Hello Team,
In order to do site-to-site IMP transfer, the QP in the EU is requesting IMPD update and to submit a substantial CTIS amendment to obtain approval in writing to do this. Is this normal? I feel that it is excessive. I recall having to do emergency site-to-site IMP transfer in the EU before (for another company), and I don’t think we had to do what the QP is requesting. We do not have 90 days to wait for an approval for a substantial amendment review. Any thoughts on how to handle this or experience with site-to-site transfer in the EU with QP?
Thank you so much!!