CELEX: C2000/211/12
Language: en
Date: 2000-07-22 00:00:00
Title: Case C-176/00: Action brought on 11 May 2000 by the Commission of the European Communities against the Hellenic Republic

22.7.2000                EN                  Official Journal of the European Communities                                        C 211/7
1. Do Articles 28 EC and 30 EC preclude national law which              represented by Maria Kondou-Durande, of its Legal Service,
    prohibits the marketing of medicinal product X,                     with an address for service in Luxembourg at the office of
                                                                        Carlos Gómez de la Cruz, of its Legal Service, Wagner Centre,
    — for which there existed hitherto in Member State A an             Kirchberg.
         implied licence which has now expired because the
         licence holder has surrendered it,
                                                                        The Commission claims that the Court should:
    — which for several years has been brought as a parallel
         import from Member State B to Member State A and               1. declare that, by not adopting the laws, regulations and
         has been placed on the market there with reference to               administrative provisions required to comply with
         the abovementioned implied licence,
                                                                             — Council Directive 96/24/EC (1) of 29 April 1996
    — which the manufacturer and licence holder is replacing                     amending Directive 79/373/EEC on the marketing of
         with a new preparation Y [which it] is placing on                       compound feedingstuffs and
         the market in Member State A on the basis of an
         independent licence, and                                            — Council Directive 96/25/EC (2) of 29 April 1996 on
                                                                                 the circulation of feed materials, amending Directives
    — [where preparation Y] differs from preparation X only                      70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC
         in respect of modified excipients, so that those excipi-                and repealing Directive 77/101/EEC,
         ents lead to improved temperature stability and thus
         make storage in the refrigerator unnecessary?                       the Hellenic Republic has failed to fulfil its obligations
                                                                             under the Treaty and those directives;
2. Does it affect the judgment if there was available to the
    holder of the licence which has now expired a lawful
                                                                        2. order the Hellenic Republic to pay the costs.
    means of surrendering that licence in such a way that the
    marketability of the medicinal product was preserved for a
    certain (transitional) period?
                                                                        Pleas in law and main arguments
    If yes, according to which criteria must the previous
    holder, when taking a decision on his action, take into
    consideration the European free movement of goods?                  In accordance with the third paragraph of Article 249 EC,
                                                                        directives are binding, as to the result to be achieved, upon
3. Does it affect the judgment if medicinal product Y in the            each Member State to which they are addressed.
    new formulation is placed on the market only in Member
    State A or if it is also found on the market in other Member
    States?                                                             Under the first paragraph of Article 10 EC, Member States are
                                                                        to take all appropriate measures, whether general or particular,
                                                                        to ensure fulfilment of the obligations arising out of the Treaty
4. Does it affect the judgment if, when the two formulations            or resulting from action taken by the institutions of the
    exist side by side simultaneously in Member State A, there          Community.
    is a danger of incorrect storage of medicinal product X?
                                                                        It is not disputed by the Hellenic Republic that it must adopt
                                                                        measures to comply with the abovementioned directives.
                                                                        The Commission records that until now the Hellenic Republic
                                                                        has not adopted the appropriate measures for the full incorpor-
                                                                        ation of the directives at issue into Greek law.
Action brought on 11 May 2000 by the Commission of
the European Communities against the Hellenic Republic
                           (Case C-176/00)
                                                                        (1) OJ L 125, 23.5.1996, p. 33.
                           (2000/C 211/12)                              (2) OJ L 125, 23.5.1996, p. 35.
An action against the Hellenic Republic was brought before
the Court of Justice of the European Communities on 11 May
2000 by the Commission of the European Communities,