CELEX: C2001/173/38
Language: en
Date: 2001-06-16 00:00:00
Title: Order of the Court (Third Chamber) of 15 December 2000 in Case C-86/98 (reference for a preliminary ruling from the Consiglio di Stato): Questore Macerata v Claudio Peroni (Article 104(3) of the Rules of Procedure — Question identical to a question on which the Court has already ruled)

C 173/22                 EN                       Official Journal of the European Communities                                          16.6.2001
1.    Declares that,                                                         (J. L. Iglesias Buhigues and U. Wölker, assisted by B. Wägen-
                                                                             baur), supported by the French Republic (K. Rispal-Bellanger
      —     by failing to take all the measures necessary to ensure          and C. Vasak), Freistaat Thüringen, represented by
            that, within 10 years of the notification of Council             G. M. Berrisch, of the Brussels Bar, with an address for service
            Directive 76/160/EEC of 8 December 1975 concerning               in Luxembourg at the Chambers of G. Harles, 8-10 Rue
            the quality of bathing water, the quality of bathing water       Mathias Hardt and Molkerei und Weichkäserei K-H. Zimmer-
            conformed to the limit values set in accordance with the         mann GmbH, established in Falkenhain, (Germany), represent-
            directive, contrary to Article 4(1) thereof;                     ed by P. Lotze and S. Lehr, of the Brussels Bar, with an address
                                                                             for service in Luxembourg at the Chambers of R. Faltz, 6 Rue
      —     by failing to carry out sampling operations in line with         Heinrich Heine, the Court (Second Chamber), composed of
            the minimum frequency laid down in the Annex to                  V.Skouris, President of the Chamber, R. Schintgen (Rapporteur)
            Directive 76/160 in respect of inland bathing waters,            and N. Colneric, Judges; P. Léger, Advocate General, R. Grass,
            contrary to Article 6(1), and                                    Registrar, made an order on 26 October 2000 the operative
                                                                             part of which is as follows:
      —     by failing to carry out sampling operations for the ‘total
            coliform’ parameter,
                                                                             1.     The appeal is dismissed;
      the French Republic has failed to fulfil its obligations under
      Articles 3, 4, 5 and 6 of Directive 76/160;                            2.     Molkerei Grossbraunshain GmbH and Bene Nahrungsmittel
                                                                                    GmbH are ordered to pay the costs;
2.    Orders the French Republic to pay the costs.
                                                                             3.     The French Republic and the Freistaat Thüringen shall bear
(1) OJ C 176 of 24.6.2000.
                                                                                    their own costs.
                                                                             (1) OJ C 33 of 6 February 1999.
                     ORDER OF THE COURT
                         (Second Chamber)
                         of 26 October 2000
in Case C-447/98 P: Molkerei Grossbraunshain GmbH                                                 ORDER OF THE COURT
and Bene Nahrungsmittel GmbH v Commission of the
                    European Communities (1)
                                                                                                        (Third Chamber)
(Community protection of designations of origin — Com-
mission Regulation registering the designation ‘Altenburger
                                                                                                     of 15 December 2000
Ziegenkäse’ — Application for annulment — Inadmissibility
                — Appeal manifestly ill-founded)
                                                                             in Case C-86/98 (reference for a preliminary ruling from
                           (2001/C 173/37)                                   the Consiglio di Stato): Questore Macerata v Claudio
                                                                                                            Peroni (1)
                    (Language of the case: German)
                                                                             (Article 104(3) of the Rules of Procedure — Question
                                                                             identical to a question on which the Court has already ruled)
(Provisional translation; the definitive translation will be published
                    in the European Court Reports)
                                                                                                         (2001/C 173/38)
In Case C-447/98 P, Molkerei Grossbraunshain GmbH, and
Bene Nahrungsmittel GmbH, both established in Altenburg
(Germany), represented by M. Lochschelder and T. Klingbell,                                       (Language of the case: Italian)
of the Cologne Bar, with an address for service in Luxembourg
at the Chambers of M. Loesch, 4 rue Carlo Hemmer — appeal
against the order of the Court of First Instance of the European             (Provisional translation; the definitive translation will be published
Communities (Second Chamber) of 15 September 1998 in                                             in the European Court Reports)
Case T-109/97 Molkerei Grossbraunshain GmbH and Bene
Nahrungsmittel GmbH v Commission [1998] ECR II-3533,
seeking to have that order set aside, the other parties to the               In Case C-86/98: reference to the Court under Article 177 of
proceedings being: Commission of the European Communities                    the EC Treaty (now Article 234 EC) from the the Consiglio di
 ---pagebreak--- 16.6.2001                EN                        Official Journal of the European Communities                                       C 173/23
Stato (Council of State), Italy for a preliminary ruling in the                    6/10 years ago, is a national competent authority ever
proceedings pending before that court between Questore                             entitled to cross-refer, without consent, to data submitted
Macerata v Claudio Peroni — on the interpretation of the                           in support of a product (B) which was authorised within
provisions of the EC Treaty concerning the freedom to                              the last 6/10 years?
provide services — the Court (Third Chamber), composed
of: C. Gulmann, (President of Chamber), J.-P. Puissochet
(Rapporteur), F. Macken, Judges; C. Stix-Hackl, Advocate
General; R. Grass Registrar, has given an order on 15 December                2.   If so, may such cross-reference be made in circumstances
2000, in which it has ruled:                                                       where:
The EC Treaty provisions on the freedom to provide services do not
preclude national legislation, such as the Italian legislation, which              (a)   product B was authorised under the Article 4.8(a)
reserves to certain bodies the right to take bets on sporting events if                  hybrid abridged procedure, referencing product A;
that legislation is in fact justified by social-policy objectives intended               and
to limit the harmful effects of such activities and if the restrictions
which it imposes are not disproportionate in relation to those
objectives.
                                                                                   (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
(1) OJ C 209 of 4.7.1998.                                                                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?
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                               (b) Is essential similarity a prerequisite for the use of the
application of Novartis Pharmaceuticals UK Ltd against                                   proviso?
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
                                                                              4.   Can products ever be essentially similar for the purposes
                                                                                   of Article 4.8(a)(i) and (iii) of Directive 65/65 when they
                           (Case C-106/01)                                         are not bioequivalent, and if so in what circumstances?
                           (2001/C 173/39)
                                                                              5.   What is the meaning of the term pharmaceutical form, as
                                                                                   used by the Court in its Judgment in Case C-368/96
Reference has been made to the Court of Justice of the                             Generics (2)? In particular, do two products have the same
European Communities by an order of the Court of Appeal                            pharmaceutical form when they are administered to the
(England & Wales) (Civil Division) of 22 February 2001, which                      patient in the form of a solution diluted to a macro-
was received at the Court Registry on 5 March 2001, for a                          emulsion, micro-emulsion and nano-dispersion respect-
preliminary ruling in the case of The Queen on the application                     ively?
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:                 6.   Is it consistent with the general principle of non-
                                                                                   discrimination for a national competent authority, faced
                                                                                   with hybrid applications for marketing authorisations
1.    In considering a marketing authorisation for a new                           under Article 4.8(a) of Directive 65/65 referencing prod-
      product (C) under Article 4.8(a)(iii) of Directive 65/65 (1),                uct A for two products, neither of which is bioequivalent
      referencing a product (A) authorised more than                               to product A: