Pharmaceuticals

List of documents for pharmaceutical products registration

I. Administrative documents

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

II. Data on pharmaceutical product manufacture and quality control

1. Primary and secondary (consumer’s) product package
2. Normative document for the 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. Drug product stability data
8. Drug container closure system
9. certificates of analyses of 3 series of product
10. Drug product manufacturing process flow chart
11. Critical steps and intermediates of product manufacturing process
12. Drug product process validation
13. Batch formula of product
14. Certificates of analyses
15. Product substance manufacturing process flow chart
16. Product substance name
17. Name and address of the drug substance manufacturer;
18. shelf life of drug substance;
19. Document that includes information on quality parameters of drug substance used to produce drug products (CoA);
20. Normative documentation or normative document for drug substance or reference to the corresponding Pharmacopoeia monograph;
21. Validation of analytical methods for drug substance;
22. Product substance container closure system;
23. Information on conditions of product storage and transportation, and other information;
24. Product preclinical trial report
25. Clinical trial protocol;
26. Investigator’s brochure;
27. List of Informed consent form and Information for patient
28. Report of international multicenter clinical trials of product
29. SmPC