CASubmissionOfApplication object
Responsible for study submission
Sponsor
Legal representative domiciled in the EU/EEA
Guidance on submission of application available
Yes
Guidance on submission of application
Avis aux promoteurs d’essais cliniques de médicaments, y compris les essais cliniques portant sur les médicaments de thérapie innovante (MTI) - Tome 1 (31/05/2018) (855 ko)
Available at : www. ansm.sante.fr/Activites/Medicaments-et-produits-biologiques/Avis-aux-promoteurs-Formulaires/
It covers in detail the legal framework, the submission procedure and all other relevant requirements on amendments, safety reporting and trial termination .
National legal framework in place
Yes
Additional Information
PLEASE NOTE THAT WE ARE CURRENTLY UPDATING OUR DATABASE