Case C-41/03 P: Appeal brought on 4 February 2003 by Rica Foods (Free Zone) NV against the judgment delivered on 14 November 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
Date: 2003-04-05
Institutions: Court of Justice
Subjects: European Commission, General Court (EU), action for annulment (EU), import, overseas countries and territories, production quota, protective clause, sugar product

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

C 83/8

EN

Official Journal of the European Union

5.4.2003

that still to be assessed; in the further alternative,
order the Community to pay compensation to be
determined on an equitable basis by the Court of
Justice, plus annual interest of 8 % from the date of
the application at first instance to the date of full
and final payment;

— Infringement of the preferential status of the OCT: the
Court of First Instance erred in its determination of the
relevant facts to such an extent that its appraisal in the
grounds of its judgment here referred to is, in the light of
the procedural documents, incomprehensible.

(3) order the respondent to pay the costs of both sets of
proceedings, in accordance with Article 69(2) of the Rules
of Procedure.

(1) Commission Regulation (EC) No 465/2000 of 29 February 2000
introducing safeguard measures for imports from the overseas
countries and territories of sugar sector products with EC/OCT
cumulation of origin (OJ 2000 L 56, p. 39).

(2) — Council Decision 91/482/EEC of 25 July 1991 on the
association of the overseas countries and territories with the
European Economic Community (OJ 1991 L 263, p. 1).

Pleas in law and main arguments

— Breach of Article 109(1) of the OCT Decision (2): the
Court of First Instance failed to take into account the fact
that Article 109(1) of the OCT Decision constitutes a
derogation from the prohibition in Article 101 of the
OCT Decision of import duties and measures having
equivalent effect. As in the case of every derogation which
departs from the principal rule, and in this case from the
objective of the successive OCT Decisions, this derogation
must be narrowly construed and applied. The ‘wide
discretion’ of the Commission and the limited appraisal
of the Community judicature on which the Court of
First Instance based itself are incompatible with such a
possibility of applying Article 109(1) of the OCT Decision
that is limited to exceptional cases (Article 109(1) of the
OCT Decision as an ‘emergency brake’);

— Failure to provide reasons: it was wrong in law and also, in
light of the documents on the case-file, incomprehensible
and/or indicative of inadequate reasoning that the Court
that any additional
of First Instance should hold (i)
imports of OCT sugar under the EC/OCT cumulation of
origin regime would increase the amount of surplus sugar
on the Community market, and (ii) that
‘additional
imports’ within the meaning of (i) impose an extra burden
on the Community budget;

— Breach of Article 109(1) of the OCT Decision: the Court
of First Instance erred in law in its construction of the
terms ‘difficulties’ and ‘deterioration’ and consequently
erred in law in its application of
those terms. The
appellant refers to its application at first instance;

— Breach of Article 109(2) of the OCT Decision: there is no
quantitative correlation between the quota in Regulation
No 465/2000 and ‘difficulties’ and/or ‘deterioration’. In
the light of the historical quantities, the measure is also
entirely arbitrary and inequitable;

Reference for a preliminary ruling by the Tribunale di
Catania — Prima Sezione Civile, by order of that Court of
19 January 2003 in the case of Catania Commissary
General of Police against Oxana Dem’Yanenko

(Case C-45/03)

(2003/C 83/14)

Reference has been made to the Court of
Justice of the
European Communities by order of the Tribunale di Catania
— Prima Sezione Civile (Catania District Court, First Civil
Chamber) of 19 January 2003, received at the Court Registry
on 7 February 2003, for a preliminary ruling in the case
of Catania Commissary General of Police against Oxana
Dem’Yanenko on the following questions:

1. Are the Community rules set out above — Articles 7, 8
and 9 of Council Directive 64/221/EEC (1) of 25 February
1964 and Articles 2, 5, 6, 13 and 14 of the Convention
for the Protection of Human Rights and Fundamental
Freedoms, signed in Rome on 4 November 1950 — and
the general, fundamental principles of Community law to
be interpreted as meaning that any foreigner deported
from a Member State of the European Community is
entitled to have his deportation order reviewed before it
is enforced by an impartial authority different from that
which adopted the order?

2. Are the Community rules set out above — Articles 7, 8
and 9 of Council Directive 64/221/EEC of 25 February
1964 and Articles 2, 5, 6, 13 and 14 of the Convention
for the Protection of Human Rights and Fundamental
Freedoms, signed in Rome on 4 November 1950 — and
the general, fundamental principles of Community law to
be interpreted as meaning that it is unacceptable and
unlawful for the police of a Member State of the European
Community, without prior review by any other authority,