Judgment — ECLI:EU:C:2005:42
Date: 2005-01-20
Language of the case: French
Court formation: Second Chamber
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Approximation of laws
Concepts: General
Procedure: Reference for a preliminary ruling
Origin: Belgium

Summary of the Judgment Approximation of laws – Pharmaceutical products – Directive 89/105 – Medicinal products for human use – Application for entry of a medicinal product on the list of medicinal products covered by the national sickness insurance scheme – Mandatory nature of the time-limit for determining the application – Annulment of the decision determining the application – Adoption of a new decision – Whether permissible – Conditions – Observance of the time-limit for determining the application (Council Directive 89/105, Art. 6(1), first subpara.) The time-limit for determining an application for entry of a medicinal product on the list of medicinal products covered by the national sickness insurance scheme which is laid down in the first subparagraph of Article 6(1) of Directive 89/105 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems is a mandatory time-limit which the national authorities are not entitled to exceed. It is for the Member States to determine whether the fact that that time-limit is exceeded precludes the competent authorities from formally adopting a new decision when the previous decision has been annulled in court proceedings, although such a possibility can be exercised only within a reasonable time which may not in any event exceed the time-limit laid down in that article. (see paras 30, 39, operative part 1-2)