Judgment of the Court (Sixth Chamber) of 1 April 2004 in Case C-112/02 (reference for a preliminary ruling from the Oberverwaltungsgericht für das Land Nordrhein-Westfalen): Kohlpharma GmbH v Bundesrepublik Deutschland (‘Free movement of goods — Medicinal products — Importation — Application for marketing authorisation under a simplified procedure — Common origin’)
Date: 2004-04-30
Institutions: Court of Justice
Subjects: Germany, import, interpretation of the law, marketing, medicinal product

C 106/8

EN

Official Journal of the European Union

30.4.2004

JUDGMENT OF THE COURT

JUDGMENT OF THE COURT

(Fifth Chamber)

of 1 April 2004

(Sixth Chamber)

of 1 April 2004

in Case C-99/02: Commission of the European Commu-
nities v Italian Republic (1)

(‘Failure of a Member State to fulfil obligations — State aid
— Second subparagraph of Article 88(2) EC — Aids incom-
patible with the common market — Obligation to recover —
Absolute impossibility of implementation’)

in Case C-112/02 (reference for a preliminary ruling from
the Oberverwaltungsgericht für das Land Nordrhein-West-
falen): Kohlpharma GmbH v Bundesrepublik Deutsch-
land (1)

(‘Free movement of goods — Medicinal products — Importa-
tion — Application for marketing authorisation under a
simplified procedure — Common origin’)

(2004/C 106/11)

(Language of the case: Italian)

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

In Case C-99/02: Commission of the European Commu-
nities (Agent: V. Di Bucci), with an address for service in
Luxembourg, v Italian Republic (Agent: I. Braguglia, assisted
by O. Fiumara), with an address for service in Luxembourg –
application for a declaration that, by not adopting within the
time-limit prescribed all measures necessary for the recovery
from the recipients of the aid which was found, according to
Commission Decision 2000/128/EC of 11 May 1999
concerning aid granted by Italy to promote employment (OJ
2000 L 42, p. 1), notified on 4 June 1999, to be unlawful and
incompatible with the common market, and in any event by
not notifying the Commission of such measures, the Italian
Republic had failed to fulfil its obligations under Articles 3 and
4 of that decision and under the EC Treaty – the Court (Fifth
Chamber), composed of: P. Jann, acting for the President of the
Fifth Chamber, C.W.A. Timmermans, A. Rosas, A. La Pergola
and S. von Bahr (Rapporteur), Judges; D. Ruiz-Jarabo Colomer,
Advocate General; M. Múgica Arzamendi, Principal Adminis-
trator, for the Registrar, delivered a judgment on 1 April 2004,
in which it:

1) Declares that, by not adopting within the time-limit prescribed all
measures necessary for the recovery from the recipients of the aid
which was
Commission Decision
2000/128/EC of 11 May 1999 concerning aid granted by Italy
to promote employment, to be unlawful and incompatible with the
common market, the Italian Republic has failed to fulfil its obliga-
tions under Articles 3 and 4 of that decision;

according

found,

to

2) Orders the Italian Republic to pay the costs.

(2004/C 106/12)

(Language of the case. German)

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

In Case C-112/02: reference to the Court under Article 234 EC
by the Oberverwaltungsgericht für das Land Nordrhein-West-
falen (Higher Regional Court for the Land of North Rhine-
Westphalia (Germany) for a preliminary ruling in the proceed-
ings pending before that court between Kohlpharma GmbH
and Bundesrepublik Deutschland – on the interpretation of
Community law, in particular Articles 28 EC and 30 EC – the
Court (Sixth Chamber), composed of: C. Gulmann (Rapporteur),
acting for the President of the Sixth Chamber,
J.N. Cunha
Rodrigues, J.-P. Puissochet, R. Schintgen and F. Macken, Judges;
A. Tizzano, Advocate General; H.A. Rühl, Principal Adminis-
trator, for the Registrar, has given a judgment on 1 April 2004,
in which it ruled:

In the case where

an application for a marketing authorisation for a medicinal
product is submitted with reference to a medicinal product that
has already been authorised,the medicinal product which is the
subject of the application is imported from a Member State in
which it has obtained a marketing authorisation,the assessment
of safety and efficacy carried out for the medicinal product
which is already authorised can be used in the application for a
marketing authorisation for
the second medicinal product
without any risk to public health,Articles 28 EC and 30 EC
preclude the application being rejected solely on the ground
that the two medicinal products do not have a common origin.

(1) OJ C 118 of 18.5.2002.

(1) OJ C 156 of 29.6.2002.