COS变更的程序

CertificationUnitAddress:226AvenuedeColmar(entrancerueSchertz)B.P.907-F67029StrasbourgCedex1Telephone:33(0)388413030-E-mail:certification@pheur.org-Fax:33(0)388412771Internet:http://www.pheur.orgCP/CBPUBLICDOCUMENT(Level1)English/FrenchPA/PH/Exp.CEP/T(04)18July2004CertificationofsuitabilityofMonographsoftheEuropeanPharmacopoeiaNewproceduresformanagementofrevisions/renewalsofcertificates(RevisionoftheAnnexXItoResolutionAP-CSP(93)5asamended)StrasbourgPA/PH/Exp.CEP/T(04)18p.2de5NEWPROCEDURESFORMANAGEMENTOFREVISIONS/RENEWALSOFCERTIFICATESOFSUITABILITYTOTHEEUROPEANPHARMACOPOEIAMONOGRAPHS(RevisionofAnnexXIofResolutionAP-CSP(99)4:CertificationofsuitabilitytothemonographsoftheEuropeanPharmacopoeia)Introduction:FollowingtheimplementationofEuropeanRegulationsonvariations(EC)1084/2003and(EC)1085/2003whichcameintoforceon1October2003,theproceduresforthemanagementofrevisionsofcertificatesofsuitabilityaregoingtoberevisedaccordingly.Themainchangesareanewclassificationofdifferenttypesofrevisionsaswellaschangestotheevaluationtimetables.AnnexXItoResolutionAP-CSP(99)4hasbeenrevisedandreplacedbyanewguidelineon“RequirementsonRevisions/RenewalsofCertificates”(seedocumentPA/PH/CEP(04)2).Thisguidelinedescribestheconditionstobefulfilledaswellasdocumentationtobesubmittedforeachrequestforrevision.Theprocedurestobeappliedaredescribedbelow.Thenewsystemallowsthesubmissionofseveralchangesinasamerequestforrevision,withalimitof3changes.Inaddition,applicantsshouldbeawarethatthesubmitteddocumentationshallbefullyinaccordancewiththerequirementsoftheprocedure,sinceforreasonsofefficacythenumberofassessmentsperrequestwillbelimitedandthereforerequestswhicharedeemeddeficientwillberejected.1.ImplementationAllrequestsforrevision/renewalreceivedfrom1September2004willbetreatedaccordingtothisnewpolicy.2.Howtoapplyforarequestforrevision/renewalApplicationform:Aspecificapplicationformforrevisions/renewalsistobesubmittedtogetherwitheachrequestforrevision.ItcanbedownloadedfromourwebsiteinorAcrobatformat.Documentationtobesubmitted:Thedocumentationtobesubmittedforeachrequestforrevision/renewalisdescribedinthe“GuidelineonRequirementsonRevisions/RenewalsofCertificates”(seedocumentPA/PH/CEP(04)2).3.Procedures3.1.NotificationsPA/PH/Exp.CEP/T(04)18p.3de5Thedeterminationofvalidityofanotificationiscompletedwithin2weeksafterreceiptofarequest.Theneitheranacknowledgementofavalidnotificationissentorarevisedcertificateisgrantedifnecessary.Ifthenotificationdossierisincompleteatreceipt,therequestisrejectedwithoutaskingforanyadditionalinformationandaletterofrejectionissenttotheapplicant.Thismeansthattheapplicantwillhavetoresubmittheappropriatepackageofdataandpaytherelevantfee.Anapplicationformultiplesimultaneousnotificationsispossibleunderconditions:-maximum3changes-feeanddeadlinesareincreased(seeTableinSection4).3.2.MinorchangesT0(within5daysafterreceiptoftherequest):aletterofacknowledgementofreceiptissenttotheapplicant.T30days:eithertherequestisapprovedandarevisedcertificateisgranted,oraletterofrequestforadditionalinformationissent(clock-stop).Ifclock-stop:theapplicantisrequestedtosubmitareplywithin30days.Failuretosubmitareplyintimewillleadtotherejectionoftherequestforrevision.NewT0:responsefromtheapplicantreceivedattheCertificationSecretariat.NewT30days:Approval(arevisedcertificateisgranted),orletterofrejectionoftherequestiftheanswerisdeemeddeficient.Iftheapplicationisrejected,theapplicantwillhavetoresubmittheappropriatepackageofdataandpaytherelevantfee.Anapplicationformultiplesimultaneousminorchanges,orminor+notificationsispossibleunderconditions:-maximum3changes-feeanddeadlineareextended(seeTableinSection4).3.3.MajorchangesT0(within5daysafterreceipt):aletterofacknowledgementofreceiptissenttotheapplicant.T90days:eithertherequestisapprovedandarevisedcertificateisgranted,oraletterofrequestforadditionalinformationissent(clock-stop).Ifclock-stop:theapplicantisrequestedtosubmitareplywithin30days.Failuretosubmitareplyintimewillleadtotherejectionoftherequestforrevision.NewT0:responsefromtheapplicantreceivedattheCertificationSecretariat.NewT30days(exceptTSEcertificates:90days):Approval(arevisedcertificateissent),orletterofrejectionoftherequestiftheanswerisdeemeddeficient.Iftheapplicationisrejected,theapplicantwillhavetoresubmittheappropriatepackageofdataandpaytherelevantfee.Anapplicationformultiplesimultaneouschanges,i.e.onemajor+minor/notificationsispossibleunderconditions:PA/PH/Exp.CEP/T(04)18p.4de5-maximum3changes,whichincludesonly1majorchange-feeisincreased(seeTableinSection4).3.4.QuinquennialrenewalTheholderofthecertificateshouldapplyfortherenewaloftheircertificateabout6monthspriortoexpirydate.Consideringthetimetakenfortheassessmentofthedossier,failuretosubmitarequestforrenewalsufficientlyinadvancecouldleadtoagapbetweentheexpirydateofthecertificateanditsrenewal.T0(within5daysafterreceipt):aletterofacknowledgementofreceiptissenttotheapplicant.T120days:eitherapprovalandarenewedcertificateissent,oraletterofrequestforadditionalinformationissent(clock-stop).Ifclock-stop:theapplicantisrequestedtosubmitareplywithin30days.NewT0:responsefromtheapplicantreceivedattheCertificationSecretariat.NewT30days(exceptTSEcertificates:90days):Approval(arenewedcertificateissent)ornewrequestforinformation.Introductionofchangesintheapplicationispossibleatthetimeofrenewal,withnoconditions.3.5.MonographsrevisionsWhenarevisedmonographispublished,aletterissentbytheCertificationSecretariattotherelevantholdersofcertificatestoaskthemtoupdatetheirdossier.Theholderisrequestedtosubmitthedatawithin90days.T0:Atreceiptofthedata,startofevaluation(noletterfromEDQM)T120days:sendingofanacknowledgementofvaliddata,orarevisedcertificateifnecessary,oraletterofrequestforadditionalinformation(clock-stop).Ifclock-stop:theapplicantisrequestedtosubmitareplywithin30days.NewT0:responsefromtheapplicantreceivedattheCertificationSecretariat.NewT30days:Approvalornewrequestforinformation.PA/PH/Exp.CEP/T(04)18p.5de54.Feeandtimetables:TypeofrevisionFee(Euros)TimetableSimpleNotification5002weeksMultiplenotifications100030daysSimpleMinorchange100030daysMultipleminorchanges/minorchanges+notifications150060daysSimplemajorchange150090daysMajorchange+minorchanges/notifications150090daysQuinquennialrenewal1500120daysMonographrevision0120daysMoreinformation:Foranyquestionconcerningthenewproceduresforrevisions/renewals:pleasecontactusatceprevision@pheur.org