Case C-106/01: Reference for a preliminary ruling by the Court of Appeal (England & Wales) (Civil Division), by order of that court of 22 February 2001, in the case of The Queen on the application of Novartis Pharmaceuticals UK Ltd against the Licensing Authority established by the Medicines Act 1968 (acting by the Medicines Control Agency), 1) Sangstat UK Ltd and 2) Imtix-Sangstat UK Ltd, interveners
Date: 2001-06-16
Institutions: Court of Justice
Subjects: interpretation of the law, marketing standard, medicinal product, pharmaceutical legislation, pharmaceutical product, product quality

16.6.2001

EN

Official Journal of the European Communities

C 173/23

Stato (Council of State), Italy for a preliminary ruling in the
proceedings pending before that court between Questore
Macerata v Claudio Peroni — on the interpretation of the
provisions of
the EC Treaty concerning the freedom to
provide services — the Court (Third Chamber), composed
of: C. Gulmann,
J.-P. Puissochet
(President of Chamber),
(Rapporteur), F. Macken,
Judges; C. Stix-Hackl, Advocate
General; R. Grass Registrar, has given an order on 15 December
2000, in which it has ruled:

The EC Treaty provisions on the freedom to provide services do not
preclude national legislation, such as the Italian legislation, which
reserves to certain bodies the right to take bets on sporting events if
that legislation is in fact justified by social-policy objectives intended
to limit the harmful effects of such activities and if the restrictions
which it
imposes are not disproportionate in relation to those
objectives.

(1) OJ C 209 of 4.7.1998.

Reference for a preliminary ruling by the Court of Appeal
(England & Wales) (Civil Division), by order of that court
of 22 February 2001, in the case of The Queen on the
application of Novartis Pharmaceuticals UK Ltd against
the Licensing Authority established by the Medicines
Act 1968 (acting by the Medicines Control Agency),
1) Sangstat UK Ltd and 2) Imtix-Sangstat UK Ltd, inter-
veners

(Case C-106/01)

(2001/C 173/39)

Reference has been made to the Court of Justice of the
European Communities by an order of the Court of Appeal
(England & Wales) (Civil Division) of 22 February 2001, which
was received at the Court Registry on 5 March 2001, for a
preliminary ruling in the case of The Queen on the application
of Novartis Pharmaceuticals UK Ltd against the Licensing
Authority established by the Medicines Act 1968 (acting by
the Medicines Control Agency), Interveners: 1) Sangstat UK
Ltd and 2) Imtix-Sangstat UK Ltd, on the following questions:

1.

In considering a marketing authorisation for a new
product (C) under Article 4.8(a)(iii) of Directive 65/65 (1),
than
(A)
referencing a product

authorised more

6/10 years ago, is a national competent authority ever
entitled to cross-refer, without consent, to data submitted
in support of a product (B) which was authorised within
the last 6/10 years?

2.

If so, may such cross-reference be made in circumstances
where:

(a)

product B was authorised under the Article 4.8(a)
hybrid abridged procedure, referencing product A;
and

(b)

the data to which reference is made consists of
clinical trials which the national competent auth-
ority indicated would be necessary if the marketing
authorisation was to be granted and which were
submitted in order to demonstrate that product B,
though suprabioavailable to product A when admin-
istered in the same dose, is safe?

3.

(a) Does the final sub-paragraph of Article 4.8(a) of
Directive 65/65 (‘the proviso’) apply only to appli-
cations made under Article 4.8(a)(iii) or to appli-
cations made under Article 4.8(a)(i) also?

(b)

Is essential similarity a prerequisite for the use of the
proviso?

4.

Can products ever be essentially similar for the purposes
of Article 4.8(a)(i) and (iii) of Directive 65/65 when they
are not bioequivalent, and if so in what circumstances?

5. What is the meaning of the term pharmaceutical form, as
used by the Court in its Judgment in Case C-368/96
Generics (2)? In particular, do two products have the same
pharmaceutical form when they are administered to the
patient in the form of a solution diluted to a macro-
emulsion, micro-emulsion and nano-dispersion respect-
ively?

6.

Is it consistent with the general principle of non-
discrimination for a national competent authority, faced
with hybrid applications for marketing authorisations
under Article 4.8(a) of Directive 65/65 referencing prod-
uct A for two products, neither of which is bioequivalent
to product A:

C 173/24

EN

Official Journal of the European Communities

16.6.2001

(i)

to indicate that it is necessary for a marketing
authorisation to be granted for product B to be
supported by full clinical data of the type required
by Part 4(F) of the Annex to Directive 75/318/EC (3);
but

or its ancillary site? Is it relevant generally, with
respect to falling within the definition of waste,
whether the said by-products of mining operations
are stored on the area of the mining concession, its
ancillary site or further away?

(ii) having considered the data filed in support of
product B, to grant a marketing authorisation for
product C if that application is supported by trials
not meeting the requirements of Part 4(F) of the
Annex to Directive 75/318/EEC?

(1) Council Directive 65/65/EEC of 26 January 1965 on the approxi-
mation of provisions laid down by Law, Regulation or Adminis-
trative Action relating to proprietary medicinal products (OJ 22,
09.02.1965, p. 369 [SE SER 1 (65-66) p. 201]).

(2) ECR 1998 p. I-7967.
(3) Council Directive 75/318/EEC of 20 May 1975 on the approxi-
mation of the laws of Member States relating to analytical,
pharmaco-toxicological and clinical standards and protocols in
respect of the testing of proprietary medicinal products (OJ L 147,
09.06.1975, p. 1).

Reference for a preliminary ruling from the Korkein
hallinto-oikeus by order of that court of 5 March 2001 in
the proceedings brought by Outokumpu Chrome Oy

(Case C-114/01)

(2001/C 173/40)

Reference has been made to the Court of Justice of the
European Communities by an order of the Korkein hallinto-
oikeus (Supreme Administrative Court), Finland, of 5 March
2001, which was received at the Court Registry on 14 March
2001, for a preliminary ruling in the proceedings brought by
Outokumpu Chrome Oy on the following questions:

(1) Are leftover rock resulting from the extraction of ore
and/or ore-dressing sand resulting from the dressing of
ore in mining operations to be regarded as waste
within the meaning of Article 1(a) of Council Directive
75/442/EEC of 15 July 1975 on waste (1), as amended by
Council Directive 91/156/EEC of 18 March 1991 (2),
having regard to points (a) to (d) below?

(a) What relevance,

in deciding the above question,
does it have that the leftover rock and ore-dressing
sand is stored on the area of the mining concession

(b) What relevance does it have, in assessing the matter,
that the leftover rock is the same as regards its
composition as the basic rock from which it is
quarried, and that it does not change its composition
regardless of how long it is kept and how it is kept?
Should ore-dressing sand which results from the
ore-dressing process perhaps be assessed differently
from leftover stone in this respect?

(c) What relevance does it have, in assessing the matter,
that leftover rock is harmless to human health and
the environment, but that, according to the view of
the environmental
licence authorities, substances
harmful to health and the environment dissolve
from ore-dressing sand? To what extent generally is
importance to be attached to the possible effect of
leftover rock and ore-dressing sand on health and
the environment
in assessing whether they are
waste?

(d) What relevance does it have, in assessing the matter,
that leftover rock and ore-dressing sand are not
intended to be discarded? Leftover rock and ore-
dressing sand may be re-used without special pro-
cessing measures, for example for supporting mine
galleries, and leftover rock also for landscaping the
mine after it has ceased operation. Minerals may in
future with the development of
technology be
recovered from ore-dressing sand for utilisation. To
what extent should attention be paid to how definite
plans the person carrying on mining operations has
for such utilisation and to how soon after the
leftover rock and ore-dressing sand has been tipped
on the mining concession or its ancillary site the
utilisation would take place?

(2)

If the answer to the first question is that leftover rock
and/or ore-dressing sand is to be regarded as waste within
the meaning of Article 1(a) of the Council Directive on
waste, it is further necessary to obtain an answer to the
following supplementary questions:

(a) Does ‘other legislation’ within the meaning of
Article 2(1)(b) of the Waste Directive (91/156/EEC),
waste covered by which is excluded from the scope
of the directive, and which under point (ii) concerns
inter alia waste resulting from prospecting, extrac-
tion, treatment and storage of mineral resources,