CELEX: C2001/173/39
Language: en
Date: 2001-06-16 00:00:00
Title: Case C-106/01: Reference for a preliminary ruling by the Court of Appeal (England & Wales) (Civil Division), by order of that court of 22 February 2001, in the case of The Queen on the application of Novartis Pharmaceuticals UK Ltd against the Licensing Authority established by the Medicines Act 1968 (acting by the Medicines Control Agency), 1) Sangstat UK Ltd and 2) Imtix-Sangstat UK Ltd, interveners

16.6.2001                EN                        Official Journal of the European Communities                                       C 173/23
Stato (Council of State), Italy for a preliminary ruling in the                    6/10 years ago, is a national competent authority ever
proceedings pending before that court between Questore                             entitled to cross-refer, without consent, to data submitted
Macerata v Claudio Peroni — on the interpretation of the                           in support of a product (B) which was authorised within
provisions of the EC Treaty concerning the freedom to                              the last 6/10 years?
provide services — the Court (Third Chamber), composed
of: C. Gulmann, (President of Chamber), J.-P. Puissochet
(Rapporteur), F. Macken, Judges; C. Stix-Hackl, Advocate
General; R. Grass Registrar, has given an order on 15 December                2.   If so, may such cross-reference be made in circumstances
2000, in which it has ruled:                                                       where:
The EC Treaty provisions on the freedom to provide services do not
preclude national legislation, such as the Italian legislation, which              (a)   product B was authorised under the Article 4.8(a)
reserves to certain bodies the right to take bets on sporting events if                  hybrid abridged procedure, referencing product A;
that legislation is in fact justified by social-policy objectives intended               and
to limit the harmful effects of such activities and if the restrictions
which it imposes are not disproportionate in relation to those
objectives.
                                                                                   (b) the data to which reference is made consists of
                                                                                         clinical trials which the national competent auth-
                                                                                         ority indicated would be necessary if the marketing
(1) OJ C 209 of 4.7.1998.                                                                authorisation was to be granted and which were
                                                                                         submitted in order to demonstrate that product B,
                                                                                         though suprabioavailable to product A when admin-
                                                                                         istered in the same dose, is safe?
                                                                              3.    (a) Does the final sub-paragraph of Article 4.8(a) of
                                                                                         Directive 65/65 (‘the proviso’) apply only to appli-
                                                                                         cations made under Article 4.8(a)(iii) or to appli-
                                                                                         cations made under Article 4.8(a)(i) also?
Reference for a preliminary ruling by the Court of Appeal
(England & Wales) (Civil Division), by order of that court
of 22 February 2001, in the case of The Queen on the                               (b) Is essential similarity a prerequisite for the use of the
application of Novartis Pharmaceuticals UK Ltd against                                   proviso?
the Licensing Authority established by the Medicines
Act 1968 (acting by the Medicines Control Agency),
1) Sangstat UK Ltd and 2) Imtix-Sangstat UK Ltd, inter-
                                  veners
                                                                              4.   Can products ever be essentially similar for the purposes
                                                                                   of Article 4.8(a)(i) and (iii) of Directive 65/65 when they
                           (Case C-106/01)                                         are not bioequivalent, and if so in what circumstances?
                           (2001/C 173/39)
                                                                              5.   What is the meaning of the term pharmaceutical form, as
                                                                                   used by the Court in its Judgment in Case C-368/96
Reference has been made to the Court of Justice of the                             Generics (2)? In particular, do two products have the same
European Communities by an order of the Court of Appeal                            pharmaceutical form when they are administered to the
(England & Wales) (Civil Division) of 22 February 2001, which                      patient in the form of a solution diluted to a macro-
was received at the Court Registry on 5 March 2001, for a                          emulsion, micro-emulsion and nano-dispersion respect-
preliminary ruling in the case of The Queen on the application                     ively?
of Novartis Pharmaceuticals UK Ltd against the Licensing
Authority established by the Medicines Act 1968 (acting by
the Medicines Control Agency), Interveners: 1) Sangstat UK
Ltd and 2) Imtix-Sangstat UK Ltd, on the following questions:                 6.   Is it consistent with the general principle of non-
                                                                                   discrimination for a national competent authority, faced
                                                                                   with hybrid applications for marketing authorisations
1.    In considering a marketing authorisation for a new                           under Article 4.8(a) of Directive 65/65 referencing prod-
      product (C) under Article 4.8(a)(iii) of Directive 65/65 (1),                uct A for two products, neither of which is bioequivalent
      referencing a product (A) authorised more than                               to product A:
 ---pagebreak--- C 173/24                 EN                      Official Journal of the European Communities                                     16.6.2001
      (i)   to indicate that it is necessary for a marketing                          or its ancillary site? Is it relevant generally, with
            authorisation to be granted for product B to be                           respect to falling within the definition of waste,
            supported by full clinical data of the type required                      whether the said by-products of mining operations
            by Part 4(F) of the Annex to Directive 75/318/EC (3);                     are stored on the area of the mining concession, its
            but                                                                       ancillary site or further away?
      (ii) having considered the data filed in support of
            product B, to grant a marketing authorisation for
            product C if that application is supported by trials                 (b) What relevance does it have, in assessing the matter,
            not meeting the requirements of Part 4(F) of the                          that the leftover rock is the same as regards its
            Annex to Directive 75/318/EEC?                                            composition as the basic rock from which it is
                                                                                      quarried, and that it does not change its composition
                                                                                      regardless of how long it is kept and how it is kept?
                                                                                      Should ore-dressing sand which results from the
(1) Council Directive 65/65/EEC of 26 January 1965 on the approxi-                    ore-dressing process perhaps be assessed differently
    mation of provisions laid down by Law, Regulation or Adminis-                     from leftover stone in this respect?
    trative Action relating to proprietary medicinal products (OJ 22,
    09.02.1965, p. 369 [SE SER 1 (65-66) p. 201]).
(2) ECR 1998 p. I-7967.
(3) Council Directive 75/318/EEC of 20 May 1975 on the approxi-
    mation of the laws of Member States relating to analytical,                  (c)  What relevance does it have, in assessing the matter,
    pharmaco-toxicological and clinical standards and protocols in                    that leftover rock is harmless to human health and
    respect of the testing of proprietary medicinal products (OJ L 147,               the environment, but that, according to the view of
    09.06.1975, p. 1).                                                                the environmental licence authorities, substances
                                                                                      harmful to health and the environment dissolve
                                                                                      from ore-dressing sand? To what extent generally is
                                                                                      importance to be attached to the possible effect of
                                                                                      leftover rock and ore-dressing sand on health and
                                                                                      the environment in assessing whether they are
                                                                                      waste?
                                                                                 (d) What relevance does it have, in assessing the matter,
                                                                                      that leftover rock and ore-dressing sand are not
                                                                                      intended to be discarded? Leftover rock and ore-
Reference for a preliminary ruling from the Korkein
                                                                                      dressing sand may be re-used without special pro-
hallinto-oikeus by order of that court of 5 March 2001 in
                                                                                      cessing measures, for example for supporting mine
   the proceedings brought by Outokumpu Chrome Oy
                                                                                      galleries, and leftover rock also for landscaping the
                                                                                      mine after it has ceased operation. Minerals may in
                           (Case C-114/01)                                            future with the development of technology be
                                                                                      recovered from ore-dressing sand for utilisation. To
                                                                                      what extent should attention be paid to how definite
                           (2001/C 173/40)                                            plans the person carrying on mining operations has
                                                                                      for such utilisation and to how soon after the
                                                                                      leftover rock and ore-dressing sand has been tipped
Reference has been made to the Court of Justice of the                                on the mining concession or its ancillary site the
European Communities by an order of the Korkein hallinto-                             utilisation would take place?
oikeus (Supreme Administrative Court), Finland, of 5 March
2001, which was received at the Court Registry on 14 March
2001, for a preliminary ruling in the proceedings brought by
Outokumpu Chrome Oy on the following questions:                             (2) If the answer to the first question is that leftover rock
                                                                                 and/or ore-dressing sand is to be regarded as waste within
                                                                                 the meaning of Article 1(a) of the Council Directive on
(1) Are leftover rock resulting from the extraction of ore                       waste, it is further necessary to obtain an answer to the
      and/or ore-dressing sand resulting from the dressing of                    following supplementary questions:
      ore in mining operations to be regarded as waste
      within the meaning of Article 1(a) of Council Directive
      75/442/EEC of 15 July 1975 on waste (1), as amended by
      Council Directive 91/156/EEC of 18 March 1991 (2),
                                                                                 (a)  Does ‘other legislation’ within the meaning of
      having regard to points (a) to (d) below?
                                                                                      Article 2(1)(b) of the Waste Directive (91/156/EEC),
                                                                                      waste covered by which is excluded from the scope
      (a)   What relevance, in deciding the above question,                           of the directive, and which under point (ii) concerns
            does it have that the leftover rock and ore-dressing                      inter alia waste resulting from prospecting, extrac-
            sand is stored on the area of the mining concession                       tion, treatment and storage of mineral resources,