List of documents for post-registration variations (with expertise)

I.Administrative documents

1. Application for state registration
2. Documents confirming competence of application for state registration
3. Original payment order
4. Confirmation registration of product outside the Russian Federation
5. Certificate of GMP for product and active substance manufacturer
6. Certificate of trademark
7. EAN codes for all the dosages
8. Submission letter to Ministry of Public Health

II. Data on drug product manufacture and quality control

1. Primary and secondary product package
2. Normative document for product
3. Validation of analytical methods for product
4. Reference standards or materials, certificates of analyses of reference standards
5. Justification of drug formulation
6. Justification of specification
7. Product stability data
8. Product container closure system
9. certificates of analyses of drug product
10. Product manufacturing process flow chart
11. Critical steps and intermediates of product manufacturing process
12. Product process validation
13. Batch formula of product
14. Certificates of analyses of drug product excipients
15. Product substance manufacturing process flow chart
16. Name and address of the drug substance manufacturer
17. shelf life of drug substance
18. Document that includes information on quality parameters of drug substance used to produce drug products (CoA)
19. Normative document for substance
20. Validation of analytical methods for drug substance
21. Drug substance container closure system
22. Storage and transportation information
23. Product clinical trial report
24. Package
25. SmPC
26. Marketing Authorization copy
27. Copy of approved patient package
28. Copy of approved normative document