# C_2021072EN.01001101.xml

| 1.3.2021 | EN | Official Journal of the European Union | C 72/11 |
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1.3.2021

EN

Official Journal of the European Union

C 72/11

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Request for a preliminary ruling from the Verwaltungsgericht Köln (Germany) lodged on 19 November 2020 — M2Beauté Cosmetics GmbH v Federal Republic of Germany

(Case C-616/20)

(2021/C 72/15)

Language of the case: German

Referring court

Verwaltungsgericht Köln

Parties to the main proceedings

Applicant: M2Beauté Cosmetics GmbH

Defendant: Federal Republic of Germany, represented by the Federal Institute for Drugs and Medical Devices

Questions referred

| 1. | Is a national authority, when classifying a cosmetic product as a medicinal product by function, within the meaning of Article 1(2)(b) of Directive 2001/83/EC (1) of 6 November 2001, and, in so doing, examining all the characteristics of that product, entitled to base the necessary scientific assessment of the pharmacological properties of that product and the risks associated with it on a ‘structural analogy’, in a case where the active substance used has only recently been developed, is comparable in its structure to pharmacological active substances which are already known and studied, but no comprehensive pharmacological, toxicological or clinical studies of the new substance in relation to its effects and its dosage, which are necessary only if Directive 2001/83/EC is applicable, have been submitted by the applicant? |
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1.

Is a national authority, when classifying a cosmetic product as a medicinal product by function, within the meaning of Article 1(2)(b) of Directive 2001/83/EC (1) of 6 November 2001, and, in so doing, examining all the characteristics of that product, entitled to base the necessary scientific assessment of the pharmacological properties of that product and the risks associated with it on a ‘structural analogy’, in a case where the active substance used has only recently been developed, is comparable in its structure to pharmacological active substances which are already known and studied, but no comprehensive pharmacological, toxicological or clinical studies of the new substance in relation to its effects and its dosage, which are necessary only if Directive 2001/83/EC is applicable, have been submitted by the applicant?

| 2. | Is Article 1(2)(b) of Directive 2001/83/EC of 6 November 2001 to be interpreted as meaning that a product which is placed on the market as a cosmetic and which significantly modifies physiological functions by producing a pharmacological effect is to be regarded as a medicinal product by function only in the case where it has a specific positive health-promoting effect? Is it sufficient in this regard even that the product has on a person’s appearance a predominantly positive effect which, by increasing self-esteem or wellbeing, is of indirect benefit to health? |
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2.

Is Article 1(2)(b) of Directive 2001/83/EC of 6 November 2001 to be interpreted as meaning that a product which is placed on the market as a cosmetic and which significantly modifies physiological functions by producing a pharmacological effect is to be regarded as a medicinal product by function only in the case where it has a specific positive health-promoting effect? Is it sufficient in this regard even that the product has on a person’s appearance a predominantly positive effect which, by increasing self-esteem or wellbeing, is of indirect benefit to health?

| 3. | Or is that product also a medicinal product by function in the case where its positive effect is confined to an improvement in a person’s appearance, without being of direct or indirect benefit to health, but where it does not have properties that are exclusively harmful to health and is not therefore comparable to a narcotic? |
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3.

Or is that product also a medicinal product by function in the case where its positive effect is confined to an improvement in a person’s appearance, without being of direct or indirect benefit to health, but where it does not have properties that are exclusively harmful to health and is not therefore comparable to a narcotic?

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(1)  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. 67as amended by Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 (OJ 2019 L 198, p. 241).

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