EXPERTISE.QUALITY.PRIVACY
– The whole range of registration procedures on the territory of the Russian Federation and the EEU
– Development of a strategy for registration procedures in the Russian Federation and the EEU
– Monitoring of legislative initiatives in the Russian Federation and the EEU countries
– Individual expert advice
– Development of a strategy for registration procedures in the Russian Federation and the EEU
– Monitoring of legislative initiatives in the Russian Federation and the EEU countries
– Individual expert advice
VetRegister LLC
Legislation
You will know everything about the new legislative initiatives of the regulatory authorities of the Russian Federation and the EEU
Experience
Experts with over 25 years of experience in the industry will work on your project
Confidentiality
Confidentiality Agreement and Anti-Corruption Code in the contract
Unique service package
- Expert review
- Development of an individual strategy
- Budget and time optimization
Quality
Over 400 successful dossiers in 15 years
Failures
Over 15 years less than 0.1%
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.
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.
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.
About the CEO
Kiriukhina Nina
FAQ
Registration of VMPs and feed additives for animals is the main and obligatory 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" http://www.consultant.ru/document/cons_doc_LAW_4438/
- Federal Law of April 12, 2010 No. 61-FZ "On the Circulation of Medicines" http://www.consultant.ru/document/cons_doc_LAW_99350/
In case of non-compliance with the requirements of the law, administrative and criminal liability is provided
- Law of the Russian Federation of May 14, 1993 No. 4979-1 "On Veterinary Medicine" http://www.consultant.ru/document/cons_doc_LAW_4438/
- Federal Law of April 12, 2010 No. 61-FZ "On the Circulation of Medicines" http://www.consultant.ru/document/cons_doc_LAW_99350/
In case of non-compliance with the requirements of the law, administrative and criminal liability is provided
- An accelerated procedure for state registration is being established for the purpose of import substitution until 09/01/2023.
- State registration of VMP - no more than 60 working days from the date of registration of the Application
- To reduce the registration period, an examination of the quality of samples will not be carried out if there is a Conclusion on the compliance of the production site with the requirements of GMP of the Russian Federation
- Fast track registration procedure applies to all reproduced VMPs
- Under the accelerated procedure for state registration, VMP is included in the list of drugs attached to the Conclusion on the compliance of the manufacturer with respect to the production site with the requirements of the GMP of the Russian Federation, without submitting requests and applications to the 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 writing and electronically, assesses the conformity / non-compliance of the manufacturer with the requirements of the regulatory document
- The term for the assessment for VMP is no more than 10 working days after receiving the drug
- The evaluation period for immunobiological preparations is no more than 35 working days after receiving the preparation
- In case of compliance with the requirements with a positive assessment of compliance with the requirements, the drug enters the civil circulation
- Making changes when the manufacturer replaces excipients, primary and secondary packaging - in a notification manner with a written obligation to submit all necessary reports within 12 months after the changes are made
- Import of pharmaceutical substances for veterinary use - for registered VMP is allowed on a notification basis
- Manufacturers of immunobiological medicinal products are allowed not to submit information on the state registration of GMOs until December 31, 2022
- State registration of VMP - no more than 60 working days from the date of registration of the Application
- To reduce the registration period, an examination of the quality of samples will not be carried out if there is a Conclusion on the compliance of the production site with the requirements of GMP of the Russian Federation
- Fast track registration procedure applies to all reproduced VMPs
- Under the accelerated procedure for state registration, VMP is included in the list of drugs attached to the Conclusion on the compliance of the manufacturer with respect to the production site with the requirements of the GMP of the Russian Federation, without submitting requests and applications to the 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 writing and electronically, assesses the conformity / non-compliance of the manufacturer with the requirements of the regulatory document
- The term for the assessment for VMP is no more than 10 working days after receiving the drug
- The evaluation period for immunobiological preparations is no more than 35 working days after receiving the preparation
- In case of compliance with the requirements with a positive assessment of compliance with the requirements, the drug enters the civil circulation
- Making changes when the manufacturer replaces excipients, primary and secondary packaging - in a notification manner with a written obligation to submit all necessary reports within 12 months after the changes are made
- Import of pharmaceutical substances for veterinary use - for registered VMP is allowed on a notification basis
- Manufacturers of immunobiological medicinal products are allowed not to submit information on the state registration of GMOs until December 31, 2022
-VMP and immunobiological drugs manufactured in the territory of the Russian Federation, registered for the purpose of import substitution of drugs manufactured in countries that commit unfriendly actions against the Russian Federation
- For live vaccines against especially dangerous animal diseases specified in the list of contagious diseases for which restrictive measures (quarantine) can be established
- For immunobiological preparations against especially dangerous animal diseases specified in the list of contagious diseases for which restrictive measures (quarantine) can be established
- For immunobiological preparations against especially dangerous animal diseases specified in the list of contagious diseases for which restrictive measures (quarantine) can 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 VMP with expertise - no more than 90 working days;
- Making changes to the registration documents of the VMP without examination - no more than 30 working days;
- The term for providing samples of VMP or API is 30 working days;
- The term for suspension of registration procedures for the provision of additional materials is no more than 90 working days (excluding the term for preparing a written notice from Rosselkhoznadzor)
- Entry into the State Register of a pharmaceutical substance produced for sale - no more than 75 working days;
- Making changes to the documents for the pharmaceutical substance produced for sale and included in the register, with expertise - no more than 90 working days;
- Making changes to the documents for the 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 (when submitting an 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 VMP with expertise - no more than 90 working days;
- Making changes to the registration documents of the VMP without examination - no more than 30 working days;
- The term for providing samples of VMP or API is 30 working days;
- The term for suspension of registration procedures for the provision of additional materials is no more than 90 working days (excluding the term for preparing a written notice from Rosselkhoznadzor)
- Entry into the State Register of a pharmaceutical substance produced for sale - no more than 75 working days;
- Making changes to the documents for the pharmaceutical substance produced for sale and included in the register, with expertise - no more than 90 working days;
- Making changes to the documents for the 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 (when submitting an 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 documents of the registration dossier for a registered VMP with an expert evaluation - 70,000 rubles;
- Making changes to the documents of the registration dossier for a registered VMP without an expert evaluation - 2,600 rubles;
- Inclusion in the State Register of Medicinal Products of a pharmaceutical substance produced for sale - 145,000 rubles;
- Issuance of a registration certificate - 10,000 rubles;
- Making changes to the documents for the pharmaceutical substance for sale, included in the state register with an expert evaluation - 75,000 rubles;
- Making changes to the documents for the pharmaceutical substance for sale, included in the state register without an expert evaluation- 5,000 rubles;
- Issuance of a duplicate registration certificate - 2000 rubles.
- Confirmation of state registration of VMP - 70,000 rubles;
- Making changes to the documents of the registration dossier for a registered VMP with an expert evaluation - 70,000 rubles;
- Making changes to the documents of the registration dossier for a registered VMP without an expert evaluation - 2,600 rubles;
- Inclusion in the State Register of Medicinal Products of a pharmaceutical substance produced for sale - 145,000 rubles;
- Issuance of a registration certificate - 10,000 rubles;
- Making changes to the documents for the pharmaceutical substance for sale, included in the state register with an expert evaluation - 75,000 rubles;
- Making changes to the documents for the pharmaceutical substance for sale, included in the state register without an expert evaluation- 5,000 rubles;
- Issuance of a duplicate registration certificate - 2000 rubles.
- State registration of 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 (similar to a registration certificate) - no more than 10 working days;
- Making changes to the documents of the registration dossier for a registered feed additive with expertise - no more than 35 working days;
- Making changes to the documents of the registration dossier for a registered feed additive without examination - no more than 15 working days
- Issuance of an extract from the State Register of Feed Additives (similar to a registration certificate) - no more than 10 working days;
- Making changes to the documents of the registration dossier for a registered feed additive with expertise - no more than 35 working days;
- Making changes to the documents of the registration dossier for a registered feed additive without examination - no more than 15 working days
- State registration of feed additive - 85,000 rubles;
- Making changes to the documents of the registration dossier for a registered feed additive with an expert evaluation - 34,700 rubles;
- Making changes to the documents of the registration dossier for a registered feed additive without an expert evaluation - 7,700 rubles
- Making changes to the documents of the registration dossier for a registered feed additive with an expert evaluation - 34,700 rubles;
- Making changes to the documents of the registration dossier for a registered feed additive without an expert evaluation - 7,700 rubles
If a decision is made on the state registration of a feed additive:
- Rosselkhoznadzor enters information about the design documentation into the State Register of Feed Additives;
- Rosselkhoznadzor issues to the Applicant an agreed instruction on the use of the feed additive.
- Rosselkhoznadzor enters information about the design documentation into the State Register of Feed Additives;
- Rosselkhoznadzor issues to the Applicant an agreed instruction on the use of the feed additive.
No.
The Rosselkhoznadzor shall issue to the Applicant an agreed instruction on the use of the feed additive strictly in accordance with the Application.
Without the Application, the extract will not be issued to the Applicant.
The Rosselkhoznadzor shall issue to the Applicant an agreed instruction on the use of the feed additive strictly in accordance with the Application.
Without the 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.
