CELEX: C1998/184/01
Language: en
Date: 1998-06-13 00:00:00
Title: JUDGMENT OF THE COURT (Fifth Chamber) of 2 April 1998 in Case C-127/95 (reference for a preliminary ruling from the Court of Appeal in Northern Ireland): Norbrook Laboratories Limited v. Ministry of Agriculture, Fisheries and Food (Directives 81/851/EEC and 81/852/EEC - Veterinary medicinal products - Marketing authorisation)

13.6.98              EN                Official Journal of the European Communities                                   C 184/1
                                                               I
                                                        (Information)
                                           COURT OF JUSTICE
                                                     COURT OF JUSTICE
              JUDGMENT OF THE COURT                               1. On a proper construction of the second paragraph
                                                                      of Article 5 of Council Directive 81/851/EEC of
                       (Fifth Chamber)                                28 September 1981 on the approximation of the laws
                                                                      of the Member States relating to veterinary medicinal
                       of 2 April 1998
                                                                      products, read in conjunction with the other
in Case C-127/95 (reference for a preliminary ruling from             provisions of that directive and Council Directive 81/
the Court of Appeal in Northern Ireland): Norbrook                    852/EEC of 28 September 1981 on the approximation
Laboratories Limited v. Ministry of Agriculture, Fisheries            of the laws of the Member States relating to analytical,
                         and Food (1)                                 pharmaco-toxicological and clinical standards and
                                                                      protocols in respect of the testing of veterinary
(Directives 81/851/EEC and 81/852/EEC Ð Veterinary                    medicinal products, the competent authority is not
      medicinal products Ð Marketing authorisation)                   authorised to require particulars and documents other
                                                                      than those expressly listed in that provision, as set out
                        (98/C 184/01)                                 in detail in the Annex to Directive 81/852/EEC. More
                                                                      particularly, the competent authority is not authorised
                                                                      to require an applicant for marketing authorisation
               (Language of the case: English)
                                                                      Ð to disclose the name(s) and address(es) of the
                                                                          manufacturer(s) of a substance used in the
                                                                          manufacture of one of the active ingredients of the
                                                                          medicinal product concerned and information
In Case C-127/95: reference to the Court under Article 177
                                                                          concerning the manufacturing site(s), unless
of the EC Treaty from the Court of Appeal in Northern
                                                                          disclosure of that information constitutes the only
Ireland (United Kingdom) for a preliminary ruling in the
                                                                          reliable means of obtaining a particular required
proceedings pending before that court between Norbrook
                                                                          by Directives 81/851/EEC and 81/852/EEC;
Laboratories Limited and Ministry of Agriculture,
Fisheries and Food Ð on the interpretation and validity of
Council Directive 81/851/EEC of 28 September 1981 on                  Ð to disclose the results of tests carried out on each
the approximation of the laws of the Member States                        batch of such a substance with a view to approval
relating to veterinary medicinal products (OJ L 317 of                    thereof; or
6.11.1981, p. 1) and Council Directive 81/852/EEC of
28 September 1981 on the approximation of the laws of
the Member States relating to analytical, pharmaco-                   Ð to purchase the active ingredient from a specified
toxicological and clinical standards and protocols in                     third party.
respect of the testing of veterinary medicinal products (OJ
L 317 of 6.11.1981, p. 16) Ð the Court (Fifth Chamber),
composed of: C. Gulmann, President of the Chamber, M.                 Part 1(C) of the Annex to Directive 81/852/EEC does,
Wathelet, J. C. Moitinho de Almeida, J.-P. Puissochet and             however, allow particulars to be required of the
L. Sevón (Rapporteur), Judges; P. LeÂger, Advocate-                   manufacturing process and control testing methods
General; L. Hewlett, Administrator, for the Registrar, has            used by the manufacturer of a starting material. In
given a judgment on 2 April 1998, in which it has ruled:              that regard, it is for the national court to determine
 ---pagebreak--- C 184/2             EN                   Official Journal of the European Communities                                      13.6.98
   whether the said substance is a starting material                     relating to similar domestic claims and must not be so
   within the meaning of the first paragraph of that                     framed as to make it in practice impossible or
   provision. If it is not, such particulars may                         excessively difficult to obtain reparation.
   nevertheless be required in so far as the features of the
   process by which the starting material is manufactured           (1) OJ C 174, 8.7.1995.
   from the substance are such that no other means of
   assessing the purity of the starting material is
   available. Where the competent authority requires an
   applicant for marketing authorisation to provide
   information under Article 9, point 3, of Directive 81/
   851/EEC, the time-limits laid down in Article 8 of
   that directive are to be suspended until that                                   JUDGMENT OF THE COURT
   information is provided.
                                                                                            (Sixth Chamber)
                                                                                           of 30 April 1998
2. The fact that the process by which a medicinal
   product is manufactured is continuous or other than              in Case C-230/96 (reference for a preliminary ruling from
   continuous does not affect the answers to the first              the Cour d'Appel, Douai): Cabour SA and Nord
   question.                                                        Distribution Automobile SA, supported by Automobiles
                                                                    Peugeot SA and Automobiles CitroeÈn SA v. Arnor SOCO'
                                                                                                 SARL (1)
3. The competent authority is not authorised to exempt
   an applicant for marketing authorisation from                    (Competition Ð Vehicle distribution Ð Validity of
   providing a particular or document required under                exclusive dealership agreement Ð Article 85(1) and (3) of
   Article 5 of Directive 81/851/EEC even if it appears             the EC Treaty Ð Regulation (EEC) No 123/85 Ð
   practically impossible, in a given case, to obtain that                          Regulation (EC) No 1475/95)
   information.                                                                              (98/C 184/02)
4. Consideration of the fourth question has disclosed no                            (Language of the case: French)
   factor of such a kind as to affect the validity, in the
   light of the principle of proportionality, of points 3, 4
   or 9 of the second paragraph of Article 5 of Directive             (Provisional translation; the definitive translation will be
   81/851/EEC or Part 1(A), (B) or (C) of the Annex to                        published in the European Court Reports)
   Directive 81/852/EEC.
                                                                    In Case C-230/96: reference to the Court under Article 177
5. Consideration of the fifth question has disclosed no             of the EC Treaty from the Cour d'Appel (Court of
   factor of such a kind as to affect the validity, in the          Appeal), Douai, France, for a preliminary ruling in the
   light of Articles 30 to 36 of the EC Treaty, of                  proceedings pending before that court between Cabour SA
   Directives 81/851/EEC and 81/852/EEC.                            and Nord Distribution Automobile SA, supported by
                                                                    Automobiles Peugeot SA and Automobiles CitroeÈn SA and
                                                                    Arnor SOCO' SARL Ð on the interpretation of
6. Article 40 of Directive 81/851/EEC must be                       Article 85(1) of the EC Treaty and certain provisions of
   interpreted as meaning that a request for further                Commission Regulation (EEC) No 123/85 of 12 December
   information based on Article 9, point 3, of that                 1984 on the application of Article 85(3) of the EEC
   directive need not state the reasons on which it is              Treaty to certain categories of motor vehicle distribution
   based.                                                           and servicing agreements (OJ L 15 of 18.1.1985, p. 16),
                                                                    and of Commission Regulation (EC) No 1475/95 of
                                                                    28 June 1995 (OJ L 145 of 29.6.1995, p. 25) Ð the Court
7. A Member State is required to make good loss and                 (Sixth Chamber), composed of: H. Ragnemalm, President
   damage caused to an applicant for marketing                      of the Chamber, R. Schintgen (Rapporteur), G. F.
   authorisation as a result of requests for information            Mancini, P. J. G. Kapteyn and G. Hirsch, Judges; G.
   and requirements which infringe Directives 81/851/               Tesauro, Advocate-General; D. Louterman-Hubeau,
   EEC and 81/852/EEC where the rule of Community                   Principal Administrator, for the Registrar, has given a
   law infringed is intended to confer rights on                    judgment on 30 April 1998, in which it has ruled:
   individuals, the breach is sufficiently serious and there
   is a direct causal link between that breach and the
   damage sustained by the individuals concerned.                   1. On a proper construction of Article 5(2)(1)(a) and (b)
   Subject to that reservation, it is on the basis of rules of           of Commission Regulation (EEC) No 123/85 of
   national law on liability that the State must make                    12 December 1984 on the application of Article 85(3)
   reparation for the consequences of the loss and                       of the EEC Treaty to certain categories of motor
   damage caused by a breach of Community law for                        vehicle distribution and servicing agreements, the
   which it can be held responsible, with the proviso that               exemption granted by the regulation applies to a
   the conditions laid down by the applicable national                   clause in an exclusive dealership agreement which does
   legislation must not be less favourable than those                    no more than provide that the parties may, in order to