Judgment;Summary — ECLI:EU:C:2025:663
Date: 2025-09-04
Language of the case: German
Court formation: Ninth Chamber
Procedure: Reference for a preliminary ruling;Reference for a preliminary ruling - inadmissible
Origin: Austria

Summary C-451/24 – 1 
Case C-451/24 
Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged: 
26 June 2024 
Referring court: 
Verwaltungsgericht Wien (Austria) 
Date of the decision to refer: 
15 June 2024 
Applicant: 
Kwizda Pharma GmbH 
Defendant authority: 
Landeshauptmann von Wien 
  
Subject matter of the main proceedings 
Administrative proceedings before the Verwaltungsgericht Wien (Administrative 
Court, Vienna), as court of first instance, ruling again on the action against four 
decisions of the Landeshauptmann von Wien (Head of Government of the 
Province of Vienna, Austria) prohibiting the applicant from continuing to market 
four of its products as food for special medical purposes following the setting 
aside of its judgments by the Verwaltungsgerichtshof (Supreme Administrative 
Court, Austria) 
Subject matter and legal basis of the request 
Interpretation of EU law under Article 267 TFEU in the areas of food, medicinal 
products and health protection 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-451/24 
 
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Questions referred for a preliminary ruling 
1. How is the expression ‘product covered by other Community legislation’ in 
Article 2(2) of Directive 2001/83/EC to be interpreted? 
Is it the case that only a product 
(1) that is prepared industrially within the meaning of Article 2(1) of 
Directive 2001/83/EC, or 
(2) 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/EC, 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? 
2. How is the expression ‘in cases of doubt’ in Article 2(2) of Directive 
2001/83/EC to be interpreted? 
3. How is the expression ‘may fall’ in Article 2(2) of Directive 2001/83/EC 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’? 
4a. To what extent do Article 2(2) of Directive 2001/83/EC 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? 
4b. Must Article 2(2) of Directive 2001/83/EC or other Community legislation 
be interpreted as meaning that the national authority is not entitled, in respect of a 
product 
KWIZDA PHARMA II 
 
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(a) which is classified as a medicinal product following an examination 
procedure carried out by the medicines agency, and 
(b) 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’)? 
5a. To what extent does Article 2(2) of Directive 2001/83/EC 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? 
5b. Must Article 2(2) of Directive 2001/83/EC or other Community legislation 
be interpreted as meaning that the national authority is not entitled, in respect of a 
product 
(a) 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 
(b) 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 1 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 
 
1 See, for example, Article 2(3)(d) of Regulation 178/2002/EC as regards food, recital 6 of 
Regulation 1223/2009/EC as regards cosmetic products, Article 1(6)(b) of Regulation 
2017/745/EC as regards medical devices, Article 1(2) of Directive 2002/46/EC as regards food 
supplements, Article 2(3)(d) of Regulation (EC) No 178/2002 as regards food for special 
medical purposes. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-451/24 
 
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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/EC 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? 
Provisions of national legislation relied on 
Paragraph 1(3a) of the Arzneimittelgesetz (Austrian Law on Medicines, ‘the 
AMG’): ‘Where a product … falls within the definition of a medicinal product, … 
only the provisions of this Federal Law shall apply to that product.’ 
Provisions of European Union law relied on 
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, in particular Article 2 
Directive 2004/27/EC of the European Parliament and of the Council of 31 March 
2004 amending Directive 2001/83/EC on the Community code relating to 
medicinal products for human use, in particular recital 7 
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, in particular Article 2(3)(d) 
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 
30 November 2009 on cosmetic products, in particular recital 6 
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, in particular Article 1(6)(b) 
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, in particular Article 1(2) 
KWIZDA PHARMA II 
 
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Succinct presentation of the facts and procedure and the main arguments of 
the parties 
1 The applicant challenges four decisions of the Head of Government of the 
Province of Vienna of 5 and 6 August 2021 prohibiting it from continuing to 
market four of its products as food for special medical purposes. The reason for 
the prohibition was that those products did not meet the requirements for 
classification as food for special medical purposes, but only the requirements for 
food supplements. 
2 In those proceedings, on 26 November 2021, the referring court requested a 
preliminary ruling by the Court of Justice concerning several provisions of EU 
law. The Court ruled on that request by judgment of 2 March 2023, Kwizda 
Pharma (C-760/21, EU:C:2023:143). 
3 Subsequently, on 2 May 2023, the referring court adopted four judgments by 
which it confirmed the four contested decisions on the ground that the four 
products at issue did not satisfy several conditions for a product to be classified as 
a ‘food for special medical purposes’. 
4 The applicant challenged those judgments before the Supreme Administrative 
Court, arguing that the products in question are medicinal products by 
presentation. As regards the latter, Paragraph 1(3a) of the AMG applies. By 
judgments of 11 April 2024, the Supreme Administrative Court set aside the 
judgments of the referring court. It based its decision on the fact that, under 
Article 2(2) of Directive 2001/83 and the considerations set out in paragraphs 34 
and 35 of the judgment of the Court of Justice of March 2023, Kwizda Pharma 
(C-760/21, EU:C:20:143), only the provisions of the legislation relating to 
medicinal products are applicable to a product that is to be classified as a 
medicinal product. The products at issue are medicinal products by presentation. 
The authority that adopted the contested decisions was therefore not competent to 
do so, with the result that the referring court had to annul those decisions. 
Succinct presentation of the reasoning in the request for a preliminary ruling 
The first question referred 
5 The first question concerns the interpretation of the expression ‘product covered 
by other Community legislation’ in Article 2(2) of Directive 2001/83. 
6 The referring court interprets that expression restrictively and understands it as 
covering only a product prepared industrially or manufactured by a method 
involving an industrial process, within the meaning of Article 2(1) of Directive 
2001/83, 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 such a given 
‘product covered by other Community legislation’. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-451/24 
 
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7 Directive 2001/83 is essentially limited to regulating the manufacture and 
permissibility of the placing on the market of medicinal products. It is therefore 
only with regard to those rules that there may be a conflict with other Community 
legislation. It is therefore logical that the exclusionary effect of Article 2(2) of 
Directive 2001/83 can also apply only to Community legislation corresponding to 
the regulatory subject matter expressly referred to in the directive. Then, however, 
it must be assumed that Community rules with other regulatory subject matter are 
not covered by the expression ‘covered by other provisions of Community law’. 
8 That interpretation is borne out by the judgment of the Court of Justice of 
15 January 2009, Hecht-Pharma (C-140/07, EU:C:2009:5, paragraphs 21, 25, 26 
and 41 to 45), and by the Opinion of Advocate General Trstenjak in that case 
(EU:C:2008:352, points 46, 54 and 56 et seq.). That is not precluded by the 
judgment of 9 June 2005, HLH Warenvertrieb and Orthica (Joined Cases 
C-211/03, C-299/03 and C-316/03 to C-318/03, EU:C:2005:370, paragraphs 40 to 
45), which concerned the question of the permissibility of the placing on the 
market of given medicinal products by presentation. 
9 The case in the main proceedings concerns products which, during the 
administrative procedure, were indisputably classified as food by all the parties, 
whereas it was not clear whether they should be classified as food for special 
medical purposes. The referring court accepted the lawfulness of the prohibition 
on their being placed on the market as food for special medical purposes and 
therefore upheld the contested decisions. 
10 According to the referring court, Article 2(2) of Directive 2001/83 did not apply 
since it covers only the rules governing the permissibility of the placing on the 
market of a product and matters closely linked to those rules on the placing on the 
market. It was not relevant in the present case. Moreover, due to the explicit 
finding that the products were not to be classified as food for special medical 
purposes, there was also no ‘case of doubt’ within the meaning of Article 2(2). 
11 However, the Supreme Administrative Court found that Article 2(2) of Directive 
2001/83 was applicable. In that regard, it adopted a broad concept of product 
within the meaning of Article 2(2), according to which any food is to be classified 
as a product within the meaning of Article 2(2). 
12 However, the broad interpretation of the Supreme Administrative Court runs 
counter to the objective of a high level of safeguarding of health pursued by 
Article 2(2) of Directive 2001/83, in accordance with recital 2 thereof and the 
case-law of the Court (judgment of 2 March 2023, Kwizda Pharma, C-760/21, 
EU:C:2023:143, paragraph 34). This would have the consequence that the placing 
on the market, for example, of a product that is to be classified as a medicinal 
product as a ‘food for special medical purposes’ could be prohibited only if that 
product was no longer placed on the market as a medicinal product. Until then, the 
authority competent for enforcing the rules relating to food for special medical 
purposes could not even initiate a procedure for verifying whether the product in 
KWIZDA PHARMA II 
 
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question meets the requirements applicable to a food for special medical purposes 
or, a fortiori, initiate a procedure to prohibit the placing on the market of that 
product as a food for special medical purposes. Thus, it would be possible for the 
product to continue (unlawfully) to be placed on the market for several years as a 
food for special medical purposes. 
13 Moreover, the broad interpretation of Article 2(2) of Directive 2001/83 is contrary 
to the principle of effectiveness of EU law (‘effet utile’), enshrined in Article 4(3) 
TEU, since, according to that interpretation, the authorities are not entitled to 
prevent the placing on the market of a product as a given product for which 
specific placement requirements are laid down on the ground that it does not fulfil 
the requirements relating to placing on the market as a given other product for 
which other specific requirements for placing on the market are laid down. It 
seems absurd and contrary to the effet utile that a product which does not fulfil the 
requirements for classification as a ‘food for special medical purposes’, but which 
is nevertheless unlawfully placed on the market as such and which, by reason of 
its packaging, must be classified as a medicinal product by presentation, cannot be 
withdrawn from the market by the food agency in view of its having being placed 
on the market as a food for special medical purposes, on the ground that, because 
of its packaging, that product must be classified as a medicinal product by 
presentation (and therefore also placed on the market as a medicinal product). 
14 The question therefore arises as to the criteria for determining whether a product 
is to be classified as a ‘product covered by other Community legislation’. In the 
context of the application of those criteria, it would then be for the referring court 
to determine whether only ‘food for special medical purposes’ or all ‘food’ is to 
be classified as a ‘product covered by other Community legislation’. 
The second question referred 
15 The second question concerns the fact that Article 2(2) of Directive 2001/83 
applies only in ‘case of doubt’. 
16 The version of Article 2(2) currently in force was inserted into Directive 2001/83 
by Directive 2004/27. In that regard, recital 7 of Directive 2004/27 states, inter 
alia: ‘With the same objective of clarifying the situations, where a given product 
comes under the definition of a medicinal product but could also fall within the 
definition of other regulated products …’ That wording already suggests that 
Article 2(2) of Directive 2001/83 does not apply where a product in fact falls 
within the definition of a ‘product covered by other Community legislation’. 
17 Furthermore, recital 7 of Directive 2004/27 states: ‘Where a product comes clearly 
under the definition of other product categories, in particular food … this 
Directive should not apply’. That makes it clear that Article 2(2) of Directive 
2001/83 does not apply where a product in fact falls within the definition of a 
‘product covered by other Community legislation’. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-451/24 
 
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18 According to recital 7, Article 2(2) thus applies neither to a product which is 
(definitively) not to be classified as a ‘product covered by other Community 
legislation’ nor to a product which is (definitively) to be classified as a ‘product 
covered by other Community legislation’. In that case, there is no doubt as to 
whether a specific product may fall within the definition of a ‘product covered by 
other Community legislation’. On the contrary, such a ‘case of doubt’ can only be 
considered to exist if it is not clear whether a given product must be classified as a 
‘product covered by other Community legislation’. 
19 As Advocate General Trstenjak observes in points 59 and 60 of her Opinion in 
Hecht-Pharma (C-140/07, EU:C:2008:352), such a case of doubt, within the 
meaning of Article 2(2) of Directive 2001/83, must be assumed, for example, for 
categories of products for which Community law does not provide that 
classification as a medicinal product precludes classification in that category of 
products. 
The third question referred 
20 The third question concerns the interpretation of the words ‘may fall’. 
21 Those words could be interpreted broadly as excluding only cases in which it is 
already established, without further examination, that the product is not to be 
classified as a ‘product’. In that case, the term ‘may fall’ would be examined ex 
ante. Any product that demonstrably should be classified as a ‘product’ would 
therefore also be subsumed under it. Depending on whether a broad or narrow 
concept of a product is used, it will immediately be clear, without examination, 
that the product is not to be classified as a ‘product’. Thus, it is often difficult to 
determine whether a product should not be classified as a food, whereas it is often 
obvious and no separate examination is required to ascertain whether it should not 
be classified as a food supplement, as a food for special medical purposes or as a 
medical device. In the context of that interpretation, it can be assumed that that 
requirement is fulfilled in the case of the products at issue in the present case. 
22 By contrast, a restrictive interpretation of the words ‘may fall’, according to which 
it cannot be assumed that that requirement has been met once it has been 
established that a product must definitively be classified either as a ‘product’ or as 
a ‘non-product’, leads to entirely different conclusions. 
The fourth question referred 
23 According to the national court, a teleological, historical and literal interpretation 
of Article 2(2) of Directive 2001/83 requires the authority competent to deal with 
a given ‘product covered by other Community legislation’ always to be entitled to 
prohibit the (continued) placing on the market of a product as a ‘product covered 
by other Community legislation’. 
KWIZDA PHARMA II 
 
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24 If one follows that interpretation, in the present proceedings the food agency 
would always have been entitled to prohibit the placing on the market of the 
products at issue as ‘foods for special medical purposes’. 
25 On the other hand, if one follows the view of the Supreme Administrative Court, 
the authority competent to deal with a given ‘product covered by other 
Community legislation’ would never be entitled to prohibit the (continued) 
placing on the market of a product as a ‘product covered by other Community 
legislation’. 
26 Question 4a is deliberately formulated in a broader manner so as not to limit the 
Court’s reasoning. By contrast, Question 4b focuses the issue of interpretation 
raised on the appeal proceedings at issue here. 
The fifth question referred 
27 The fifth question extends the fourth question in order to ascertain whether the 
rule of precedence in Article 2(2) of Directive 2001/83 must be complied with not 
only where the medicines agency has definitively classified a product as a 
medicinal product, but also where there are grounds for suspecting that the 
product concerned should be classified as a medicinal product. 
28 The clarification of that question is relevant since almost all the package leaflets 
or labels contain health-related information, so that in the case of all food for 
special medical purposes, each food supplement and, in some cases, medical 
device, there are de facto grounds for suspecting that the product concerned must 
be classified as a medicinal product. 
29 According to the referring court, the interpretation of the Supreme Administrative 
Court cannot be reconciled with the judgment of the Court of Justice of 
15 January 2009, Hecht-Pharma (C-140/07, EU:C:2009:5). In paragraph 24 of 
that judgment, the Court confirms that Article 2(2) of Directive 2001/83 applies 
only to a product that satisfies the conditions for classification as a medicinal 
product. However, that ultimately means that the medicines agency must have 
established definitively that the product concerned should be classified as a 
medicinal product. 
30 Similarly, according to the referring court, that interpretation contradicts the 
judgment of 19 January 2023, Bundesrepublik Deutschland (Nasal drops) 
(C-495/21 and C-496/21, EU:C:2023:34). In paragraph 44 of that judgment, the 
Court requires the existence of ‘available scientific knowledge’ of the 
pharmacological, immunological or metabolic action of the product concerned. 
The existence of such knowledge regularly suffices to classify the product as a 
medicinal product by function. 
31 That clarification by the Court is therefore either consistent with the requirement 
set out in paragraph 24 of the judgment of 15 January 2009, Hecht-Pharma 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-451/24 
 
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(C-140/07, EU:C:2009:5), according to which, for the purposes of the application 
of Article 2(2) of Directive 2001/83, it must be established that the product 
satisfies the conditions for classification as a medicinal product, or another 
requirement to be met under Article 2(2) must be inferred from that statement. 
That is the context in which the fifth question arises. 
32 Question 5a is deliberately formulated in a broader manner so as not to limit the 
Court’s reasoning. By contrast, Question 5b focuses the question of interpretation 
raised on the appeal proceedings at issue here. 
The sixth question referred 
33 The referring court’s argument relating to the interpretation of the precedence of 
medicinal product legislation mentioned in the footnote to the sixth question is 
based on the premiss that those precedence rules do not apply to a product which 
is not to be classified as a ‘product covered by other Community legislation’. 
34 The sixth question therefore seeks to ascertain whether, and to what extent, that 
interpretation must be approved or whether the precedence of medicinal product 
legislation in question does not apply where it is established (in any case) that the 
product concerned is not to be classified as a given ‘product covered by other 
Community legislation’. 
The seventh question referred 
35 According to the interpretation advocated by the referring court, the rule of 
precedence laid down in Article 2(2) of Directive 2001/83 does not repeat the 
precedence of medicinal product legislation referred to in the sixth question, 
which requires a product to fulfil the negative classification requirement of non-
qualification as a medicinal product in order to be classified as a given regulated 
product, but supplements it as regards ‘borderline’ products sitting between the 
area of medicinal products and other areas, as is also apparent from recital 7 of 
Directive 2004/27. 
36 It is in the light of that interpretation, in particular, that the question arises as to 
the extent to which, in view of the precedence of medicinal product legislation at 
issue, the rule of precedence laid down in Article 2(2) of Directive 2001/83 is 
(still) applicable. In other words, clarification is sought as to when the latter rule 
of precedence should apply at all.