《cepnewapplicationCEP证书申请表.pdf》由会员分享，可在线阅读，更多相关《cepnewapplicationCEP证书申请表.pdf（15页珍藏版）》请在金锄头文库上搜索。
1、European Directorate for the Quality of Medicines HealthCare Certification of Substances Division Page 1 15FORM 055 Rev 07 19 11 2012 Application Form REQUEST FOR NEW CERTIFICATE OF SUITABILITY to be filled in for each request for a new Certificate of Suitability to the monographs of the European Ph
2、armacopoeia in accordance with Resolution AP CSP 07 1 Date of submission Format of submission select one only eCTDNeeSPDFPaper 1 General Information 1 1 Type of application for a new Certificate of Suitability Please tick the appropriate option select one only ChemicalChemical and sterileTSE Double
3、Chemical and TSE Double and sterileHerbal 1 2 Name of the substance using the Recommended International Nonproprietary Name rINN Specify any subtitle requested such as sterile micronized 1 3 Monograph s you are referring to Name Number Year of publication 1 4 Re test period not applicable for TSE Ce
4、rtificate of Suitability Proposed re test period in months Commercial packaging Recommended storage conditions if applicable T o others Tick this box if you do not wish a re test period European Directorate for the Quality of Medicines HealthCare Certification of Substances Division Page 2 15FORM 05
5、5 Rev 07 19 11 2012 2 Names and addresses 2 1 Intended certificate holder N B for exceptional cases where the holder will not be the manufacturer please refer to 4 4 Name of the company Address Postcode Town Country Telephone Fax E mail Name of a contact person within the company if different from 2
6、 2 Fields marked are mandatory 2 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 Department Name of the company Address for correspondence
7、 Postcode Town Country Telephone Fax E mail Fields marked are mandatory European Directorate for the Quality of Medicines HealthCare Certification of Substances Division Page 3 15FORM 055 Rev 07 19 11 2012 2 3Manufacturing site s detailed name and address of all sites involved in the manufacture of
8、this substance if different from the intended holder please also refer to 4 4 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 sterilisati
9、on sites should be listed in separate boxes and their role should be specified Role Name of the company site 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 Alternativel
10、y 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 Fields marked are mandatory Role Name of the company site Address Postcode Town Country Telephone Fax E mail GPS WGS 84 coord
11、inates 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 main entrance if not main entrance specify the place DUNS number F
12、ields marked are mandatory European Directorate for the Quality of Medicines HealthCare Certification of Substances Division Page 4 15FORM 055 Rev 07 19 11 2012 3 History of the substance 3 1List of marketed medicinal products Please provide a list of marketed medicinal products containing the subst
13、ance 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 name Country Registration number and date Commercialisation date 3 2List of submitted ASMF Please provide a list o
14、f countries where your company has submitted an ASMF for the substance manufactured by your company according to the synthetic route presented in the dossier CountryRegistration NumberDate of submission Date of the last update when relevant European Directorate for the Quality of Medicines HealthCar
15、e Certification of Substances Division Page 5 15FORM 055 Rev 07 19 11 2012 4 Declarations mandatory see templates in Annex 4 1 Signed declaration of manufacture for each manufacturing site if relevant in accordance with the dossier and according to GMP rules as described in Annex 3a or if the substa
16、nce is not a drug substance a suitable quality assurance system specifying which rules guidelines standards are followed as described in Annex 3b 4 2 Signed declaration of willingness to be inspected for each manufacturing site if relevant This also applies for holders when different from manufacturers as described in Annex 4 4 3 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 certifi
