Issues associated with the state registration of veterinary products are regulated by the Committee of State Control and Supervision of the Ministry of Agriculture of the Republic of Kazakhstan (Committee). In accordance with the law "On veterinary" dated July 10, 2002 veterinary products (medicinal products, feed supplements and premixes), which are not registered in any of the member states of the Eurasian Economic Union (Russia, Belarus, Kazakhstan, Kyrgyzstan or Armenia) are allowed for use in Kazakhstan only after state registration.
What is required for registration
In order to register the veterinary product (medicinal product, feed supplement or premix), it is necessary to provide the following to the Committee:
1) Application form with the attached documents:
- legalized Power of Attorney from the applicant to the representative;
- reasonable information on the efficiency, immunogenicity, virulence in case of veterinary biological product and strains of microorganisms used in its production;
- summary of product characteristics (composition, product form, species of animals, indications for use, contraindications, using special warnings, shelf-life, storage conditions, etc.);
- manufacturing process of raw materials;
- specification and methods of control of raw materials;
- specification and methods of control of packaging materials;
- manufacturing process of final product;
- specification and methods of control of final product;
- passport for production and control strains of microorganisms and for transplantable cell culture lines (for products containing living organisms);
- document confirming the registration of veterinary product and/or entering into the state official pharmacopoeia of other countries;
- legalized copy of Contract between the manufacturer and the holder of patents, which are valid in Kazakhstan (in case of state registration of veterinary medicinal product related to the intellectual property objects);
- scientific data;
- acts or protocol of laboratory and production testing;
- certificate of analysis;
- stability data.
2) Samples of veterinary product and standard samples (required amount will be requested after submission of the registration dossier to the Committee and approval of the Normative documentation).
The procedure of the state registration of veterinary product is conducted by the Committee on the basis of decision of the Republican State Enterprise "National Veterinary Reference Center" (Center) and includes the following steps:
- examination of registration documents by the Center and approval of Normative documentation by the Committee;
- conducting approbation of methods of control in the State laboratory of the Center.
For previously known (generic) veterinary product the procedure of state registration is carried out by examination of provided documents and conducting approbation of methods of control of veterinary product in the State laboratory only, while for original (innovator) veterinary product, which is submitted for registration in Kazakhstan as a first country, the procedure of state registration additionally includes conducting clinical, toxicological studies, as well as studies of residual quantities of active substances for veterinary medicinal product and toxicological and veterinary studies for veterinary feed supplement or premix. 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 approval of the Normative documentation.
Duration of registration
According to the Kazakh legislation the procedure of state registration of veterinary product should be conducted within 95 days for veterinary medicinal products and within 100 days for veterinary feed supplement or premix without considering the time for preparation of responses to remarks and/or conducting additional studies in case of original (innovator) veterinary product, which is submitted for registration in Kazakhstan as a first country. 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 in Kazakhstan may constitute about 5-6 months without considering the time for preparation of responses to remarks and/or conducting additional studies in case of original (innovator) veterinary product, which is submitted for registration in Kazakhstan as a first country.
Validity term and renewal
The Certificate about the state registration of veterinary product (medicinal product, feed supplement or premix) in Kazakhstan is valid on the permanent basis, however, it is necessary to renew the registration of veterinary products that are first registered in Kazakhstan within 5 years.
In order we could provide you with the information on costs associated with the registration of veterinary products (medicinal product, feed supplement or premix) in Kazakhstan 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.