CertificationUnitECEP/05b01/2005p.ofNUMPAGES15ApplicationForm–REQUESTFORREVISIONORRENEWALOFCERTIFICATEOFSUITABILITY(tobefilledinforeachrequestforrevisionofaCertificateofSuitabilitytothemonographsoftheEuropeanPharmacopoeiainaccordancewithResolutionAPCSP(99)4)Dateofsubmission:……./……/……1.GeneralInformation:Dossiernumber:CEP…………………………1.1.Typeofapplication(Pleasetickagainsttheappropriateoption:)FORMCHECKBOX
NotificationFORMCHECKBOX
MinorchangeFORMCHECKBOX
MajorchangeFORMCHECKBOX
QuinquennialrenewalFORMCHECKBOX
Multipleminorrevisions(max3)FORMCHECKBOX
Multiplerevisions(1major,max3intotal)FORMCHECKBOX
Consolidatedrevision(morethan3changes)SCOPEPleasespecifythescopeofthechange(s)inaconcisewayForNotificationsandMinorchanges,TableofSection3shouldalsobefilledin.1.2NameofthesubstanceusingtheRecommendedInternationalNonproprietaryName(rINN)(specifyanysubtitlerequestedsuchas'sterile','micronized’)Monograph(s)youarereferringto:(Name,Number,Month/Yearofpublication)2.Namesandaddresses2.1Intendedcertificateholder(N.B.forexceptionalcaseswheretheholderwillnotbethemanufacturerpleasereferto4.4)Name*:Streetname*:Buildingnumber:Locality,district:Postcode*:City*:POBox:State/county/province/area:Country*:Tel*:Fax*:E-mail:Fieldsmarked*arerequired.2.2Contactnameorperson/companyauthorisedforcommunicationonbehalfoftheintendedholder(ifdifferentfrommanufacturerpleaseprovideanauthorisationletter-seeAnnex1)Titleandsurname:*Firstname:*Jobtitle:Department:Nameofthecompany:StreetAddress*:Buildingnumber:Locality/district:Postcode*:City*:POBox:State/county/province/area:Country*:Tel*:Fax*:E-mail*:Fieldsmarked*arerequired.TickthisboxifyoudonotwishtoreceiveanycommunicationfromEDQMbye-mailconcerningthisapplicationFORMCHECKBOX
2.3Manufacturer(ifdifferentfromtheholderpleasereferto4.4):Name:*Streetname*:Buildingnumber:Locality,district:Postcode*:City*:POBox:State/county/province/area:Country*:Tel*:Fax*:E-mail: