Judgment of the Court (Second Chamber) of 9 December 2004 in Case C-36/03 (reference for a preliminary ruling from the High Court of Justice of England and Wales, Queen's Bench Division (Administrative Court)): The Queen, on the application of: Approved Prescription Services Ltd, v Licensing Authority (Medicinal products — Marketing authorisation — Procedures for essentially similar products)
Date: 2005-02-19
Institutions: Court of Justice
Subjects: interpretation of the law, marketing, medicinal product, pharmaceutical legislation

19.2.2005

EN

Official Journal of the European Union

C 45/5

JUDGMENT OF THE COURT OF JUSTICE

(Fourth Chamber)

of 16 December 2004

in Case C-24/03: Italian Republic v Commission of the
European Communities (1)

(EAGGF — Partial annulment of Commission Decision
2002/881/EC — Financial corrections — Fruit and vegetable
and public grain storage sector)

(2005/C 45/08)

(Language of the case: Italian)

In Case C-24/03: Italian Republic (Agent: M. Fiorilli) against
Commission of the European Communities (Agents: C.
Cattabriga and L. Visaggio) – action for annulment under
Article 230 EC, brought on 15 January 2003 – the Court of
Justice (Fourth Chamber), composed of K. Lenaerts, President of
the Chamber, J.N. Cunha Rodrigues and K. Schiemann (Rappor-
teur), Judges; L.A. Geelhoed, Advocate General, R. Grass, Regis-
trar, has given a judgment on 16 December 2004, in which it:

1. Dismisses the action.

2. Orders the Italian Republic to pay the costs.

(1) OJ C 70 of 22.03.2004.

The Queen, on the application of: Approved Prescription
Services Ltd, and Licensing Authority, acting by the Medi-
cines and Healthcare products Regulatory Agency,
interested
party: Eli Lilly & Co. Ltd, – the Court (Second Chamber),
composed of: C.W.A. Timmermans, 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 Administrator, for the Registrar,
has given a judgment on 9 December 2004, in which it has
ruled:

An application for marketing authorisation for a Product C may be
made under Article 10(1)(a)(iii) of Directive 2001/83/EC of the
European Parliament and of the Council of 6 November 2001 on the
Community code relating to medicinal products for human use where
the application seeks to demonstrate that Product C is essentially
similar to a Product B, in circumstances where:

— Product B is a new pharmaceutical form of Product A, and

— Product A, but not Product B, has been authorised for marketing
in the Community for at least the six or ten year period stipulated
therein.

(1) OJ C 83 of 5.4.2003.

JUDGMENT OF THE COURT

(Third Chamber)

of 16 December 2004

JUDGMENT OF THE COURT

(Second Chamber)

of 9 December 2004

in Case C-36/03 (reference for a preliminary ruling from
the High Court of Justice of England and Wales, Queen's
Bench Division (Administrative Court)): The Queen, on
the application of: Approved Prescription Services Ltd, v
Licensing Authority (1)

(Medicinal products — Marketing authorisation — Proce-
dures for essentially similar products)

(2005/C 45/09)

(Language of the case: English)

In Case C-36/03: reference for a preliminary ruling under
Article 234 EC from the High Court of Justice of England and
Wales, Queen's Bench Division (Administrative Court) (United
Kingdom), made by order of 23 December 2002, received at
in the proceedings between
the Court on 3 February 2003,

in Case C-62/03: Commission of the European Commu-
nities v United Kingdom of Great Britain and Northern
Ireland (1)

(Waste — Directives 75/442/EEC and 91/156/EEC — Trans-
position)

(2005/C 45/10)

(Language of the case: English)

the European Communities

In Case C-62/03, action under Article 226 EC for failure to
fulfil obligations, brought on 14 February 2003, between the
(Agents:
Commission of
X. Lewis and M. Konstantinidis) and United Kingdom of
Great Britain and Northern Ireland (Agents: K. Manji and by
D. Wyatt QC) – the Court (Third Chamber), composed of: A.
Rosas, President of the Chamber, A. Borg Barthet, J. P. Puisso-
chet (Rapporteur), J. Malenovský and U. Lõhmus, Judges; C.
Stix-Hackl, Advocate General; L. Hewlett, Principal Adminis-
trator, for the Registrar, has given a judgment on 16 December
2004, in which it: