Jim,
In your last post you talked about the facility being in the US i.e. outside
TGA's "zone of responsibility". In my original post, I described my
experience that that the Danish agency accepted the MHRA's inspection report
of a facility based in India. I don't think it's too big a stretch to argue
that an EU based agency will request a copy of the TGA's report and accept
its findings.
Like you I don't know the contents of the MRA between the EU and TGA. In
order to put this discussion to bed, perhaps Thiru could request a copy from
the EMEA or TGA under Freedom of Information. Could s/he also let the group
know the outcome?
Sincerely,
Steve
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