The problem in the case discussed is one of dilution. The MRA is
between two countries which are not your country of location. The
prime responsibility for your continued GMP compliance devolves on
the regulatory agency of your country. They are the ones primarily
responsible for your actions, they are the ones who can turn up
without notifying you in advance and they are the ones who would take
legal action against you. I would therefore expect a third country to
want to rely on the primary authority rather than via a twice removed
MRA.
With regards the shortage of inspectors etc, I can only agree with
you, particularly in the latest story of the FDA inspecting the wrong
factory in China [and not noticing that it was making different
materials]-at least that is what the press is reporting.
It is a little surprising to me that no-one has actually posted a
definitive opinion on this subject-I would have anticipated that
there must be a ruling somewhere rather than us expressing our
opinions.
Good luck
Malcolm Ross
Generapharm-Training and Consultancy
Basel-CH
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