16 AVRIL 2013. - Arrêté royal modifiant l'arrêté royal du 15 juillet 2004 déterminant les redevances à payer dans le cadre d'une demande d'avis ou d'autorisation pour la conduite d'un essai clinique ou d'une expérimentation
ALBERT II, Roi des Belges,
A tous, présents et à venir, Salut.
Vu la Constitution, notamment l'article 108;
Vu la loi du 7 mai 2004 relatif aux expérimentations sur la personne humaine, notamment l'article 30, § 2, § 3 et § 6;
Vu l'arrêté royal du 15 juillet 2004 déterminant les redevances à payer dans le cadre d'une demande d'avis ou d'autorisation pour la conduite d'un essai clinique ou d'une expérimentation;
Vu l'avis du Comité de transparance institué auprès de l'Agence fédérale des médicaments et des produits de santé, donné le 26 avril 2012;
Vu l'avis de l'Inspecteur des Finances, donné le 15 mai 2012;
Vu l'accord du Ministre du Budget, donné le 27 août 2012;
Vu l'avis 52.434/3 du Conseil d'Etat, donné le 17 décembre 2012, en application de l'article 84, § 1er, alinéa 1er, 1°, des lois sur le Conseil d'Etat coordonnées le 12 janvier 9173;
Sur la proposition du Ministre de la Santé publique,
Nous avons arrêté et arrêtons :
Article 1er. A l'article 1er de l'arrêté royal du 15 juillet 2004 déterminant les redevances à payer dans le cadre d'une demande d'avis ou d'autorisation pour la conduite d'un essai clinique ou d'une expérimentation, le chiffre « 2.000 » est remplacé par le chiffre « 2.659,55 » et le chiffre « 250 » est remplacé par le chiffre « 600 ».
Art. 2. A l'article 4, § 1er, du même arrêté, les modifications suivantes sont apportées :
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A l'alinéa 1er, mes mots « au compte numéro 001-4272336-47 de l'Inami. » sont remplacés par les mots « sur le compte numéro 679-0001514-59 de l'Agence fédérale des médicaments et des produits de santé, ci-après dénommée « l'AFMPS ».;
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l'alinéa 2 est supprimé;
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l'alinéa 3 est remplacé comme suit :
45,855 % du montant ainsi obtenu sont destinés à...
Pour continuer la lecture
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