Documents for registration of a vaccine for animals.

1. Application for state registration of a medicinal product - 2 copies.
2. Registration dossier containing the following documents:

1) a copy of the license for the production of medicinal products issued to the manufacturer of the registered medicinal product for veterinary use, for Russian manufacturers;

2) a copy of the license for the production of medicinal products issued to the manufacturer of the pharmaceutical substance that is part of the registered medicinal product for veterinary use, for Russian manufacturers;

A copy of the document issued by the authorized body of the country of origin for each production site of the registered medicinal product for veterinary use and confirming the compliance of the medicinal product manufacturer with the requirements of the rules of good manufacturing practice, and its translation into Russian, certified in accordance with the established procedure, as well as a copy of the conclusion on the compliance of the medicinal product manufacturer with the requirements of the rules of good manufacturing practice issued by the authorized Federal Agency for Veterinary Medicine. for each production site of the registered medicinal product for veterinary use, or a copy of the decision on conducting an inspection of the manufacturer of medicinal products adopted by the authorized federal executive body for each production site of the registered medicinal product for veterinary use. These documents are submitted if the medicinal product is manufactured outside the Russian Federation;

A copy of the document issued by the authorized body of the country of manufacture of the pharmaceutical substance and confirming the compliance of the manufacturer of the pharmaceutical substance that is part of the registered medicinal product for veterinary use with the requirements of the rules of good manufacturing practice, and its translation into Russian, certified in accordance with the established procedure, if the production of the pharmaceutical substance is carried out outside the Russian Federation;

3. Draft regulatory document for a medicinal product for veterinary use – 4 copies;

4. A document containing the following information about a pharmaceutical substance or pharmaceutical substances that are part of a medicinal product for veterinary use:
5. a) name of the pharmaceutical substance, its structure, general properties (when state registration of immunobiological medicinal products for veterinary use, information about the strain is provided, including its name, information about its origin, properties, characteristics and place of deposit);
6. b) name and address of the manufacturer;
7. c) production technology with a description of the stages of production and control methods at all stages of production;
8. d) information on impurities (not provided for state registration of immunobiological medicinal products for veterinary use);
9. e) specification for a pharmaceutical substance (not submitted for state registration of immunobiological medicinal products for veterinary use);
10. f) description of quality control techniques;
11. g) results of analysis of pharmaceutical substance batches (not submitted for state registration of immunobiological medicinal products for veterinary use);
12. h) a list of standard samples or substances used in the implementation of quality control;
13. i) description of the characteristics and properties of packaging materials and closures;
14. j) stability data (not provided for state registration of immunobiological medicinal products for veterinary use);
15. l) shelf life, storage conditions;
16. Report on the results of a preclinical study of a medicinal product for veterinary use, including a description of methods for determining the residual amounts of the active substance (s) reaching the systemic blood flow in animal products after the use of such a medicinal product, as well as documentary confirmation (validation) of these methods;
17. Report on the results of a clinical study of a medicinal product for veterinary use in each type of animal specified in the instructions for veterinary use;
18. Draft instructions for the use of a medicinal product - 6 copies signed with the organization's seal, must comply with the requirements of the Order of the Ministry of Agriculture of August 22, 2017 No. 430 "On approval of requirements for instructions for veterinary use of medicinal products");
19. Draft layouts of primary packaging and secondary (consumer) packaging of a medicinal product (in 3 copies) issued in accordance with Article 46 of the Law, the following information about the medicinal product for veterinary use:
20. a) description and composition of the medicinal product for veterinary use;
21. b) description of the pharmaceutical development;
22. c) description of the production process and its control;
23. d) a description of the control of critical stages of production and intermediate products, signed in accordance with the procedure established in accordance with part 1 of Article 17 of the Law;
24. e) names and addresses of the developer, holder or holder of the registration certificate of the medicinal product, production sites of the manufacturer of the medicinal product for veterinary use, indicating the stages of the technological process carried out at the production sites of the manufacturer of the medicinal product for veterinary use;
25. f) pharmaceutical compatibility;
26. g) microbiological characteristics;
27. h) material balance for the production of a batch of the finished product;
28. i) description of the characteristics and properties of packaging materials and closures;
29. j) documenting (validating) processes and / or evaluating them;
30. k) quality requirements for excipients (certificate, specification for excipients and their justification);
31. m) analytical methods used in the implementation of quality control of excipients;
32. h) documentary confirmation (validation) of analytical methods used in the implementation of quality control of excipients;
33. o) information on the use of excipients of human and animal origin;
34. p) quality requirements of the medicinal product for veterinary use (certificate, specification for the medicinal product and their justification);
35. p) analytical methods used in the implementation of quality control of a medicinal product for veterinary use;
36. c) documentary confirmation (validation) of analytical methods used in the implementation of quality control of a medicinal product for veterinary use;
37. t) a document confirming the quality of the medicinal product of three industrial series (protocol of analysis or certificate of analysis), one series of which must coincide with the series of the sample of the medicinal product submitted for registration;
38. y) characteristics of impurities;
39. f) a list of standard samples used in the implementation of quality control of a medicinal product for veterinary use;
40. x) data on the stability of the medicinal product for veterinary use;

9. A copy of the document containing information about the presence or absence of facts of registration of a medicinal product for veterinary use outside the Russian Federation;
10. Written consent provided for in Part 6 of this Article of the Federal Law in the case of registration of a reproduced medicinal product;
11. A copy of the document in Russian certified in accordance with the established procedure and confirming the validity of the application for state registration of a medicinal product for veterinary use (power of attorney);
12. Copies of documents confirming payment of state fees (2 copies): - for conducting an expert examination of the quality of the medicinal product and an expert examination of the ratio of the expected benefit to the possible risk of using the medicinal product during its state registration; - for issuing a registration certificate of the medicinal product;
13. Information on the state registration of genetically engineered organisms intended for release into the environment (in the case of state registration of medicinal products for veterinary use obtained with the use of genetically engineered organisms or containing such organisms).
14. Inventory of submitted registration documents-2 copies.