Steve
I am afraid I am not bale to explain the intricacies of
international treaties and agreements nor am I able to
comment upon the limitations therein. I suggest you
take this up with your competent authority / lawyers.
Re the Danish situation I did explain this but I will
do so again. The MHRA are the competent authority of
the UK and the UK is a member of the EU as is Denmark
therefore it is reasonable to expect the Danes to
accpet the MHRA's report of the Indian facility. This
is a completely different legal situation to MHRA /
TGA auditing a facility in the US.
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