1、Application FormREQUEST FOR REVISION OR RENEWAL OF CERTIFICATE OF SUITABILITY(to be filled in for each request for revision or renewal of a Certificate of Suitability to the monographs of the European Pharmacopoeia, in accordance with ResolutionAP-CSP (07) 1)Date of submission: ./Format of submissio

2、n (select one only): FORMCHECKBOX eCTD FORMCHECKBOX NeeS FORMCHECKBOX PDF FORMCHECKBOX Paper1. General InformationDossier number and substanceCEP / Substance name Subtitle (if applicable) .In case of grouped revision (a revision affecting several CEPs), please list the dossier numbers and substances

3、 here: CEP / Substance name Type of application (Please tick one box only) FORMCHECKBOX Notification (may include several changes) FORMCHECKBOX Minor revision (may include several changes including notifications) FORMCHECKBOX Major revision (may include notifications and minor changes) FORMCHECKBOX

4、Renewal (notifications and minor changes may be included) FORMCHECKBOX Grouped revision (several dossiers affected) FORMCHECKBOX Transfer of holdership 2.Names and addresses2.1Certificate holder:(N.B. for exceptional cases where the holder will not be the manufacturer please refer to 4.2)Name of the

5、 company*Address*Postcode*Town*Country*Telephone*Fax*E-mail*Name of a contact person within the company (if different from 2.2)Fields marked * are mandatory2.2 Contact person authorised for communication on behalf of the holder :(if different from manufacturer please provide an authorisation letter

6、- see Annex 1): Title* (Mrs, Mr, Dr)First name*Family name*Job title/DepartmentName of the company*Address for correspondence*Postcode*Town*Country*Telephone*Fax*E-mail*Fields marked * are mandatoryManufacturing site(s): detailed name and address of all sites involved in the manufacture of this subs

7、tance (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 material(s), including quality control / in process testing sites, intermediate manufacturers, milling, micronisation and sterilisat

8、ion sites should be listed in separate boxes and their role should be specifiedRole*Name of the company *Address*Postcode*Town*Country*Telephone*Fax*E-mail*GPS (WGS 84) coordinates of the site*:Latitude (S or N) and Longitude (E or W) expressed in Degrees Minutes Seconds to 1 decimal place (Alternat

9、ively it can be expressed in Degrees to at least 5 decimal places or Degrees Minutes to at least 3 decimal places) FORMCHECKBOX main entrance FORMCHECKBOX if not main entrance, specify the place:DUNS numberFields marked * are mandatoryRole*Name of the company *Address*Postcode*Town*Country*Telephone

10、*Fax*E-mail*GPS (WGS 84) coordinates of the site*:Latitude (S or N) and Longitude (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) FORMCHECKBOX main entrance FO

11、RMCHECKBOX if not main entrance, specify the placeDUNS numberFields 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* FOR

12、MCHECKBOX -Change in the name and/or address of the manufacturing site or quality control site for the final substance* FORMCHECKBOX -Deletion of a manufacturer of intermediate or of a manufacturing or quality control testing site for the final substance FORMCHECKBOX -Change in the name and/or addre

13、ss of a manufacturer of an intermediate used in the manufacture of the final substance* FORMCHECKBOX -Change or addition 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 c

14、urrently approved manufacturer FORMCHECKBOX -Change or addition of a manufacturing site/workshop for the final substance when the proposed manufacturer is part of the same group as the currently approved manufacturer* FORMCHECKBOX -Changes to quality control testing for an intermediate or for the fi

15、nal substance FORMCHECKBOX -Introduction of a new site of micronisation* FORMCHECKBOX -Tightening of the specification limits for the final substance FORMCHECKBOX -Minor changes to a test procedure for the final substance. Editorial changes to a method description annexed to a certificate of suitabi

16、lity FORMCHECKBOX -Addition of a specification parameter for the final substance FORMCHECKBOX -Change in the composition of the immediate packaging FORMCHECKBOX -Change in the composition of the secondary packagingRemoval/reduction of the re-test period from the Certificate of suitability / change t

17、o more restrictive storage conditions FORMCHECKBOX -Change to an approved stability protocol FORMCHECKBOX -Deletion of an approved change management protocol related to the final substance FORMCHECKBOX -Implementation of changes foreseen in an approved change management protocol that does not requir

18、e further supportive data FORMCHECKBOX -Introduction of a new CEP to describe a starting material used in the manufacturing process of a final substance FORMCHECKBOX -Introduction of a revised CEP for a starting material when the manufacturing sites mentioned on this CEP are changed FORMCHECKBOX -De

19、letion of a CEP for a starting material FORMCHECKBOX -Change in the name and/or address of a manufacturer of a starting material used in the manufacture of the final substance- FORMCHECKBOX Deletion of a manufacturer or a quality control site for a starting material used in the manufacture of the fi

20、nal substance- FORMCHECKBOX Change in the code product/reference number and/or in the brand name of the final substance or any material used in its manufacture- FORMCHECKBOX Changes to quality control testing for a starting material- FORMCHECKBOX Minor change in the manufacturing process of the fina

21、l substance- FORMCHECKBOX Change in batch size of final substance or intermediate up to 10-fold compared to the original batch size- FORMCHECKBOX Change in batch size of final substance or intermediate: downscaling up to 10-fold- FORMCHECKBOX Addition of a new in-process test and limit applied durin

22、g the manufacture of the final substance- FORMCHECKBOX Deletion of a non significant in-process test applied during the manufacture of the final substance- FORMCHECKBOX Tightening of the limits of in-process tests applied during the manufacture of the final substance- FORMCHECKBOX Addition of a spec

23、ification parameter for a starting material/intermediate/reagent- FORMCHECKBOX Deletion of a non-significant specification parameter for the final substance/starting material/intermediate or deletion of a test procedure for a starting material/intermediate/reagent- FORMCHECKBOX Minor changes to a te

24、st procedure for a starting material/intermediate/reagent used in the manufacturing process of the final substance- FORMCHECKBOX Tightening of the specification limits for a starting material/ intermediate/reagent used in the manufacturing process of the final substance- FORMCHECKBOX Change in the s

25、pecification parameters and/or limits of the immediate packaging of the final substance- FORMCHECKBOX Change in the specification of the secondary packaging- FORMCHECKBOX Submission of a revised CEP for a starting material, when the manufacturing sites mentioned on this CEP are unchanged- FORMCHECKB

26、OX * updated declarations according to the relevant annexes are to be submittedNotifications for TSE certificatesImmediateAnnualImplementation dateDeletion of a source country or deletion of a tissue used in the preparation of the final product FORMCHECKBOX -Change or addition of a manufacturing sit

27、e for the final substance when the proposed manufacturer is part of the same group as the approved manufacturer* FORMCHECKBOX -Change in the quality assurance system applied in the manufacturing site* FORMCHECKBOX -Minor change in the specification of the final substance FORMCHECKBOX -Minor change i

28、n the manufacturing process (including process parameters) of the final substance- FORMCHECKBOX * updated declarations according to the relevant annexes are to be submittedMinor changesChange or addition of a manufacturer of a starting material used in the manufacturing process of the final substanc

29、e FORMCHECKBOX Change or addition of a manufacturer of an intermediate used in the manufacturing process of the final substance* FORMCHECKBOX Change or addition of a manufacturer of a starting material used in the manufacturing process of a biological substance FORMCHECKBOX Change or addition of a m

30、anufacturer of an intermediate used in the manufacturing process of a biological substance* FORMCHECKBOX Change or addition of a manufacturing site/workshop for the final substance* FORMCHECKBOX Change or addition of a manufacturer for a biological substance* FORMCHECKBOX Addition of an alternative

31、sterilisation site for the final substance* FORMCHECKBOX Minor changes to the manufacturing process of a biological substance FORMCHECKBOX For a “double” Certificate of suitability (for chemical purity and microbiological quality and for TSE risk), change in source of a material used in the preparat

32、ion of the final substance from a TSE risk material to a vegetable, synthetic, or non-TSE risk material FORMCHECKBOX Change in batch size of final substance or an intermediate more than 10-fold compared to the original batch size FORMCHECKBOX Change in batch size of a biological substance FORMCHECKB

33、OX Widening of approved specification limits for the final substance to be in line with the limits of the Ph. Eur monograph/ICH/VICH guidelines FORMCHECKBOX Minor changes to the manufacturing process of a biological substance, including change in batch size FORMCHECKBOX Changes to a test procedure (

34、including replacement or addition) for the biological substance/starting material/intermediate or changes to a biological method FORMCHECKBOX Extension/addition of the re-test period of the final substance and/or change in the storage conditions for the final substance FORMCHECKBOX Proposed retest p

35、eriod (in months)Commercial packagingRecommended storage conditionsMinor changes to an approved change management protocol that do not change the strategy defined in the protocol FORMCHECKBOX Implementation of changes foreseen in an approved change management protocol that requires further supportiv

36、e data FORMCHECKBOX Introduction of a new CEP for a starting material, when the specifications of the starting material are changed FORMCHECKBOX Submission of a revised CEP for a starting material, when the specifications mentioned on this CEP are changed FORMCHECKBOX Other minor changes (by default

37、) FORMCHECKBOX Describe briefly any non-listed minor changes in this box : * updated declarations according to the relevant annexes are to be submittedMajor changesChange/addition of the manufacturer of a starting material or intermediate, when the proposed manufacturer uses a substantially differen

38、t route of synthesis or manufacturing conditions, which are likely to change the qualitative and/or quantitative impurity profile (eg. new reagents, solvents, materials are introduced in the synthesis)* FORMCHECKBOX Change in the manufacturing process of the final substance that regards the steriliz

39、ation step(s), including changes in batch size of a sterile substance FORMCHECKBOX Substantial change to the manufacturing process/addition of an alternative manufacturing process for a starting material, intermediate or final substance likely to change the qualitative and/or quantitative impurity p

40、rofile (eg. new reagents, solvents, materials are introduced in the synthesis) FORMCHECKBOX Changes in the manufacturing process of a herbal substance related to geographical source or production FORMCHECKBOX Widening or deletion of approved in-process test limits, which may have a significant effec

41、t on the overall quality of the final substance FORMCHECKBOX Widening of the approved specification limits for the final substance FORMCHECKBOX Widening of the approved specification limits for starting materials/ intermediates, which may have a significant effect on the overall quality of the final

42、 substance FORMCHECKBOX Deletion of a specification parameter which may have a significant effect on the overall quality of the final substance FORMCHECKBOX Change in the composition of immediate packaging for a sterile substance FORMCHECKBOX Introduction of a new design space or extension of an app

43、roved design space or of a post approval change management protocol related to the final substance FORMCHECKBOX Introduction of a post approval change management protocol related to the final substance FORMCHECKBOX Major changes to an approved change management protocol FORMCHECKBOX Deletion of a CE

44、P for a starting material and replacement by another source that does not have a CEP FORMCHECKBOX Major changes for TSE certificatesChange/addition of a source country or tissues for TSE risk material FORMCHECKBOX Change/addition of a manufacturer of a starting material or intermediate* FORMCHECKBOX

45、 Change/addition of a manufacturing site where other TSE materials than the substance are processed* FORMCHECKBOX Substantial changes in the manufacturing process that are likely to affect the TSE risk FORMCHECKBOX * for a manufacturer of intermediate or the final substance, updated declarations acc

46、ording to the relevant annexes are to be submitted4.Comparative table (as described in Annex 7) (mandatory for all submissions)The comparative table should highlight the differences between the approved and proposed text of module 3, together with the correct classification of each change according

47、to the EDQM Guideline for revisions.5.Declarations5.1. Signed holders commitments (as described in Annex 6) (for all submissions)5.2 Updated declarations (when relevant)Signed declaration of manufacture (for each manufacturing site, if relevant) in accordance with the dossier and according to GMP ru

48、les (as described in Annex 3a) (or, if the substance is not a drug substance, a suitable quality assurance system, specifying which rules/guidelines/standards are followed, as described in Annex 3b).Signed declaration of willingness to be inspected (for each manufacturing site, if relevant). This al

49、so applies for holders when different from manufacturers (as described in Annex 4).Signed declaration on use or non-use of materials of human or animal origin including TSE risk materials (not to be submitted in case of an application for a TSE certificate) (as described in Annex 5)Holder different

50、from manufacturer: In exceptional cases where the holder of the certificate will not be the manufacturer, please provide the following declarations:A declaration from the manufacturer to commit to inform the holder of any change made so that the dossier submitted to the EDQM can be updated without a

51、ny delay by the holder (see Annex 2).Declarations of willingness to be inspected from both the holder and the manufacturer (as described in Annex 4)6.History of the productThis section is to be filled in only for renewal.6.1List of marketed medicinal productsPlease provide a list of marketed medicin

52、al products containing the product manufactured by your company according to the synthetic route presented in the dossier, and key dates (use additional sheets if necessary) Brand name of medicinal products and company nameCountryRegistration number anddateCommercialisation date7.Ways of submission:

53、Submission of electronic files (strongly recommended): - Via the Common European Submission Platform “CESP”. Users can register for a CESP account on the HYPERLINK :/ edqm.eu/site/head-of-medicines-agency-en-752-1.html o head of medicines agency Heads of Medicines Agencies website*.- CD-ROM or DVD,

54、appropriately identified (to be sent to the address below) Paper submissions: European Directorate for the Quality of Medicines (Council of Europe)Certification of Substances Division7, alle KastnerCS 30026 F - 67081 Strasbourg, France*Alternatively if there is an issue using the CESP, an Internet s

55、ecured Dropbox is available for files up to 100 MB - Access codes can be obtained upon request to cepedqm.eu.8.Invoicing details (mandatory)Following receipt of the application EDQM will send you an invoice. Please proceed with payment after you receive the invoice.CEP number: Name of the substance:

56、Date of receipt of the application (for EDQM):ReferenceItemPriceTick as appropriateCEP 004Renewal 1 500 FORMCHECKBOX CEP 009Notification1000 FORMCHECKBOX CEP 005Minor revision1500 FORMCHECKBOX CEP 019Grouped revisions (affecting several dossiers)2000 FORMCHECKBOX CEP 020Major revision ( may include

57、minor changes and notifications )2000 FORMCHECKBOX CEP 006Transfer of Holdership1500 FORMCHECKBOX CEP 015Evaluation of sterility data 3000 FORMCHECKBOX Contact person for the application, authorised for communication on behalf of the holder:Title* (Mrs, Mr, Dr)Contact first name*Contact family name*

58、Job title/DepartmentCompany name*Address*Postcode*City*Country*Telephone*Fax*Email*Fields marked * are mandatoryINVOICING ADDRESSCOMPANY DETAILSEDQM Client CodeCompany name (*):Address(*)City (*):Postcode (*)Region/StateCountry (*)VAT Number (*)Tel (switchboard) (*)Fax (*)Email (*)Contact name(*)Con

59、tact first name (*)Job title (*)Department (*)Tel (*)Fax (*)Email (*)Fields marked (*) are mandatory. Fields marked with (*) are required for EU only.If payment will come from several sources, please identify below the names of those companies that will pay:_PREFERRED LANGUAGE (for invoicing/account

60、ing only): English FrenchAREA OF ACTIVITY/OCCUPATION (please tick the appropriate box)Manufacturer of raw materialRetail Private LaboratoryManufacturer of pharmaceutical productsDistributorOtherManufacturer of other products (e.g. cosmetics)UniversityHospitalNational Authority, Regulatory Authority,