Information required YES NO (please comment below, if requirements not fully met) 1 Is the product strength currently invited? Comment Does the cover letter include a statement indicating that the 2 information and data submitted is "true, complete and correct"? Comment Has the applicant submitted a valid manufacturing licence and/or 3 valid Good Manufacturing Practice certificate for the FPP? Comment 4 Has the applicant submitted valid marketing authorization data? Comment If PQ-API, APIMF or CEP is used to present API data, are the respective Confirmation of API Prequalification, Letters of Access or EDQM CEP provided? 5 For CEP, ensure the valid version on the EDQM website at the time of screening is submitted or request the valid version. Comment If the full dossier route is used to present API data for an API site that is not part of the same pharmaceutical group as the FPP manufacturer, has a declaration been provided from the API manufacturer that: 6 it has provided to the FPP manufacturer all confidential and information regarding the preparation, control and stability of the API as per ICH module 3.S.2; and, it will inform the FPP manufacturer of any changes to the preparation, control and stability of the API? Comment If the full dossier route is used to present API data for an API site, 7 has a complete module 3.2.S been provided? Comment Has the applicant submitted Quality Overall Summary Product – 8(a) Dossier (QOS-PD) and Quality Information Summary (QIS) as Word documents using the most recent version? Comment Has the QOS and/or QIS template been altered (missing sections, 8(b) subsections, tables, etc)? Comment Is the QOS-PD completed in an acceptable way, including 9 references to dossier volumes and pages? Comment If a bioequivalence study is required (no biowaiver application), has 10(a) the applicant submitted the Bioequivalence Trial Information (BTIF) as a Word document? Comment
Information required (please comment below, if requirements not fully met) YES NO 1 Is the product strength currently invited? Comment 2 Does the cover letter include a statement indicating that the information and data submitted is "true, complete and correct"? Comment 3 Has the applicant submitted a valid manufacturing licence and/or valid Good Manufacturing Practice certificate for the FPP? Comment 4 Has the applicant submitted valid marketing authorization data? Comment 5 If PQ-API, APIMF or CEP is used to present API data, are the respective Confirmation of API Prequalification, Letters of Access or EDQM CEP provided? For CEP, ensure the valid version on the EDQM website at the time of screening is submitted or request the valid version. Comment 6 If the full dossier route is used to present API data for an API site that is not part of the same pharmaceutical group as the FPP manufacturer, has a declaration been provided from the API manufacturer that: it has provided to the FPP manufacturer all confidential and information regarding the preparation, control and stability of the API as per ICH module 3.S.2; and, it will inform the FPP manufacturer of any changes to the preparation, control and stability of the API? Comment 7 If the full dossier route is used to present API data for an API site, has a complete module 3.2.S been provided? Comment 8(a) Has the applicant submitted Quality Overall Summary – Product Dossier (QOS-PD) and Quality Information Summary (QIS) as Word documents using the most recent version? Comment 8(b) Has the QOS and/or QIS template been altered (missing sections, subsections, tables, etc)? Comment 9 Is the QOS-PD completed in an acceptable way, including references to dossier volumes and pages? Comment 10(a) If a bioequivalence study is required (no biowaiver application), has the applicant submitted the Bioequivalence Trial Information (BTIF) as a Word document? Comment
83%20Screening%20checklist%20generic%20product_May2018.docx