SOP No.: EP-INS-001 Page 1 Annexure-3 Checklist for documents to be submitted for application of “Written Confirmation” for active substances exported...
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Annexure-3
Checklist for documents to be submitted for application of “Written Confirmation” for active substances exported to the EU for medicinal products for human use, In accordance with Article 46(2)(b) of Directives No. 2001/83/EC 1. Covering Letter – The covering letter is an important part of the application and should clearly specify the intent of the application (whether the application is being submitted for the first time, whether the application is for re-issue or is for the additional products to an existing Written Confirmation) the list of documents that are being submitted (Index with page no’s) as well as any other important and relevant information may be provided in the covering letter. The covering letter should be duly signed and stamped by the authorized signatory, indicating the name & designation of the authorized signatory alongwith the name and address of the firm. 2. An Authorization letter in original issued by the Director/Company Secretary/Partner of the firm revealing the name & designation of the person authorized to sign (along with the name and address of the firm) on behalf of the firm should be submitted at the time of submission of the application Duly self attested photocopies of the Authorization letter may be submitted at the time of submission of subsequent applications. 3. Copy of GMP certificate issued as Certificate of Pharmaceutical Product issued as per WHO guidelines, USFDA, EDQM, etc. if any 4. Copy of Manufacturing License issued by SLA 5. List of all APIs approved by SLA. 6. List of Products applied for issue of “Written Confirmation” for active substances exported to the EU for medicinal products for human use, in accordance with Article 46(2)(b) of Directives No. 2001/83/EC 7. List of SOPs and STPs 8. Summary of Stability data (3 batches) Accelerated/ Real time (as prescribed) 9. List of Equipment and Instruments 10. List of Technical staff, their qualification, experience and their approval by SLA. 11. Manufacturing Layout Plan as approved by SLA 12. Validation Master Plan SOP No.: EP-INS-001
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13. Summary of Process validation data for 3 batches of each product. 14. Export data of last 3 years 15. Good Distribution Practices followed by the firm. 16. Summary of Annual Product review. 17. Summary of Market Complaint Review 18. Summary data of Impurity profiling 19. Summary data of Analytical Method Validation 20. Good Distribution Practices followed by the firm. 21. NSQ reports 22. Legal undertaking stating that Inspection/ Investigation reports of any regulatory inspection by Indian regulatory Authority including Show Cause Notices/ Suspensions/ Cancellations if any shall be communicated to “Competent Authority” i.e. DCG(I), CDSCO within 15 working days. 23. Site Master File (as specified under WHO TRS 823)
