CASubmissionFormat object

Format option(s)

Email

Standard application form

CAEC Form (Formulaire - Courrier de demande d'autorisation d'essai clinique)

Document available in French at:
http://ansm.sante.fr/Mediatheque/Publications/Formulaires-et-demarches-Essais-cliniques

Title in French:
Annexe 2-Liste récapitulative des pièces constitutives du dossier de demande d’autorisation d’essai clinique de médicament (01/06/2015) (127 ko)

Standard application form - Additional information

Standard application form is available on the website in section: Activités > Médicaments et produits biologiques > Avis aux promoteurs - Formulaires.

Guidance on submission format available

Yes

Guidance on submission format

The required content of the application dossier is provided in Annex II, available on the ANSM website

Document available in French at:
http://ansm.sante.fr/Mediatheque/Publications/Formulaires-et-demarches-Essais-cliniques

Title in French:
Annexe 2-Liste récapitulative des pièces constitutives du dossier de demande d’autorisation d’essai clinique de médicament (01/06/2015) (127 ko)

Applicable national legal framework/ Reference

Additional Information

PLEASE NOTE THAT WE ARE CURRENTLY UPDATING OUR DATABASE

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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