Upjohn Ltd v The Licensing Authority established by the Medicines Act 1968 and Others.
Date: 1999-01-21
30 Upjohn maintains that, since Article 11 of Directive 65/65, as amended, is directly applicable, the national court must be able to review fully the action taken by the administrative authority.  Otherwise, the rights enjoyed by Upjohn by virtue of the direct effect of that provision would not be effectively safeguarded.
31 In that connection, it is apparent from the Court's case-law that, in so far as Article 11 of Directive 65/65 lays down the criteria for revocation of a marketing authorisation, it has direct effect, in the same way as Article 21, which provides that a marketing authorisation may be revoked only on the public health grounds expressly mentioned in the directive (Case 301/82 Clin-Midy and Others v Belgium [1984] ECR 251, paragraphs 4 and 10).
32 It is settled case-law that in the absence of Community rules governing the matter it is for the domestic legal system of each Member State to designate the courts and tribunals having jurisdiction and to lay down the detailed procedural rules governing actions for safeguarding rights which individuals derive from Community law, provided, however, that such rules are not less favourable than those governing similar domestic actions (the principle of equivalence) and do not render virtually impossible or excessively difficult the exercise of rights conferred by Community law (the principle of effectiveness) (see, in particular, Case C-312/93 Peterbroeck v Belgian State [1995] ECR I-4599, paragraph 12, and paragraph 18 of the judgment in Case C-326/96 Levez [1998] ECR I-7835).
34 According to the Court's case-law, where a Community authority is called upon, in the performance of its duties, to make complex assessments, it enjoys a wide measure of discretion, the exercise of which is subject to a limited judicial review in the course of which the Community judicature may not substitute its assessment of the facts for the assessment made by the authority concerned.  Thus, in such cases, the Community judicature must restrict itself to examining the accuracy of the findings of fact and law made by the authority concerned and to verifying, in particular, that the action taken by that authority is not vitiated by a manifest error or a misuse of powers and that it did not clearly exceed the bounds of its discretion (see, in particular, Joined Cases 56/64 and 58/64 Consten and Grundig v Commission [1966] ECR 299, Case 55/75 Balkan-Import Export v Hauptzollamt Berlin-Packhof [1976] ECR 19, paragraph 8, Case 9/82 hrgaard and Delvaux v Commission [1983] ECR 2379, paragraph 14, Case C-225/91 Matra v Commission [1993] ECR I-3203, paragraphs 24 and 25, and Case C-157/96 National Farmers' Union and Others [1998] ECR I-2211, paragraph 39).
35 Consequently, Community law does not require the Member States to establish a procedure for judicial review of national decisions revoking marketing authorisations, taken pursuant to Directive 65/65 and in the exercise of complex assessments, which involves a more extensive review than that carried out by the Court in similar cases.
36 Nevertheless, any national procedure for judicial review of decisions of national authorities revoking marketing authorisations must enable the court or tribunal seised of an application for annulment of such a decision effectively to apply the relevant principles and rules of Community law when reviewing its legality.