Hi Davisite,
You are correct in saying about the European approvals.
1 of my other bio company, had EMA in 2017 and then last year received the new regulations approval.
While this company is not a drug company, yet it is a Medical Device, which had to re-apply again.
Below is a snippet of the announcement.
IMHO.
Regards
Rossi70
IND before Australian ethics?, page-13
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