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A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. R5121-41\n
\n

\n
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Le titulaire de l'autorisation de mise sur le marché soumet au directeur général de l'Agence française de sécurité sanitaire des produits de santé tout projet de modification d'un élément relatif à l'étiquetage ou à la notice, autre que les modifications du résumé des caractéristiques du produit.

Si le directeur général de l'agence ne s'est pas prononcé dans un délai de quatre-vingt-dix jours à compter de la date de présentation de la demande, le demandeur peut procéder à la mise en oeuvre des modifications.

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Article 31 ENTIEREMENT_MODIF (Décret n° 2008-435 du 6 mai 2008 relatif à la mise sur le marché des spécialités pharmaceutiques à usage humain)