Case C-451/24, Kwizda Pharma II: Judgment of the Court (Ninth Chamber) of 4 September 2025 (request for a preliminary ruling from the Verwaltungsgericht Wien – Austria) – Kwizda Pharma GmbH (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)
Date: 2025-09-04
Institutions: Court of Justice
Subjects: application of EU law, industrial production, market approval, medicinal product, national competent authority, pharmaceutical legislation, primacy of EU law








C_202505561EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/5561


27.10.2025






Judgment of the Court (Ninth Chamber) of 4 September 2025 (request for a preliminary ruling from the Verwaltungsgericht Wien – Austria) – Kwizda Pharma GmbH


(Case C-451/24,
                (1)
Kwizda Pharma II)

(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)
(C/2025/5561)
Language of the case: German

Referring court

Verwaltungsgericht Wien

Parties to the main proceedings


Applicant: Kwizda Pharma GmbH

other party: Landeshauptmann von Wien

Operative part of the judgment







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.










(1)  OJ C, C/2024/5496.


ELI: http://data.europa.eu/eli/C/2025/5561/oj
ISSN 1977-091X (electronic edition)