CAAmendment object

Authorisation mandatory for

Any substantial modifications having a significant impact on any aspect of research

Responsible for submission of SA

Sponsor
Legal representative

Standard notification form

The standard form 'Form of request for substantial modification' (Formulaire 3) is provided on the ANMS website in section: Formulaires et modèles à télécharger (Forms and Downloads).

Timeline for approval of SA (max nr days)

35
From date of receipt of valid application
By silent (implicit) approval
By explicit authorization only for research relating to MD incorporating products of human or animal origin

Guidance on submission of SA

(1) The contents of the dossier of request for authorisation of substantial modification are detailed in section 2.2.2.1 of the comprehensive guidance 'Avis au promoteurs/ Notice to sponsors'.

(2) 'Tome 3- Fiche pratiques' provides examples for substantial and non-substantial amendments as defined by ANSM

Both documents available on ANSM website in section: Activités > Dispositifs médicaux > Essais cliniques portant sur les dispositifs médicaux et dispositifs médicaux de diagnostic in vitro > Avis aux promoteurs / fiches (Notice to sponsors/ guidelines)

Applicable national legal framework/ Reference

Articles R.1123-35 to 37 of the CSP
Decree Substantial Modification

Additional Information

ANSM may notify the applicant of its decision before the expiry of this 35 day deadline.

Submission format: Electronically (see Application Format). In exceptional circumstances, it is possible to transmit the file of request by post or messenger.

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