Official Journal of the European Union

C series

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C/2024/5496

23.9.2024

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

(C/2024/5496)

Language of the case: German

Referring court

Parties to the main proceedings

Applicant: Kwizda Pharma GmbH

Defendant authority: Landeshauptmann von Wien

Questions referred

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 that directive, or

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, 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 to be interpreted?

3.How is the expression ‘may fall’ in Article 2(2) of Directive 2001/83 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 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 or other Community legislation be interpreted as meaning that the national authority is not entitled, in respect of a product

(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 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 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 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 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 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?

* Language of the case: German.

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).

See, for example, Article 2(3)(d) of 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 (OJ 2002 L 31, p. 1) as regards food and food for special medical purposes,

Recital 6 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (OJ 2009 L 342, p. 59)

Article 1(6)(b) of 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 (OJ 2017 L 117, p. 1) as regards medical devices,

Article 1(2) of 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 (OJ 2002 L 183, p. 51) as regards food supplements.

ELI: http://data.europa.eu/eli/C/2024/5496/oj

ISSN 1977-091X (electronic edition)

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