Steve
The original questioner confirms the facility is in
the US i.e. outside TGA's "zone of responsibility" as
I originally described it. In this case EEA
authorities will require an inspection and will not
rely on the TGA's findings. I would love to be wrong
on this if someone can confirm that, great. Perhaps
this is the next logical step?
As for the Indian facility's MHRA report being
accepted by the Danish, why wouldn't it be? both are
in the EU and (EEA) & if one EU competent authority
approves a facility it would be a ittle silly if
another insisted on their own inspection, assuming
nothing has changed.
JT
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