Steve,
From own experience I can confirm the situation is exactly as Jim put
it: a 3rd country GMP inspection by one EU member state is recognized by
other EU member states as long as it covers similar dosage
forms/manufacturing stages and no more than 2-3 years have passed since
inspection. GMP inspections done by MRA country authorities are only
accepted by EU authorities for facilities within their respective
territories. Such said, you may always try to negotiate with your
competent authority but chances are low they will accept.
In section 2 "Scope and coverage" of the document "Guide to the MRAs in
operation" it says that MRAs are limited to the manufacturing
process(es) carried out and subject to inspections in the respective
territories of the MRA partner country and the European Union.
You can find this and related documents on inspections and MRA via the
EMEA website.
Here's the link:
http://www.emea.europa.eu/Inspections/docs/0002203en.pdf
Sincerely,
Klaus
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