最新CEP变更申请表 cepapplicationformforrevisionandrenewalofcepupdatedseptWord文档格式.docx

1、Date of submission: ./Format of submission （select one only）: eCTD NeeS PDF Paper1. General Information1.1 Dossier number and substance CEP / Substance name Subtitle （if applicable） .In case of grouped revision （a revision affecting several CEPs）, please list the dossier numbers and substances here:

2、 1.2 Type of application （Please tick one box only） Notification （may include several changes） Minor revision （may include several changes including notifications） Major revision （may include notifications and minor changes） Renewal （notifications and minor changes may be included） Grouped revision

3、（several dossiers affected） Transfer of holdership 2. Names and addresses2.1 Intended certificate holder: （N.B. for exceptional cases where the holder will not be the manufacturer please refer to 4.2）Name of the company*Address*Postcode*Town*Country*Telephone*Fax*E-mail*Name of a contact person with

4、in the company （if different from 2.2）Fields marked * are mandatory2.2 Contact person authorised for communication on behalf of the intended holder :（if different from manufacturer please provide an authorisation letter - see Annex 1）:Title* （Mrs, Mr, Dr）First name*Family name*Job title/DepartmentAd

5、dress for correspondence*2.3 Manufacturing site（s）: detailed name and address of all sites involved in the manufacture of this substance （if different from the intended holder, please also refer to 4.2） All sites involved in the manufacture of the active substance from the introduction of starting m

6、aterial（s）, including quality control / in process testing sites, intermediate manufacturers, milling, micronisation and sterilisation sites should be listed in separate boxes and their role should be specifiedRole*Name of the company *GPS （WGS 84） coordinates of the site*:Latitude （S or N） and Long

7、itude （E or W） expressed in Degrees Minutes Seconds to 1 decimal place （Alternatively it can be expressed in Degrees to at least 5 decimal places or Degrees Minutes to at least 3 decimal places） main entrance if not main entrance, specify the place:DUNS number if not main entrance, specify the place

8、Fields marked * are mandatory 3. Specific InformationTick the appropriate change（s）NotificationsImmediateAnnualImplementation date （annual notifications）Change in the name and/or address of the certificate holder of the final substance*-Change in the name and/or address of the manufacturing site or

9、quality control site for the final substance*Deletion of a manufacturer of intermediate or of a manufacturing or quality control testing site for the final substanceChange in the name and/or address of a manufacturer of an intermediate used in the manufacture of the final substance*Change or additio

10、n of a manufacturer of a starting material or intermediate used in the manufacturing process of the final substance when the proposed manufacturer is part of the same group as the currently approved manufacturerChange or addition of a manufacturing site/workshop for the final substance when the prop

11、osed manufacturer is part of the same group as the currently approved manufacturer*Changes to quality control testing for an intermediate or for the final substanceIntroduction of a new site of micronisation*Tightening of the specification limits for the final substanceMinor changes to a test procedure for the final substance. Editorial changes to a method description annexed to a certificate of suitabilityAddition of a specification parameter for the final substanceChange in the composition of the immediate packagingChange in the composition of the secondary packagingRemoval/reduct