EXPERTISE.QUALITY.PRIVACY
– The whole range of registration procedures on the territory of the EEU
– Development of a strategy for registration procedures in the EEU
– Monitoring legislative initiatives in the EEU
– Individual consultations with leading experts in the industry
– Development of a strategy for registration procedures in the EEU
– Monitoring legislative initiatives in the EEU
– Individual consultations with leading experts in the industry
VetRegister LLC
Trust
We are trusted by over 150 companies from 30 countries
Quality
Over 450 successful dossiers in 18 years
Unique service package
- Expert assessment
- Development of an individual strategy
- Optimization of budget and deadlines
Confidentiality
Confidentiality Agreement and Anti-Corruption Code in the Contract
Experience
Your project will be worked on by experts with industry experience more than 30 years
Legislation
You will know everything about new legislative initiatives of regulatory bodies of the Russian Federation and the EEU
Advantages
She is an international expert with more than 35 years of experience in conducting registration procedures and developing legal regulations of the Russian Federation and the EEU in various categories of animal products, including veterinary drugs, feed additives, zoo hygienic products, pharmaceutical substances and innovative developments in the field of veterinary medicine pharmaceuticals and also participated in the development of innovative domestic immunobiological drugs.
She graduated with honors from the Moscow State Academy of Veterinary Medicine and Biotechnology - MBA named after K. I. Skryabin, having received the specialty of a veterinarian and completed postgraduate studies at the Federal State Budgetary Institution VGNKI in the specialty "virology"
She graduated with honors from the Moscow State Academy of Veterinary Medicine and Biotechnology - MBA named after K. I. Skryabin, having received the specialty of a veterinarian and completed postgraduate studies at the Federal State Budgetary Institution VGNKI in the specialty "virology"
About the manager
Kiriukhina Nina
Questions and Answers (Q&A)
Registration of veterinary drugs and feed additives for animals is the main and mandatory condition for their sale and use on the territory of the Russian Federation.
- Law of the Russian Federation of May 14, 1993 No. 4979-1 "On Veterinary Medicine" (clickable link below the text - https://www.consultant.ru/document/cons_doc_LAW_4438/)
- Federal Law of April 12, 2010 No. 61-FZ "On the Circulation of Medicines" (clickable link below the text - https://www.consultant.ru/document/cons_doc_LAW_99350/)
Failure to comply with the requirements of the law will result in administrative and criminal liability.
- Law of the Russian Federation of May 14, 1993 No. 4979-1 "On Veterinary Medicine" (clickable link below the text - https://www.consultant.ru/document/cons_doc_LAW_4438/)
- Federal Law of April 12, 2010 No. 61-FZ "On the Circulation of Medicines" (clickable link below the text - https://www.consultant.ru/document/cons_doc_LAW_99350/)
Failure to comply with the requirements of the law will result in administrative and criminal liability.
- An accelerated state registration procedure for import substitution purposes is being established until 31.12.2024.
- State registration of VMP - no more than 60 working days from the date of registration of the Application
- In order to reduce the registration period, the quality of samples will not be examined if there is a Conclusion on the compliance of the production site with the requirements of the GMP of the Russian Federation
- The accelerated registration procedure applies to all reproduced VMPs
- In the case of an accelerated state registration procedure, the VMP is included in the list of drugs attached to the Conclusion on the manufacturer's compliance with the GMP requirements of the Russian Federation in relation to the production site, without submitting requests and applications to Rosselkhoznadzor
- Samples of the first 2 series of VMP are sent to the expert body of the Russian Federation
- The expert body of the Russian Federation, free of charge, in written and electronic form, carries out an assessment of the manufacturer's compliance/non-compliance with the requirements of the regulatory document
- The assessment period for VMPs is no more than 10 working days after receiving the drug
- The assessment period for immunobiological drugs is no more than 35 working days after receiving the drug
- If the requirements are met, and the assessment of compliance with the requirements is positive, the drug is put into civil circulation.
- Making changes when the manufacturer replaces excipients, primary and secondary packaging - by notification with a written obligation to submit all necessary reports within 12 months after making the changes
- Import of pharmaceutical substances for veterinary use - for registered VMPs is permitted by notification procedure
- State registration of VMP - no more than 60 working days from the date of registration of the Application
- In order to reduce the registration period, the quality of samples will not be examined if there is a Conclusion on the compliance of the production site with the requirements of the GMP of the Russian Federation
- The accelerated registration procedure applies to all reproduced VMPs
- In the case of an accelerated state registration procedure, the VMP is included in the list of drugs attached to the Conclusion on the manufacturer's compliance with the GMP requirements of the Russian Federation in relation to the production site, without submitting requests and applications to Rosselkhoznadzor
- Samples of the first 2 series of VMP are sent to the expert body of the Russian Federation
- The expert body of the Russian Federation, free of charge, in written and electronic form, carries out an assessment of the manufacturer's compliance/non-compliance with the requirements of the regulatory document
- The assessment period for VMPs is no more than 10 working days after receiving the drug
- The assessment period for immunobiological drugs is no more than 35 working days after receiving the drug
- If the requirements are met, and the assessment of compliance with the requirements is positive, the drug is put into civil circulation.
- Making changes when the manufacturer replaces excipients, primary and secondary packaging - by notification with a written obligation to submit all necessary reports within 12 months after making the changes
- Import of pharmaceutical substances for veterinary use - for registered VMPs is permitted by notification procedure
- VMPs produced in the territory of the Russian Federation, registered for the purpose of import substitution of drugs produced in countries committing unfriendly acts against the Russian Federation
- For live vaccines against particularly dangerous animal diseases specified in the list of contagious diseases for which restrictive measures (quarantine) may be established
- For immunobiological preparations against particularly dangerous animal diseases specified in the list of contagious diseases for which restrictive measures (quarantine) may be established
- For immunobiological preparations against particularly dangerous animal diseases specified in the list of contagious diseases for which restrictive measures (quarantine) may be established
- State registration of VMP - no more than 160 working days from the date of registration of the Application;
- Confirmation of state registration of VMP - no more than 60 working days;
- Making changes to the registration documents of the medicinal product with examination - no more than 90 working days;
- Making changes to the registration documents of medicinal products without examination - no more than 30 working days;
- The deadline for providing samples of medicinal products or active pharmaceutical substances is 30 working days;
- The period for suspending registration procedures for the provision of additional materials is no more than 90 working days (excluding the period for preparing a written notification to Rosselkhoznadzor)
- Entry into the State Register of a pharmaceutical substance produced for sale - no more than 75 working days;
- Making changes to documents for a pharmaceutical substance produced for sale and included in the register, with examination - no more than 90 working days;
- Making changes to documents for a pharmaceutical substance produced for sale and included in the register, without examination - no more than 30 working days;
- Decision to cancel the state registration of a medicinal product for veterinary use - no more than 30 working days (upon submission of the Application);
- Provision of a duplicate of the registration certificate of a medicinal product for veterinary use – no more than 10 working days.
- Confirmation of state registration of VMP - no more than 60 working days;
- Making changes to the registration documents of the medicinal product with examination - no more than 90 working days;
- Making changes to the registration documents of medicinal products without examination - no more than 30 working days;
- The deadline for providing samples of medicinal products or active pharmaceutical substances is 30 working days;
- The period for suspending registration procedures for the provision of additional materials is no more than 90 working days (excluding the period for preparing a written notification to Rosselkhoznadzor)
- Entry into the State Register of a pharmaceutical substance produced for sale - no more than 75 working days;
- Making changes to documents for a pharmaceutical substance produced for sale and included in the register, with examination - no more than 90 working days;
- Making changes to documents for a pharmaceutical substance produced for sale and included in the register, without examination - no more than 30 working days;
- Decision to cancel the state registration of a medicinal product for veterinary use - no more than 30 working days (upon submission of the Application);
- Provision of a duplicate of the registration certificate of a medicinal product for veterinary use – no more than 10 working days.
- State registration of VMP - 215,000 rubles;
- Confirmation of state registration of VMP – 70,000 rubles;
- Making changes to the registration dossier documents for a registered medicinal product with examination - 70,000 rubles;
- Making changes to the registration dossier documents for a registered medicinal product without examination - 2,600 rubles;
- Inclusion in the State Register of Medicines of a pharmaceutical substance produced for sale – 145,000 rubles;
- Issuance of a registration certificate – 10,000 rubles;
- Making changes to documents for a pharmaceutical substance for sale, included in the state register with examination - 75,000 rubles;
- Making changes to documents for a pharmaceutical substance for sale, included in the state register without examination - 5,000 rubles;
- Issuance of a duplicate registration certificate – 2000 rubles.
- Confirmation of state registration of VMP – 70,000 rubles;
- Making changes to the registration dossier documents for a registered medicinal product with examination - 70,000 rubles;
- Making changes to the registration dossier documents for a registered medicinal product without examination - 2,600 rubles;
- Inclusion in the State Register of Medicines of a pharmaceutical substance produced for sale – 145,000 rubles;
- Issuance of a registration certificate – 10,000 rubles;
- Making changes to documents for a pharmaceutical substance for sale, included in the state register with examination - 75,000 rubles;
- Making changes to documents for a pharmaceutical substance for sale, included in the state register without examination - 5,000 rubles;
- Issuance of a duplicate registration certificate – 2000 rubles.
- State registration of the FA - no more than 45 working days from the date of registration of the Application;
- Issuance of an extract from the State Register of Feed Additives (analogous to a registration certificate) - no more than 10 working days;
- Making changes to the registration dossier documents for a registered feed additive with examination - no more than 35 working days;
- Making changes to the registration dossier documents for a registered feed additive without examination - no more than 15 working days
- Issuance of an extract from the State Register of Feed Additives (analogous to a registration certificate) - no more than 10 working days;
- Making changes to the registration dossier documents for a registered feed additive with examination - no more than 35 working days;
- Making changes to the registration dossier documents for a registered feed additive without examination - no more than 15 working days
- State registration of feed additives - 85,000 rubles;
- Making changes to the registration dossier documents for a registered feed additive with examination - 34,700 rubles;
- Making changes to the registration dossier documents for a registered feed additive without examination - 7,700 rubles
- Making changes to the registration dossier documents for a registered feed additive with examination - 34,700 rubles;
- Making changes to the registration dossier documents for a registered feed additive without examination - 7,700 rubles
In case of a decision on state registration of a feed additive:
- Rosselkhoznadzor enters information about the feed additives into the state Register of feed additives;
- Rosselkhoznadzor issues the Applicant with the agreed instructions for the use of the feed additive.
- Rosselkhoznadzor enters information about the feed additives into the state Register of feed additives;
- Rosselkhoznadzor issues the Applicant with the agreed instructions for the use of the feed additive.
No.
Rosselkhoznadzor issues the Applicant with the agreed instructions for the use of the feed additive strictly according to the Application.
Without an Application, the extract will not be issued to the Applicant.
Rosselkhoznadzor issues the Applicant with the agreed instructions for the use of the feed additive strictly according to the Application.
Without an Application, the extract will not be issued to the Applicant.
State registration of a feed additive may be suspended for a period not exceeding 18 months.
