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Drug Registration
Requisite data of import pharmaceutical register and declare
Declare import pharmaceutical register need file data hereinafter:
(1) Certification and notarization document that national pharmaceutical administration of pharmaceutical productive country ratify pharmaceutical register, production, distribution export and production factory correspond with GMP
(2) Certification document that authorize Chinese agent to surrogate declaration; Register certificate copy of foreign pharmacy manufacturer representation organization reside in China
(3) Pharmaceutical patent certification document
(4) Pharmaceutical specification that ratified by national pharmaceutical administration of pharmaceutical production country
(5) Pharmaceutical quality standard and text method
(6) Comprehensive relation of pharmaceutical research result
(7) Detailed technology document of pharmaceutical prescription, production technic, pharmacology and clinic research etc.
(8) Sample of pharmaceutical and package and other data. Concrete request of declaration data execute according to appendix of this method ˇ®export pharmaceutical declaration data detailed rules' (appendix No.1)
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