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1、CEPsubmission:CEPsubmission:HowtoprepareaNewHowtoprepareaNewApplication?Application?NathalieVicenteCertificationofSubstancesDivisionN.Vicente,28-29/01/10©2010EDQM,CouncilofEurope,AllrightsreservedSummarySummaryHowtoprepareaNewApplication?–RequirementsforanewCEPa
2、pplication–Contentofthedossier–CEPprocessoverview–Validationatreceipt–SomefiguresDeficienciesafterevaluationRecentchangesPerspectivesConclusionsN.Vicente,28-29/01/10©2010EDQM,CouncilofEurope,Allrightsreserved2RequirementsforanewCEPapplicationRequirementsforanewC
3、EPapplication•Applicationform(specifictonewapplication–seeEDQMWebsite)•SinglecopyofthedossierinCTDformatinEnglishpreferably(orFrench)–Papercopy–Electronicsubmissionrecommended:NEES,eCTD,pdf(newinstructionspublishedonEDQMwebsite)•QualityOverallSummary:usetheEDQMt
4、emplate•Samples:commitmenttoprovidesamplesuponrequestfromEDQM(APIandimpuritiesifappropriate)•FeetobepaidafterreceiptofapplicationandinvoicingN.Vicente,28-29/01/10©2010EDQM,CouncilofEurope,Allrightsreserved3ContentofthedossierContentofthedossier•CTDformat•SeeCEPp
5、oliciesonEDQMWebsite:–ResolutionAP-CSP(07)1oftheCoE:DescribestheprocessfortheCertificationprocedure–PA/PH/CEP(04)14R«Contentofthedossierforchemicalpurityandmicrobiologicalquality»–PA/PH/ExpCEP(06)2«ContentofthedossierforasubstanceforTSEriskassessment»–PA/PH/Exp.
6、CEP/T(06)131R«Certificatesofsuitabilityforsterileactivesubstances»–PA/PH/CEP026«Contentofthedossierforherbaldrugsandherbaldrugpreparationqualityevaluation»N.Vicente,28-29/01/10©2010EDQM,CouncilofEurope,Allrightsreserved4»CEPProcessOverview(1/2)CEPProcessOverview
7、(1/2)•Validationatreceipt•FromSeptember2008,only2phasesforevaluation:FromSeptember2008–1deficiencyletteronly–ifresponsesunsuitable→dossierclosed•Changeswhenansweringtodeficiencyletternolongeraccepted•Assessorstoapplyriskbasedevaluation•Monitoringofdeadlinesforap
8、plicants–No«sleeping»applications–Possibilitytoaskforanextension(withjustification)–SomeapplicationsclosedN.Vicente,28-29/01/10©2010EDQM,CouncilofEurope,Allrightsrese
