CELEX: C1999/020/19
Language: en
Date: 1999-01-23 00:00:00
Title: JUDGMENT OF THE COURT (Fifth Chamber) of 3 December 1998 in Case C-67/97 (request for a preliminary ruling from the Kriminalret i Frederikshavn): Criminal proceedings against Ditlev Bluhme (Free movement of goods - Prohibition of quantitative restrictions and measures having equivalent effect between Member States - Derogations - Protection of the health and life of animals - Bees of the subspecies Apis mellifera mellifera (Læsø brown bee))

C 20/12               EN                  Official Journal of the European Communities                                    23.1.1999
Wales), Queen's Bench Division (United Kingdom), for a                    may be authorised under the abridged procedure
preliminary ruling in the proceedings pending before that                 provided for in Article 4.8(a)(iii) of Directive
court between The Queen and The Licensing Authority                       65/65/EEC, as amended, for all dosage forms, doses
established by the Medicines Act 1968 (acting by The                      and dosage schedules already authorised for that
Medicines Control Agency), ex parte: Generics (UK) Ltd,                   product.
intervener: E. R. Squibb & Sons Limited, between The
Queen and The Licensing Authority established by the
Medicines Act 1968 (represented by The Medicines                     4. The fact that the original or abridged applications for
Control Agency), ex parte: The Wellcome Foundation                        marketing authorisations were made before entry into
Limited and between The Queen and The Licensing                           force of Commission Regulation (EC) No 541/95 of
Authority established by the Medicines Act 1968                           10 March 1995 concerning the examination of
(represented by The Medicines Control Agency), ex parte:                  variations to the terms of a marketing authorisation
Glaxo Operations UK Ltd and Others, intervener:                           granted by a competent authority of a Member State
Generics (UK) Ltd, on the interpretation and validity of                  does not affect the answers to the second and third
Article 4.8(a)(iii) of Council Directive 65/65/EEC of                     questions.
26 January 1965 on the approximation of provisions laid
down by law, regulation or administrative action relating,
to medicinal products (OJ, English Special Edition
1965Ð1966, p. 20), as amended by Council Directive                   5. Consideration of the fifth question has not disclosed
87/21/EEC of 22 December 1986 (OJ L 15, 17.1.1987,                        any factor of such a nature as to affect the validity of
p. 36) Ð the Court (Fifth Chamber), composed of: J.-P.                    Article 4.8(a)(iii) of Directive 65/65/EEC, as amended.
Puissochet, President of Chamber, J. C. Moitinho de
Almeida, C. Gulmann (Rapporteur), L. Sevón and M.                    (1) OJ C 40, 8.2.1997.
Wathelet,       Judges;      D.     Ruiz-Jarabo      Colomer,
Advocate-General; H. von Holstein, Deputy Registrar, has
given a judgment on 3 December 1998, in which it has
ruled:
1. Article 4.8(a)(iii) of Directive 65/65/EEC of 26 January                         JUDGMENT OF THE COURT
    1965 on the approximation of provisions laid down
                                                                                              (Fifth Chamber)
    by law, regulation or administrative action relating to
    medicinal products, as amended by Council Directive                                    of 3 December 1998
    87/21/EEC of 22 December 1986, must be interpreted
    as meaning that a medicinal product is essentially               in Case C-67/97 (request for a preliminary ruling from the
    similar to an original medicinal product where it                Kriminalret i Frederikshavn): Criminal proceedings against
    satisfies the criteria of having the same qualitative and                                 Ditlev Bluhme (1)
    quantitative composition in terms of active principles,
                                                                     (Free movement of goods Ð Prohibition of quantitative
    of having the same pharmaceutical form and of being
                                                                     restrictions and measures having equivalent effect between
    bioequivalent, unless it is apparent in the light of
                                                                     Member States Ð Derogations Ð Protection of the health
    scientific knowledge that it differs significantly from
                                                                     and life of animals Ð Bees of the subspecies Apis
    the original product as regards safety or efficacy. The
                                                                                 mellifera mellifera (Lñsù brown bee))
    competent authority of a Member State may not
    disregard the three criteria set out above when it is                                      (1999/C 20/19)
    required to determine whether a particular medicinal
    product is essentially similar to an original medicinal
    product.
                                                                                     (Language of the case: Danish)
2. A medicinal product that is essentially similar to a
    product which has been authorised for not less than                (Provisional translation; the definitive translation will be
    six or ten years and is marketed in the Member State                       published in the European Court Reports)
    for which the application is made may be authorised,
    under the abridged procedure provided for in Article
    4.8(a)(iii) of Directive 65/65/EEC, as amended, for all          In Case C-67/97: reference to the Court under Article 177
    therapeutic indications already authorised for that              of the EC Treaty by the Kriminalret i Frederikshavn
    product.                                                         (Denmark) for a preliminary ruling in the criminal
                                                                     proceedings before that court against Ditlev Bluhme Ð on
                                                                     the interpretation of Article 30 of the EC Treaty and
                                                                     Article 2 of Council Directive 91/174/EEC of 25 March
3. A medicinal product that is essentially similar to a              1991 laying down zootechnical and pedigree requirements
    product which has been authorised for not less than              for the marketing of pure-bred animals and amending
    six or ten years in the Community and is marketed in             Directives 77/504/EEC and 90/425/EEC (OJ L 85,
    the Member State for which the application is made               5.4.1991, p. 37) Ð the Court (Fifth Chamber), composed
 ---pagebreak--- 23.1.1999             EN                  Official Journal of the European Communities                                      C 20/13
of: J.-P. Puissochet, President of the Chamber, J. C.                of new Member States to the European Union (OJ L 1,
Moitinho de Almeida, C. Gulmann, L. Sevón (Rapporteur)               1.1.1995, p. 1) Ð the Court (First Chamber), composed
and M. Wathelet, Judges; N. Fennelly, Advocate-General;              of: D. A. O. Edward (Rapporteur), acting as President of
H. von Holstein, Registrar, has given a judgment on                  the Chamber, L. Sevón and M. Wathelet, Judges; G.
3 December 1998 in which it has ruled:                               Cosmas, Advocate-General; H. von Holstein, Deputy
                                                                     Registrar, has given a judgment on 3 December 1998 in
                                                                     which it has ruled:
1. A national legislative measure prohibiting the keeping
     on an island such as Lñsù of any species of bee other
     than the subspecies Apis mellifera mellifera (Lñsù              Article 99 of the Act concerning the conditions of
     brown bee) constitutes a measure having an effect               accession of the Republic of Austria, the Republic of
     equivalent to a quantitative restriction within the             Finland and the Kingdom of Sweden and the adjustments
     meaning of Article 30 of the EC Treaty.                         to the Treaties on which the European Union is founded,
                                                                     as amended by Council Decision 95/1/EC, Euratom,
                                                                     ECSC of 1 January 1995 adjusting the instruments
2. A national legislative measure prohibiting the keeping            concerning the accession of new Member States to the
     on an island such as Lñsù of any species of bee other           European Union, is to be interpreted as not having
     than the subspecies Apis mellifera mellifera (Lñsù              permitted the Republic of Finland to levy, for a period of
     brown bee) must be regarded as justified, under                 three years from its accession to the Community on
     Article 36 of the Treaty, on the ground of the                  1 January 1995, customs duties on imports of products
     protection of the health and life of animals.                   which had already been released into free circulation in
                                                                     another Member State.
(1) OJ C 108, 5.4.1997.
                                                                     (1) OJ C 252, 16.8.1997.
               JUDGMENT OF THE COURT
                        (First Chamber)                                            JUDGMENT OF THE COURT
                     of 3 December 1998                                                     (First Chamber)
in Case C-233/97 (reference for a preliminary ruling from                                 of 3 December 1998
the Uudenmaan Lääninoikeus (Finland)): Proceedings                   in Case C-247/97 (reference for a preliminary ruling from
                  brought by KappAhl Oy (1)                          the Cour de Cassation): Marcel Schoonbroodt, Marc
(Free movement of goods Ð Products in free circulation               Schoonbroodt, Transports A. M. Schoonbroodt SPRL v.
Ð Act of Accession of the Republic of Austria, the                                           Belgian State (1)
Republic of Finland and the Kingdom of Sweden Ð                      (Article 177 of the EC Treaty Ð Jurisdiction of the Court
                  Derogations Ð Article 99)                          Ð National legislation reproducing Community provisions
                        (1999/C 20/20)                               Ð Relief from customs duties Ð Fuel on board motorised
                                                                            road vehicles Ð Definition of standard tanks')
                                                                                             (1999/C 20/21)
                (Language of the case: Finnish)
                                                                                    (Language of the case: French)
  (Provisional translation; the definitive translation will be
          published in the European Court Reports)
                                                                       (Provisional translation; the definitive translation will be
In Case C-233/97: reference to the Court under Article 177                    published in the European Court Reports)
of the EC Treaty by the Uudenmaan Lääninoikeus
(Finland) for a preliminary ruling in the proceedings
brought before that court by KappAhl Oy Ð on the                     In Case C-247/97, reference to the Court under Article 177
interpretation of Article 99 of the Act concerning the               of the EC Treaty by the Cour de Cassation (Belgium) for a
conditions of accession of the Republic of Austria, the              preliminary ruling in the proceedings pending before that
Republic of Finland and the Kingdom of Sweden and the                court between Marcel Schoonbroodt, Marc Schoonbroodt,
adjustments to the Treaties on which the European Union              Transports A. M. Schoonbroodt SPRL and Belgian State
is founded (OJ C 241, 29.8.1994, p. 21), as amended by               Ð on the interpretation of Article 112 of Council
Council Decision 95/1/EC, Euratom, ECSC of 1 January                 Regulation (EEC) No 918/83 of 28 March 1983 setting up
1995 adjusting the instruments concerning the accession              a Community system of reliefs from customs duty (OJ