State registration of veterinary products in Uzbekistan

Matters related to the state registration of veterinary products are regulated by the State Committee of Veterinary Medicine and Livestock Development of the Republic of Uzbekistan. In accordance with the Law of Uzbekistan “On Veterinary Medicine,” veterinary medicinal products and feed supplements are allowed for use in Uzbekistan only after the state registration.

Documents required for registration

1) Application form with the attached documents:

• Legalized Power of Attorney from the applicant to the representative;
• Qualitative and quantitative composition;
• Methods of control for the product, texts of relevant international or state pharmacopoeial articles;
• Instruction for use (composition, product form, species of animals, indications for use, contraindications, using special warnings, etc.);
• Certificates of analysis for three production batches of a product from its manufacturer;
• Manufacturing process (including manufacturing schedules and a manufacturing scheme);
• Results of studies confirming the safety, efficiency (for each declared species of animals), and stability of the veterinary product;
• Supporting information on efficiency, immunogenicity and virulence in the case of a veterinary biological product and strains of microorganisms used in its production;

2) Samples of the veterinary product and standard samples in an amount required for the approbation of control methods (required only for an original (new) veterinary product).

Registration procedure

The state registration procedure for a veterinary product (medicinal product, feed supplement) is conducted by the State Committee of Veterinary Medicine and Livestock Development of the Republic of Uzbekistan (the Committee) on the basis of the decision of the State Scientific Center for Quality Control and Circulation of Veterinary Medicinal Products and Feed Additives (the Center).

For previously known (generic) veterinary product, the state registration procedure is carried out by examining the provided documents only, while for an original (new) veterinary product, the procedure includes both the examination of the provided documents and the analytical assessment of the product’s quality. This includes the validation of analytical methods for the product quality to ensure their repeatability and authenticity, as well as examination of the compliance of the quantitative and qualitative composition with the declared specifications. The required scope of studies and the number of product samples depend on the type of the product and are requested after submission of the registration dossier to the Committee and its preliminary expertise.

After conducting all the required studies and examination, the Center forwards the registration dossier and its expert conclusion to the Committee for review and a final decision on whether the product should be registered. The Registration Certificate is issued within about one business day from the date of acceptance of the positive decision.

Duration of registration process

According to Uzbek legislation, the state registration procedure for a veterinary product (medicinal product or feed supplement) must be completed within 28 business days, excluding the time required for preparing responses to requests and/or validating control methods in the case of an original (new) product. However, in practice, depending on the completeness of the provided materials, the scope of documentation, the number of requests from the competent authority, and other factors, the state registration procedure for a veterinary product (medicinal product or feed supplement) in Uzbekistan takes about 3 to 4 months, excluding the time required for preparing responses to requests and/or validating control methods in the case of an original (new) product.

Important

Please also note that after submission of the registration dossier and its preliminary expertise, the Center requests to conduct a GMP inspection of all manufacturing sites involved in the manufacturing process if no veterinary medicinal products manufactured at these sites have already been registered in Uzbekistan.

Validity term and renewal

The State Registration Certificate for a veterinary product (medicinal product or feed supplement) in Uzbekistan is valid for 5 years, after that it must be renewed every 5 years. The renewal procedure must be initiated at least 3 months before the expiration of the current registration. The standard renewal procedure typically takes 3 to 4 months, excluding the time required for preparing responses to the requests.

To provide you with information on the costs associated with the registration of veterinary products (medicinal products or feed supplements) in Uzbekistan, as well as detailed requirements, a list of documents required from your side, and a sample Power of Attorney for execution, etc. please contact our specialists.