Opinion of the Advocate General — ECLI:EU:C:2004:573
Date: 2004-09-30
Language of the case: French
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Approximation of laws
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 – Exceeding of the time-limit – Consequences – No automatic entry on the list (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 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. However, the first subparagraph of Article 6(1) does not impose the automatic entry of a medicinal product on the list of proprietary medicinal products covered by the sickness insurance system where the time-limit laid down in that article is exceeded. (see paras 24, 34, operative part 1-2)