CELEX: C1997/040/16
Language: en
Date: 1997-02-08 00:00:00
Title: References for a preliminary ruling by the Tribunale di Trento by orders of that Court of 24 October 1996 in the cases of 1. Ministero delle Finanze against Cotonificio del Trention SpA (C-371/96) and 2. Ministero delle Finanze against Merkur Chemical Srl (C-373/96) (Cases C-371/96 and C-373/96)

No c 40/8                  ΓΕΝ ]                      Official Journal of the European Communities                                                8 . 2 . 97
    ( b) only those indications for which product A has                          4 . Does it make any difference to the answer to
              been authorized in the EU in accordance with                               Questions 2 and/or 3 whether the original or abridged
              Community provisions in force for 6/10 years; or                           applications for marketing authorizations were made
                                                                                         before     16 March            1995 , the date upon which
    ( c ) only :                                                                         Regulation ( EC ) No 541 /95 entered into forece ?
              1 . those indications for which product A has been
                   authorized       in   the   EU in     accordance   with
                   Community provisions in force for 6/ 10 years;                5 . In the light of the answers to Questions 1 —4 above, is
                   and                                                                   Article 4.8 ( a ) ( iii ) invalid as contrary to the principles
                                                                                         of protection of innovation and/or non-discrimination
              2 . those indications for which product A has been                         and/or proportionality and/or respect for property ?
                   authorized for a shorter period, and which did
                   not require an application for the grant of a
                   new marketing authorization under the                         (') Official Journal English Special Edition 1995— 1996 , p. 20 .
                   provisions of Annex II of Commission                          ( 2 ) OJ No E 55 , IE 3 . 1995 , p. 7 .
                   Regulation ( EC ) No 541 /95 or ( as the case
                   may be ) would not have required such an
                   application had the said Regulation been in
                   force at the time the indication in question was
                   added       by        variation     to    an    existing
                   authorization ; or
     ( d ) some other category of indications, and if so                         References for a preliminary ruling by the Tribunale di
              which ?                                                            Trento by orders of that Court of 24 October 1996 in the
                                                                                 cases of 1 . Ministero delle Finanze against Cotonificio del
                                                                                 Trention SpA ( C-371/96 ) and 2 . Ministero delle Finanze
3 . May product B be authorized in accordance with
                                                                                               against Merkur Chemical Sri ( C-373/96 )
     Article 4.8           (a)   ( iii ) of Directive 65/65/EEC ( as
     amended) in respect of:                                                                         ( Cases C-371 /96 and C-373/96 )
      ( a ) all dosage forms and/or doses and/or dosage                                                             ( 97/C 40/ 16 )
              schedules for which product A is currently
              authorized in the relevant Member State at the
              date of the application made in relation to
              product B; or                                                       Reference has been made to the Court of Justice of the
                                                                                  European Communities by orders of the Tribunale di
      ( b ) only those dosage forms and/or doses and/or                           Trento ( Trento District Court ) of 24 October 1996 ,
              dosage schedules for which product A has been                       received at the Court Registry on 25 November 1996 , for
              authorized       in      the   EU    in    accordance    with       a preliminary ruling in the cases of 1 . Ministero delle
               Community provisions in force for 6/ 1 0 years; or                 Finanze against Cotonificio del Trention SpA ( C-371 /96 )
                                                                                  and 2 . Ministero delle Finanze against Merkur Chemical
       ( c) only:                                                                  Sri ( C-373/96 ) on the following question:
               1 . those dosage forms and/or doses and/or dosage
                    schedules for which product A has been
                    authorized in the EU in               accordance with          'Does Community law, as interpreted by the Court of
                    Community provisions in force for 6/10 years;                 Justice in its judgment in Case C-208/90 Emmott v.
                    and                                                            Minister for Social Welfare and the Attorney General
                                                                                   ( 1991 ) ('), preclude the Italian State, in an action brought
               2 . those dosage forms and/or doses and/or dosage                   against it by a company for reimbursement of sums paid
                    schedules for which product A has been                         by way of taxes which were prohibited by Article 10 of
                    authorized for a shorter period, and which did                 Council Directive 69/335/EEC (2 ), from pleading a
                    not require an application for the grant of a                  national       time-limit       for   submission  of  reimbursement
                    new marketing authorization under the                          claims where, as is provided in Article 13 ( 2 ) of
                    provisions of Annex II of Commission                           Presidential Decree No 641 /72 of 26 October 1972 , time
                    Regulation ( EC ) No 541 /95 ( 2 ) of 10 March                  begins to run from the date of the undue payment of the
                     1995 concerning the examination of variations                 above sums, rather than from the point in time at which,
                    to the terms of a marketing authorization                      with the subsequent abolition of the tax falling within the
                    granted by a competent authority of a Member                    prohibition of Article 10 of the above Directive, the
                     State or ( as the case may be ) would not have                 Italian State abolished the measure which conflicted with
                    required such an application had the said                       that Directive ?'
                     Regulation been in force at the time the dosage
                     form and/or dose and/or dosage schedule in
                     question was added by variation to an existing                 (') ECR 1-4269 , 1991 .
                     authorization; or                                              (2 ) Official Journal English Special Edition 1969 ( II ) p. 412.
         ( d ) some other category of dosage forms and/or doses
                and/or dosage schedules, and if so which ?