1. application on inclusion of the drug substance in the State register of drugs;

2. document proving payment of state fee for inclusion of the drug substance not used in the manufacture of drug products in the State register of drugs;

3. drug substance manufacturing process flow-chart, its description;

4. a document translated into Russian and certifying that the drug substance manufacturer complies with GMP,issued by the competent authority of the drug substance manufacturer’s country, certified in accordance with the prescribed procedure and including the following:

a) drug substance name (international nonproprietary name or chemical name, and trade name);
b) drug substance manufacturer’s name and address;
c) drug substance shelf-life;

5. document containing quality parameters of a drug substance used in the manufacture of drug products;

6. regulatory documentation for the drug substance or a reference to the relevant monograph.

7. drug substance samples in quantities necessary for quality control methods.

8. test strains of microorganisms, cell cultures, samples of substances used for quality control by comparing them with the test product, in amount sufficient for quality control methods.

Based on:

Russian Federation Law №61-ФЗ "On drugs”, Chapter 6 State registration of drug products, Article 34. Quality evaluation of drug substances not used in the manufacture of drug products

Order of Russian MoH No. 750н dated 26.08.2010 Regulations on Expert Evaluation of Drug Products for Human Use and Forms of Expert Opinions on the Results of the Evaluation

Article 333.32.1. State fees for competent federal executive authority activities related to state registration of drugs. Russian Federation Law N 41-ФЗ dated 05.04.2010