CAAmendment object

Authorisation mandatory for

Any substantial amendments to the study protocol

Responsible for submission of SA

Sponsor
Legal representative domiciled in the EU/EEA

Standard notification form available

Yes

Standard notification form

Substantial Amendment Notification Form (en) / Meldeformular für Substantielle Amendments (de)

Content of application: Covering letter describing the planned changes + “Substantial Amendment Notification Form” + Summary of changes and the changed documents of the dossier
The standard form and the documents required for the assessment shall be submitted electronically on a data medium (e.g. CD). The application should be sent to the BASG together with a covering letter by mail.

Timeline for approval of SA (max nr days)

35
From automatic confirmation of receipt
By silent (implicit) approval
(explicit authorisation also possible)

Guidance on submission of SA available

Yes

Guidance on submission of SA

L I206 Leitfaden KP Einreichung (de) + L I207 Klassifizierung von Amendments (de)
L I209 Guidance CT submission (en) + L I219 Classification of Amendments (en)

National legal framework in place

Yes

Applicable national legal framework/ Reference

Art 37a AMG

Additional Information

NB: Substantial amendments for clinical trials with ATMPs need to be approved by written notification by BASG.

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