The declaration of conformity of products is an official document certifying that the veterinary drug fully meets the requirements that are appropriate for undergoing the conformity assessment procedure. Responsibility for the accuracy of the information contained in the submitted document (in the declaration of conformity) is borne by the manufacturer, seller or supplier of the relevant veterinary drug.

The official manufacturers of the Russian Federation or organizations that represent the interests of the respective foreign manufacturers (provided that the organization has the status of a legal entity registered in the territory of the Russian Federation) have the right to adopt a declaration of product conformity. The declaration of conformity adopted by the manufacturer (performer / seller) is subject to official registration by accredited certification bodies.

What documents are required for certification of veterinary drugs in the Russian Federation?

The set of documents includes:
• Certificate of state registration (copy) / Registration Certificate of the Ministry of Health.
• Charter (for legal entities, copy).
• Certificate of registration with the state tax authority (copy).
• Full details of the applicant company, including data of the persons holding the positions of the head and chief accountant.
• License for the manufacture of veterinary drugs.
• Technical documentation.
• Instructions for use of a certified drug for veterinary use, its registration certificate, as well as product quality certificates (if any).


To increase the chances of successful certification of veterinary drugs in the Russian Federation, it is recommended that other documentation be presented, which in one way or another may indicate that the certified product complies with the requirements and standards established by law.


What are the steps involved in certification of veterinary drugs in the Russian Federation?




There are several such stages:
• Filing an application and providing a complete set of documentation for product certification.
• Analysis of the complete set of documentation, including the final decision on the application and selection of the appropriate certification / declaration scheme.
• Sampling and identification process.
• Processes associated with the organization of the testing of samples of drugs that have been selected and identified as a result of the previous stage.
• An objective analysis of the test results.
• Decision on refusal or issuance of a document of conformity / declaration.
• Issuance of certificate / declaration.
• Inspection control of products that received a certificate of conformity.


In that case, if the products have not passed the certification of veterinary drugs (in the Russian Federation), then certain corrective measures are appointed and organized to correct for violations of compliance.