CELEX: C2002/109/99
Language: en
Date: 2002-05-04 00:00:00
Title: Case T-19/02: Action brought on 25 January 2002 by Albert Albrecht GmbH + Co. KG and 17 others against the Commission of the European Communities and the European Agency for the Evaluation of Medicinal Products

4.5.2002               EN                     Official Journal of the European Communities                                        C 109/51
In addition, the applicant pleads a failure to provide a statement       pharmacologically active substance benzathine penicillin. That
of reasons and infringement of the rights of defence, as well as         substance is a general antibiotic used in veterinary injectable
non-compliance with the principles of sound administration               medicinal products for food producing animals.
and with the duty to have regard for the welfare and interests
of officials. Lastly, according to the applicant, there has
been an infringement of the Charter of Fundamental Rights,
inasmuch as the Commission did not adopt a decision within               The application is lodged against the decisions of the European
a reasonable time.                                                       Agency for the Evaluation of Medicinal Products (EMEA) of
                                                                         15 November 2001, requesting the applicants, on the basis of
                                                                         Article 20 of the Directive 81/851 (1), to reply to questions put
                                                                         by the Committee for Veterinary Medicinal Products (CVMP)
                                                                         regarding medicinal products containing benzathine penicillin
                                                                         by 25 March 2002 in the framework of a referral procedure
                                                                         initiated by the Irish authorities and each to pay a fee of
                                                                         10 000 Euro to the EMEA.
Action brought on 25 January 2002 by Albert Albrecht
GmbH + Co. KG and 17 others against the Commission
of the European Communities and the European Agency                      In support of their conclusions, the applicants submit that:
           for the Evaluation of Medicinal Products
                                                                         —     The contested decision infringes Article 20 of Directive
                         (Case T-19/02)                                        81/851, which is only applicable in the framework of the
                                                                               mutual recognition procedure and not to strictly national
                        (2002/C 109/99)                                        marketing authorisations.
                   (Language of the case: English)                       —     As the Directives are addressed only to Member States
                                                                               and are therefore not able to impose obligations directly
                                                                               on individuals, the Decision in question should be
                                                                               annulled, as Article 20 of the Directive 81/851 cannot
An action against the Commission of the European Communi-                      constitute a legal basis upon which to oblige the Appli-
ties and the European Agency for the Evaluation of Medicinal                   cants to comply. The EMEA cannot therefore oblige the
Products was brought before the Court of First Instance of the                 applicants to pay an arbitration fee of 10 000 Euro.
European Communities on 25 January 2002 by Albert
Albrecht GmbH + Co. KG and 17 others, represented by Mr
Dirk Brinckman and Mr Denis Waelbroeck of Liedekerke                     —     Even if were to be accepted that the arbitration procedure
Siméon Wessing Houthoff, Brussels (Belgium).                                   under Article 20 could be applied to veterinary medicinal
                                                                               products authorised under purely national authorisation
                                                                               procedures, which is not the case, the procedure can in
The applicant claims that the Court should:                                    any event only affect on the marketing authorisation that
                                                                               is directly affected by the referral. Moreover, it should
—     annul the contested Decisions requesting the applicants                  follow from the very wording of Article 20 that it is
      to submit data under the referral procedure of Article 20                only the person responsible for placing the veterinary
      of Directive 81/851 and requesting them each to pay the                  medicinal product concerned on the market who is
      sum of 10 000 Euro;                                                      bound to forward to the CVMP all available information
                                                                               relating to the matter in question. The procedure under
                                                                               Article 20 should not permit holders of national authoris-
—     alternatively, declare the contested Decisions null and                  ations of different medicinal products to be compelled to
      void;                                                                    submit data.
—     declare the Notice to Applicants illegal in so far as any of
      its provisions could be read as implying that the referral         —     The arbitration procedure could apply in the absence of
      procedure under Article 20 is applicable to marketing                    a mutual recognition procedure, which is not the case: at
      authorisations issued under national law;                                most it allows information to be requested from the
                                                                               holder of the national marketing authorisation whose
—     order the defendants to bear the costs.                                  product is directly concerned by the referral procedure.
                                                                         (1) Council Directive 81/851/EEC of 28 September 1981 on the
Pleas in law and main arguments                                              approximation of the laws of the Member States relating to
                                                                             veterinary medicinal products (OJ L 317, 6.11.1981, p. 1).
The applicants in the present case are all companies holding a
national marketing authorisation issued by national competent
authorities for a veterinary medicinal product containing the