CELEX: C1995/299/08
Language: en
Date: 1995-11-11 00:00:00
Title: JUDGMENT OF THE COURT (Sixth Chamber) of 5 October 1995 in Case C-440/93 (reference for a preliminary ruling from the High Court of Justice, Queen's Bench Division, Divisional Court): The Queen v. Licensing Authority of the Department of Health, Norgine Limited, ex-parte: Scotia Pharmaceuticals Ltd (Medicinal products - Placing on the market - Summary of the proceedings)

No C 299/6           EN                 Official Journal of the European Communities                                      11 . 11 . 95
              JUDGMENT OF THE COURT                                 or administrative action relating to proprietary medicinal
                       ( Sixth Chamber )                            products.
                      of 5 October 1995
                                                                    (') OJ No C 1 , 4 . 1 . 1994 .
in Case C-440/93 ( reference for a preliminary ruling from
the High Court of Justice, Queen 's Bench Division,
Divisional Court ): The Queen v. Licensing Authority of the
Department of Health, Norgine Limited, ex-parte: Scotia
                   Pharmaceuticals Ltd (')
 (Medicinal products — Placing on the market — Summary
                      of the proceedings)                                          JUDGMENT OF THE COURT
                         ( 95/C 299/08 )                                                     ( Sixth Chamber )
                                                                                            of 5 October 1995
                                                                    in Case C-96/94 ( reference for a preliminary ruling from the
               (Language of the case: English)                     Tribunale di Genova ): Centro Servizi Spediporto Srl gegen
                                                                                Spedizioni Marittima del Golfo Srl (')
                                                                    (Road transport — Tariffs — State legislation —
In Case C-440/93 : reference to the Court under Article 177                                     Competition)
of the EC Treaty from the High Court of Justice, Queen 's                                      ( 95/C 299/09 )
Bench Division, Divisional Court ( United Kingdom ) for a
preliminary ruling in the proceedings pending before that
court between The Queen and ( 1 ) Licensing Authority of the                        (Language of the case: Italian)
Department of Health, ( 2 ) Norgine Limited, ex-parte : Scotia
Pharmaceuticals Ltd — on the interpretation of point ( 8 ) ( a )
                                                                    (Provisional translation: the definitive translation will he
( ii ) of the second paragraph of Article 4 of Council
Directive 65/65/EEC of 26 January 1965 on the
                                                                             published in the European Court Reports)
approximation of provisions laid down by law, regulation
or administrative action relating to proprietary medicinal         In Case C-96/94 : reference to the Court under Article 1 77 of
products ( OJ , English Special Edition 1965— 1966 , p. 20 ),      the EEC Treaty by the Tribunale di Genova ( District Court,
as amended by Council Directive 87/21 /EEC of                      Genoa ) ( Italy ) for a preliminary ruling in the proceedings
22 December 1986 ( OJ 1987L 15 , p. 36 ) — the Court ( Sixth       pending before that court between Centro Servizi
Chamber ), composed of: F. A. Schockweiler, President of           Spediporto Sri and Spedizioni Marittima del Golfo Sri on the
the Chamber, G. F. Mancini, C. N. Kakouris, J. L. Murray           interpretation of Articles 3 ( g ), 5 , 30 , 85 , 86 and 90 of the
( Rapporteur ) and G. Hirsch , Judges; P. Leger,                   EC Treaty, of Council Regulation ( EEC ) No 4055/86 of
Advocate-General ; L. Hewlett, Administrator, for the              22 December 1986 applying the principle of freedom to
Registrar, has given a judgment on 5 October 1995 , in             provide services to maritime transport between Member
which it rules :                                                   States and between Member States and third countries ( OJ
                                                                    1986 L 378 , p. 1 ), and of Council Directive 92/ 106/EEC of
                                                                   7 December 1992 on the establishment of common rules for
                                                                   certain types of combined transport of goods between
on a proper construction, point (8) (a) (ii) of the second         Member States ( OJ 1992 L 368 , p. 38 ) — the Court ( Sixth
paragraph of Article 4 of Council Directive 65/65/EEC of           Chamber ), composed of F. A. Schockweiler ( Rapporteur ),
26 January 1965 on the approximation of provisions laid            President of Chamber , G. F. Mancini , J. L. Murray,
down by law, regulation or administrative action relating to       G. Hirsch and H. Ragnemalm , Judges; P. Leger;
proprietary medicinal products, as amended by Council              Advocate-General ; L. Hewlett, Administrator, for the
Directive 87/21 /EEC of 22 December 1986 , means that              Registrar, has given a judgment on 5 October 1995 , in
a national authority with competence to issue an                   which it rules :
authorization to place a medicinal product on the domestic
market may not issue such authorization where the
particulars and documents submitted in support of the               1 . neither Articles 3 (g), 5, 85 , 86 or 90 of the EC Treaty,
application for an authorization do not contain detailed                nor Article 30 of that Treaty, preclude the legislation of
references to published scientific literature presented in              a Member State from providing for roadhaulage tariffs
accordance with each of the requirements laid down                      to be approved and brought into force by the State on
in Parts 2 and 3 of the Annex to Council                                the basis of proposals submitted by a committee, where
Directive 75/31 8/EEC of 20 May 1975 on the                             that committee is composed of a majority of
approximation of the laws of Member States relating to                  representatives of the public authorities and a minority
analytical, pharmaco-toxicological and clinical standards               of representatives of the economic agents concerned and
and protocols in respect of the testing of proprietary                  in its proposals must observe certain public interest
medicinal products, and where those documents do not                    criteria, and ivhere, moreover, the public authorities do
comprise experts ' reports complying with each of the                   not relinquish their rights and powers by taking into
requirements laid down in Articles 1 and 2 of Council                   consideration, before the proposals are approved, the
Directive 75/319/EEC of 20 May 1975 on the                              observation of other public and private bodies , or even
approximation of provisions laid down by law, regulation                by fixing tariffs ex officio;