State Registration Expertise of Veterinary Vaccines, Sera and Diagnostic Products
What is the state registration expertise of veterinary biological products
The state registration expertise of veterinary vaccines, sera, and diagnostic products is a process of scientific and expert evaluation during which the quality, efficacy, and safety of submitted veterinary medicinal products are assessed.
Based on the results of the expertise, an expert conclusion is prepared and submitted to the authorized state body (Ministry of Economy of the Republic of Armenia) for a decision on state registration or refusal of registration.
The expertise is carried out in accordance with the RA Government Decision No. 1335-N of September 9, 2004.
Who can apply
The following may apply for expertise:
- manufacturers of veterinary medicinal products
- importing organizations
- distributing organizations
How to apply
For the purpose of state registration, the applicant submits an application to the authorized state body in accordance with the form approved by RA Government Decision No. 1335-N.
After submission, samples of the veterinary medicinal product and the required documentation are provided to the “Scientific Center for Food Safety Risk Assessment and Registration” CJSC of the RA Ministry of Economy for scientific expert evaluation.
During the expertise, submitted materials are reviewed and the necessary expert assessment is carried out.
Further processing of the application
After completion of the expertise, an expert conclusion is prepared and submitted to the authorized state body.
Based on the conclusion, the authorized body makes a decision on state registration or refusal of registration of the veterinary medicinal product.
In case of a positive decision, the applicant is issued a state registration certificate.