Beslissing houdende de delegatie van handtekening met betrekking tot klinische proeven en grondstoffen, de 22 juin 2022
Artikel 1. Aan de Administrateur-generaal van het Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (hierna: FAGG) en aan de Directeur-generaal van het DG PRE van het FAGG, wordt delegatie van handtekening verleend voor de toelatingen voor de volgende beslissingen:
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de toelatingen bedoeld in artikel 17 van de wet van 7 mei 2004 inzake experimenten op de menselijke persoon;
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de gemotiveerde bezwaren bedoeld in artikel 16 of in artikel 19, § 4, derde lid van de wet van 7 mei 2004 inzake experimenten op de menselijke persoon;
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de goedkeuringen en vergunningen bedoeld in de artikelen 3, § 2., tweede en derde lid; en 6 van het koninklijk besluit van 19 december 1997 betreffende de controle en de analyse van de grondstoffen die door de officina-apothekers gebruikt worden.
Art. 2. De in artikel 1 bedoelde ambtenaar die gebruik maakt van de bij dit besluit gedelegeerde handtekeningsbevoegdheid, plaatst boven de vermelding van zijn graad en handtekening, de formule:
"Minister van Volksgezondheid
I.o. [Naam van de in artikel 1 bedoelde ambtenaar]
[Rang of mandaat van de in artikel 1 bedoelde ambtenaar]".
Art. 3. De Administrateur-generaal van het FAGG brengt om de drie maanden verslag uit aan de Minister van Volksgezondheid van de toelatingen die middels deze delegatie werden ondertekend.
Handtekening
Brussel, 22 juni 2022.
De Minister van Volksgezondheid
F. VANDENBROUCKE
Aanhef
De Minister...
Pour continuer la lecture
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