Judgment of the Court (Sixth Chamber) of 29 April 2004 in Case C-106/01 (reference for a preliminary ruling from the Court of Appeal (Civil Division) (England and Wales)): The Queen, on the application of Novartis Pharmaceuticals UK Ltd v The Licensing Authority established by the Medicines Act 1968 (acting by the Medicines Control Agency), and SangStat UK Ltd, and Imtix-SangStat UK Ltd (Medicinal products — Marketing authorisation — Procedure relating to essentially similar products)
Date: 2004-04-30
Institutions: Court of Justice
Subjects: interpretation of the law, marketing standard, medicinal product, pharmaceutical legislation, pharmaceutical product, product quality

30.4.2004

EN

Official Journal of the European Union

C 118/7

it is for the national court to establish whether the transactions
concerned in the main proceedings involve only very limited
use of assets or services subject to value added tax and, if so,
to exclude interest generated by those transactions from the
denominator of the fraction used to calculate the deductible
proportion.

2. Operations such as those at issue in the main proceedings, carried
out by the members of a consortium in accordance with the provi-
sions of a consortium contract and corresponding to the share
assigned to each of
them in that contract, do not constitute
supplies of goods or services ‘effected for consideration’ within the
meaning of Article 2(1) of Sixth Directive 77/388, nor, conse-
quently, a taxable transaction under that directive. The fact that
such operations are carried out by the member of the consortium
which manages it is irrelevant in that respect. On the other hand,
where the performance of more of the operations than the share
thereof fixed by the said contract for a consortium member involves
payment by the other members against the operations exceeding
that share, those operations constitute a supply of goods or services
‘effected for consideration’ within the meaning of that provision.

(1) OJ C 118, 21.4.2001.

JUDGMENT OF THE COURT

(Fifth Chamber)

of 29 April 2004

in Case C-91/01: Italian Republic v Commission of the
European Communities (1)

(State aid — Recommendation concerning the definition of
small and medium-sized enterprises — Guidelines for State
aid to small and medium-sized enterprises — Independence
criterion — Protection of legitimate expectations — Legal
certainty)

(2004/C 118/12)

(Language of the case: Italian)

(Provisional translation; the definitive translation will be published in
the European Court Reports)

In Case C-91/01: Italian Republic (Agent: I. Braguglia, assisted
by D. Del Gaizo), with an address for service in Luxembourg v
the European Communities (Agents: V. Di
Commission of
Bucci and J. M. Flett), with an address for service in Luxem-
bourg — application for annulment of Commission Decision
2001/779/EC of 15 November 2000 on the State aid which
Italy is planning to grant to Solar Tech Srl (OJ 2001 L 292, p.
45), in so far as it did not allow the application to that aid of
the bonus of 15 % gross grant equivalent provided for for small
and medium-sized enterprises — the Court (Fifth Chamber),
composed of: C. W. A. Timmermans, acting for the President

of the Fifth Chamber, A. Rosas and S. von Bahr (Rapporteur),
Judges; Advocate General: F. G. Jacobs; Registrar: M. Múgica
Arzamendi, Principal Administrator, has given a judgment on
29 April 2004, in which it:

1) Dismisses the action;

2) Orders the Italian Republic to pay the costs

(1) OJ C 118, 21.4.2001.

JUDGMENT OF THE COURT

(Sixth Chamber)

of 29 April 2004

in Case C-106/01 (reference for a preliminary ruling from
the Court of Appeal (Civil Division) (England and Wales)):
The Queen, on the application of Novartis Pharmaceuticals
UK Ltd v The Licensing Authority established by the
Medicines Act 1968 (acting by the Medicines Control
Agency), and SangStat UK Ltd, and Imtix-SangStat UK
Ltd (1)

(Medicinal products — Marketing authorisation — Procedure
relating to essentially similar products)

(2004/C 118/13)

(Language of the case: English)

(Provisional translation; the definitive translation will be published in
the European Court Reports)

In Case C-106/01: reference to the Court under Article 234 EC
from the Court of Appeal (Civil Division) (England and Wales)
for a preliminary ruling in the proceedings pending before that
court between The Queen on the application of Novartis Phar-
maceuticals UK Ltd andThe Licensing Authority established by
the Medicines Act 1968 (acting by the Medicines Control
Agency), and SangStat UK Ltd, and Imtix-SangStat UK Ltd —
on the interpretation of Article 4.8(a) of Council Directive
65/65/EEC of 26 January 1965 on the approximation of provi-
sions laid down by law, regulation or administrative action
relating to medicinal products (OJ, English Special Edition
1965-1966, p. 20),
amended by Council Directives
87/21/EEC of 22 December 1986 (OJ 1987 L 15, p. 36),
89/341/EEC of 3 May 1989 (OJ 1989 L 142, p. 11) and
93/39/EEC of 14 June 1993 (OJ 1993 L 214, p. 22) — the
Court (Sixth Chamber), composed of: V. Skouris, acting for the
President of the Sixth Chamber, C. Gulmann (Rapporteur), J.-N.
Cunha Rodrigues, J.-P. Puissochet and R. Schintgen, Judges; F.G.
Jacobs, Advocate General; M.-F. Contet, Principal Adminis-
trator, for the Registrar, has given a judgment on 29 April
2004, in which it has ruled:

as

C 118/8

EN

Official Journal of the European Union

30.4.2004

1. Products cannot be regarded as essentially similar for the purposes
of the application of Article 4.8(a)(i) or (iii) of Council Directive
65/65/EEC of 26 January 1965 on the approximation of provi-
regulation or administrative action
sions
relating to 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, where they are not
bioequivalent.

laid down by law,

infringe the principle of non-discrimination where, as a precondi-
tion for the grant of marketing authorisation, it requires full clin-
ical data on the bioavailability of product B, but, having examined
the data filed in support of product B, does not require the same
data for product C.

(1) OJ C 173, 16.6.2001.

including the physical

2. For the purposes of the procedure laid down by Article 4.8(a)(i)
in determining the
and (iii) of Directive 65/65, as amended,
pharmaceutical
form of a medicinal product, account must be
taken of the form in which it is presented and the form in which it
is administered,
In that context,
medicinal products such as those at issue in the main proceedings,
which are presented in the form of a solution to be mixed in a
drink for administration to the patient and which, after mixing,
form, respectively, a macroemulsion, a microemulsion and a nano-
dispersion, are to be treated as having the same pharmaceutical
form, provided that the differences in the form of administration
are not significant in scientific terms.

form.

3. The proviso, that is, the hybrid abridged procedure laid down by
the final subparagraph of Article 4.8(a) of Directive 65/65, as
amended, applies
for marketing authorisation
based on Article 4.8(a)(i) or (iii).

to applications

An application for marketing authorisation for a medicinal
product may be made under the proviso, that is, by the abridged
hybrid procedure provided for in the final subparagraph of Article
4.8(a) of Directive 65/65, as amended, with reference to an
authorised medicinal product provided that the medicinal product
in respect of which marketing authorisation is sought is essentially
similar to the authorised medicinal product, unless one or more of
the differences set out in the proviso apply, as the case may be.

4. In considering an application for marketing authorisation for a
new product C under Article 4.8(a)(iii) of Directive 65/65, as
amended, with reference to a product A authorised for more than
six or 10 years, the competent authority of a Member State is
entitled, with a view to granting marketing authorisation, to refer
without the consent of the person responsible for marketing to
data submitted in support of a product B which was authorised
within the previous six or 10 years under the hybrid abridged
procedure laid down by Article 4.8(a) of Directive 65/65, as
amended, with reference to product A, where those data consist of
clinical trials provided in order to demonstrate that product B,
though suprabioavailable to product A when administered in the
same dose, is safe.

JUDGMENT OF THE COURT

(Fifth Chamber)

of 29 April 2004

in Case C-159/01: Kingdom of the Netherlands v Commis-
sion of the European Communities (1)

(State aid — Partial exemption from mineral levies for crops
grown under glass or on substrate)

(2004/C 118/14)

(Language of the case: Dutch)

(Provisional translation; the definitive translation will be published in
the European Court Reports)

In Case C-159/01: Kingdom of the Netherlands (Agent: J. van
Bakel) with an address for service in Luxembourg v Commis-
sion of the European Communities (Agents: D. Triantafyllou
and H. van Vliet) with an address for service in Luxembourg —
application for the partial annulment of Commission Decision
2001/371/EC of 21 December 2000 on the exemption from
mineral
levies under the manure law which the Netherlands
intends to grant (OJ 2001 L 130, p. 42), — the Court (Fifth
Chamber), composed of: P. Jann, acting for the President of the
Fifth Chamber, A. Rosas and S. von Bahr (Rapporteur), Judges;
P. Léger, Advocate General; M.-F. Contet, Principal Adminis-
trator, for the Registrar, has given a judgment on 29 April
2004 in which it:

1) Dismisses the application;

2) Orders the Kingdom of the Netherlands to pay the costs.

5. In considering two hybrid applications for marketing authorisation
for products B and C brought under the final subparagraph of
Article 4.8(a) of Directive 65/65, as amended, and referring to
product A, the competent authority of a Member State does not

(1) OJ C 212, 28.7.2001.