Judgment of the Court (Fifth Chamber) of 29 April 2004 in Case C-159/01: Kingdom of the Netherlands v Commission of the European Communities (State aid — Partial exemption from mineral levies for crops grown under glass or on substrate)
Date: 2004-04-30
Institutions: Court of Justice
Subjects: European Commission, Netherlands, action for annulment (EU), fertiliser, tax exemption

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.