# C_2013026EN.01003203.xml

| 26.1.2013 | EN | Official Journal of the European Union | C 26/32 |
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26.1.2013

EN

Official Journal of the European Union

C 26/32

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Reference for a preliminary ruling from the Conseil d’État (France) lodged on 13 November 2012 — Octapharma France v Agence nationale de sécurité du médicament et des produits de santé (ANSM), Ministère des affaires sociales et de la santé

(Case C-512/12)

2013/C 26/61

Language of the case: French

Referring court

Referring court

Conseil d’État

Parties to the main proceedings

Parties to the main proceedings

Applicant: Octapharma France

Applicant:

Defendants: Agence nationale de sécurité du médicament et des produits de santé (ANSM), Ministère des affaires sociales et de la santé

Defendants:

Questions referred

Questions referred

| 1. | Is plasma from whole blood which is prepared by a method involving an industrial process and which is intended for transfusions capable of having the provisions of Directive 2001/83 (1) [as amended by Directive 2004/27
   (2)] and those of Directive 2002/98 (3) applied to it simultaneously, as regards not only its collection and testing, but also its processing, storage and distribution; for that purpose may the rule laid down in Article 2(2) of Directive 2001/83 be interpreted as meaning that the Community legislation on medicinal products alone applies to a product which falls simultaneously within the scope of another piece of Community legislation only where that latter is less strict than the legislation on medicinal products? |
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1.

Is plasma from whole blood which is prepared by a method involving an industrial process and which is intended for transfusions capable of having the provisions of Directive 2001/83 (1) [as amended by Directive 2004/27
   (2)] and those of Directive 2002/98 (3) applied to it simultaneously, as regards not only its collection and testing, but also its processing, storage and distribution; for that purpose may the rule laid down in Article 2(2) of Directive 2001/83 be interpreted as meaning that the Community legislation on medicinal products alone applies to a product which falls simultaneously within the scope of another piece of Community legislation only where that latter is less strict than the legislation on medicinal products?

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as amended by Directive 2004/27

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| 2. | Must Article 4(2) of Directive 2002/98 be interpreted, where necessary in the light of Article 168 of the Treaty on the Functioning of the European Union, as allowing the maintenance or introduction of national provisions which, because they submit plasma which is prepared by a method involving an industrial process to a stricter scheme than that to which medicinal products are subject, provide justification for setting aside the application of all or part of the provisions of Directive 2001/83, in particular those which make the marketing of medicinal products subject to the sole condition of the prior grant of a marketing authorisation and, in the affirmative, under what conditions and to what extent? |
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2.

Must Article 4(2) of Directive 2002/98 be interpreted, where necessary in the light of Article 168 of the Treaty on the Functioning of the European Union, as allowing the maintenance or introduction of national provisions which, because they submit plasma which is prepared by a method involving an industrial process to a stricter scheme than that to which medicinal products are subject, provide justification for setting aside the application of all or part of the provisions of Directive 2001/83, in particular those which make the marketing of medicinal products subject to the sole condition of the prior grant of a marketing authorisation and, in the affirmative, under what conditions and to what extent?

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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. 67)

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(2)  Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance) (OJ 2004 L 136, p. 34)

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(3)  Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ 2003 L 33, p. 30)

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