cos 申请表Application

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1、CertificationUnitApplicationForm–REQUESTFORREVISIONORRENEWALOFCERTIFICATEOFSUITABILITY(tobefilledinforeachrequestforrevisionofaCertificateofSuitabilitytothemonographsoftheEuropeanPharmacopoeiainaccordancewithResolutionAPCSP(99)4)Dateofsubmission:……./……/……1.GeneralInforma

2、tion:Dossiernumber:CEP…………………………1.1.Typeofapplication(Pleasetickagainsttheappropriateoption:)NotificationMinorchangeMajorchangeQuinquennialrenewalMultipleminorrevisions(max3)Multiplerevisions(1major,max3intotal)Consolidatedrevision(morethan3changes)SCOPEPleasespecifythesc

3、opeofthechange(s)inaconcisewayForNotificationsandMinorchanges,TableofSection3shouldalsobefilledin.1.2NameofthesubstanceusingtheRecommendedInternationalNonproprietaryName(rINN)(specifyanysubtitlerequestedsuchas'sterile','micronized’)1.3Monograph(s)youarereferringto:(Name,N

4、umber,Month/Yearofpublication)ECEP/05b01/2005p.15of152.Namesandaddresses2.1Intendedcertificateholder(N.B.forexceptionalcaseswheretheholderwillnotbethemanufacturerpleasereferto4.4)Name*:Streetname*:Buildingnumber:Locality,district:Postcode*:City*:POBox:State/county/provinc

5、e/area:Country*:Tel*:Fax*:E-mail:Fieldsmarked*arerequired.2.2Contactnameorperson/companyauthorisedforcommunicationonbehalfoftheintendedholder(ifdifferentfrommanufacturerpleaseprovideanauthorisationletter-seeAnnex1)Titleandsurname:*Firstname:*Jobtitle:Department:Nameofthec

6、ompany:StreetAddress*:Buildingnumber:Locality/district:Postcode*:City*:POBox:State/county/province/area:Country*:Tel*:Fax*:E-mail*:Fieldsmarked*arerequired.TickthisboxifyoudonotwishtoreceiveanycommunicationfromEDQMbye-mailconcerningthisapplicationECEP/05b01/2005p.15of152.

7、3Manufacturer(ifdifferentfromtheholderpleasereferto4.4):Name:*Streetname*:Buildingnumber:Locality,district:Postcode*:City*:POBox:State/county/province/area:Country*:Tel*:Fax*:E-mail:2.4Manufacturingsite(s):Name:*Streetname*:Buildingnumber:Locality,district:Postcode*:City*

8、:State/county/province/area:Country*:Tel*:Fax*:Name:*Streetname*:Buildingnumber:Locality,distric