Case C-223/01: Reference for a preliminary ruling by the Østre Landsret, by decision of that court of 23 May 2001 in the case of AstraZeneca A/S v Lægemiddelstyrelsen, intervener: Generics (UK) Ltd, and in the case of A/S GEA Farmaceutisk Fabrik v Lægemiddelstyrelsen, joined party: Sundhedsministeriet, interveners: Generics (UK) Ltd and AstraZeneca A/S
Date: 2001-08-11
Institutions: Court of Justice
Subjects: interpretation of the law, marketing, pharmaceutical product, trade regulations

C 227/12

EN

Official Journal of the European Communities

11.8.2001

Reference for a preliminary ruling by the Østre Landsret,
by decision of that court of 23 May 2001 in the case
of AstraZeneca A/S v Lægemiddelstyrelsen, intervener:
Generics (UK) Ltd, and in the case of A/S GEA Farmaceut-
isk Fabrik v Lægemiddelstyrelsen, joined party: Sund-
hedsministeriet, interveners: Generics (UK) Ltd and Astra-
Zeneca A/S

(Case C-223/01)

(2001/C 227/19)

Reference has been made to the Court of Justice of the
European Communities by decision of the Østre Landsret of
23 June 2001, received at the Court Registry on 5 June 2001,
for a preliminary ruling in the cases of AstraZeneca A/S and
A/S GEA Farmaceutisk Fabrik v Lægemiddelstyrelsen, joined
party: Sundhedsministriet, intervener: Generics (UK) Ltd, on
the following questions:

Question 1

In a case where an undertaking applies for marketing authoris-
ation on the basis of an abridged application (simplified
procedure) under Article 4, third paragraph, point 8(a)(iii)
of the first medicinal products directive (Council Directive
65/65/EEC (1) as subsequently amended) and states that the
product for which marketing authorisation is sought is essen-
tially similar to a reference product which has been approved
in the Community for the necessary period of time pursuant
to the directive, is it necessary and sufficient that the reference
product:

(a)

(b)

(c)

at the time of the application has been marketed in the
Member State for which the application is made, or

at the time of the application is still being marketed in
the Member State for which the application is made, or

is still being marketed at the time of the application and
at the time of notification of marketing authorisation in
the Member State for which the application is made?

Question 2

in Article 4,

Does the term ‘marketed’
third paragraph,
point 8(a)(iii) mean that it is sufficient and necessary that there
be approval in the form of marketing authorisation for the
reference product in the Member State for which the appli-
cation is made?

Question 3

If Questions 1(b) or 1(c) are answered in the affirmative, does
the first medicinal products directive contain a legal basis
for enabling the national authorities to dispense with the
requirements in question so that an abridged application can
nevertheless be examined as to its substance?

(1) of 26 January 1965 on the approximation of provisions laid
down by law, regulation or administrative action relating to
proprietary medicinal products (OJ, English Special Edition,
1965/1966, p. 20).

Reference for a preliminary ruling by the First Civil
Chamber of the Tribunale Civile di Genova by order of
that court of 24 May 2001 in the joined cases of Off-road
Action Sas and Model Toys di Luca Luperini against
Prefetto di Genova

(Case C-225/01)

(2001/C 227/20)

Reference has been made to the Court of Justice of the
European Communities by order of the First Civil Chamber of
the Tribunale Civile, (Civil District Court), Genoa, of 24 May
2001, received at the Court Registry on 6 June 2001, for a
preliminary ruling in the joined cases of Off-road Action Sas
and Model Toys di Luca Luperini against the Prefetto di Genova
on the following questions:

— In the light of the principles of the free movement of
goods and of proportionality, does Community law
preclude in all cases the application of national legislation
under which the confiscation of goods is applied by way
of secondary penalty for any infringement of administrat-
ive regulations governing the importation of such goods
into Italian territory, for trade, use or exploitation; or is
that penalty compatible with Community law in certain
circumstances, because of the seriousness of the offence
or the importance of the legal good which the rule
infringed seeks to protect?

— In the light of the principle of proportionality, does
Community law preclude the application of national
legislation which does not confer on the administrative
authorities or the courts any discretion — having regard
to the seriousness of the offence or the importance of the
legal good which the rule infringed seeks to protect — in
deciding whether or not to order the confiscation of
goods, that being the secondary penalty prescribed for any
infringement of the administrative regulations govern-
ing the manufacture, use, carriage, holding or alienation
of such goods within Italian territory?