CELEX: C1999/020/18
Language: en
Date: 1999-01-23 00:00:00
Title: JUDGMENT OF THE COURT (Fifth Chamber) of 3 December 1998 in Case C-368/96 (reference for a preliminary ruling from the High Court of Justice (England & Wales), Queen's Bench Division): The Queen v. The Licensing Authority established by the Medicines Act 1968 (acting by The Medicines Control Agency) (Medicinal products - Marketing authorisation - Abridged procedure - Essentially similar products)

23.1.1999             EN                 Official Journal of the European Communities                                   C 20/11
Ferriere di Servola SpA (AFS) Ð on the interpretation of            company incorporated under English law, whose
Article 92 of the EC Treaty Ð the Court (Fifth Chamber),            registered office is at Oxted (the United Kingdom),
composed of: J.-P. Puissochet, President of the Chamber,            represented initially by Kanaar & Co., Solicitors, Ð
J. C. Moitinho de Almeida, C. Gulmann, D. A. O.                     Application for the recovery of moneys advanced to the
Edward and M. Wathelet (Rapporteur), Judges; N.                     defendant by the Commission in the context of a
Fennelly, Advocate-General; L. Hewlett, Administrator, for          demonstration project relating to the conversion of an
the Registrar, has given a judgment on 1 December 1998              existing refuse transfer station to electrical power
in which it has ruled:                                              generation from the preparation of raw urban refuse and a
                                                                    counterclaim for payment of the balance of the maximum
                                                                    subsidy contractually provided for and for damages Ð the
                                                                    Court (First Chamber), composed of: P. Jann
Application to an undertaking within the meaning of                 (Rapporteur), President of the Chamber, D. A. O. Edward
Article 80 of the ECSC Treaty of a system of the kind               and M. Wathelet, Judges; A. Saggio, Advocate-General; R.
introduced by Law No 95/79 of 3 April 1979, and                     Grass, Registrar, has given a judgment on 3 December
derogating from the rules of ordinary law relating to               1998, in which it:
insolvency, is to be regarded as giving rise to the grant of
State aid, which is prohibited by Article 4(c) of the ECSC
Treaty, where it is established that the undertaking
                                                                    1. Orders Industrial Refuse & Coal Energy Ltd to
                                                                        reimburse to the Commission the sum of ECU
                                                                        191 438, together with the sum of ECU 50 796 by
Ð has been permitted to continue trading in                             way of interest in respect of the period from 18 August
    circumstances in which it would not have been                       1987 to 23 November 1990, together with interest at
    permitted to do so if the rules of ordinary law relating            the annual rate of 8,15 % from 20 October 1993 on
    to insolvency had been applied, or                                  the sum of ECU 191 438;
Ð has enjoyed one or more advantages, such as a State               2. Dismisses the counterclaim lodged by Industrial
    guarantee, a reduced rate of tax, exemption from the                Refuse & Coal Energy Ltd;
    obligation to pay fines and other pecuniary penalties
    or waiver in practice of public debts wholly or in part,
    which could not have been claimed by another                    3. Orders Industrial Refuse & Coal Energy Ltd to pay
    insolvent undertaking in connection with the                        the costs.
    application of the rules of ordinary law relating to
    insolvency.
                                                                    (1) OJ C 388, 21.12.1996.
(1) OJ C 228, 26.7.1997.
                                                                                   JUDGMENT OF THE COURT
                                                                                           (Fifth Chamber)
              JUDGMENT OF THE COURT
                                                                                         of 3 December 1998
                       (First Chamber)
                                                                    in Case C-368/96 (reference for a preliminary ruling from
                     of 3 December 1998                             the High Court of Justice (England & Wales), Queen's
in Case C-337/96: Commission of the European                        Bench Division): The Queen v. The Licensing Authority
  Communities v. Industrial Refuse & Coal Energy Ltd (1)            established by the Medicines Act 1968 (acting by The
                                                                                     Medicines Control Agency) (1)
         (Arbitration clause Ð Breach of contract)
                                                                    (Medicinal products Ð Marketing authorisation Ð
                        (1999/C 20/17)                                  Abridged procedure Ð Essentially similar products)
                                                                                            (1999/C 20/18)
               (Language of the case: English)
                                                                                    (Language of the case: English)
In Case C-337/96: Commission of the European
Communities (Agent: Thomas F. Cusack and Fergus                     In Case C-368/96: reference to the Court under Article 177
Randolph) v. Industrial Refuse & Coal Energy Ltd, a                 of the EC Treaty by the High Court of Justice (England &
 ---pagebreak--- C 20/12               EN                  Official Journal of the European Communities                                    23.1.1999
Wales), Queen's Bench Division (United Kingdom), for a                    may be authorised under the abridged procedure
preliminary ruling in the proceedings pending before that                 provided for in Article 4.8(a)(iii) of Directive
court between The Queen and The Licensing Authority                       65/65/EEC, as amended, for all dosage forms, doses
established by the Medicines Act 1968 (acting by The                      and dosage schedules already authorised for that
Medicines Control Agency), ex parte: Generics (UK) Ltd,                   product.
intervener: E. R. Squibb & Sons Limited, between The
Queen and The Licensing Authority established by the
Medicines Act 1968 (represented by The Medicines                     4. The fact that the original or abridged applications for
Control Agency), ex parte: The Wellcome Foundation                        marketing authorisations were made before entry into
Limited and between The Queen and The Licensing                           force of Commission Regulation (EC) No 541/95 of
Authority established by the Medicines Act 1968                           10 March 1995 concerning the examination of
(represented by The Medicines Control Agency), ex parte:                  variations to the terms of a marketing authorisation
Glaxo Operations UK Ltd and Others, intervener:                           granted by a competent authority of a Member State
Generics (UK) Ltd, on the interpretation and validity of                  does not affect the answers to the second and third
Article 4.8(a)(iii) of Council Directive 65/65/EEC of                     questions.
26 January 1965 on the approximation of provisions laid
down by law, regulation or administrative action relating,
to medicinal products (OJ, English Special Edition
1965Ð1966, p. 20), as amended by Council Directive                   5. Consideration of the fifth question has not disclosed
87/21/EEC of 22 December 1986 (OJ L 15, 17.1.1987,                        any factor of such a nature as to affect the validity of
p. 36) Ð the Court (Fifth Chamber), composed of: J.-P.                    Article 4.8(a)(iii) of Directive 65/65/EEC, as amended.
Puissochet, President of Chamber, J. C. Moitinho de
Almeida, C. Gulmann (Rapporteur), L. Sevón and M.                    (1) OJ C 40, 8.2.1997.
Wathelet,       Judges;      D.     Ruiz-Jarabo      Colomer,
Advocate-General; H. von Holstein, Deputy Registrar, has
given a judgment on 3 December 1998, in which it has
ruled:
1. Article 4.8(a)(iii) of Directive 65/65/EEC of 26 January                         JUDGMENT OF THE COURT
    1965 on the approximation of provisions laid down
                                                                                              (Fifth Chamber)
    by law, regulation or administrative action relating to
    medicinal products, as amended by Council Directive                                    of 3 December 1998
    87/21/EEC of 22 December 1986, must be interpreted
    as meaning that a medicinal product is essentially               in Case C-67/97 (request for a preliminary ruling from the
    similar to an original medicinal product where it                Kriminalret i Frederikshavn): Criminal proceedings against
    satisfies the criteria of having the same qualitative and                                 Ditlev Bluhme (1)
    quantitative composition in terms of active principles,
                                                                     (Free movement of goods Ð Prohibition of quantitative
    of having the same pharmaceutical form and of being
                                                                     restrictions and measures having equivalent effect between
    bioequivalent, unless it is apparent in the light of
                                                                     Member States Ð Derogations Ð Protection of the health
    scientific knowledge that it differs significantly from
                                                                     and life of animals Ð Bees of the subspecies Apis
    the original product as regards safety or efficacy. The
                                                                                 mellifera mellifera (Lñsù brown bee))
    competent authority of a Member State may not
    disregard the three criteria set out above when it is                                      (1999/C 20/19)
    required to determine whether a particular medicinal
    product is essentially similar to an original medicinal
    product.
                                                                                     (Language of the case: Danish)
2. A medicinal product that is essentially similar to a
    product which has been authorised for not less than                (Provisional translation; the definitive translation will be
    six or ten years and is marketed in the Member State                       published in the European Court Reports)
    for which the application is made may be authorised,
    under the abridged procedure provided for in Article
    4.8(a)(iii) of Directive 65/65/EEC, as amended, for all          In Case C-67/97: reference to the Court under Article 177
    therapeutic indications already authorised for that              of the EC Treaty by the Kriminalret i Frederikshavn
    product.                                                         (Denmark) for a preliminary ruling in the criminal
                                                                     proceedings before that court against Ditlev Bluhme Ð on
                                                                     the interpretation of Article 30 of the EC Treaty and
                                                                     Article 2 of Council Directive 91/174/EEC of 25 March
3. A medicinal product that is essentially similar to a              1991 laying down zootechnical and pedigree requirements
    product which has been authorised for not less than              for the marketing of pure-bred animals and amending
    six or ten years in the Community and is marketed in             Directives 77/504/EEC and 90/425/EEC (OJ L 85,
    the Member State for which the application is made               5.4.1991, p. 37) Ð the Court (Fifth Chamber), composed