Avis relatif à la suppression d'une autorisation de mise sur le marché d'un médicament vétérinaire
Jurisdiction | France |
Publication au Gazette officiel | JORF n°95 du 22 avril 2004 |
Date de publication | 22 avril 2004 |
Court | MINISTERE DE LA SANTE ET DE LA PROTECTION SOCIALE |
Record Number | JORFTEXT000000600662 |
Décision du 24 novembre 2003 du directeur général de l'Agence française de sécurité sanitaire des aliments (Agence nationale du médicament vétérinaire)
Vu la cinquième partie, livre Ier, du code de la santé publique, et notamment les articles L. 5141-7 et R. 5146-37 ;
Vu la décision d'autorisation de mise sur le marché accordée le 24 juillet 1992 au médicament vétérinaire dénommé Biogar des laboratoires Noé ;
Vu le courrier du 11 avril 2001 des laboratoires Noé faisant état d'une modification de la composition du médicament vétérinaire Biogar, consistant notamment en l'ajout de méthyldiglycol ;
Vu la demande d'information complémentaire de l'AFSSA-ANMV en date du 1er juin 2001 et la réponse des laboratoires Noé le 2 juillet 2001 nous informant de la réalisation d'essais de formulation dans le but de supprimer ou de substituer le méthyldiglycol de la formule ;
Vu la décision de suspension de l'autorisation de mise sur le marché du Biogar pour un an à compter du 19 juillet 2001 après identification du méthyldiglycol comme éther de glycol à propriétés toxiques pour la reproduction ;
Vu le courrier des laboratoires Noé en date du 10 janvier 2002 informant l'AFSSA-ANMV de sa démarche pour revenir à une composition sans méthyldiglycol ;
Vu la décision de suspension de l'autorisation de mise sur le marché du Biogar...
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