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 Lægemiddelstyrelsen (Medicinal products — Marketing authorisation — Abridged procedure — Essentially similar products — Active substance in different forms of salt — Additional documentation)
Date: 2005-03-05
Institutions: Court of Justice
Subjects: document, interpretation of the law, marketing, medicinal product, pharmaceutical product

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: