CELEX: C2001/227/19
Language: en
Date: 2001-08-11 00:00:00
Title: 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

C 227/12                EN                    Official Journal of the European Communities                                      11.8.2001
Reference for a preliminary ruling by the Østre Landsret,                Question 3
by decision of that court of 23 May 2001 in the case
of AstraZeneca A/S v Lægemiddelstyrelsen, intervener:                    If Questions 1(b) or 1(c) are answered in the affirmative, does
Generics (UK) Ltd, and in the case of A/S GEA Farmaceut-                 the first medicinal products directive contain a legal basis
isk Fabrik v Lægemiddelstyrelsen, joined party: Sund-                    for enabling the national authorities to dispense with the
hedsministeriet, interveners: Generics (UK) Ltd and Astra-               requirements in question so that an abridged application can
                            Zeneca A/S                                   nevertheless be examined as to its substance?
                          (Case C-223/01)                                (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).
                          (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             Reference for a preliminary ruling by the First Civil
A/S GEA Farmaceutisk Fabrik v Lægemiddelstyrelsen, joined                Chamber of the Tribunale Civile di Genova by order of
party: Sundhedsministriet, intervener: Generics (UK) Ltd, on             that court of 24 May 2001 in the joined cases of Off-road
the following questions:                                                 Action Sas and Model Toys di Luca Luperini against
                                                                                                Prefetto di Genova
                                                                                                  (Case C-225/01)
Question 1
                                                                                                  (2001/C 227/20)
In a case where an undertaking applies for marketing authoris-           Reference has been made to the Court of Justice of the
ation on the basis of an abridged application (simplified                European Communities by order of the First Civil Chamber of
procedure) under Article 4, third paragraph, point 8(a)(iii)             the Tribunale Civile, (Civil District Court), Genoa, of 24 May
of the first medicinal products directive (Council Directive             2001, received at the Court Registry on 6 June 2001, for a
65/65/EEC (1) as subsequently amended) and states that the               preliminary ruling in the joined cases of Off-road Action Sas
product for which marketing authorisation is sought is essen-            and Model Toys di Luca Luperini against the Prefetto di Genova
tially similar to a reference product which has been approved            on the following questions:
in the Community for the necessary period of time pursuant
to the directive, is it necessary and sufficient that the reference      —     In the light of the principles of the free movement of
product:                                                                       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
(a)   at the time of the application has been marketed in the
                                                                               of secondary penalty for any infringement of administrat-
      Member State for which the application is made, or
                                                                               ive regulations governing the importation of such goods
                                                                               into Italian territory, for trade, use or exploitation; or is
(b) at the time of the application is still being marketed in                  that penalty compatible with Community law in certain
      the Member State for which the application is made, or                   circumstances, because of the seriousness of the offence
                                                                               or the importance of the legal good which the rule
(c)   is still being marketed at the time of the application and               infringed seeks to protect?
      at the time of notification of marketing authorisation in
      the Member State for which the application is made?                —     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
Question 2                                                                     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-
Does the term ‘marketed’ in Article 4, third paragraph,                        ing the manufacture, use, carriage, holding or alienation
point 8(a)(iii) mean that it is sufficient and necessary that there            of such goods within Italian territory?
be approval in the form of marketing authorisation for the
reference product in the Member State for which the appli-
cation is made?