CELEX: C1997/026/05
Language: en
Date: 1997-01-25 00:00:00
Title: JUDGMENT OF THE COURT of 12 November 1996 in Case C-201/94 (reference for a preliminary ruling from the High Court of Justice, Queen's Bench Division): The Queen v. The Medicines Control Agency, ex parte: Smith & Nephew Pharmaceuticals Ltd and Primecrown Ltd v. The Medicines Control Agency (Proprietary medicinal products - Parallel imports - Direct effect of Directive 65/65/EEC - Marketing authorization)

25 . 1 . 97          1 EN                 Official Journal of the European Communities                                    No C 26/3
                 JUDGMENT OF THE COURT                                       support of claims for the reimbursement of sums
                                                                             levied before 1 6 July 1 992 by way of droit additionnel
                          (Fifth Chamber)                                    on goods from non-member countries which are not
                       of 7 November 1996                                    linked to the Community by a special agreement,
                                                                             except by claimants who have initiated legal
in Case C-126/94 (reference for a preliminary ruling from                   proceedings or raised an equivalent claim before that
the Tribunal d'Instance, Paris XII): Société Cadi Surgelés                   date. This also applies to sums levied on such goods
and Others v. Ministre des Finances and Directeur général                    before that date by way of octroi de mer to the extent
                          des douanes (')                                   that the levying of such sums is declared unlawful in
                                                                            application of this judgment.
(Free movement of goods — Common Customs Tariff —
Common commercial policy — Fiscal rules applicable to
French overseas departments — Goods from non-member                   I 1 ) OJ No C 188 , 9 . 7. 1994.
                               countries)
                            ( 97/C 26/04 )
                  (Language of the case: French)
                                                                                      JUDGMENT OF THE COURT
                                                                                             of 12 November 1996
  (Provisional translation; the definitive translation will be
            published in the European Court Reports)
                                                                      in Case C-201/94 ( reference for a preliminary ruling from
                                                                     the High Court of Justice, Queen's Bench Division ): The
                                                                      Queen v. The Medicines Control Agency, ex parte: Smith
In Case C-126/94: reference to the Court pursuant to                  & Nephew Pharmaceuticals Ltd and Primecrown Ltd v.
Article 177 of the EC Treaty from the Tribunal d'Instance                            The Medicines Control Agency (' )
(District Court), Paris XII for a preliminary ruling in the
proceedings pending before that court between, on the one             (Proprietary medicinal products — Parallel imports —
hand, Societe Cadi Surgelés, Societe Sofrigu, Societe Sofroi         Direct effect of Directive 65/65/EEC — Marketing
and Societe Sofriber, and, on the other, Ministre des                                             authorization)
Finances and Directeur general des douanes — on the
interpretation of Articles 9, 12, 113 and 227 ( 2 ) of the EC                                      ( 97/C 26/05 )
Treaty — the Court ( Fifth Chamber), composed of: J. C.
Moitinho de Almeida, President of the Chamber, C.
Gulmann, D. A. O. Edward ( Rapporteur), J. -P. Puissochet
and M. Wathelet, Judges; G. Tesauro, Advocate-General;                                 (Language of the case: English)
H. von Holstein, Assistant Registrar, for the Registrar, has
given a judgment on 7 November 1996 , in which it has
ruled :
                                                                     In Case C-201/94: reference to the Court pursuant to
                                                                     Article 177 of the EC Treaty from the High Court of
1 . It is incompatible with the EC Treaty to levy a                  Justice, Queen 's Bench Division, United Kingdom, for a
      customs duty or a charge having equivalent effect              preliminary ruling in the proceedings pending before that
      which has been unilaterally introduced by a Member             court between The Queen and The Medicines Control
      State after the introduction of the Common Customs             Agency, ex parte: Smith & Nephew Pharmaceuticals Ltd
      Tariff on 1 July 1968 on goods imported directly from           and Primecrown Ltd and The Medicines Control Agency
      non-member countries which are not linked to the               — on the interpretation of Council Directive 65/65/EEC
      Community by a special agreement. However, the                  of 26 January 1965 on the approximation of provisions
      Treaty does not preclude the levying of a charge                laid down by law, regulation or administrative action
      having equivalent effect to a customs duty on imports           relating to proprietary medicinal products (2), as amended
      which, having regard to all its essential characteristics,      in particular by Council Directive 87/21 /EEC of
      must be regarded as a charge already in existence on            22 December 1986 ( 3 ), and of the obligations associated
      1 July 1968, provided that the level at which it is             with the authorization of proprietary medicinal products
      levied has not been raised. Where the level has been           — the Court, composed of: G. C. Rodriguez Iglesias,
      raised, only the amount by which it has been raised             President, J. C. Moitinho de Almeida, J. L. Murray
      must be regarded as incompatible with the Treaty.               ( Rapporteur) and L. Sevón (Presidents of Chambers ), C. N.
                                                                      Kakouris, P. J. G. Kapteyn, D. A. O. Edward, P. Jann and
                                                                      H. Ragnemalm, Judges; P. Leger, Advocate-General; D.
                                                                      Louterman-Hubeau, Principal Administrator, for the
2 . The Treaty provisions relating to customs duties and              Registrar, has given a judgment on 12 November 1996 , in
      charges having equivalent effect cannot be relied on in         which it has ruled :
 ---pagebreak--- No C 26 /4                EN                    Official Journal of the European Communities                                      25 . 1 . 97
1 . ( a ) When a competent authority of a Member State                                      JUDGMENT OF THE COURT
            concludes that a proprietary medicinal product
                                                                                                    ( Second Chamber )
            covered by a marketing authorization in another
            Member State and a proprietary medicinal product                                     of 14 November 1996
            for which it has already issued a marketing
            authorization are manufactured by independent                  in Case C-305/94 (reference for a preliminary ruling from
             companies pursuant to agreements concluded with               the Tribunal du Travail, Brussels): Claude Rotsart de
             the same licensor and that those two products,                Hertaing v. J. Benoidt SA, in liquidation, and IGC
            although not identical in all respects, have at                                      Housing Service SA (*)
             least been manufactured according to the same
             formulation and using the same active ingredient              (Safeguarding of employees ' rights in the event of transfers
            and that they also have the same therapeutic                   of undertakings, businesses or parts of businesses —
             effects, it must treat the imported proprietary                Transfer to the transferee of the rights and obligations
             medicinal product as being covered by                 the     arising from a contract of employment — Date of
             latter marketing authorization unless there           are                                     transfer)
             countervailing considerations relating to             the                                  ( 97/C 26/06 )
             effective protection of the life and health            of
             humans .
                                                                                             (Language of the case: French)
        (b) If the competent authority concludes that the
             proprietary medicinal product to be imported does
             not satisfy those criteria, a new marketing
             authorization is required. That authorization can                (Provisional translation; the definitive translation will be
             be issued only in accordance with the conditions                         published in the European Court Reports)
             laid down in Articles 3 and 4 of Council
             Directive 65/65/EEG of 26 January 1965 on the
             approximation of provisions laid down by law,                  In Case C-305/94 : reference to the Court pursuant to
             regulation or administrative action relating to                Article 177 of the EC Treaty from the Tribunal du Travail
             proprietary medicinal products, as amended in                  ( Labour Court), Brussels, for a preliminary ruling in the
             particular by Council Directive 87/21 /EEC of                  proceedings pending before that court between Claude
              22 December 1986.                                             Rotsart de Hertaing and J. Benoidt SA, in liquidation, and
                                                                            IGC Housing Service SA — on the interpretation of
                                                                            Council Directive 77/187/EEC of 14 February 1977 on
                                                                            the approximation of the laws of the Member States
 2 . The fact that the grantor of the licences in respect of                relating to the safeguarding of employees' rights in the
        the two proprietary medicinal products in question is               event of transfers of undertakings, businesses or parts of
        situated outside the European Community does not                    businesses (2 ) — the Court ( Second Chamber ), composed
        affect the answer given above.                                      of: G. F. Mancini, President of the Chamber ( Rapporteur),
                                                                            J. L. Murray and G. Hirsch, Judges; C. O. Lenz,
                                                                            Advocate-General; R. Grass, Registrar, has given a
                                                                            judgment on 14 November 1996 , in which it has ruled:
 3 . The holder of an original marketing authorization
         issued pursuant to the procedure referred to in
         Directive 65/65/EEC may rely on the provisions of                   1 . Article 3 (1 ) of Council Directive 77/187/EEC of
         that Directive, as amended in particular by Directive                    14 February 1977 on the approximation of the laws
         87/21 /EEC, and specifically on Article 5 thereof, in                    of the Member States relating to the safeguarding
         proceedings before a national court in order to                          of employees ' rights in the event of transfers of
         challenge the validity of an authorization issued by the                 undertakings, businesses or parts of businesses is
         competent national authority on the basis of Directive                   to be interpreted as meaning that the contracts
         65/65/EEC, as amended, to one of its competitors for                     of employment and employment relationships existing
         a proprietary medicinal product bearing the same                         on the date of the transfer of an undertaking between
         name. The same applies where the authorization,                          the transferor and the workers employed in the
         although issued under another procedure laid down at                     undertaking transferred are automatically transferred
         national level, should have been issued on the basis of                  from the transferor to the transferee by the mere fact
         the Directive.
                                                                                  of the transfer of the undertaking, despite the contrary
                                                                                  intention of the transferor or transferee and despite the
                                                                                  latter's refusal to fulfil his obligations.
  (!) OJ No C 275 , 1 . 10 . 1994 .
  (2 ) Official Journal , English Special Edition 1965— 1966 , p. 20 .
  ( 3 ) OJ No L 15 , 17. 1 . 1987, p . 36 .
                                                                              2 . The transfer of the contracts of employment and
                                                                                   employment relationships pursuant to Article 3 (1 ) of
                                                                                   Directive 77/187/EEC necessarily takes place on the
                                                                                   date of the transfer of the undertaking and cannot be