CAAmendment object
Substantial amendments (as determined by CA)
Sponsor
Legal representative domiciled in the EU/EEA
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
45/ extension to 60 possible (if further questions; for trials with cell therapy, gene therapy, or GMOs)
Yes
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)
Articles L1123-42 and L1123-44 of the French Public Health Code (Code de la santé publique).
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.