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)
Date: 2003-11-29
Institutions: Court of Justice
Subjects: interpretation of the law, marketing, pharmaceutical product, trade regulations

C 289/2

EN

Official Journal of the European Union

29.11.2003

JUDGMENT OF THE COURT

JUDGMENT OF THE COURT

(Fifth Chamber)

of 16 October 2003

in Case C-339/00: Ireland v Commission of the European
Communities (1)

(EAGGF — Clearance of accounts — Financial years
1997 and 1998 — Aid for afforestation of agricultural land
— Article 2(1)(c) and (2)(b) of Regulation (EEC) No 2080/
92 — Concept of a ‘private-law legal person’ — Principle of
the protection of legitimate expectations — Duty to cooperate
in good faith)

(2003/C 289/02)

(Language of the case: English)

In Case C-339/00, Ireland (Agent: D. J. O’Hagan, assisted by
R. Brady, SC, and A. M. Collins, BL) v Commission of the
European Communities (Agents: M. Niejahr and K. Fitch,
assisted by J. O’Reilly, SC): Application for annulment of
Commission Decision 2000/449/EC of 5 July 2000 excluding
from Community financing certain expenditure incurred by
the Member States under the Guarantee Section of
the
European Agricultural Guidance and Guarantee Fund (EAGGF)
(OJ 2000 L 180, p. 49) in so far as it excludes from Community
financing the sum of EUR 4 844 345,35 in afforestation aid
paid by Ireland for the financial years 1997 and 1998, the
Court (Fifth Chamber), composed of: C.W.A. Timmermans,
President of the Fourth Chamber, acting for the President of
the Fifth Chamber, A. La Pergola, P.
Jann, S. von Bahr
Judges; A. Tizzano, Advocate
(Rapporteur) and A. Rosas,
General; L. Hewlett, Principal Administrator, for the Registrar,
has given a judgment on 16 October 2003, in which it:

1. Dismisses the application;

2. Orders Ireland to pay the costs.

(1) OJ C 335 of 25.11.2000.

(Sixth Chamber)

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)

(Medicinal products — Marketing authorisation of a generic
medicinal product — Withdrawal of the marketing authoris-
ation of the reference medicinal product — Abridged pro-
cedure)

(2003/C 289/03)

(Language of the case: Danish)

(Provisional translation; the definitive translation will be published
in the European Court Reports)

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
down by law, regulation or administrative action relating to
medicinal products (OJ, English Special Edition 1965-1966,
p. 20), as amended by Council Directive 93/39/EEC of 14 June
1993 (OJ 1993 L 214, p. 22), the Court (Sixth Chamber),
composed of:
J.-P. Puissochet, President of the Chamber,
R. Schintgen, C. Gulmann (Rapporteur), N. Colneric and
J.N. Cunha Rodrigues, Judges; F.G. Jacobs, Advocate General;
H. von Holstein, Deputy Registrar, has given a judgment on
16 October 2003, in which it has ruled:

1. On a proper construction of point 8(a)(iii) of

the third
paragraph of Article 4 of Council Directive 65/65/EEC of
26 January 1965 on the approximation of provisions laid
down by Law, Regulation or Administrative Action relating to
medicinal products, as amended by Council Directive 93/39/
EEC of 14 June 1993,
refers to
a medicinal product which has been granted a marketing
authorisation in the Member State concerned.

... marketed’

‘product

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
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 227 of 11.8.2001.