26.1.2013   

EN

Official Journal of the European Union

C 26/32

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?

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?