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5.3.2005 |
EN |
Official Journal of the European Union |
C 57/9 |
JUDGMENT OF THE COURT
(Second Chamber)
of 20 January 2005
in Case C-296/03 (reference for a preliminary ruling by the Conseil d'État): Glaxosmithkline SA v État Belge (1)
(Directive 89/105/EEC - Medicinal products for human use - Application for entry on a positive list - Nature of the time-limit for responding - Mandatory nature - Consequences of exceeding the time-limit where a decision refusing entry is annulled)
(2005/C 57/16)
Language of the case: French
In Case C-296/03: reference for a preliminary ruling under Article 234 EC by the Conseil d'État (Belgium) by decision of 27 June 2003, received at the Court on 8 July 2003, in the proceedings Glaxosmithkline SA v État Belge – the Court: (Second Chamber), composed of C.W.A. Timmermans, President of the Chamber, R. Silva de Lapuerta (Rapporteur), C. Gulmann, P. Kūris and G. Arestis, Judges; A. Tizzano, Advocate General, M. Múgica Arzamendi, Principal Administrator, for the Registrar, has given a judgment on 20 January 2005, the operative part of which is as follows:
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1. |
The time-limit laid down in the first subparagraph of Article 6(1) of Council Directive 89/105/EEC of 21 December 1988 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. |
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2. |
It is for the Member States to determine whether the fact that the time-limit laid down in the first subparagraph of Article 6(1) of Directive 89/105 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. |