Substances

List of documentation for pharmaceutical substances registration

I. Administrative documents

1. Application
2. Documents confirming competence of application for state registration
3. Original payment order for drug registration fee
4. Translated into the Russian and duly legalized, document copy confirmed registration outside the Russian Federation
5. GMP Certificate for pharmaceutical substance
6. original name and trademark in accordance with the Russian Federation Law (certificate of trademark)
7. Submission letter to the Ministry of Public Health

II. Data on drug manufacture and quality control

1. Regulatory documents or regulatory document for pharmaceutical substance
2. Validation of analytical techniques\methods
3. Standards or comparison materials, certificates of analyses for standards
4. Justification of specification
5. Diagram of substance manufacturing process flow
6. Critical stages of manufacturing drugs and by-products
7. experimental industrial justification
8. Validation and/or qualification of manufacturing process
9. Mass balance
10. pharmaceutical substance name (international generic or chemical and  commercial name)
11. Name and address of the pharmaceutical substance manufacturer
12. shelf life of pharmaceutical substance (stability report)
13. Document that includes information on quality indexes
14. Regulatory documents for pharmaceutical substance or reference to the corresponding Pharmacopoeia monograph
15. Validation of analytical techniques\methods for pharmaceutical substance
16. Pharmaceutical substance packaging
17. Stability report and other information about substance storage and transportation conditions