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
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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