Issues associated with the state registration of veterinary products are regulated by the State Committee of Veterinary Medicine of the Republic of Uzbekistan. In accordance with law of the Republic of Uzbekistan "On veterinary medicine" veterinary medicinal products and feed supplements are allowed for use in Uzbekistan only after state registration.
What is required for registration
For conducting the procedure of the state registration, it is necessary to provide the following:
1) Application form with the attached documents:
- legalized Power of Attorney from the applicant to the representative;
- qualitative and quantitative composition;
- methods of control of product, texts of relevant international or state pharmacopoeia articles;
- summary of product characteristics (composition, product form, species of animals, indications for use, contraindications, using special warnings, etc.);
- certificates of analysis for 3 production batches of product from its manufacturer;
- manufacturing process (manufacturing schedules, manufacturing scheme);
- studies results that confirm safety, efficiency (for each declared species of animals) and stability of veterinary product;
- reasonable information on the efficiency, immunogenicity, virulence in case of veterinary biological product and strains of microorganisms used in its production;
2) Samples of veterinary product and standard samples in an amount required for the approbation of methods of control (required for original (new) veterinary product only).
The procedure of the state registration of veterinary product (medicinal product, feed supplement) is conducted by the State Committee of Veterinary Medicine of the Republic of Uzbekistan (Committee) on the basis of decision of the State Scientific Center for Quality Control and Circulation of Veterinary Medicinal Products and Feed Additives (Center).
For previously known (generic) veterinary product the procedure of state registration is carried out by examination of provided documents only, while for original (new) veterinary product the procedure of state registration is made both by examination of provided documents and conducting analytical assessment of quality of product. It includes assay of methods of analysis of product quality for their repeatability and authenticity, examination of compliance of quantitative and qualitative composition to claimed one. Required amount of studies and samples of the product depends on the type of product and is requested after submission of the registration dossier to the Committee and its preliminary expertise.
After conduction of all required studies and examination the Center forwards the registration dossier and its expert conclusion to the Committee for review and concluding whether the product should be registered or not. The Registration Certificate is issued within about 1 workday from the date of acceptance of the positive decision.
Duration of registration process
According to the Uzbek legislation the procedure of state registration of veterinary product (medicinal product or feed supplement) should be conducted within 36 workdays without considering the time for preparation of responses to remarks and/or approbation of methods of control in case of original (new) product. However, in accordance with the usual practice depending upon the completion of the provided materials and scope of documentation, number of requests of the competent authority and other factors, the procedure of state registration of veterinary product (medicinal product or feed supplement) in Uzbekistan may constitute about 3-4 months without considering the time for preparation of responses to remarks and/or approbation of methods of control in case of original (new) product.
Validity term and renewal
The Certificate about the state registration of veterinary product (medicinal product or feed supplement) in Uzbekistan is valid for 5 years and after that it is necessary to renew it each time for the next 5 years. The procedure of the renewal of the registration must be initiated within 3 months before expiration of previous registration. The usual renewal procedure lasts for about 3-4 months without considering the time for preparation of responses to the remarks.
In order we could provide you with the information on costs associated with the registration of veterinary products (medicinal product or feed supplement) in Uzbekistan together with the detailed information and list of documents required from your side, as well as a sample of the Power of Attorney for execution, etc. please contact our specialists.