This is a note regarding Jim Tyrrel's comment: 'If you are outside the zone
of responsibility of TGA and have merely been inspected by them in
your territory I don't think this
will suffice.'
We all know that agency resources are limited and inspectors prefer not to
travel if it can be avoided.
I've had the experience with an Indian client whose facility had been
successfully inspected by MHRA. This inspection report was subsequently
accepted by the Danish inspectorate on the basis of mutual recognition. In
the present situation, where there is an MRA between Australia and the EU, I
would have thought that the EU agency would have requested a copy of the
TGA's inspection report. Or am I being simplistic/have missed something?
Sincerely,
Steve Binysh
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