CELEX: C2003/289/03
Language: en
Date: 2003-11-29 00:00:00
Title: Judgment of the Court (Sixth Chamber) of 16 October 2003 in Case C-223/01 (Reference for a preliminary ruling from the Østre Landsret): AstraZeneca A/S v Lægemiddelstyrelsen (Medicinal products — Marketing authorisation of a generic medicinal product — Withdrawal of the marketing authorisation of the reference medicinal product — Abridged procedure)

C 289/2                EN                          Official Journal of the European Union                                            29.11.2003
                 JUDGMENT OF THE COURT                                                      JUDGMENT OF THE COURT
                                                                                                    (Sixth Chamber)
                         (Fifth Chamber)
                                                                                                  of 16 October 2003
                       of 16 October 2003                                  in Case C-223/01 (Reference for a preliminary ruling from
                                                                           the Østre Landsret): AstraZeneca A/S v Lægemiddelstyr-
                                                                                                         elsen (1)
in Case C-339/00: Ireland v Commission of the European
                         Communities (1)                                   (Medicinal products — Marketing authorisation of a generic
                                                                           medicinal product — Withdrawal of the marketing authoris-
                                                                           ation of the reference medicinal product — Abridged pro-
(EAGGF — Clearance of accounts — Financial years                                                          cedure)
1997 and 1998 — Aid for afforestation of agricultural land
— Article 2(1)(c) and (2)(b) of Regulation (EEC) No 2080/                                           (2003/C 289/03)
92 — Concept of a ‘private-law legal person’ — Principle of
the protection of legitimate expectations — Duty to cooperate
                                                                                              (Language of the case: Danish)
                           in good faith)
                                                                           (Provisional translation; the definitive translation will be published
                                                                                              in the European Court Reports)
                         (2003/C 289/02)
                   (Language of the case: English)                         In Case C-223/01: Reference to the Court under Article 234
                                                                           EC by the Østre Landsret (Denmark) for a preliminary ruling
                                                                           in the proceedings pending before that court between Astra-
                                                                           Zeneca A/S and Lægemiddelstyrelsen, participant: Generics
                                                                           (UK) Ltd, on the interpretation of Council Directive 65/65/EEC
                                                                           of 26 January 1965 on the approximation of provisions laid
In Case C-339/00, Ireland (Agent: D. J. O’Hagan, assisted by               down by law, regulation or administrative action relating to
R. Brady, SC, and A. M. Collins, BL) v Commission of the                   medicinal products (OJ, English Special Edition 1965-1966,
European Communities (Agents: M. Niejahr and K. Fitch,                     p. 20), as amended by Council Directive 93/39/EEC of 14 June
assisted by J. O’Reilly, SC): Application for annulment of                 1993 (OJ 1993 L 214, p. 22), the Court (Sixth Chamber),
Commission Decision 2000/449/EC of 5 July 2000 excluding                   composed of: J.-P. Puissochet, President of the Chamber,
from Community financing certain expenditure incurred by                   R. Schintgen, C. Gulmann (Rapporteur), N. Colneric and
the Member States under the Guarantee Section of the                       J.N. Cunha Rodrigues, Judges; F.G. Jacobs, Advocate General;
European Agricultural Guidance and Guarantee Fund (EAGGF)                  H. von Holstein, Deputy Registrar, has given a judgment on
(OJ 2000 L 180, p. 49) in so far as it excludes from Community             16 October 2003, in which it has ruled:
financing the sum of EUR 4 844 345,35 in afforestation aid
paid by Ireland for the financial years 1997 and 1998, the                 1.   On a proper construction of point 8(a)(iii) of the third
Court (Fifth Chamber), composed of: C.W.A. Timmermans,                          paragraph of Article 4 of Council Directive 65/65/EEC of
President of the Fourth Chamber, acting for the President of                    26 January 1965 on the approximation of provisions laid
the Fifth Chamber, A. La Pergola, P. Jann, S. von Bahr                          down by Law, Regulation or Administrative Action relating to
(Rapporteur) and A. Rosas, Judges; A. Tizzano, Advocate                         medicinal products, as amended by Council Directive 93/39/
General; L. Hewlett, Principal Administrator, for the Registrar,                EEC of 14 June 1993, ‘product ... marketed’ refers to
has given a judgment on 16 October 2003, in which it:                           a medicinal product which has been granted a marketing
                                                                                authorisation in the Member State concerned.
1.    Dismisses the application;                                           2.   In order for an application for marketing authorisation of a
                                                                                generic medicinal product to be dealt with by way of the
                                                                                abridged procedure provided for in point 8(a)(iii) of the third
2.    Orders Ireland to pay the costs.                                          paragraph of Article 4 of Directive 65/65, as amended, it is
                                                                                necessary and sufficient that the marketing authorisation of the
                                                                                reference medicinal product be in force in the Member State
                                                                                concerned on the date of that application.
(1) OJ C 335 of 25.11.2000.
                                                                           (1) OJ C 227 of 11.8.2001.