Medicinal product - Marketing authorisation - Opinion of the European Agency for the Evaluation of Medicinal Products - Admissibility - Interest in bringing proceedings - Public health - Verification of reported data - Review of scientific evaluations - Professional reputation.

«(Medicinal product – Marketing authorisation – Opinion of the European Agency for the Evaluation of Medicinal Products – Admissibility – Interest in bringing proceedings – Public health – Verification of reported data – Review of scientific evaluations – Professional reputation)» Summary of the Judgment 1.. Actions for annulment – Interest in bringing proceedings – None (Art. 230, fourth para., EC) 2.. Approximation of laws – Uniform laws – Community procedures for the authorisation and supervision of medicinal products – Regulation No 2309/93 – Central marketing authorisations – Requirement for a high level of health protection – Whether observations of persons other than the applicant may be taken into account – Admissibility – Scope (Art. 152 EC; Council Regulation No 2309/93, Art. 11) 3.. Approximation of laws – Uniform laws – Community procedures for the authorisation and supervision of medicinal products – Regulation No 2309/93 – Central marketing authorisations – Assessment of scientific data – Bilateral procedure between the applicant and the Community administration (Council Regulation No 2309/93) 4.. Approximation of laws – Uniform laws – Community procedures for the authorisation and supervision of medicinal products – Regulation No 2309/93 – Central marketing authorisations – Whether the professional reputation of a third person may be taken into account – Not permitted (Council Regulation No 2309/93, Art. 68) JUDGMENT OF THE COURT OF FIRST INSTANCE (Fifth Chamber)18 December 2003 (1) ((Medicinal product – Marketing authorisation – Opinion of the European Agency for the Evaluation of Medicinal Products – Admissibility – Interest in bringing proceedings – Public health – Verification of reported data – Review of scientific evaluations – Professional reputation)) applicant, v defendants, intervener, THE COURT OF FIRST INSTANCE OF THE EUROPEAN COMMUNITIES (Fifth Chamber), having regard to the written procedure and further to the hearing on 10 April 2003, gives the following On those grounds, THE COURT OF FIRST INSTANCE (Fifth Chamber) García-Valdecasas Lindh Cooke H. Jung P. Lindh Registrar President 1 – Language of the case: English.