State registration of veterinary products (medicinal products, disinfectants and feed supplements) in Ukraine
Issues associated with the state registration of veterinary products in Ukraine are regulated by the State Department of Veterinary Medicine of Ukraine. In accordance with the law "On veterinary medicine" and Decree of the Cabinet of Ministers of Ukraine of 21.11.2007 № 1349 "On approval of provisions on the state registration of veterinary medicinal products, feed supplements, premixes and finished feeds" any type of veterinary products such as, for instance, medicinal products, disinfectants and feed supplements are allowed for use in Ukraine only after state registration.
The procedure of the state registration of veterinary products in Ukraine is conducted by the State Veterinary Medicine Committee (Committee) on the basis of decision of the State Pharmacological Commission of Veterinary Medicine (Commission) and expert conclusion of the National Agency of Veterinary Products and Supplementary Feed (Agency) of Ukraine.
For conducting the procedure of the state registration it is necessary to provide the following:
1) Legalized Power of Attorney from the applicant to the representative.
2) Application for state registration of veterinary product (medicinal product, disinfectant or feed supplement) containing general information about the applicant, manufacturer of the product, representative of the applicant, species of animals for which the product is used, quantitative and qualitative composition, form of production, storage conditions, shelf-life, etc..
3) Registration dossier compiled according to the demands of Order of the State Veterinary Medicine Committee of Ukraine of 14.07.2008 № 133 "On approval of forms of applications, text information on the packaging (labeling), the list of materials of the registration dossier and the order of its compilation" .
4) Samples of the product in sufficient quantity for the quality control of the product (exact required amount is requested by Agency after preliminary examination of the registration dossier).
The requirements to materials in the registration dossier on veterinary medicinal product and disinfectant and the registration procedure itself are more complicated and strict than one on feed supplement.
Upon filing the application for registration of veterinary product (medicinal product, disinfectant or feed supplement) analytical assessment of quality of said product is conducted simultaneously with examination of analytical normative documentation. 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 said product depends on the type of product and is requested after submission of the registration dossier to Agency and its preliminary expertise.
Also please note that after submission of the registration dossier on veterinary medicinal product, disinfectant or feed supplement and its preliminary expertise the Agency may request to conduct GMP inspection of all manufacturing sites involved in manufacturing process.
After conduction of all required studies and examination the Agency by the approbation of the Commission forwards the registration dossier to the Committee for review and concluding whether the product should be registered or not. The Registration Certificate is issued within about 30 days from the date of acceptance of the positive decision.
According to the Ukrainian legislation the procedure of state registration should be conducted within 210 days for veterinary medicinal product and disinfectant or within 90 days for feed supplement without considering the time for preparation of responses to the remarks. However, in accordance with the usual practice the procedure of state registration may last from 7 to 12 months for veterinary medicinal product and disinfectant and from 5 to 10 months for feed supplement without considering the time for preparation of responses to the remarks depending on the completion of the provided materials and scope of documentation, number of requests of the Agency and other factors.
The Certificate about the state registration of veterinary product (medicinal product, disinfectant or feed supplement) in Ukraine is valid for 5 years with subsequent re-registration. The re-registration procedure may be initiated no later than 3 months before expiration of previous registration. The usual re-registration procedure lasts within about 7 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, disinfectant or feed supplement) in Ukraine together with the detailed information and list of documents required from your side, sample of the Power of Attorney for execution, etc. please contact our specialists.
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