«(Appeal – Directives 65/65/EEC and 75/319/EEC – Medicinal products for human use – Anorectics: amfepramone, clobenzorex, fenproporex, norpseudoephedrine, phentermine – Withdrawal of a marketing authorisation – Competence of the Commission – Conditions for withdrawal)»

Approximation of laws – Proprietary medicinal products – Marketing authorisation – Withdrawal of authorisation – Authorisations granted in accordance with the mutual recognition procedure, coupled with arbitration procedures – Competence of the Commission with regard to authorisation initially granted under national procedures – None (Council Directive 75/319, Art. 15a) Article 15a of Directive 75/319 relating to proprietary medicinal products, as amended by Directive 93/39, applies to marketing authorisations which have been granted in accordance with the mutual recognition procedure, coupled with arbitration procedures, provided for in Chapter III of Directive 75/319. That provision cannot be used as a legal basis for Commission decisions ordering the Member States to withdraw marketing authorisations initially granted under purely national procedures. see paras 45-46, 51

JUDGMENT OF THE COURT (Full Court) 24 July 2003 (1)

((Appeal – Directives 65/65/EEC and 75/319/EEC – Medicinal products for human use – Anorectics: amfepramone, clobenzorex, fenproporex, norpseudoephedrine, phentermine – Withdrawal of a marketing authorisation – Competence of the Commission – Conditions for withdrawal))

In Case C-39/03 P,

appellant,

APPEAL against the judgment of the Court of First Instance of the European Communities (Second Chamber, Extended Composition) of 26 November 2002 in Joined Cases T-74/00, T-76/00, T-83/00 to T-85/00, T-132/00, T-137/00 and T-141/00

the other parties to the proceedings being:

THE COURT (Full Court),,

composed of: G.C. Rodríguez Iglesias, President, J.-P. Puissochet, M. Wathelet, R. Schintgen, C.W.A. Timmermans (Presidents of Chambers), C. Gulmann, D.A.O. Edward, A. La Pergola, P. Jann (Rapporteur), V. Skouris, F. Macken, N. Colneric, S. von Bahr, J.N. Cunha Rodrigues and A. Rosas, Judges,

Advocate General: S. Alber,

having regard to the decision of the President of the Court that the appeal was to be determined pursuant to an expedited procedure in accordance with Article 62a of the Rules of Procedure, after hearing oral argument from the parties at the hearing on 10 June 2003,

after hearing the Advocate General,

gives the following

Directive 65/65/EEC

Second Directive 75/319/EEC

Commission Decision C(96) 3608 final/1

The decisions at issue

On those grounds,

THE COURT (Full Court),

hereby:

Rodríguez Iglesias

Puissochet

Wathelet

Schintgen

Timmermans

Gulman

Edward

La Pergola

Jann

Skouris

Macken

Colneric

von Bahr

Cunha Rodrigues

Rosas

Delivered in open court in Luxembourg on 24 July 2003.

R. Grass

G.C. Rodríguez Iglesias

Registrar

President