List of documentation for registration veterinary products

I. Administrative documents of veterinary products manufacturer 
1. application
2. Registration certificate (Marketing Autorization) for legal entity in the source country
3. Original name and document of trademark registration (when the name has been registered as a trademark in accordance with the Russian Federation Law)
4. Confirmation about product registration outside the Russian Federation

II. Documents for manufacture and quality control 
5. Certificate for production site (legalization)
6. Data on manufacture of veterinary product 
7. Information on veterinary product components: quality certificate for all the components included into the veterinary product; Pharmacopoeia monograph or control methods for active substances; information on shelf lives of active substances included into the veterinary product; certificate for production site (legalization) for manufacturers of active substances
8. Quality certificate 
9. Quality control methods 

III. Clinical and preclinical studies reports:
10. Results of pre-clinical studies
- toxicity (acute, subchronic and chronic) on laboratory and target animal species
- teratogenecity, mutagenicity, carcinogenicity, immunotoxicity, allergenicity  
11. Results of pharmacological and toxicological studies:
- pharmakokinetics report
12. Efficacy and safety reports:
- literature references with about development the product
- therapeutic effectiveness report
13. Stability report 

IV. Additional documents:
14. Instruction for use
15. Label for packaging 
16. Samples of three preparation series in the commercial package