LEXICON
No.81 September 12, 2011

Marketing authorization holder
製造販売業者
Manufacturing/manufacturer
製造(元)
Sales, distribution/distributor
販売(元)
Marketing/marketer (marketing authorization holder)
発売(元)
Promotion
販促

The amended Pharmaceutical Affairs Law (PAL;薬事法), which went into effect in April 2005, has introduced a new marketing business licensing system (製造販売業の許可体系) and has changed the conventional manufacturing approval system (製造承認制度) to the new marketing approval system (製造販売承認制度). Under the...

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