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chemical entity development

) A GMP inspection is not necessary for a manufacturing site that only performs sterilization of the product as part of the manufacturing process when the GMP compliance of the manufacturing site has already been confirmed by an inspection conducted at the request of another marketing authorization holder and if a copy of the GMP Inspection Result Notification accompanies the application form. In this case, a copy of the submitted application form for the GMP inspection should be submitted to the competent approval authority 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. (11) A GMP inspection is not necessary for a manufacturing site when the GMP compliance of the same product as the one manufactured at the site (refers to those manufactured at the same manufacturing site, by the same manufacturing method, manufacturing process, or manufacturing facility, or according to the same specification, etc.; the same shall apply hereinafter) has already been confirmed by an inspection conducted at the request of another marketing authorization holder, and if each copy of the GMP Inspection Result Notification for the same product and a document proving the equivalence of the two products is submitted to the competent inspection authority and approval authority. In this case, also submit these copies to the competent approval authority without delay.