艾昆玮-档案提交更新：马来西亚卫生部药品上市第三版的关键变化（英）-2024-17页

UpdatesforDossierSubmission:KeyChangesinthe3rdEditionforListingMedicineswiththeMalaysiaMinistryofHealthSummaryofChangesTableofcontentsSummaryofchanges1Listingworkflow2Typesofdossierforms3Emailandmailingaddress3Intentiontosubmit4Dossierformatting6Dossierarrangement(hardcopy)7Submissionformat(hardcopyvs.softcopy)8DossierD1checklistandDossierD1form8DossierD2checklistandDossierD2form9Medicinepricedeclarationform9Applicantstatementofdeclaration9Supportingclinicalevidence10Supportingeconomicevidence10Provisionofone-yearutilisationdatapost-listing10Appendix:Workflow11Listofabbreviations12Glossary13References14Authors14AboutIQVIAAsiaPacific14CUpdatesforDossierSubmission:KeyChangesinthe3rdEditionforListingMedicineswiththeMalaysiaMinistryofHealthSummaryofchangesNo.ItemChangeUpdatesondurationofeachprocessingstage1ListingworkflowChangesintypesofdossierformsChangesinaddress2TypeofdossierformsNewinstructionsAdditionalinstructions3EmailandmailingaddressNewinstructionsNewinstructions4IntentiontosubmitChangesincontentsChangesincontents5DossierformattingNochangesincontentAdditionalclauses6Dossierarrangement(hardcopy)NochangesNochanges7Submissionformat(hardcopyvs.softcopy)NewrequirementUpdatesondurationofeachprocessingstage8DossierD1checklistandDossierD1form9DossierD2checklistandDossierD2form10Medicinepricedeclarationform11Appl...