Judgment of the Court (Second Chamber) of 13 January 2005 in Case C-117/03 (reference for a preliminary ruling from the Consiglio di Stato): Società Italiana Dragaggi SpA and Others v Ministero delle Infrastrutture e dei Trasporti and Regione Autonoma del Friuli Venezia Giulia (Directive 92/43/EEC — Conservation of natural habitats — Wild fauna and flora — National list of sites eligible for identification as sites of Community importance — Conservation measures)
Date: 2005-03-05
Institutions: Court of Justice
Subjects: biotope, environmental protection, interpretation of the law, project evaluation, protected species, transport policy

5.3.2005

EN

Official Journal of the European Union

C 57/7

1. Declares that,

— by laying down the technical criteria to be met by wheelchairs
in order to be eligible for reimbursement by social security in
such a way as to exclude from the list of reimbursable wheel-
chairs those bearing EC markings but which do not meet the
relevant criteria, namely, as regards the diameter of the front
and rear wheels, the cover and filling of the seat and back, the
dimensions of the flat sections and crossbars, head rests and/
or foot or leg rests;

— by laying down more general criteria which the economic
operator must meet in order to be included on the list of reim-
bursable wheelchairs, namely special conditions for manual
wheelchairs, as well as special conditions for power wheelchairs
according to which such wheelchairs must be available in a
minimum number of seat sizes;

— by being too rigid in its updating of the list of equipment

admitted to the reimbursement scheme,

the Kingdom of Belgium has failed to fulfil its obligations under
Article 28 EC.

2. Orders the Kingdom of Belgium to pay the costs.

3. Orders the Kingdom of Spain to bear its own costs.

Administrator, for the Registrar, has given a judgment on 20
January 2005, in which it has ruled:

1. Article 4.8(a)(iii) of Council Directive 65/65/EEC of 26 January
1965 on the approximation of provisions laid down by law, regu-
lation or administrative action relating to proprietary medicinal
products, as amended by Council Directives 87/21/EEC of 22
December 1986, 89/341/EEC of 3 May 1989 and 93/39/EEC
of 14 June 1993, must be interpreted as not preventing an appli-
cation for marketing authorisation in respect of a medicinal
product from being handled under the abridged procedure under
that provision where that product contains the same therapeutic
moiety as the reference product but combined with another salt.

2. In support of an application under Article 4.8(a)(iii) of Directive
65/65 as amended, an applicant may, either spontaneously or at
the request of the competent authority of a Member State, supply
additional documentation in the form of certain pharmacological
and toxicological tests or clinical trials in order to demonstrate
that his product is essentially similar to the reference product.

(1) OJ C 101 of 26.04.2003.

(1) OJ C 70, 22.03.2003.

JUDGMENT OF THE COURT

JUDGMENT OF THE COURT

(Second Chamber)

of 20 January 2005

in Case 74/03 (reference for a preliminary ruling by the
Østre Landsret): SmithKline Beecham plc v Lægemiddel-
styrelsen (1)

(Medicinal products — Marketing authorisation — Abridged
procedure — Essentially similar products — Active substance
in different forms of salt — Additional documentation)

(2005/C 57/12)

(Language of the case: Danish)

In Case 74/03: reference for a preliminary ruling under Article
234 EC by the Østre Landsret (Denmark), made by decision of
14 February 2003, received at the Court on 19 February 2003,
in the proceedings between SmithKline Beecham plc and Læge-
middelstyrelsen,
interveners: Synthon BV and Genthon BV –
the Court (Second Chamber), composed of C.W.A. Timmer-
mans, President of the Chamber, C. Gulmann (Rapporteur), J.-P.
Puissochet, N. Colneric and J.N. Cunha Rodrigues, Judges; F.G.
Jacobs, Advocate General; M. Múgica Arzamendi, Principal

(Second Chamber)

of 13 January 2005

in Case C-117/03 (reference for a preliminary ruling from
the Consiglio di Stato): Società Italiana Dragaggi SpA and
Others v Ministero delle Infrastrutture e dei Trasporti and
Regione Autonoma del Friuli Venezia Giulia (1)

(Directive 92/43/EEC — Conservation of natural habitats —
Wild fauna and flora — National list of sites eligible for
identification as sites of Community importance — Conser-
vation measures)

(2005/C 57/13)

(Language of the case: Italian)

In Case C-117/03: reference for a preliminary ruling under
Article 234 EC from the Consiglio di Stato (Italy), made by
order of 17 December 2002, received at the Court on 18
in the proceedings between Società Italiana
March 2003,
Dragaggi SpA and Others v Ministero delle Infrastrutture e
dei Trasporti and Regione Autonoma del Friuli Venezia
Giulia – the Court (Second Chamber) composed of C.W.A.
Timmermans, President of the Chamber, C. Gulmann (Rappor-
teur), J.-P. Puissochet, N. Colneric and J.N. Cunha Rodrigues,
Judges;
J. Kokott, Advocate General; M. Múgica Arzamendi,
Principal Administrator, for the Registrar, has given a judgment
on 13 January 2005, the operative part of which is as follows:

C 57/8

EN

Official Journal of the European Union

5.3.2005

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.

2. The first subparagraph of Article 6(1) of Directive 89/105 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.

(1) OJ C 213 of 06.09.2003.

On a proper
construction of Article 4(5) of Council Directive
92/43/EEC of 21 May 1992 on the conservation of natural habitats
and of wild fauna and flora, the protective measures prescribed in
Article 6(2), (3) and (4) of that directive are required only as regards
sites which, in accordance with the third subparagraph of Article 4(2)
of the directive, are on the list of sites selected as sites of Community
importance adopted by the Commission of the European Communities
in accordance with the procedure laid down in Article 21 of the direc-
tive.

In the case of sites eligible for identification as sites of Community
importance which are included in the national lists transmitted to the
Commission and, in particular, sites hosting priority natural habitat
types or priority species, the Member States are, by virtue of Directive
92/43, required to take protective measures that are appropriate,
from the point of view of the directive's conservation objective, for the
interest which those
purpose of safeguarding the relevant ecological
sites have at national level.

(1) OJ C 146 of 21.06.2003.

JUDGMENT OF THE COURT

(First Chamber)

of 13 January 2005

JUDGMENT OF THE COURT

in Case C-254/03 P Eduardo Vieira SA v Commission of
the European Communities (1)

(Second Chamber)

of 20 January 2005

(Appeal — Fisheries — Fisheries agreement with Argentina
— Community financial aid — Reduction)

in Case C-245/03 (reference for a preliminary ruling by the
Conseil d'État): Merck, Sharp & Dohme BV 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 — Conse-
quences of exceeding the time-limit)

(2005/C 57/14)

(Language of the case: French)

In Case C-245/03: reference for a preliminary ruling under
Article 234 EC from the Conseil d'État (Belgium), by decision
of 9 May 2003, received at the Court on 10 June 2003, in the
proceedings, between Merck, Sharp & Dohme BV and État
belge – the Court (Second Chamber), composed of C.W.A.
Timmermans, President of the Chamber, R. Silva de Lapuerta
(Rapporteur), C. Gulmann, R. Schintgen and G. Arestis, Judges;
A. Tizzano, Advocate General; M. Múgica Arzamendi, Principal
Administrator, for the Registrar, has given a judgment on 20
January 2005, in which it has ruled:

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

(2005/C 57/15)

(Language of the case: Spanish)

In Case C-254/03 P: appeal under Article 56 of the Statute of
the Court of Justice brought on 13 June 2003 by Eduardo
Vieira SA (lawyers: J.-R. García-Gallardo Gil-Fournier and D.
Domínguez Pérez), the other party to the proceedings being:
Commission of the European Communities (Agents: S. Pardo
Quintillán, and J. Rivas-Andres and J. Gutiérrez Gisbert) – the
Court (First Chamber), composed of P. Jann, President of the
Chamber, N. Colneric (Rapporteur), J.N. Cunha Rodrigues, M.
Ilešič and E. Levits, Judges; A. Tizzano, Advocate General; R.
Grass, Registrar, has given a judgment on 13 January 2005, in
which it:

1. Dismisses the appeal;

2. Orders Eduardo Vieira SA to pay the costs.

(1) OJ C 184, 2.8.2003.