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Periodic infection for biological products

A GMP inspection is not necessary for a testing laboratory to which the tests and
inspections concerning the relevant product have been outsourced when the GMP
compliance of the laboratory has already been confirmed by an inspection conducted at
the request of another marketing authorization holder or manufacturer of drugs etc. for
export, and if a copy of the GMP Inspection Result Notification accompanies the
application form.
In this case, submit to the competent approval authority each copy of the submitted
application form for the GMP inspection and the GMP Inspection Result Notification
for the testing laboratory without delay after submission of the application.
In this case, the copy of the GMP Inspection Result Notification issued not more than
two years prior to the date of application for the inspection must, in principle, be
attached to the application form. If the copy of the GMP Inspection Result Report
issued not more than two years after the date of the inspection is also attached, however,
the copy of the GMP Inspection Result Notification issued not more than five years
prior to the same application date is acceptable.
(14) A GMP inspection is not necessary for a design and development control organization
to which the design and development control concerning the relevant product have been
outsourced when the GMP compliance of the organization has already been confirmed
by an inspection conducted at the request of another marketing authorization holder or
manufacturer of drugs etc. for export, and if a copy of the GMP Inspection Result
Notification accompanies the application form. In this case, submit to the competent
approval authority each copy of the submitted application form for GMP inspection and
the GMP Inspection Result Notification for the design and development control
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organization without delay after submission of the application.
In this case, the copy of the GMP Inspection Result Notification issued not more than
two years prior to the date of application for the inspection must, in principle, be
attached to the application form. If the copy of the GMP Inspection Result Report
issued not more than two years after the date of the inspection is also attached, however,
the copy of the GMP Inspection Result Notification issued not more than five years
prior to the said application date is acceptable.