ISO 9001 CERTIFIED
State registration of veterinary products (medicinal products, premixes and feed supplements) in Russia
Issues associated with the state registration of veterinary products in Russia are regulated by the Ministry of Agriculture of the Russian Federation. In accordance with the law of the Russian Federation "On circulation of medicinal products" with last amendments dated July 03, 2016 and the Order of the Ministry of Agriculture of the Russian Federation of 01.04.2005 N 48 "On approval of the state registration of veterinary medicinal products and feed supplements regulation" any type of veterinary products such as, for instance, medicinal products, premixes and feed supplements are allowed for use in Russia only after state registration.
The procedure of the state registration of veterinary products in Russia is conducted by the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) on the basis of decision of the Federal State Institution "Russian State Center for Quality Control and Standardization of Veterinary Drugs and Feeds" (Institution).
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, premix, 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 the law of the Russian Federation "On circulation of medicinal products" for registration of veterinary medicinal product or according to the demands of the Order of the Ministry of Agriculture of the Russian Federation of 01.04.2005 N 48 "On approval of the state registration of veterinary medicinal products and feed supplements regulation" for registration of premix (feed supplement).
4) Samples of the product in sufficient quantity for the quality control of the product (exact required amount is requested by the Institution after preliminary examination of the registration dossier).
The requirements to materials in the registration dossier on veterinary medicinal product and the registration procedure itself are more complicated and strict than ones on premix (feed supplement). Also we would like to draw your attention that registration dossier on veterinary medicinal product should contain legalized copies of Conclusions of Compliance to the GMP requirements for all manufacturing sites involved in manufacturing process (including manufacturing site for API) issued by the competent Authority of the Russian Federation (the procedure of issuance of these documents is conducted before submitting the Application for registration).
Please note that in case of absence of own pharmacological studies, toxicological studies, residue studies or clinical studies for veterinary medicinal product and toxicological studies or veterinary studies confirming the efficiency for premix (feed supplement) it is necessary to include all well-known public information into the registration dossier. If this information is not enough after submission of the registration dossier the Institution will require to conduct the additional studies in the territory of Russia during the registration procedure.
Upon filing the application for registration of veterinary product (medicinal product, premix or feed supplement) analytical assessment of quality of veterinary 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 the product depends on the type of product and is requested after submission of the registration dossier to the Rosselkhoznadzor and its preliminary expertise.
After conduction of all required studies and examination the Institution forwards the registration dossier and its expert conclusion to the Rosselkhoznadzor for review and concluding whether the product should be registered or not. The Registration Certificate is issued within about 20 days from the date of acceptance of the positive decision.
According to the Russian legislation the procedure of state registration should be conducted within 110 workdays for veterinary medicinal product or within 6 months for premix (feed supplement) without considering the time for delivery of samples to the Rosselkhoznadzor and 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 from 6 to 10 months for premix (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 Institution and other factors.
The Certificate about the state registration of veterinary medicinal product in the Russian Federation is valid on the permanent basis, however, for the veterinary medicinal products that are first registered in Russia within 5 years it is necessary to renew the registration. In case of absence of the veterinary medicinal product in the market of the Russian Federation for more than 3 years the renewal procedure is not allowed and the product registration is cancelled. The procedure of the renewal of the registration may be initiated before expiration date of previous registration, but not earlier than 180 days. The usual renewal procedure lasts about 6 months without considering the time for preparation of responses to the remarks. The renewal procedure does not require checking the quality, pre-clinical and clinical data, however, it will be necessary to provide the results of monitoring the safety of veterinary medicinal product on the basis of the safety/efficacy data accumulated since the first registration.
The Certificate about the state registration of veterinary premix (feed supplement) in the Russian federation is valid for 5 years with subsequent re-registration. The re-registration procedure may be initiated not earlier than 180 days before expiration date of previous registration. The usual re-registration procedure requires providing the similar documents and conducting the similar actions as for new registration.
In order we could provide you with the information on costs associated with the registration of veterinary products (medicinal product, premix or feed supplement) in Russia 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.