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Leem
Dispositif médical, Essais cliniques, Innovation, Recherche
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ANSM
Dispositifs Médicaux
L’ANSM a indiqué le 24 septembre dans un communiqué avoir prononcé 8 M€ de sanctions financières à l’encontre de onze laboratoires pharmaceutiques n’ayant pas respecté leur obligation de disposer de 4 mois de stock de sécurité pour des médicaments d’intérêt thérapeutique majeur (MITM). Depuis septembre 2021, la loi prévoit que les MITM disposent d’un stock de sécurité de 4 mois s’ils ont fait l’objet de ruptures ou risques de rupture réguliers contre 2 mois pour les autres MITM. Cette {"date":"202505","chunks":["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","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","bnQgJmVjaXJjO3RyZSB0cmFpdCZlYWN1dGU7ICZhZ3JhdmU7IGwmcnNxdW87JmVhY3V0ZTtjaGVsbGUgZXVyb3AmZWFjdXRlO2VubmUuI202505+awxy19jAguDwvcD4K"]}