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Document:FRA AEC DOC010 V.04 01-Jun-2018

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Reference FRA AEC_DOC010 V.04 01-Jun-2018
Validity area FRA
Scope(s) HM
Document name AEC_DOC010 V.04
Version / Revision 01-Jun-2018
Status Current
Document type Official recommendation
Language(s) FR
Description AVIS AUX PROMOTEURS D’ESSAIS CLINIQUES DE MEDICAMENTS, Y COMPRIS LES ESSAIS CLINIQUES PORTANT SUR LES MEDICAMENTS DE THERAPIE INNOVANTE (MTI)

TOME I - DEMANDE D’AUTORISATION D’ESSAI CLINIQUE A L’ANSM, DEBUT DE L’ESSAI, MODIFICATIONS DE L’ESSAI ET FIN DE L’ESSAI.

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


References

Reference Scope Document part Language Preview
Reference:FRA AEC_DOC010 V.04 01-Jun-2018 - HM - FR [...] I – DEMANDE D’AUTORISATION D’ESSAI CLINIQUE DE MEDICAMENT AUPRES DE L’ANSM PrĂ©ambule [...] PrĂ©alablement Ă  la mise en place en France d’un essai clinique de mĂ©dicament, le demandeur doit ...