CELEX: C2003/101/37
Language: en
Date: 2003-04-26 00:00:00
Title: Case C-77/03: Action brought on 20 February 2003 by the Commission of the European Communities against the Federal Republic of Germany

C 101/22                  EN                          Official Journal of the European Union                                        26.4.2003
Q ues ti o n 1                                                                Pleas in law and main arguments
Is it compatible with point 8(a)(iii) of Article 4 of the                     Article 249 EC, under which a directive shall be binding, as to
First Medicinal Products Directive (Directive 65/65/EEC ( 1), as              the result to be achieved, upon each Member State, carries by
amended) for a product to be authorised under the abridged                    implication an obligation on the Member States to observe the
application procedure when a salt of the active substance in                  period for compliance laid down in the directive. That period
the product is changed from the one used in the reference                     expired on 17 July 2001 without Ireland having enacted the
product?                                                                      provisions necessary to comply with the directive referred to
                                                                              in the conclusions of the Commission.
Q ues ti o n 2                                                                (1 ) OJ L 201 of 17.7.1998, p. 88.
Can the abridged application procedure be used when an
applicant, on its own initiative or at the request of national
health authorities, submits additional documentation in the
form of certain pharmacological or toxicological tests or
clinical trials with a view to demonstrating that the product is
‘essentially similar to’ the reference product?                               Action brought on 20 February 2003 by the Commission
                                                                              of the European Communities against the Federal Repub-
                                                                                                        lic of Germany
( 1) Council Directive 65/65/EEC of 26 January 1965 on the approxi-
     mation of provisions laid down by Law, Regulation or Adminis-
     trative Action relating to proprietary medicinal products (OJ B 22                                  (Case C-77/03)
     of 9.2.1965, p. 369).
                                                                                                       (2003/C 101/37)
                                                                              An action against the Federal Republic of Germany was
                                                                              brought before the Court of Justice of the European Communi-
Action brought on 19 February 2003 by the Commission                          ties on 20 February 2003 by the Commission of the European
         of the European Communities against Ireland                          Communities, represented by Claudia Schmidt, of the Euro-
                                                                              pean Commission’s Legal Service, acting as Agent, with an
                                                                              address for service in Luxembourg at the office of Carlos
                             (Case C-75/03)                                   Gómez de la Cruz, also of the European Commission’s Legal
                                                                              Service, Wagner Centre C 254, Kirchberg.
                            (2003/C 101/36)
                                                                              The applicant claims that the Court should:
An action against Ireland was brought before the Court of                     1.    declare that, by failing to bring into force the laws,
Justice of the European Communities on 19 February 2003 by                          regulations and administrative provisions necessary to
the Commission of the European Communities, represented                             comply with Directive 98/71/EC ( 1) of the European
by Nicola Yerrell, acting as agent, with an address for service                     Parliament and of the Council of 13 October 1998 on
in Luxembourg.                                                                      the legal protection of designs and/or by failing to inform
                                                                                    the Commission of those provisions, the Federal Republic
                                                                                    of Germany has failed to fulfil its obligations under that
The Applicant claims that the Court should:                                         directive;
(1) find that Ireland has failed in its obligations under the EC              2.    order the Federal Republic of Germany to pay the costs.
       Treaty by failing to adopt the laws, regulations and
       administrative provisions necessary to comply with
       Council Directive 98/50/EC of 29th June 1998 amending
       Directive 77/187/EEC on the approximation of the laws                  Pleas in law and main arguments
       of the Member States relating to the safeguarding of
       employees’ rights in the event of transfers of undertakings,
       businesses or parts of businesses (1), or by failing to                The period for transposition expired on 28 October 2001.
       ensure that employers’ and employees’ representatives
       have introduced the necessary provisions by agreement,
       and/or by failing to inform the Commission thereof; and                (1 ) OJ L 289 of 28.10.1998, p. 28.
(2) condemn Ireland to bear the costs of the procedure.