CAAmendment object

Authorisation mandatory for

Substantial amendments (as determined by CA)

Responsible for submission of SA

Sponsor
Legal representative domiciled in the EU/EEA

Standard notification form

1) Substantial Amendment Notification Form (en) of EudraLex - Volume 10 Clinical trials guidelines
2) Formulaire FAMS - Médicaments (fr)
Both forms are available on the ANSM website in section: Activités > Médicaments et produits biologiques > Avis aux promoteurs - Formulaires

Timeline for approval of SA (max nr days)

45/ extension to 60 possible (if further questions; for trials with cell therapy, gene therapy, or GMOs)

Guidance on submission of SA available

Yes

Guidance on submission of SA

A guidance for sponsors regarding the definition and examples of substantial and non-substantial amendments to be notified to ANSM is available on the website in section:
Activités > Médicaments et produits biologiques > Avis aux promoteurs - Formulaires

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

Titles in French:
Annexe 14 : Exemples de modifications substantielles et non substantielles pour l’ANSM (01/06/2015) (266 ko)
Annexe 15 : Exemples de tableau comparatif mettant en évidence les modifications substantielles apportées à un document par rapport à la version précédemment soumise (01/06/2015) (86 ko)

Applicable national legal framework/ Reference

Articles L1123-42 and L1123-44 of the French Public Health Code (Code de la santé publique).

Additional Information

NB! Non-substantial amendments and substantial amendments on trial -related aspects falling within the EC's competence only (e.g. additional investigators) need not be notified to the CA any longer.

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