Veterinary products

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

1. Certificate for production site (legalization)
2. Data on manufacture of veterinary product
3. 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
4. Quality certificate
5. Quality control methods

III. Clinical and preclinical studies reports:

1. Results of pre-clinical studies

• toxicity (acute, subchronic and chronic) on laboratory and target animal species
• teratogenecity, mutagenicity, carcinogenicity, immunotoxicity, allergenicity

2. Results of pharmacological and toxicological studies:

• pharmakokinetics report

3. Efficacy and safety reports:

• literature references with about development the product
• therapeutic effectiveness report

4. Stability report

IV. Additional documents:

1. Instruction for use
2. Label for packaging
3. Samples of three preparation series in the commercial package