of Regulation 2018/848 is liable to be promotional in nature in particular where those elements are devoid of any value as regards health, they do not correspond to any of the indications provided for in the summary of the product characteristics, and the medicinal product can be purchased without a prescription. Indeed, in that eventuality, the information is addressed to the patient without the intermediary of a healthcare professional, with the result that it could lead, directly, to a decision to purchase on the part of the patient.
62      In the light of the foregoing considerations, the answer to the third question is that Article 62 of Directive 2001/83 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 that directive, cannot be regarded as ‘useful to the patient’ and as not being ‘of a promotional nature’.
The second question
63      Given the answer to the first question, there is no need to answer the second question.
Costs
64      Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.
On those grounds, the Court (Fifth Chamber) hereby rules:
1.      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.
2.      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’.
[Signatures]
*      Language of the case: German.