CELEX: C1999/100/02
Language: en
Date: 1999-04-10 00:00:00
Title: Judgment of the Court (Fifth Chamber) of 21 January 1999 in Case C-120/97 (reference for a preliminary ruling from the Court of Appeal): Upjohn Ltd v. The Licensing Authority established by the Medicines Act 1968 and Others (Proprietary medicinal products - Revocation of a marketing authorisation - Judicial review)

10.4.1999           EN                 Official Journal of the European Communities                                 C 100/1
                                                               I
                                                        (Information)
                                           COURT OF JUSTICE
                                                    COURT OF JUSTICE
              JUDGMENT OF THE COURT                               1. Annuls the judgment of the Court of First Instance of
                                                                      11 December 1996 in Case T-70/94 Comafrica and
                     (Sixth Chamber)                                  Dole Fresh Fruit Europe v. Commission.
                    of 21 January 1999
in Case C-73/97 P: French Republic v. Comafrica SpA and           2. Dismisses the application for annulment lodged by
                         Others (1)                                   Comafrica SpA and Dole Fresh Fruit Europe Ltd &
                                                                      Co. as inadmissible.
(Appeal Ð Banana sector Ð Annulment of Regulation
        (EC) No 3190/93 Ð Plea of inadmissibility)
                                                                  3. Orders each party to bear its own costs.
                     (1999/C 100/01)
                                                                  (1) OJ C 131, 26.4.1997.
               (Language of the case: English)
In Case C-73/97 P, French Republic (Agents: Catherine de
Salins, Kareen Rispal-Bellanger and FreÂdeÂric Pascal) Ð
appeal against the judgment of the Court of First Instance                      JUDGMENT OF THE COURT
of the European Communities (Fourth Chamber) of
11 December 1996 in Case T-70/94 Comafrica and Dole                                      (Fifth Chamber)
Fresh Fruit Europe v. Commission [1996] ECR II-1741,
seeking to have that judgment partially set aside in so far                            of 21 January 1999
as it rejected the plea of inadmissibility raised by the          in Case C-120/97 (reference for a preliminary ruling from
Commission, the other parties to the proceeding being             the Court of Appeal): Upjohn Ltd v. The Licensing
Comafrica SpA, a company governed by Italian law,                 Authority established by the Medicines Act 1968 and
established in Genoa (Italy), Dole Fresh Fruit Europe Ltd                                    Others (1)
& Co., a company governed by German law, established
in Hamburg (Germany), represented by Bernard                      (Proprietary medicinal products Ð Revocation of a
O'Connor, Solicitor, with an address for service in                       marketing authorisation Ð Judicial review)
Luxembourg at the Chambers of ArseÁne Kronshagen, 22
                                                                                        (1999/C 100/02)
Rue Marie-Adelaïde, Commission of the European
Communities (Agent: Xavier Lewis) and the United
Kingdom of Great Britain and Northern Ireland Ð the
Court (Sixth Chamber), composed of: P. J. G. Kapteyn                             (Language of the case: English)
(Rapporteur), President of the Chamber, G. F. Mancini,
J. L. Murray, H. Ragnemalm and K. M. Ioannou, Judges;
J. Mischo, Advocate-General: R. Grass, Registrar, has             In Case C-120/97: reference to the Court under Article 177
given a judgment on 21 January 1999, in which it:                 of the EC Treaty from the Court of Appeal (England and
 ---pagebreak--- C 100/2                EN                 Official Journal of the European Communities                                    10.4.1999
Wales) (United Kingdom) for a preliminary ruling in the                   the marketing authorisation in question without
proceedings pending before that court between Upjohn                      awaiting the opinion of the Committee for Proprietary
Ltd and The Licensing Authority established by the                        Medicinal Products.
Medicines Act 1968 and Others Ð on the interpretation
of Council Directive 65/65/EEC of 26 January 1965 on
                                                                     (1) OJ C 142, 10.5.1997.
the approximation of provisions laid down by law,
regulation or administrative action relating to proprietary
medicinal products (OJ, English Special Edition 1965Ð
1966, p. 20) Ð the Court (Fifth Chamber), composed of:
J.-P. Puissochet, President of the Chamber, J. C. Moitinho
de Almeida, C. Gulmann (Rapporteur), D. A. O. Edward
and M. Wathelet, Judges; P. LeÂger, Advocate-General; D.
Louterman-Hubeau, Principal Administrator, for the                                   JUDGMENT OF THE COURT
Registrar, has given a judgment on 21 January 1999, in
which it has ruled:                                                                          (Sixth Chamber)
                                                                                           of 21 January 1999
                                                                     in    Case    C-207/97: Commission of the European
                                                                                 Communities v. Kingdom of Belgium (1)
                                                                     (Failure of a Member State to fulfill its obligation Ð
1. Council Directive 65/65/EEC of 26 January 1965 on                 Council Directive 76/464/EEC Ð Water pollution Ð
     the approximation of provisions laid down by law,                                     Failure to transpose)
     regulation or administrative action relating to
     proprietary medicinal products and, more generally,                                     (1999/C 100/03)
     Community law do not require the Member States to
     establish a procedure for judicial review of national
     decisions     revoking    authorisations     to   market                         (Language of the case: French)
     proprietary medicinal products, empowering the
     competent national courts and tribunals to substitute
     their assessment of the facts and, in particular, of the          (Provisional translation; the definitive translation will be
     scientific evidence relied on in support of the                            published in the European Court Reports)
     revocation decision for the assessment made by the
     national authorities competent to revoke such
     authorisations.                                                 In Case C-207/97, Commission of the European
                                                                     Communities (Agents: initially Richard B. Wainwright and
                                                                     Jean-Francis Pasquier, and subsequently Richard B.
                                                                     Wainwright and Olivier Couvert-CasteÂra) v. Kingdom of
                                                                     Belgium (Agent: Jan Devadder) Ð application for a
                                                                     declaration that, by not adopting pollution reduction
2. Community law does not require a National Court or                programmes including quality objectives for water Ð at
     Tribunal which is seised of an application for                  least in respect of 99 substances listed in an annex to the
     annulment of a decision revoking a marketing                    application Ð or by not communicating to the
     authorisation for a particular proprietary medicinal            Commission summaries of such programmes and the
     product to take into account, when determining that             results of their implementation, in infringement of Article 7
     application, any relevant scientific material coming to         of Council Directive 76/464/EEC of 4 May 1976 on
     light after the adoption of that decision.                      pollution caused by certain dangerous substances
                                                                     discharged into the aquatic environment of the
                                                                     Community (OJ L 129, 18.5.1976, p. 23), the Kingdom of
                                                                     Belgium has failed to fulfil its obligations under the EC
                                                                     Treaty Ð the Court (Sixth Chamber), composed of: P. J. G.
                                                                     Kapteyn, President of the Chamber, G. F. Mancini, H.
                                                                     Ragnemalm, R. Schintgen and K. M. Ioannou
3. Directive 65/65/EC and Second Council Directive 75/               (Rapporteur), Judges; Advocate-General: J. Mischo; L.
     319/EEC of 20 May 1975 on the approximation of                  Hewlett, Administrator, for the Registrar, has given a
     provisions laid down by law, regulation or                      judgment on 21 January 1999, in which it:
     administrative action relating to proprietary medicinal
     products, as amended by Directive 83/570/EEC are to
     be construed as meaning that, where the matter has              1. Declares that, by not adopting pollution reduction
     been referred by various Member States to the                        programmes including quality objectives for water in
     Committee for Proprietary Medicinal Products                         respect of the 99 substances listed in the annex to the
     following the adoption by the competent national                     application, the Kingdom of Belgium has failed to
     authority of a decision revoking a marketing                         fulfil its obligations under Article 7 of Council
     authorisation and the time-limit for the issue by that               Directive 76/464/EEC of 4 May 1976 on pollution
     Committee of its opinion has expired, those directives               caused by certain dangerous substances discharged
     do not preclude that authority from deciding to revoke               into the aquatic environment of the Community.