Case C‑512/12

Octapharma France SAS

v

Agence nationale de sécurité du médicament et des produits de santé (ANSM)

and

Ministère des Affaires sociales et de la Santé

(Request for a preliminary ruling from the Conseil d’État (France))

‛Approximation of laws — Directive 2001/83/EC — Directive 2002/98/EC — Scope — Labile blood product — Plasma prepared by means of an industrial process — Simultaneous or exclusive application of the directives — Option for a Member State to provide for a more rigorous regime for plasma than for medicinal products’

Summary — Judgment of the Court (First Chamber), 13 March 2014

1. Approximation of laws — Medicinal products for human use — Blood products — Directives 2001/83 et 2002/98 — Scope — Plasma from whole blood prepared by a method involving an industrial process which is intended for transfusions — Application of the Directive 2002/98 for the collection and testing of that plasma — Application of the Directive 2001/83 for the processing, storage and distribution of that plasma — Condition

   (European Parliament and Council Directives 2001/83, as amended by Directive 2004/27, Arts 1(2), and 109, and 2002/98)

2. Public health — Blood products — Directive 2002/98 — Plasma from whole blood prepared by a method involving an industrial process which is intended for transfusions — Option for a Member State to provide for a more rigorous regime for plasma than for medicinal products only for its collection and testing

   (Art. 168 TFEU; European Parliament and Council Directive 2002/98, Art. 4(2))

1.  Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27, and Directive 2002/98 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 must be interpreted as meaning that plasma from whole blood which is prepared by a method involving an industrial process and which is intended for transfusions comes, in accordance with Article 109 of Directive 2001/83, within the scope of Directive 2002/98 with respect to its collection and testing, and within the scope of Directive 2001/83, as amended by Directive 2004/27, with respect to its processing, storage and distribution, on condition that it satisfies the definition of a medicinal product under Article 1(2) of the latter directive.

   (see paras 33, 37, 38, 40, operative part 1)

2.  Article 4(2) of Directive 2002/98 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, read in the light of Article 168 TFEU, must be interpreted as meaning that it allows the maintenance or introduction of national provisions which make plasma which is prepared by a method involving an industrial process subject to a more rigorous regime than that to which medicinal products are subject solely with respect to its collection and testing.

   (see para. 46, operative part 2)