Case C-36/03: Reference for a preliminary ruling by the High Court of Justice (England & Wales), Queen's Bench Division (Administrative Court) by order of that court dated 23 December 2002, in the case of The Queen on the application of Approved Prescription Services Ltd against the Licensing Authority (acting by the Medicines Control Agency), Interested party: Eli Lilly & Co. Ltd
Date: 2003-04-05
Institutions: Court of Justice
Subjects: interpretation of the law, marketing, medicinal product, pharmaceutical legislation

5.4.2003

EN

Official Journal of the European Union

C 83/7

Reference for a preliminary ruling by the High Court
of Justice (England & Wales), Queen’s Bench Division
(Administrative Court) by order of that court dated
23 December 2002, in the case of The Queen on the
application of Approved Prescription Services Ltd against
the Licensing Authority (acting by the Medicines Control
Agency), Interested party: Eli Lilly & Co. Ltd

Appeal brought on 4 February 2003 by Rica Foods (Free
Zone) NV against the judgment delivered on 14 Novem-
ber 2002 by the Court of First Instance (Third Chamber)
in Joined Cases T-94/00, T-110/00 and T-159/00 Rica
Foods (Free Zone) NV, Free Trade Foods NV and Suproco
NV, supported by the Kingdom of the Netherlands, v
Commission of the European Communities, supported by
the Kingdom of Spain and the French Republic

(Case C-36/03)

(2003/C 83/12)

(Case C-41/03 P)

(2003/C 83/13)

Reference has been made to the Court of Justice of the
European Communities by an order of the High Court of
Justice (England & Wales), Queen’s Bench Division (Adminis-
trative Court) dated 23 December 2002, which was received
at the Court Registry on 3 February 2003, for a preliminary
ruling in the case of The Queen on the application of Approved
Prescription Services Ltd against the Licensing Authority
(acting by the Medicines Control Agency), Interested party: Eli
Lilly & Co. Ltd, on the following questions:

An appeal has been brought before the Court of Justice of the
European Communities on 4 February 2003 by Rica Foods
(Free Zone) NV, represented by G. van der Wal, advocaat
before the Hoge Raad der Nederlanden, against the judgment
delivered on 14 November 2002 by the Court of First Instance
in Joined Cases T-94/00, T-110/00 and
(Third Chamber)
T-159/00 Rica Foods (Free Zone) NV, Free Trade Foods NV and
Suproco NV, supported by the Kingdom of the Netherlands, v
Commission of the European Communities, supported by the
Kingdom of Spain.

Can an application for a marketing authorisation for a
medicinal Product C validly be made under the first paragraph
of Article 10.1(a)(iii) of Directive 2001/83/EC (1), where the
application seeks to demonstrate that Product C is essentially
similar to another product, Product B, in circumstances where:

(1)

Product B is related to an original medicinal Product A,
in that Product B has been authorised as a ‘line extension’
of Product A, but has a different pharmaceutical form
from Product A or is otherwise not ‘essentially similar’ to
Product A within the meaning of Article 10.1(a)(iii); and

The appellant claims that the Court should:

(1) declare admissible the appeal lodged by the appellant
against the judgment delivered on 14 November 2002 by
the Court of First Instance of the European Communities
in Joined Cases T-94/00, T-110/00 and T-159/00;

(2)

set aside the judgment delivered on 14 November 2002
by the Court of First Instance of the European Communi-
ties in Joined Cases T-94/00, T-110/00 and T-159/00
and, ruling afresh pursuant to the application at first
instance lodged by the present appellant on 18 April
2000:

(2)

Product A has been authorised for marketing in the
Community for more than the six/ten year period stipu-
lated in Article 10.1(a)(iii); and

— annul Regulation No 465/2000/EC (1);

(3)

Product B has been authorised for marketing for less than
the six/ten year period stipulated in Article 10.1(a)(iii).

( 1) 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 (OJ L 311, 28.11.2001, p. 67).

— declare that the Community is liable for the damage
suffered by the appellant by reason of the fact that
imports of the products referred to in Regulation
(EC) No 465/2000 have, since 1 March 2000, been
prevented or restricted as a consequence of that
regulation, and order the parties to reach agreement
on the extent of the damage suffered by the appel-
lant, and, if no agreement is reached on that matter,
order that proceedings be continued within a period
to be laid down by the Court of Justice for the
purpose of determining the extent of the damage, or
at any rate order the Community to pay compen-
sation for the provisionally estimated damage and