34Before examining the pleas in law raised by Artegodan in support of its action, the General Court, in paragraphs 38 to 63 of the contested judgment, made preliminary observations on the conditions to be satisfied in order for the European Union to incur non-contractual liability and the scope of its judgment in Artegodan and Others v Commission which annulled the contested decision. As regards that latter point, the General Court held in paragraphs 44 to 48 of the contested judgment that:44 In the first place, before examining in turn the pleas mentioned above, it must be stated that the first two pleas, alleging the Commission’s lack of competence and the infringement of the conditions for withdrawal of a marketing authorisation for medicinal products laid down in Article 11 of Directive 65/65, were accepted by the Court in the judgment in Artegodan and Others v Commission upheld by the Court of Justice in the judgment in Commission v Artegodan and Others.45 The Commission’s lack of competence to adopt the [contested decision] and the infringement by that institution of the conditions for withdrawal of a marketing authorisation laid down by Article 11 of Directive 65/65 must therefore be regarded as established, as the applicant submits.46 However, the Commission and the Federal Republic of Germany submit that the [contested decision] does not infringe Article 11 of Directive 65/65. They thus challenge the approach taken by the General Court with respect to the interpretation and application of the conditions for withdrawal of a marketing authorisation laid down by Article 11 of Directive 65/65, arguing that the Court of Justice did not rule on that question.47 That defence plea, which alleges the absence of an infringement of Article 11 of Directive 65/65, must be declared inadmissible from the outset, since it is inconsistent with the binding nature of the judgment in Artegodan and Others v Commission.48 Following the dismissal by the Court of Justice, in the judgment in Commission v Artegodan and Others of the Commission’s appeal against the judgment in Artegodan and Others v Commission the latter has acquired the authority of a final decision with respect to all the matters of fact and law actually or necessarily settled by the General Court (see, to that effect, Case C-497/06 P CAS Succhi di Frutta v Commission, not published in the ECR, paragraph 33, and the case-law cited, and Case C-440/07 P Commission v Schneider Electric [2009] ECR I-6413, paragraph 102). The Commission is therefore not entitled to challenge the factual and legal findings made by the General Court in the judgment in Artegodan and Others v Commission concerning the infringement of the conditions for withdrawal of a marketing authorisation set out in Article 11 of Directive 65/65. The fact, relied upon by the Commission, that the Court of Justice did not consider it necessary to examine the plea alleging breach of Article 11 of Directive 65/65 by the General Court, which had also been put forward in support of the appeal, is, in that respect, irrelevant.’
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