Issues associated with the state registration of veterinary products in Ukraine are regulated by the State Service of Ukraine on Food Safety and Consumer Protection (SSUFSCP). In accordance with the laws "On veterinary medicine" and "About safety and hygiene of forages" 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 only exception is feed supplements intended for the production of feed for unproductive animals and registered (approved for use) in the European Union
The procedure of the state registration of veterinary products in Ukraine is conducted by the SSUFSCP on the basis of decision of the State Pharmacological Commission of Veterinary Medicine (Commission) for veterinary medicinal products and diinfectants 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" for veterinary medicinal products and disinfectants or Order of the Ministry of Economy of Ukraine of 26.07.2021 № 307-21 "On approval of the procedure for the formation of a registration dossier" for feed supplements.
4) Samples of the product in sufficient quantity for the quality control of the product.
Within the procedure of registration of any veterinary product (medicinal product, disinfectant and feed supplement) analytical assessment of quality of said product is conducted together 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 depends on the type of product.
Also please note that after submission of the registration dossier on veterinary medicinal product and its preliminary expertise the Agency may request to conduct GMP inspection of all manufacturing sites involved in manufacturing process.
According to the Ukrainian legislation the procedure of state registration should be conducted within 210 days for veterinary medicinal product and disinfectant or within 195 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 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 a veterinary medicinal product or disinfectant 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.
According to the Ukrainian legislation a Registration Certificate for a veterinary feed supplement is not issued. A veterinary feed supplement is considered to be registered after the information about it is entered into the State Register of Feed Additives. The period of validity of the state registration of a veterinary feed supplement in Ukraine is 10 years with subsequent re-registration. The re-registration procedure may be initiated no later than one year before expiration of previous registration. The usual re-registration procedure lasts within about 6 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.