Décision relative à la Délégation de signature concernant les essais cliniques et les matières premières, de 22 juin 2022
Article 1er. Délégation est accordée à l'Administrateur-général de l'Agence fédérale des médicaments et des produits de santé (ci-après : AFMPS) et au Directeur-général du DG PRE de l'AFMPS pour signer les décisions suivantes :
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les autorisations visées à l'article 17 de la loi du 7 mai 2004 relative aux expérimentations sur la personne humaine ;
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les objections motivées visées aux articles 16 ou 19, § 4, alinéa 3 de la loi du 7 mai 2004 relative aux expérimentations sur la personne humaine ;
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les approbations et les autorisations visées aux articles 3, § 2., alinéa 2 et 3 ; et 6 de l'arrêté royal du 19 décembre 1997 relatif au contrôle et à l'analyse des matières premières utilisées par les pharmaciens d'officine.
Art. 2. Le fonctionnaire visé à l'article 1er qui fait usage du pouvoir de signature délégué par le présent arrêté placera au-dessus de la mention de son grade et de sa signature la formule :
" Ministre de la Santé Publique
P.o. [Nom du fonctionnaire visé à l'article 1er ]
[Rang ou fonction du fonctionnaire visé à l'article 1er] ".
Art. 3. L'Administrateur-général de l'AFMPS fait rapport tous les trois mois au Ministre de la Santé publique sur les autorisations signées par le biais de cette délégation.
Signatures
Bruxelles, le 22 juin 2022.
Le Ministre de la Santé publique,
F. VANDENBROUCKE
Préambule
Le Ministre de la...
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