CELEX: C2000/192/44
Language: en
Date: 2000-07-08 00:00:00
Title: Case T-123/00: Action brought on 9 May 2000 by Dr. Karl Thomae GmbH against the Commission of the European Communities

8.7.2000               EN                     Official Journal of the European Communities                                    C 192/23
Action brought on 8 May 2000 by K & N Efthymiadis S.A.                   — subsidiarily declare Article 4, paragraph 3, point 2 of
against the Commission of the European Communities                           Council Directive 65/65/EEC as amended and Article 1,
                                                                             point 2, 1st indent, Article 2 point 1a and Article 7,
                         (Case T-122/00)                                     point 1a of Council Directive 92/27 as amended as well as
                                                                             the Guideline on Packaging Information illegal in so far as
                         (2000/C 192/43)                                     any of these provisions could be read as containing — as
                                                                             alleged — a requirement to use a single trademark and a
                                                                             single package layout for medicinal products authorised
                   (Language of the case: French)                            under the central marketing authorisation procedure; and
An action against the Commission of the European Communi-                — order the defendant to bear the costs of the present
ties was brought before the Court of First Instance of the                   proceedings.
European Communities on 8 May 2000 by K & N Efthymiadis
S.A., established in Thessaloniki (Greece), represented by
Miquel Roca Junyent and Joan Roca Sagarra, of the Barcelona
Bar.                                                                     Pleas in law and main arguments
The applicant claims that the Court should:
                                                                         The present application is for the annulment of the decision of
— declare null and void Commission Regulation (EC)                       the European Agency for the Evaluation of Medicinal Products
    No 451/2000 of 28 February 2000 laying down the                      (EMEA/H/C/135/I/04) rejecting the application for variation of
    detailed rules for the implementation of the second                  the marketing authorisation for ‘Daquiran’ submitted by the
    and third stages of the work programme referred to in                applicant, concerning a change in the name of the product.
    Article 8(2) of Council Directive 91/414/EEC;
— order the European Commission to pay the costs.                        The refusal has been justified on the grounds that:
Pleas in law and principal arguments                                     — the granting of a single Community Marketing Authoris-
                                                                             ation under the Centralised Procedure requires one single
                                                                             name for the medicinal product being authorised;
The pleas in law and main arguments are the same as those
advanced in Case T-112/00.
                                                                         — the presentations of a medicinal product must be identical
                                                                             throughout the Community.
                                                                         In support of its action, the applicant makes the following
                                                                         submissions:
Action brought on 9 May 2000 by Dr. Karl Thomae
GmbH against the Commission of the European Com-                         — authorisations and variations to marketing authorisations
                             munities                                        may only be refused when the safety, quality or efficacy of
                                                                             the medicinal product has not been adequately or suf-
                         (Case T-123/00)                                     ficiently demonstrated. A ‘single trademark’ and a ‘single
                                                                             package layout’, to be used in all Member States of
                         (2000/C 192/44)                                     the European Community, should, accordingly, not be
                                                                             considered as a prerequisite for obtaining a marketing
                                                                             authorisation under the Community Marketing Authoris-
                  (Language of the case: English)                            ation regime, and may not be used to refuse marketing
                                                                             authorisations or variations to marketing authorizations.
An action against the Commission of the European Communi-
ties was brought before the Court of First Instance of the               — The contested decision illegally interferes with the appli-
European Communities on 9 May 2000 by Dr. Karl Thomae                        cant’s right of property as guaranteed by Article 222 of
GmbH, a company incorporated under the law of Germany,                       the EC Treaty (now Article 295 EC) and Article 36 of the
represented by Denis Waelbroeck and Dirk Brinckman, of                       EC Treaty (now Article 30 EC), as well as with the
Liedekerke Siméon Wessing Houthoff, Brussels.                                fundamental right to pursue economic activities.
The applicant claims that the Court should:
                                                                         — The defendant does not provide adequate reasoning for its
— annul the decision of the European Agency for the                          decision.
    Evaluation of Medicinal Products rejecting the applicant’s
    request for variation to the marketing authorisation of the
    medicinal product Daquiran concerning a change in the
    name of the product;