Subsequent amendments
Here you will find answers to frequently asked questions about subsequent amendments.
I have received a notice from the BfArM on the "Determination of Substantiality". What does that mean and what do I need to do next?
Please note that since 26.05.2021 this only applies to subsequent changes in performance studies of in vitro diagnostics.
In the case of notified "other changes", the competent higher federal authority (here: BfArM) may determine that the notified change fulfils the requirements of a substantial change. The BfArM informs the sponsor of this without delay by means of the notice "Determination of Substantiality" (Section 8 (1) sentence 3 MPKPV).
The sponsor is thus requested to resubmit an application for assessment of a substantial modification via the DMIDS for the previously notified modification.
Does it constitute a substantial amendment if investigators or clinical investigation sites change?
Yes, since substantial amendments include all amendments that affect the other requirements assessed by the Ethics Committee.
For a substantial modification, an application for assessment must be submitted to the competent higher federal authority and for evaluation to the competent ethics committee. In its current practice, the BfArM only takes note of substantial changes that exclusively affect the requirements of the Ethics Committee.