# C_2021471EN.01002502.xml

| 22.11.2021 | EN | Official Journal of the European Union | C 471/25 |
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22.11.2021

EN

Official Journal of the European Union

C 471/25

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Request for a preliminary ruling from the Bundesverwaltungsgericht (Germany) lodged on 12 August 2021 — H. Ltd. v Federal Republic of Germany

(Case C-496/21)

(2021/C 471/32)

Language of the case: German

Referring court

Bundesverwaltungsgericht

Parties to the main proceedings

Appellant on a point of law: H. Ltd.

Respondent in the appeal on a point of law: Federal Republic of Germany

Questions referred

| 1. | Can the principal intended action of a substance be pharmacological within the meaning of Article 1(2)(a) of Directive 93/42/EEC (1) even if it is not based on a receptor-mediated mode of action and the substance is not absorbed by the human body but remains on and reacts with the surface of, for example, the mucosa? On what criteria should a distinction be drawn between pharmacological and non-pharmacological means, in particular physico-chemical means, in such a case? |
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1.

Can the principal intended action of a substance be pharmacological within the meaning of Article 1(2)(a) of Directive 93/42/EEC (1) even if it is not based on a receptor-mediated mode of action and the substance is not absorbed by the human body but remains on and reacts with the surface of, for example, the mucosa? On what criteria should a distinction be drawn between pharmacological and non-pharmacological means, in particular physico-chemical means, in such a case?

| 2. | Can a product be regarded as a substance-based medical device within the meaning of Article 1(2)(a) of Directive 93/42/EEC if, according to current scientific knowledge, the mode of action of the product is open to debate and it is thus not possible to definitively determine whether the principal intended action is achieved by pharmacological or physico-chemical means? |
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2.

Can a product be regarded as a substance-based medical device within the meaning of Article 1(2)(a) of Directive 93/42/EEC if, according to current scientific knowledge, the mode of action of the product is open to debate and it is thus not possible to definitively determine whether the principal intended action is achieved by pharmacological or physico-chemical means?

| 3. | In such a case, is the classification of the product as a medicinal product or as a medical device to be carried out on the basis of an overall assessment of its other properties and all other circumstances, or, in so far as it is intended to prevent, treat or alleviate diseases, is the product to be regarded as a medicinal product by presentation within the meaning of Article 1(2)(a) of Directive 2001/83/EC, (2) irrespective of whether or not a specific medicinal effect is being claimed? |
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3.

In such a case, is the classification of the product as a medicinal product or as a medical device to be carried out on the basis of an overall assessment of its other properties and all other circumstances, or, in so far as it is intended to prevent, treat or alleviate diseases, is the product to be regarded as a medicinal product by presentation within the meaning of Article 1(2)(a) of Directive 2001/83/EC, (2) irrespective of whether or not a specific medicinal effect is being claimed?

| 4. | Does the primacy of the regime governing medicinal products also apply in such a case in accordance with Article 2(2) of Directive 2001/83/EC? |
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4.

Does the primacy of the regime governing medicinal products also apply in such a case in accordance with Article 2(2) of Directive 2001/83/EC?

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(1)  Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1), as last amended by Directive 2007/45/EC of the European Parliament and of the Council of 5 September 2007 (OJ 2007 L 247, p. 17).

(2)  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) in the version of Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 (OJ 2012 L 299, p. 1) applicable here.

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