Provisional text
JUDGMENT OF THE COURT (Ninth Chamber)
4 September 2025 (*)
( Reference for a preliminary ruling – Medicinal products – Product which may fall within the definition of ‘medicinal product’ and within the definition of ‘product covered by other Community legislation’ – Applicable legal framework – Directive 2001/83/EC – Article 2(2) – Rule of precedence – Scope – Effectiveness – Procedural autonomy of the Member States – Article 4(3) TEU – Principle of sincere cooperation )
In Case C‑451/24,
REQUEST for a preliminary ruling under Article 267 TFEU from the Verwaltungsgericht Wien (Administrative Court, Vienna, Austria), made by decision of 15 June 2024, received at the Court on 26 June 2024, in the proceedings
Kwizda Pharma GmbH
other party:
Landeshauptmann von Wien,
THE COURT (Ninth Chamber),
composed of N. Jääskinen, President of the Chamber, M. Condinanzi and R. Frendo (Rapporteur), Judges,
Advocate General: T. Ćapeta,
Registrar: A. Calot Escobar,
having regard to the written procedure,
after considering the observations submitted on behalf of:
–        Kwizda Pharma GmbH, by J. Hütthaler-Brandauer, Rechtsanwalt,
–        the Austrian Government, by J. Schmoll and P. Selim, acting as Agents,
–        the European Commission, by T.S. Bohr, E. Mathieu and A. Spina, acting as Agents,
having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,
gives the following
Judgment
1        This reference for a preliminary ruling concerns the interpretation 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 as amended’) and, in particular, Article 2(2) thereof.
2        The request has been made in proceedings between Kwizda Pharma GmbH and Landeshauptmann von Wien (Head of Government of the Province of Vienna, Austria) concerning the latter’s decisions prohibiting Kwizda Pharma from continuing to market four of its products as food for special medical purposes.
Legal context
European Union law
Directive 2001/83 as amended
3        According to recital 2 of Directive 2001/83 as amended:
‘The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health.’
4        Article 1(2) of that directive 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’.
5        Article 2 of that directive 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        Under Article 6(1) of that directive:
‘No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State …’
7        Article 26(1) of Directive 2001/83 as amended provides:
‘The marketing authorisation shall be refused if, after verification of the particulars and documents [required], it is clear that:
…
(b)      its therapeutic efficacy is insufficiently substantiated by the applicant; …
…’
Regulation (EC) No 178/2002
8        Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1) provides, in the first and third paragraphs of Article 2 thereof:
‘For the purposes of this Regulation, “food” (or “foodstuff”) means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans.
…
“Food” shall not include:
…
(d)      medicinal products …
…’
Directive 2002/46/EC
9        Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ 2002 L 183, p. 51), provides, in Article 1(2) thereof:
‘This Directive shall not apply to medicinal products as defined by Directive [2001/83]’.
Directive 2004/27
10      Recital 7 of Directive 2004/27 states:
‘… the definitions and scope of Directive [2001/83] should be clarified … In order to take account both of the emergence of new therapies and of the growing number of so-called “borderline” products between the medicinal product sector and other sectors, the definition of “medicinal product” should be modified so as to avoid any doubt as to the applicable legislation when a product, whilst fully falling within the definition of a medicinal product, may also fall within the definition of other regulated products. … Also, in view of the characteristics of pharmaceutical legislation, provision should be made for such legislation to apply. With the same objective of clarifying situations, where a given product comes under the definition of a medicinal product but could also fall within the definition of other regulated products, it is necessary, in case of doubt and in order to ensure legal certainty, to state explicitly which provisions have to be complied with. Where a product comes clearly under the definition of other product categories, in particular food, food supplements, medical devices, biocides or cosmetics, this Directive should not apply. …’
Regulation (EC) No 1223/2009
11      Recital 6 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ 2009 L 342, p. 59) states:
‘This Regulation relates only to cosmetic products and not to medicinal products, medical devices or biocidal products. …’
Regulation (EU) No 609/2013
12      Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ 2013 L 181, p. 35), provides, in Article 2(2):
‘The following definitions shall … apply:
…
(g)      “food for special medical purposes” means food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone;
…’
13      Article 4(1) of that regulation provides:
‘Food [for special medical purposes] may only be placed on the market if it complies with this Regulation.’
14      Article 11(1) of that regulation provides that:
‘… the Commission shall be empowered to adopt delegated acts … with respect to the following:
…
(d)      the notification requirements for the placing on the market of food [for special medical purposes], in order to facilitate the efficient official monitoring of such food, and on the basis of which food business operators shall notify the competent authorities of Member States where that food is being marketed;
…’
Delegated Regulation (EU) 2016/128
15      Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes (OJ 2016 L 25, p. 30), provides, in Article 9 thereof:
‘When food for special medical purposes is placed on the market, the food business operator shall notify the competent authority of each Member State where the product concerned is being marketed of the information appearing on the label, by sending to it a model of the label used for the product, and of any other information the competent authority may reasonably request to establish compliance with this Regulation, unless a Member State exempts the food business operator from that obligation under a national system that guarantees an efficient official monitoring of the product concerned.’
Regulation (EU) 2017/745
16      Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ 2017 L 117, p. 1.), provides, in Article 1(6) thereof:
‘This Regulation does not apply to:
…
(b)      medicinal products as defined in point 2 of Article 1 of Directive
[2001/83 as amended]. …
…’
Austrian law
17      Article 10 of the Bundes-Verfassungsgesetz (Federal Constitutional Law), in the version applicable to the facts in the main proceedings, provides:
‘(1)      The Federal State has legislative and executive powers in the following matters:
…
12.      Public health …
…’
18      The Bundesgesetz über die Herstellung und das Inverkehrbringen von Arzneimitteln (Federal Law on the manufacture and marketing of medicinal products) of 2 March 1983 (BGBl. 185/1983), in the version applicable to the facts in the main proceedings, provides in Paragraph 1 thereof:
‘(1)      Medicinal products are substances or preparations made from substances that
1.      are intended for use in or on the human body and are intended for use as remedies with properties for the curing, alleviating or preventing of human diseases or disease symptoms, or
2.      can be used in or on the human body or can be administered to a human being or an animal, either:
(a)      to restore, correct or influence the physiological functions through a pharmacological, immunological or metabolic effect, or
(b)      to make a medical diagnosis.
…
(3)      The term “medicinal product” does not apply to:
…
2.      the foodstuffs referred to in Article 2 … of Regulation [No 178/2002]
…
(3a)      If a product falls both within the definition of medicinal product in subparagraphs 1 to 3 [of this Paragraph 1] and within the definition of a product regulated by another federal law, only the provisions of that federal law shall apply to that product.
(3b)      The Bundesamt für Sicherheit im Gesundheitswesen [(Federal Office for Safety in Healthcare, Austria)] is required to determine, at the request of any person wishing to place a product on the market, whether that product falls within the definition of a medicinal product. [That Federal Office] may also determine of its own motion whether a product falls within the definition of a medicinal product. …’
19      Under Paragraph 38 of the Allgemeines Verwaltungsverfahrensgesetz 1991 (General Law on Administrative Procedures of 1991) (BGBl. 51/1991):
‘[Each authority is, in principle, empowered] to decide on preliminary issues raised during the investigation procedure which should be decided by other administrative or judicial authorities as principal issues, on the basis of the circumstances of the case and by basing its decision on that assessment. …’
The dispute in the main proceedings and the questions referred for a preliminary ruling
20      Kwizda Pharma markets four products in respect of which it states that the ingredients prevent bacteria from adhering to the mucous membranes of the urinary tract, so that the consumption of those products is recommended in the event of urinary tract infections (‘the products in question’).
21      In accordance with Article 9 of Delegated Regulation 2016/128, it notified the Austrian authorities of the placing on the market of the products in question as food for special medical purposes within the meaning of Article 2(2)(g) of Regulation No 609/2013.
22      By two decisions of 5 August 2021 and two decisions of 6 August 2021 (‘the contested decisions’), the Head of Government of the Province of Vienna refused to classify the products in question as food for special medical purposes, which had the effect of prohibiting Kwizda Pharma from continuing to place those products on the market.
23      Kwizda Pharma challenged those decisions before the Verwaltungsgericht Wien (Administrative Court, Vienna, Austria), which is the referring court.
24      By its decision of 26 November 2021, that court referred several questions to the Court of Justice for a preliminary ruling concerning, inter alia, the criteria for distinguishing between the concepts of ‘medicinal product’, within the meaning of Article 1(2) of Directive 2001/83, and ‘food for special medical purposes’, within the meaning of Article 2(2)(g) of Regulation No 609/2013. By judgment of 2 March 2023, Kwizda Pharma (C‑760/21, EU:C:2023:143), the Court answered those questions.
25      By judgments of 2 May 2023, the referring court dismissed Kwizda Pharma’s actions against the contested decisions. To that end, it found, inter alia, that the products in question did not satisfy the conditions for classification as food for special medical purposes, but that they were medicinal products by presentation within the meaning of Article 1(2)(a) of Directive 2001/83 as amended (‘medicinal products by presentation’).
26      Kwizda Pharma challenged those judgments before the Verwaltungsgerichtshof (Supreme Administrative Court, Austria), which, by judgments of 11 April 2024, set aside the referring court’s judgments of 2 May 2023.
27      The Verwaltungsgerichtshof (Supreme Administrative Court) held, in essence, that, in accordance with Article 2(2) of Directive 2001/83 as amended, which was transposed into national law by Paragraph 1(3a) of the Federal Law on the manufacture and marketing of medicinal products, only that latter law is applicable to a product which is classified as a medicinal product within the meaning of Paragraph 1(1) thereof. Thus, the legislation on food for special medical purposes is not applicable to the products in question, including the provisions of that legislation which empower the Head of Government of the Province of Vienna to prohibit an operator from continuing to place on the market, as a food for special medical purposes, a product which does not satisfy the conditions required to be regarded as such a food. The Verwaltungsgerichtshof (Supreme Administrative Court) inferred from this that the referring court should have annulled the contested decisions outright on the ground that the authority which adopted them lacked competence.
28      Since the Verwaltungsgerichtshof (Supreme Administrative Court) did not dispose of the case, it became pending again before the referring court.
29      The referring court, which has classified the products in question as medicinal products by presentation, is of the view that Article 2(2) of Directive 2001/83 as amended must be interpreted as not precluding, where a product which must be classified as a medicinal product by presentation is placed on the market as a food for special medical purposes, the authority competent to enforce the legislation relating to those foods from prohibiting the placing on the market of that product on the ground that it does not fulfil the conditions required to be classified as a food for special medical purposes. That interpretation would enable it to uphold the contested decisions.
30      Therefore, the referring court considers that it is necessary for the Court to interpret Article 2(2) of Directive 2001/83 as amended in order to determine the scope of the rule of precedence set out therein.
31      In that regard, in the first place, the referring court is of the view that that rule of precedence excludes only the application of the provisions relating to a ‘product covered by other Community legislation’, within the meaning of Article 2(2) of that directive, which would otherwise conflict with the provisions of that directive applicable to that product.
32      In the present case, the referring court notes that it has reached the undisputed conclusion that the products in question clearly cannot be classified as food for special medical purposes. Accordingly, the legislation relating to those foods does not allow those products to be placed on the market as food for special medical purposes. As a result, there is no conflict between that legislation and the provisions of Directive 2001/83 as amended which prohibit the placing on the market of those products, since they are medicinal products by presentation.
33      In the second place, the referring court, relying in particular on recital 7 of Directive 2004/27, states that the rule of precedence laid down in Article 2(2) of Directive 2001/83 as amended is applicable only where a product falls fully within the definition of a medicinal product and may possibly also fall within the definition of ‘product covered by other Community legislation’.
34      That court considers that a broader interpretation of that rule of precedence is not necessary. Indeed, other provisions of EU law, in particular point (d) of the third paragraph of Article 2 of Regulation No 178/2002, Article 1(2) of Directive 2002/46, recital 6 of Regulation No 1223/2009 and Article 1(6)(b) of Regulation 2017/745, contain exclusion rules which prevent a product which is a medicinal product from being lawfully marketed as a food, a food supplement, a cosmetic product or a medical device, respectively.
35      In the third place, the referring court recalls that, according to the judgment of 2 March 2023, Kwizda Pharma (C‑760/21, EU:C:2023:143, paragraph 34), the rule of precedence laid down in Article 2(2) of Directive 2001/83 as amended is consistent, by reason of the higher requirements deriving from the legislation relating to medicinal products for the placing on the market of products, with the objective of a high level of protection of human health pursued by Article 168 TFEU.
36      In that regard, the referring court considers that that objective would be undermined if the placing on the market, as a food for special medical purposes, of a product that must be classified as a medicinal product by presentation could be prohibited by the authority competent to enforce the legislation relating to those foods only once that product is no longer placed on the market as a medicinal product.
37      Indeed, it would follow that that product could continue to be placed on the market as a food for special medical purposes for the duration of the procedure laid down by the legislation on medicinal products, which may lead to a decision prohibiting the placing on the market of that product as a medicinal product.
38      In the fourth place, the referring court, referring to Article 4(3) TEU, submits that the interpretation of Article 2(2) of Directive 2001/83 as amended adopted by the Verwaltungsgerichtshof (Supreme Administrative Court) undermines the effectiveness of the rules of EU law governing certain products and prohibiting their placing on the market where the conditions laid down for that purpose are not satisfied.
39      In particular, the effectiveness of those rules would be undermined if a product which, first, does not fulfil the conditions required to be classified as a food for special medical purposes, second, is unlawfully placed on the market as a food for special medical purposes and, third, because of its packaging, must be classified as a medicinal product by presentation, cannot be withdrawn from the market by the authority competent to enforce the legislation relating to those foods, on account of the fact that that product must be classified as a medicinal product by presentation.
40      In the fifth and last place, the referring court considers that, in the expression ‘product covered by other Community legislation’ in Article 2(2) of Directive 2001/83 as amended, the term ‘product’ must be read in the light of paragraph 1 of that article, according to which that directive is to 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.
41      In those circumstances, the Verwaltungsgericht Wien (Administrative Court, Vienna) decided to stay the proceedings and to refer the following questions to the Court for a preliminary ruling:
‘(1)      How is the expression “product covered by other Community legislation” in Article 2(2) of [Directive 2001/83 as amended] to be interpreted?
Is it the case that only a product
–        (i) that is prepared industrially within the meaning of Article 2(1) of [that directive], or
–        (ii) that is manufactured by a method involving an industrial process comes within the expression “product covered by other Community legislation”?
If that question is to be answered in the affirmative: Is the expression “product covered by other Community legislation” to be understood as meaning only a product which has been prepared industrially or manufactured by a method involving an industrial process within the meaning of Article 2(1) of [Directive 2001/83 as amended], in so far as Community law lays down rules for the preparation of the product or rules concerning whether the product may be marketed as a (given) “product covered by other Community legislation”?
If that question is to be answered in the negative: What criteria are to be used to determine whether a given product is to be classified as a given “product covered by other Community legislation” within the meaning of Article 2(2) of [Directive 2001/83 as amended]?
(2)      How is the expression “in cases of doubt” in Article 2(2) of [Directive 2001/83 as amended] to be interpreted?
(3)      How is the expression “may fall” in Article 2(2) of [Directive 2001/83 as amended] to be interpreted? Does that expression “may fall” also cover a product which, clearly or as a result of administrative or judicial proceedings, cannot be classified as a (given) “product covered by other Community legislation”?
(4)(a)      To what extent do Article 2(2) of [Directive 2001/83 as amended] or other provisions of Community law preclude the authority competent to enforce Community legislation concerning a (given) “product covered by other Community legislation” from enforcing applicable Community provisions in respect of that given “product covered by other Community legislation” where that product has been definitively classified as a medicinal product by the medicines agency after carrying out a procedure?
(4)(b)      Must Article 2(2) of [Directive 2001/83 as amended] or other Community legislation be interpreted as meaning that the national authority is not entitled, in respect of a product
–        which is classified as a medicinal product following an examination procedure carried out by the medicines agency, and
–        which is (currently) placed on the market as a given “product covered by other Community legislation”,
to prohibit the company placing the product on the market from continuing to place that product on the market as that given “product covered by other Community legislation” (on the basis that it has failed to comply with the legal rules applicable to the placing of that product on the market as that given “product covered by other Community legislation”)?
(5)(a)      To what extent does Article 2(2) of [Directive 2001/83 as amended] or other Community legislation prohibit the authority competent to enforce Community legislation concerning a given “product covered by other Community legislation” from enforcing, in respect of that given “product covered by other Community legislation”, applicable Community provisions where there are merely grounds to suspect that the product must (also) be classified as a medicinal product and it has therefore not been definitively clarified that the product must be classified as a medicinal product?
(5)(b)      Must Article 2(2) of [Directive 2001/83 as amended] or other Community legislation be interpreted as meaning that the national authority is not entitled, in respect of a product
–        in respect of which there are merely grounds to suspect that that product must (also) be classified as a medicinal product and it has therefore not been definitively clarified that that product must be classified as a medicinal product, and
–        which is (currently) placed on the market as a given “product covered by other Community legislation”,
to prohibit the company placing the product on the market from continuing to place that product on the market as that given “product covered by other Community legislation” (on the basis that it has failed to comply with the legal rules applicable to the placing of that product on the market as that given “product covered by other Community legislation”)?
(6)      Does the precedence granted by the Community to legislation on medicinal products [see, in particular, point (d) of the third paragraph of Article 2 of Regulation No 178/2002 as regards food, recital 6 of Regulation No 1223/2009 as regards cosmetic products, Article 1(6)(b) of Regulation 2017/745 as regards medical devices and Article 1(2) of Directive 2002/46 as regards food supplements,] also apply where it is certain that a product which must be classified as a medicinal product placed on the market as a given “product covered by other Community legislation” does not satisfy the requirements for classification as that given “product covered by other Community legislation”?
(7)      How should the scope of the rule that medicinal product legislation is to take precedence[,] laid down in Article 2(2) of [Directive 2001/83 as amended][,] be distinguished from the scope of the rule concerning the precedence of medicinal product legislation which stipulates that a negative classification is required, namely that they do not qualify as a medicinal product?’
Consideration of the questions referred
The jurisdiction of the Court to answer the fourth and fifth questions
42      Kwizda Pharma submits that the Court does not have jurisdiction to answer the fourth and fifth questions, which relate to national law and not EU law.
43      In accordance with settled case-law, in proceedings under Article 267 TFEU, it is solely for the national court before which a dispute has been brought, and which must assume responsibility for the subsequent judicial decision, to determine, in the light of the particular circumstances of the case, both the need for a preliminary ruling in order to enable it to deliver judgment and the relevance of the questions which it submits to the Court. Consequently, where the questions submitted concern the interpretation of EU law, the Court is, in principle, bound to give a ruling (judgments of 21 April 1988, Pardini, 338/85, EU:C:1988:194, paragraph 8, and of 22 October 2024, Kolin Inşaat Turizm Sanayi ve Ticaret, C‑652/22, EU:C:2024:910, paragraph 36). That interpretation clearly falls within the jurisdiction of the Court under that article (judgments of 19 November 2019, A. K. and Others (Independence of the Disciplinary Chamber of the Supreme Court), C‑585/18, C‑624/18 and C‑625/18, EU:C:2019:982, paragraph 74, and of 25 February 2025, Sąd Rejonowy w Białymstoku and Adoreikė, C‑146/23 and C‑374/23, EU:C:2025:109, paragraph 33).
44      In the present case, it must be held that the fourth and fifth questions concern the interpretation of Article 2(2) of Directive 2001/83 as amended.
45      Consequently, the Court has jurisdiction to answer those questions.
The admissibility of the fifth question
46      It should be borne in mind that the justification for a reference for a preliminary ruling is not that it enables advisory opinions on general or hypothetical questions to be delivered but rather that it is necessary for the effective resolution of a dispute concerning EU law (judgments of 16 December 1981, Foglia, 244/80, EU:C:1981:302, paragraph 18 and of 6 March 2025, ONB and Others, C‑575/23, EU:C:2025:141, paragraph 52).
47      Both parts of the fifth question refer to a situation in which there is uncertainty as to the classification of certain products as medicinal products, whereas it is clear from the request for a preliminary ruling that, in the present case, the referring court classifies with certainty the products in question as medicinal products by presentation.
48      It follows that the fifth question is hypothetical and must therefore be declared inadmissible.
Substance
The first question
49      By its first question, the referring court asks, in essence, whether Article 2(2) of Directive 2001/83 as amended must be interpreted as meaning that the expression ‘product covered by other Community legislation’, which appears in that paragraph 2, refers 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’, mentioned in Article 2(1) of that directive.
50      In that regard, it is sufficient to note that Article 2(1) of Directive 2001/83 as amended lays down the conditions which must be met by ‘medicinal products for human use’ in order to come within the scope of that directive. By contrast, the expression ‘product covered by other Community legislation’ in Article 2(2) refers to regulated products other than ‘medicinal products for human use’ as defined by the acts of EU law governing those other regulated products.
51      It must therefore be held that Article 2(1) of Directive 2001/83 as amended defines the scope of that directive and is not relevant for the purpose of determining what constitutes a ‘product covered by other Community legislation’.
52      In the light of the foregoing, the answer to the first question is that Article 2(2) of Directive 2001/83 as amended must be interpreted as meaning that the expression ‘product covered by other Community legislation’, which appears in that paragraph 2, refers not 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’, mentioned to in Article 2(1), but to other regulated products, as defined by the acts of EU law governing those products.
The second, third, sixth and seventh questions
53      According to settled case-law, in the procedure laid down by Article 267 TFEU providing for cooperation between national courts and the Court of Justice, it is for the latter to provide the national court with an answer which will be of use to it and enable it to determine the case before it. To that end, the Court should, where necessary, reformulate the questions referred to it. It is for the Court to extract from all the information provided by the national court, in particular from the grounds of the order for reference, the points of EU law which require interpretation, having regard to the subject matter of the dispute (judgment of 30 April 2024, M.N. (EncroChat), C‑670/22, EU:C:2024:372, paragraph 78 and the case-law cited).
54      In the present case, it must be held that, by the second, third, sixth and seventh questions, which it is appropriate to examine together, the referring court asks, in essence, whether Article 2(2) of Directive 2001/83 as amended must be interpreted as meaning that the rule of precedence which it lays down applies where a product satisfies with certainty the conditions required for classification as a medicinal product, within the meaning of Article 1(2) of that directive, but may also fall within other categories of products regulated by EU law.
55      In order to dispel the referring court’s doubts arising from the wording of Article 2(2) of Directive 2001/83 as amended, reproduced in paragraph 5 of the present judgment, as regards the expressions ‘in case of doubt’, ‘may fall’ and ‘product governed by other Community legislation’ contained therein and how they interrelate, it should be borne in mind that, in accordance with settled case-law, in interpreting a provision of EU law, it is necessary to consider not only its wording, but also the context in which it occurs and the objectives pursued by the rules of which it is part (judgments of 17 November 1983, Merck, 292/82, EU:C:1983:335, paragraph 12, and of 25 February 2025, BSH Hausgeräte, C‑339/22, EU:C:2025:108, paragraph 27).
56      In that regard, it is important to note that Directive 2004/27 amended Directive 2001/83, in particular in order to insert the rule of precedence which now appears in Article 2(2) thereof.
57      The purpose of that rule is stated in recital 7 of Directive 2004/27. In essence, according to that recital, in view of the growing number of so-called ‘borderline’ products between the medicinal product sector and other sectors, it was necessary, in order to ensure legal certainty, to clarify the legislation applicable to a product, in order to avoid any doubt in that regard, where that product falls fully within the definition of a medicinal product but may also fall within the definition of other regulated products. In such a case, in view of the characteristics of the rules relating to medicinal products, provision had to be made for such legislation to apply. By contrast, where a product clearly comes under the definition of categories of products other than medicinal products, in particular food, it was necessary to provide that Directive 2001/83 as amended would not apply.
58      First of all, it follows from the case-law that, in the light of recital 7 of Directive 2004/27, Article 2(2) of Directive 2001/83 as amended starts from the premiss that the products covered by that provision satisfy the conditions for classification as a medicinal product (see, to that effect, judgment of 15 January 2009, Hecht-Pharma, C‑140/07, EU:C:2009:5, paragraph 24).
59      In that regard, it should be noted that that provision applies both to medicinal products by function, referred to in Article 1(2)(b) of that directive (‘medicinal products by function’), and to medicinal products by presentation (see, to that effect, judgments of 19 January 2023, Bundesrepublik Deutschland (Nasal drops), C‑495/21 and C‑496/21, EU:C:2023:34, paragraphs 28, 30 and 34, and of 2 March 2023, Kwizda Pharma, C‑760/21, EU:C:2023:143, paragraph 35).
60      Moreover, as regards medicinal products by presentation, it must be recalled that a product is ‘presented as having properties for treating or preventing disease’ within the meaning of Directive 2001/83 as amended when it is expressly ‘indicated’ or ‘recommended’ as such, possibly by means of labels, leaflets or oral representation. The same applies whenever any averagely well-informed consumer gains the impression, which, provided it is definite, may even result from implication, that the product in question should, having regard to its presentation, have the properties concerned (judgment of 19 January 2023, Bundesrepublik Deutschland (Nasal drops), C‑495/21 and C‑496/21, EU:C:2023:34, paragraphs 45 and 46).
61      Next, the rule of precedence laid down, in the event of doubt as to the correct classification of a product, in Article 2(2) of Directive 2001/83 as amended is consistent with the objective of a high level of protection of human health pursued by Article 168 TFEU, by reason of the higher requirements that EU law relating to medicinal products provides for the placing of medicinal products on the market (see, to that effect, judgment of 2 March 2023, Kwizda Pharma, C‑760/21, EU:C:2023:143, paragraph 34).
62      Lastly, in accordance with recital 7 of Directive 2004/27, the rule of precedence laid down in Article 2(2) of Directive 2001/83 as amended is not applicable where a product clearly satisfies the conditions laid down by the definition of a category of product other than medicinal products (see, to that effect, judgment of 19 January 2023, Bundesrepublik Deutschland (Nasal drops), C‑495/21 and C‑496/21, EU:C:2023:34, paragraphs 31 and 32).
63      It follows that that rule of precedence applies where a product satisfies with certainty the conditions for classification as a medicinal product by function or as a medicinal product by presentation, but there is doubt as to whether that product may also fall within other categories of products regulated by EU law, including food for special medical purposes.
64      By contrast, that rule of precedence does not apply where there is no doubt as to the classification of a product. This is particularly the case, first, where a product clearly falls within the definition of one of these other categories of regulated products.
65      In that regard, as the referring court states, in particular in its sixth question, several instruments of EU law relating to those other categories of regulated products contain rules which exclude medicinal products from their respective scope. It follows that those rules and the rule of precedence laid down in Article 2(2) of Directive 2001/83 as amended are complementary.
66      That rule of precedence does not apply, second, where it is certain that a product is solely a medicinal product and that it cannot be regarded as a product falling within other categories of products regulated by EU law. In that case, Directive 2001/83 as amended is applicable to that product by reason simply of the fact that it meets one of the definitions of medicinal product, by function or by presentation, set out in Article 1(2) of that directive and satisfies the conditions laid down in Article 2(1) thereof, with the result that it falls within its scope.
67      Accordingly, in a situation such as that described by the referring court, where there is no doubt that the products concerned, first, are medicinal products by presentation and, second, are not food for special medical purposes, the rule of precedence laid down in Article 2(2) of Directive 2001/83 as amended is irrelevant. That directive is applicable to those products by reason solely of the fact they are clearly medicinal products by presentation and therefore fall within the scope of that directive.
68      Having regard to the foregoing considerations, the answer to the second, third, sixth and seventh questions is that Article 2(2) of Directive 2001/83 as amended must be interpreted as meaning that:
–        the rule of precedence which it lays down applies where a product satisfies with certainty the conditions for classification as a medicinal product within the meaning of Article 1(2) of that directive, but there is doubt as to whether that product may also fall within other categories of products regulated by EU law;
–        by contrast, that rule of precedence does not apply where a product clearly falls within the definition of one of those other categories of regulated products;
–        that rule of precedence equally does not apply where it is certain that a product is solely a medicinal product and that it cannot be regarded as a product falling within other categories of products regulated by EU law;
–        in the latter case, that directive is applicable to that product by reason simply of the fact that it meets one of the definitions of medicinal product set out in Article 1(2) of that directive and satisfies the conditions laid down in Article 2(1) of the same directive.
The fourth question
69      In accordance with the answer given to the second, third, sixth and seventh questions, the rule of precedence laid down in Article 2(2) of Directive 2001/83 as amended is not relevant in a situation such as that described by the referring court and referred to in paragraph 67 of the present judgment.
70      However, that directive is applicable in such a situation since the products in question must be classified as medicinal products by presentation.
71      In the present case, that classification was made by the referring court, and not by the authority competent to enforce the legislation on medicinal products, to which that court refers in its fourth question.
72      As a result, in accordance with the case-law referred to in paragraph 53 of the present judgment, it must be considered that, by the fourth question, the referring court asks, in essence, whether Directive 2001/83 as amended must be interpreted as precluding the placing on the market of a product as a food for special medical purposes from being prohibited by the authority competent to enforce the legislation relating to those
foods, on the ground that that product does not satisfy the conditions laid down by that legislation, where, first, in the Member State concerned, such an authority is different from the authority competent to enforce the legislation on medicinal products, and, second, that product is a medicinal product by presentation, within the meaning of Article 1(2)(a) of Directive 2001/83 as amended, according to the assessment of the court hearing appeals against the decisions of the authority competent to enforce the legislation relating to those foods.
73      In that context, it must be borne in mind that it is apparent from the documents before the Court that, in the Austrian legal system, the Federal Office for Safety in Healthcare is competent to enforce the legislation on medicinal products, whereas the authorities of the Bundesländer (provinces), including the Head of Government of the Province of Vienna, are competent, inter alia, to enforce the legislation on food for special medical purposes.
74      Therefore, the referring court makes reference, in essence, to the risk that a product which does not meet the conditions to be placed on the market as a food for special medical purposes, but which is a medicinal product by presentation, may continue to be marketed pending the decision of the competent authority prohibiting it from being placed on the market.
75      In that regard, it should be borne in mind, first, that Article 6 of Directive 2001/83 as amended provides that no medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued, notably by the competent authority of that Member State, in accordance with that directive. Second, according to Article 26(1) of that directive, a marketing authorisation is to be refused if the therapeutic efficacy of the medicinal product in respect of which authorisation is sought is not sufficiently substantiated.
76      The category of medicinal products by presentation is intended to cover, within the scope of Directive 2001/83 as amended, products which are not sufficiently effective or which do not have the effect that their presentation would suggest, in order to protect consumers from a variety of products used instead of the proper remedies. Thus, the rules relating to medicinal products are intended in particular to prevent the placing on the market of products which have no therapeutic effect but which, for commercial purposes, are presented as medicinal products by the manufacturer or seller (see, to that effect and by analogy, judgment of 28 October 1992, Ter Voort, C‑219/91, EU:C:1992:414, paragraphs 16 and 25).
77      Similarly, Article 4(1) of Regulation No 609/2013 provides that food for special medical purposes may be placed on the market only if it complies with that regulation. Under Article 9 of Delegated Regulation 2016/128, adopted in accordance with Article 11 of Regulation No 609/2013, the placing on the market of a food for special medical purposes must, in principle, be notified to the competent authority of each Member State in which the product concerned is marketed. It follows that, although a form of control also exists for those products, it is carried out a posteriori.
78      That said, neither Directive 2001/83, Regulation No 609/2013 nor Delegated Regulation 2016/128 specifies which authority must be designated by each Member State as being responsible for the controls provided for in those acts as regards the authorisation for the placing on the market of medicinal products and the notification of the marketing of food for special medical purposes. In particular, none of those acts requires that one and the same authority be competent, within a Member State, to enforce
the legislation on medicinal products and the legislation on
food for special medical purposes.
79      Thus, in the absence of rules laid down by EU law regarding the determination of the number of those authorities and, where several authorities are designated, as to the manner in which they must interact, it is for the legal order of each Member State to address those matters, in accordance with the principle of procedural autonomy (see, to that effect and by analogy, judgment of 7 December 2010, VEBIC, C‑439/08, EU:C:2010:739, paragraph 63).
80      However, according to settled case-law, the freedom to choose the ways and means of ensuring that a directive is implemented does not affect the obligation imposed on all Member States to which the directive is addressed to adopt all the measures necessary to ensure that the directive concerned is fully effective in accordance with the objective which it pursues (see, to that effect, judgments of 6 October 2010, Base and Others, C‑389/08, EU:C:2010:584, paragraph 25 and the case-law cited, and of 11 June 2020, Prezident Slovenskej republiky, C‑378/19, EU:C:2020:462, paragraph 37).
81      Thus, it is necessary to ascertain whether the objective of protecting public health which characterises Directive 2001/83 as amended, as is apparent from recital 2 thereof and, in essence, from the case-law referred to in paragraph 61 of the present judgment, is complied with in circumstances such as those at issue in the main proceedings.
82      In that regard, it should be noted that that objective would be undermined if the attribution, by the Republic of Austria, of the competence to enforce the legislation on medicinal products to an authority other than the one competent to enforce the legislation on food for special medical purposes resulted in products which do not meet the conditions laid down by the latter legislation being able nevertheless to continue to be placed on the market, on the ground that those products are medicinal products and therefore fall within the competence of another authority, which alone is empowered to take a decision in the event they are placed on the market without authorisation.
83      It follows from paragraphs 63 to 66 of the present judgment that a product which is unequivocally a medicinal product must be subject only to the rules relating to medicinal products and, consequently, that a product may be covered by other legislation only if it is not considered to be a medicinal product.
84      Accordingly, if an administrative authority of a Member State, which does not have jurisdiction to apply the legislation on medicinal products, considers that a product which is the subject of a procedure before it is a medicinal product which was placed on the market without having the authorisation required by that legislation, it must immediately inform the competent authority thereof. Only in that way can that competent authority take the necessary measures as quickly as possible to guarantee the protection of public health.
85      It follows that, in such a situation, that protection is dependent on cooperation between different national authorities. Against that background, it should be borne in mind that, under the principle of sincere cooperation enshrined in Article 4(3) TEU, in areas covered by EU law, Member States, including their administrative authorities, must assist each other, in full mutual respect, in carrying out tasks which flow from the Treaties, take any appropriate measure to ensure fulfilment of the obligations arising from, inter alia, the acts of the institutions of the European Union and refrain from any measure which could jeopardise the attainment of the European Union’s objectives (judgment of 4 July 2023, Meta Platforms and Others (General terms of use of a social network), C‑252/21, EU:C:2023:537, paragraph 53).
86      Furthermore, where the administrative authority which is not competent to enforce the legislation on medicinal products has not considered that the product which is the subject of the proceedings before it could be a medicinal product, but the court before which its decision is challenged reaches such a conclusion, it is for the legal system of the Member State concerned to establish whether that administrative authority, following the annulment of its decision on the ground of lack of competence, must inform the competent authority, or whether that court may itself inform it.
87      In the present case, subject to verification by the referring court, the information provided by the Austrian Government permits the inference that the law of that Member State provides for the instruments necessary to prevent the products in question from continuing to be placed on the market, following the annulment of the decisions at issue which it appears the referring court must
carry out in order to comply with the judgments of the Verwaltungsgerichtshof (Supreme Administrative Court) of 11 April 2024, referred to in paragraph 26 of the present judgment.
88      Although the Federal Office for Safety in
Healthcare is the only authority competent to enforce the
legislation on medicinal products, authorities such as the Head of Government of the Province of Vienna appear to be authorised, on the basis of Article 38 of the General Law on Administrative Procedures of 1991, to determine provisionally whether products the placing on the market of which as food for special medical purposes is notified to them are prima facie medicinal products by presentation. If that is the case, those authorities must inform that office that such products have been placed on the market, in the absence of an authorisation for that purpose, so that it may intervene immediately with a view to ensuring the protection of public health.
89      In the light of the foregoing, the answer to the fourth question is that Directive 2001/83 as amended must be interpreted as meaning that:
–        it precludes the placing on the market of a product as a food for special medical purposes from being prohibited by the authority competent to enforce the legislation relating to
those foods, on the ground that that product does not satisfy the conditions laid down by that legislation, where, first, in the Member State concerned, such an authority is different from the authority competent to enforce the legislation on medicinal products, and, second, that product is a medicinal product by presentation, within the meaning of Article 1(2)(a) of Directive 2001/83 as amended, according to the assessment of the court hearing appeals against the decisions of the authority competent to enforce the legislation relating to those foods;
–        in order to ensure the effectiveness of that directive and compliance with the principle of sincere cooperation enshrined in Article 4(3) TEU, that court or authority must, however, inform the authority competent to enforce the legislation on medicinal products without delay that medicinal products by presentation have been placed on the market, so that it may adopt the measures necessary to protect public health.
Costs
90      Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring 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 (Ninth Chamber) hereby rules:
1.      Article 2(2) 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 the expression ‘product covered by other Community legislation’, which appears in that paragraph 2, refers not 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’ mentioned in Article 2(1), but to other regulated products, as defined by the acts of EU law governing those products.
2.      Article 2(2) of Directive 2001/83, as amended by Directive 2004/27,
must be interpreted as meaning that:
–        the rule of precedence which it lays down applies where a product satisfies with certainty the conditions for classification as a medicinal product within the meaning of Article 1(2) of Directive 2001/83 as amended, but there is doubt as to whether that product may also fall within other categories of products regulated by EU law;
–        by contrast, that rule of precedence does not apply where a product clearly falls within the definition of one of those other categories of regulated products;
–        that rule of precedence equally does not apply where it is certain that a product is solely a medicinal product and that it cannot be regarded as a product falling within other categories of products regulated by EU law;
–        in the latter case, that directive is applicable to that product by reason simply of the fact that it meets one of the definitions of medicinal product set out in Article 1(2) of that directive and satisfies the conditions laid down in Article 2(1) of that directive.
3.      Directive 2001/83, as amended by Directive 2004/27,
must be interpreted as meaning that:
–        it precludes the placing on the market of a product as a food for special medical purposes from being prohibited by the authority competent to enforce the legislation relating to those foods, on the ground that that product does not satisfy the conditions laid down by that legislation, where, first, in the Member State concerned, such an authority is different from the authority competent to enforce the legislation on medicinal products, and, second, that product is a medicinal product by presentation, within the meaning of Article 1(2)(a) of Directive 2001/83 as amended, according to the assessment of the court hearing appeals against the decisions of the authority competent to enforce the legislation relating to those foods;
–        in order to ensure the effectiveness of that directive and compliance with the principle of sincere cooperation enshrined in Article 4(3) TEU, that court or authority must, however, inform the authority competent to enforce the legislation on medicinal products without delay that medicinal products by presentation, within the meaning of Article 1(2)(a) of that directive, have been placed on the market, so that it may adopt the measures necessary to protect public health.
[Signatures]
*      Language of the case: German.