# C_2022463EN.01000301.xml

| 5.12.2022 | EN | Official Journal of the European Union | C 463/3 |
| --- | --- | --- | --- |

5.12.2022

EN

Official Journal of the European Union

C 463/3

---

Judgment of the Court (Second Chamber) of 13 October 2022 (request for a preliminary ruling from the Verwaltungsgericht Köln — Germany) — M2Beauté Cosmetics GmbH v Bundesrepublik Deutschland

(Case C-616/20) (1)

(Reference for a preliminary ruling - Medicinal products for human use - Directive 2001/83/EC - Article 1(2)(b) - Concept of ‘medicinal product by function’ - No scientific study - Scientific knowledge on a structural analogue - Regulation (EC) No 1223/2009 - Cosmetic product - Specific beneficial effects on human health - Direct or indirect beneficial effects - Positive effects on appearance)

(2022/C 463/03)

Language of the case: German

Referring court

Verwaltungsgericht Köln

Parties to the main proceedings

Applicant: M2Beauté Cosmetics GmbH

Defendant: Bundesrepublik Deutschland

Operative part of the judgment

| 1. | Article 1(2)(b) 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 2010/84/EU of the European Parliament and of the Council of 15 December 2010 as regards pharmacovigilance,
  must be interpreted as meaning that a national authority may, for the purpose of classifying a product as a ‘medicinal product’, within the meaning of that provision, establish the pharmacological properties of that product by relying on scientific knowledge relating to a structural analogue of that substance, where no scientific study of the substance of which that product consists is available, if the degree of analogy is such that it may be assumed on the basis of an objective scientific assessment that a substance present in a product with a given concentration has the same properties as an existing substance for which the required studies are available. |
| --- | --- |

1.

Article 1(2)(b) 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 2010/84/EU of the European Parliament and of the Council of 15 December 2010 as regards pharmacovigilance,

must be interpreted as meaning that a national authority may, for the purpose of classifying a product as a ‘medicinal product’, within the meaning of that provision, establish the pharmacological properties of that product by relying on scientific knowledge relating to a structural analogue of that substance, where no scientific study of the substance of which that product consists is available, if the degree of analogy is such that it may be assumed on the basis of an objective scientific assessment that a substance present in a product with a given concentration has the same properties as an existing substance for which the required studies are available.

| 2. | Article 1(2)(b) of Directive 2001/83, as amended by Directive 2010/84,
  must be interpreted as meaning that a product which modifies physiological functions may be classified as a ‘medicinal product’, within the meaning of that provision, only if it has specific health-promoting effects. In that regard, an improvement in appearance, which gives rise to an indirect benefit through an increase in self-esteem or well-being, is sufficient where it permits the treatment of a recognised pathological condition. By contrast, a product which improves appearance without having harmful properties and which has no beneficial effects on health cannot be classified as a ‘medicinal product’, within the meaning of that provision. |
| --- | --- |

2.

Article 1(2)(b) of Directive 2001/83, as amended by Directive 2010/84,

must be interpreted as meaning that a product which modifies physiological functions may be classified as a ‘medicinal product’, within the meaning of that provision, only if it has specific health-promoting effects. In that regard, an improvement in appearance, which gives rise to an indirect benefit through an increase in self-esteem or well-being, is sufficient where it permits the treatment of a recognised pathological condition. By contrast, a product which improves appearance without having harmful properties and which has no beneficial effects on health cannot be classified as a ‘medicinal product’, within the meaning of that provision.

---

(1)  OJ C 72, 1.3.2021.

---