Any substantial amendments to the study protocol
Legal representative domiciled in the EU/EEA
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.
From automatic confirmation of receipt
By silent (implicit) approval
(explicit authorisation also possible)
L I206 Leitfaden KP Einreichung (de) + L I207 Klassifizierung von Amendments (de)
L I209 Guidance CT submission (en) + L I219 Classification of Amendments (en)
NB: Substantial amendments for clinical trials with ATMPs need to be approved by written notification by BASG.