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
Date: 2002-05-04
Institutions: Court of First Instance
Subjects: European Commission, European Medicines Agency, action for annulment (EU), fine, market approval, pharmaceutical industry, veterinary drug

4.5.2002

EN

Official Journal of the European Communities

C 109/51

In addition, the applicant pleads a failure to provide a statement
of reasons and infringement of the rights of defence, as well as
non-compliance with the principles of sound administration
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
a reasonable time.

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

(Case T-19/02)

(2002/C 109/99)

(Language of the case: English)

An action against the Commission of the European Communi-
ties and the European Agency for the Evaluation of Medicinal
Products was brought before the Court of First Instance of the
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
Siméon Wessing Houthoff, Brussels (Belgium).

The applicant claims that the Court should:

— annul the contested Decisions requesting the applicants
to submit data under the referral procedure of Article 20
of Directive 81/851 and requesting them each to pay the
sum of 10 000 Euro;

— alternatively, declare the contested Decisions null and

void;

— declare the Notice to Applicants illegal in so far as any of
its provisions could be read as implying that the referral
procedure under Article 20 is applicable to marketing
authorisations issued under national law;

— order the defendants to bear the costs.

Pleas in law and main arguments

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

pharmacologically active substance benzathine penicillin. That
substance is a general antibiotic used in veterinary injectable
medicinal products for food producing animals.

The application is lodged against the decisions of the European
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.

In support of their conclusions, the applicants submit that:

— The contested decision infringes Article 20 of Directive
81/851, which is only applicable in the framework of the
mutual recognition procedure and not to strictly national
marketing authorisations.

— 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
constitute a legal basis upon which to oblige the Appli-
cants to comply. The EMEA cannot therefore oblige the
applicants to pay an arbitration fee of 10 000 Euro.

— Even if were to be accepted that the arbitration procedure
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
any event only affect on the marketing authorisation that
is directly affected by the referral. Moreover, it should
follow from the very wording of Article 20 that it is
only the person responsible for placing the veterinary
medicinal product concerned on the market who is
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-
ations of different medicinal products to be compelled to
submit data.

— The arbitration procedure could apply in the absence of
a mutual recognition procedure, which is not the case: at
most it allows information to be requested from the
holder of the national marketing authorisation whose
product is directly concerned by the referral procedure.

(1) Council Directive 81/851/EEC of 28 September 1981 on the
approximation of the laws of the Member States relating to
veterinary medicinal products (OJ L 317, 6.11.1981, p. 1).