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CHECKLISTOFREQUIREMENTSFORTHERE-REGISTRATIONOFIMPORTDRUGPRODUCT1.FDDApplicationForm2.Applicantnominationnotecertifiedbythemanufacturer3.ManufacturerInformation3.1GMPcertificate(issuedbythedrugregulatoryauthorityofthemanufacturingcountry3.2CertificateofFreeSale(Fromthecountryoftheoriginissuedbythedrugregulatoryauthorityofthemanufacturingcountryorexportingcountry)3.3ThepreviousoforigincertificateofdrugregistrationinLaoPDR4.TechnicalSpecification4.1CertificateofAnalysisofactiverawmateriala.Frommanufacturerofrawmaterialb.Frommanufactureroffinishedproduct4.2Technicalspecificationsoffinishedproduct4.3Certificateofanalysisoffinishedproduct4.4Assaymethodandothertestproceduresoffinishedproduction4.5Stabilitytestreport5.Sampleinmarketorcommercialpresentationforlaboratoryanalysis