LEXICON
No.100 January 30, 2012

Foreign exceptional approval system
外国特例承認制度
Appointed marketing authorization holder
選任製造販売業者

Under the “foreign exceptional approval system” (外国特例承認制度), an overseas pharmaceutical company may directly file an application for marketing approval (製造販売承認) with Korosho in order to market its product manufactured outside Japan and imported into Japan by appointing a domestic drug...

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