State registration of feed additives for animals. Features of the national registration of feed additives
Lack of clear and transparent legislative framework- a problem that prevents effective work in many areas of business in Russia. It did not bypass the participants of the Russian feed community, causing many questions, dissatisfaction and controversy.
Despite the adoption of Government Resolution No. 761 of September 28, 2009 “On ensuring the harmonization of Russian sanitary and epidemiological requirements, veterinary, sanitary and phytosanitary measures with international standards,” such harmonization has not yet been ensured in the feed additives market sector.
Meanwhile, according to market participants, the share of legal imports of raw materials for the production of feed and premixes has decreased by 50% for a number of products, which indicates the possible development of counterfeit goods and falsification of feed additives. Which is not surprising, since the legal import of feed raw materials and the development of domestic production of feed additives are associated with the formidable word “state registration”. Why is this process so frightening for market participants and should we expect changes for the better? Let's try to figure it out.
Having worked in the import and registration of feed additives for several years, I have always had questions regarding the registration process. The important thing is that many of them remain unanswered and form a vicious circle. Sometimes one gives up - after all, it turns out that if you follow the legislation, an enterprise in Russia simply cannot develop at the pace required for business, achieve its goals and, therefore, keep up with the rapidly changing market.
Often emotions do not allow us to give an objective assessment of the situation. Having received an offer to write this article, I was afraid that it might be too subjective. But it turned out that I am not alone in my emotions and they are shared by representatives of many other organizations working in the feed industry throughout Russia (as evidenced by the meetings, round tables and specially organized conferences held on the issue of state registration with the participation of business and government representatives). At the time of writing this article, my subjective feelings were also supported by the opinions included in the draft resolution of the conference “Feed Harmonization. Administrative regulation of state registration of feed additives", organized by news agency SoyaNews and the Union of Compound Feeders on September 28, 2011, and it became finally clear that this is no longer just a subjective feeling, but a completely justified reaction to the existing reality.
So what do we have?
Normative base
When registering feed additives today, one has to rely on the only document currently in force, created to regulate the procedure and procedure state registration feed additives along with medicines for animals, - Order of the Ministry Agriculture Russian Federation dated April 1, 2005 No. 48. These rules establish a unified procedure for state registration of domestic and foreign medicines for animals and feed additives, with the exception of feed additives obtained from genetically modified organisms.
The document is far from perfect and raises a number of questions. For example, what is meant by the term “feed additive”? What are the requirements for the preparation of documents provided for registration? By what criteria is the completeness of the data provided for registration assessed? The list of questions goes on. By by and large, this document imposes similar requirements on feed additives as on medicinal products for animals, and no distinction is made between domestic and foreign manufacturers.
Fortunately, changes are expected. The administrative regulations for the provision of state services for state registration of feed additives by the Federal Service for Veterinary and Phytosanitary Surveillance are being prepared for approval, which, hopefully, will clarify most of the issues and make life easier, first of all, for Russian producers of feed and feed additives. The draft regulations (currently in their seventh edition) are posted on the official website of Rosselkhoznadzor (http://www.fsvps.ru/fsvps-docs/ru/laws/projects) in open access for all interested parties.
It is necessary to note the “readiness of the federal service for a constructive dialogue with feed manufacturers” expressed by the management of Rosselkhoznadzor, which consists of the participation of top officials in meetings and conferences dedicated to the discussion of draft regulations. At the conference on September 28, it was decided to create a permanent working group with the participation of representatives of market participants (united in the Union of Compound Feeders), Rosselkhoznadzor and the Ministry of Agriculture of Russia on the issues of improving the legislative framework for regulating control and supervisory activities aimed at developing the industry.
I would like to hope that the dialogue between the state and representatives of the industry will be truly constructive and will not turn, as often happens, into a monologue. The latest (seventh) version of the regulations largely takes into account the shortcomings of previous documents, but it is not yet known whether it will become final. According to information announced at the above-mentioned conference on September 28, a draft regulation has already been sent to the Ministry of Economic Development for approval, the text of which, in a number of provisions, diverges from the text of the 7th edition of the regulation, posted on the Rosselkhoznadzor website and developed with the participation of market operating companies. As they say, no comments... In any case, until the regulations are approved, we have to work in accordance with the legislation in force on this moment, because Order No. 48 has not yet been canceled.
Who is required to register?
According to the current Order No. 48, state registration is mandatory for legal entities and individuals engaged in the production, sale, use, as well as import into the territory of the Russian Federation of medicines for animals and feed additives.
What is meant by the term “feed additive”?
Perhaps this is the main question. Order No. 48 does not provide any clarification as to what is meant by “feed additives” for the purposes of this document.
Thus, without a clear definition of this term, feed additives can “with equal success” include raw materials of biological origin (for example, soybean meal, fishmeal etc.), various substances chemical nature(for example, glycerin, ready-made mixtures for adding to food (consisting of several of the above ingredients) with constant or variable composition. It is not clear from this document whether the legislation differentiates between ingredients added directly to feed and ingredients not intended for direct use in feed (from which feed additives or premixes are first produced for subsequent addition to feed). And if with the need to register mixtures with a constant composition (domestic or imported) everything is more or less clear (although this is not directly stated in the text of the document), then in relation to individual raw materials and chemical substances(V in this case imported, since most of them are not produced in Russia) the situation is vague. As it seems today, you can only gain confidence in the need to register a particular raw material ingredient or substance by writing a specific request to Rosselkhoznadzor and waiting (if you have the patience!) for an official response 30 days later.
Let's consider an example from Russian reality: a domestic company imports several feed ingredients produced only abroad, produces a product from them (let's call it a complex feed additive), which it then sells or uses in its own production to add to feed. It turns out that this company must first register each of the ingredients used to produce the complex supplement, and then the final product. What if a large number of ingredients are used - say, seven (as, for example, in the case of a multi-enzyme complex)? The product will be golden! It’s easier (and cheaper) to import a ready-made complex import additive, since you only have to register it once. The situation is clearly not in favor of the Russian manufacturer!
It is not always possible to import raw ingredients or substances already registered in Russia (oh, happiness if you succeed!), since many of them are assigned to specific importers under exclusive contracts. By the way, the need to enter into an exclusive contract with an import supplier is very often due to the importer’s need to register the product (which means spending a lot of money and, more importantly for business, time). Obviously, if there was a clear formulation of the concept of “feed additives” and, perhaps, even a list of “feed additives” subject to registration (or definitely not), it would be easier for everyone - both market participants and regulatory authorities. And how much time would be saved by both of them on writing requests and composing answers, respectively!
The good news is that government officials understand the need to introduce a clear formulation of the concept of “feed additive” and are trying to correct the situation. Thus, the seventh edition of the draft administrative regulations (unfortunately, there is nothing more to operate with) proposes for the purposes of this regulation the following definition of the concept of “feed additives”: products or their combinations of plant, animal, microbiological, mineral and synthetic origin, intended for inclusion in feed and animal diets in order to ensure physiological completeness, stimulate animal productivity, ensure the safety of components, increase the availability of nutrients, improve the taste and technological properties of feed. In my opinion, this definition It’s unlikely to make life easier, because all feed raw materials without exception fall under it!
Nevertheless, a significant positive change proposed by the seventh edition of the regulations, in contrast to Order No. 48, is the following explanation: “Mixtures and combinations of registered feed additives with a variable composition (vitamin mixtures, mineral mixtures, vitamin-mineral mixtures, premixes) are not subject to state registration , BMWK and BMVD), if they are manufactured on the territory of the Russian Federation or the Customs Union.”
Another innovation proposed by the latest edition of the regulations is the division of feed additives into groups and the statement of special requirements for registration documentation for additives depending on the group (Appendix No. 4 to the regulations). Thus, technological additives are distinguished (including preservatives, antioxidants, emulsifiers, stabilizers, thickeners, gelling agents, binders, absorbents of radionuclides, mycotoxins and bacterial toxins, anti-caking agents, acidity regulators, silage additives, denaturants), flavoring additives (dyes, flavorings), additives that ensure the biological value of feed (vitamins and their derivatives; compounds of microelements: amino acids, their salts and analogues; urea and its derivatives; protein additives; substances that influence the normalization of the functioning of organs and tissues of the animal body), and zootechnical additives (enzymes, prebiotics, probiotics, substances that have a beneficial effect on the environment). The regulations are also supplemented by Appendix No. 5, which sets out the requirements for the registration dossier for certain categories of feed additives, including the content of potentially hazardous and harmful substances, as well as intermediate products of microbiological and chemical synthesis. Thus, in terms of safety control requirements, the following are separated into separate categories: enzyme and other additives obtained using producing microorganisms; substances of plant origin; components of animal origin, including those from aquatic organisms; minerals; products obtained by chemical synthesis and other chemical processes. It is still difficult to give any comments regarding the proposed innovations. Most likely, this will be possible only after gaining practical experience with the new document. I think it’s worth emphasizing once again that the regulations have not been approved at the moment, so we can’t say with certainty that we will eventually get it in this (latest) edition.
Authorized body
As before, the state service for state registration of feed additives is provided by the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) on the basis of the expert opinion of the federal state budgetary institution FSBI "All-Russian state center quality and standardization of medicines for animals and feed" (FSBI "VGNKI"). Thus, the draft regulations in its latest edition do not change the situation establishing the monopoly position of VGNKI in conducting the examination of feed additives. This fact, which contradicts the requirements of antimonopoly legislation, worries many participants in the feed community, and it was also included in the draft resolution of the conference on September 28.
How much does registration cost?
The Appendix to Order No. 48 does not clarify the issue of the cost of the state service for registration of feed additives and medicines for animals, stipulating only that “the examination of medicines and additives is carried out by the Federal State Institution “VGNKI” by agreement of the parties.” The seventh edition of the draft regulations contains an amendment regarding this issue, clarifying that “The performance of state functions and administrative procedures within the framework of the performance of state functions in accordance with the legislation of the Russian Federation is carried out by Rosselkhoznadzor on a free basis (with the exception of the examination of feed additives and the study of samples of feed additives).” The cost of the examination itself (which is an integral condition of state registration) is stated as follows: “The examination of feed additives is carried out by an authorized expert institution according to tariffs approved by the Ministry of Agriculture of Russia.” As far as I understand, this refers to the tariffs presented in the price list on the official website of the Federal State Budgetary Institution “VGNKI” www.vgnki.ru in the “services and prices” section.
From the practice of our company, the official cost of registering one feed additive (or rather, its examination at VGNKI) is about 80-100 thousand rubles.
How long does registration take?
Currently, registration of feed additives is carried out within six months from the date of submission of registration documents and data provided for by Order No. 48 to Rosselkhoznadzor.
No matter how many members of the forage community wish it, shortening the registration period will apparently remain a pipe dream. None of the proposed editions of the regulations contain positive changes in in this regard. The seventh edition states the same period in other words, replacing “6 months” with “180 days”.
Validity period of the registration certificate
Previously, on the basis of the decision on registration, Rosselkhoznadzor issued the registration applicant a document of the established form (certificate) of state registration for a period of 5 years. That is, upon expiration of the registration certificate (or 6 months before its expiration), you had to go through the registration procedure again.
Recently, the situation, fortunately, has changed, and the state registration certificate is now issued for an indefinite period. The seventh edition of the regulations also provides for the issuance of permanent certificates. However, despite the fact that the document has not yet been approved, this wonderful innovation is already working in practice.
Samples for registration
In addition to the list of documents required for registration (currently prescribed by Order No. 48), the registration applicant must also submit samples of the registered feed additive to Rosselkhoznadzor for examination at the Federal State Institution "VGNKI". It would seem nothing complicated. There are no special questions regarding samples of additives produced in Russia. As for imported additives, the situation with them is complicated by the delivery of these very samples from abroad, or rather, the need to obtain permits (import permit, import quarantine permit), draw up shipping documentation (contract, invoice, packing list and etc.) and then carry out customs clearance. In general, prepare everything that is necessary to import a full consignment of goods, only in this case for a consignment weighing 1-3 kg. Having experienced all the “delights” of this procedure in practice, I could probably talk for a long time about the import of imported samples for registration. But this is perhaps a topic for a separate article...
So, these are the main, most pressing and actively discussed issues regarding the state registration process of feed additives, which I tried to cover as objectively as possible. Of course, it is always easy to criticize, but it is perhaps impossible to create an ideal document that meets all the wishes of participants in the feed community on the one hand and regulatory authorities on the other. Nevertheless, I would like that, when approving the new administrative regulations on state registration of feed additives, the state listened as much as possible to the opinions of direct participants in the feed industry and, at a minimum, supported the Russian manufacturer. It is also obvious that in order for the regulatory documents being developed to work well in practice, it is necessary to regulate relations within the entire feed and feed additives sector, as well as harmonize Russian legislation with the regulations of the Customs Union and international standards in this area.
26.06.2018
- Dear Tatyana Nikolaevna, good afternoon. As you know, from July 1, 2018 Instead of issuing paid paper veterinary accompanying documents in the state veterinary service, there will be a complete transition to electronic certification products. Although this transition has been planned for a long time, experts still have many questions and concerns. In particular, representatives of the feed industry are interested in which specialist will be able to carry it out?
Good afternoon, Vera Pavlovna. Well, what can we say about fears? As in the famous joke: “Don’t just sit, but you’ll have to start!” Besides, not everything is so scary: so, according to by order of the Ministry of Agriculture RF No. 646, certification of mixed feed products can be carried out by employees of enterprises who do not have a veterinary education.
To make the transition, it is necessary to adjust the warehouse accounting system and integrate the system accounting with the Mercury system. Of course, we will have to overcome the difficulties of the transition period, but in the end this will allow product manufacturers, after a one-time investment, to significantly reduce time and money costs. In addition, this is easily feasible for feed producers, and there are already enterprises that have switched to electronic registration of VSD(veterinary and sanitary documentation). The introduction of automatic cancellation and registration of VSD at the weighing plant makes the work easier.
On the Rosselkhoznadzor website you can get information about the educational version of the Mercury system. Before moving to productive version, it is proposed to practice on a pilot project.
- How is VSD processed when exporting goods?
To ensure compliance veterinary requirements importing countries veterinary certification goods exported (to the CIS and EAEU countries), an order was issued by Rosselkhoznadzor, according to which it is necessary to conduct laboratory tests of goods to ensure their compliance with the requirements contained in the regulatory documents of the CIS and EAEU, in interstate standards, as well as the requirements of third countries.
Enterprises must submit product samples for testing to laboratories that have appropriate accreditation, implemented methods for compliance with the requirements of importing countries and use FSIS "Vesta" for collecting, transmitting and analyzing information on laboratory studies of feed quality. In veterinary accompanying documents it is enough to indicate the examination numbers for product certification. The use of the Vesta system is available to any laboratory in the Russian Federation, regardless of its form of ownership. But there is no register of laboratories that use VESTA and have implemented the necessary methods. There is an obvious flaw in the regulator here. However, according to Rosselkhoznadzor, all laboratories of the Russian Academy of Agricultural Sciences operate in this system.
- Is there any news regarding the abolition of state registration of premixes and BVMK?
Feed additives are registered in accordance with Order of the Ministry of Agriculture No. 48 of April 1, 2005 “On approval of the rules for state registration of medicines for animals and feed additives.” In 2010, Federal Law No. 61 “On the Circulation of Medicines” came into force, and Order No. 48 has since become invalid. But with regard to the registration of feed additives, no other document was adopted, and Rosselkhoznadzor still continues to require registration of premixes on the basis of this document, considering the premix a feed additive. For several years, the Ministry of Agriculture has been developing a draft resolution of the Government of the Russian Federation on the registration of feed additives, but it is rejected by the Ministry of Justice over and over again. This draft stipulates that all feed additives are subject to registration, with the exception of: those intended for export and for scientific research; registered in other states of the Eurasian Economic Union; premixes, BVMK, containing additives registered in the EAEU. This document is currently in Once again is being approved by the Ministry of Justice.
It is planned to introduce a state duty in the amount of 160 thousand rubles. for conducting an examination of feed additives and issuing a certificate of their registration from January 1, 2019. In order to legitimize the introduction of a state duty, it is necessary to amend the Tax Code and the Law “On Veterinary Medicine”.
- Industry specialists have already The long-suffering technical regulation “On the safety of feed and feed additives” has been waiting for seven years. Is there any progress on this issue?
In 2016, a coordinated Russian position, harmonized with EU directives, was sent to the EEC. But in May 2017, Rosselkhoznadzor announced the need to revise the Russian position regarding the definition of objects of technical regulation, since the inclusion of feed additives in the definition of “feed” does not correspond to the legal framework of the EAEU member states, and will also require significant changes in the system of existing industry documents, GOST etc. The protracted confrontation between part of the business community and Rosselkhoznadzor is holding back the process of agreeing on the draft technical regulations in the Eurasian Economic Commission. In the EU, feed includes all products that are to be fed to animals, which is quite logical, but it is also logical that feed carries a nutritional load, and feed additives perform various functions: zootechnical, technological, sensory, and also regulate metabolism in the body of animals . Feed is subject to declaration, and feed additives are subject to registration. In order to speed up the adoption of technical regulations, it is necessary to find a solution that meets the interests of all market participants. At the same time, adaptation remains an important task international experience To Russian realities. We consider it acceptable to divide the objects of technical regulation into feed and feed additives, both in the conceptual sense and in the legislative order. Premixes cannot be classified as feed additives, since they are a pre-mixture of registered additives, which is produced at feed and premix plants, where homogeneity of mixing is achieved. What is more dramatic is that in our work on product safety issues, we are forced to be guided by temporary MRLs developed and approved in the 70–80s, as well as individual points of the technical regulations of the Republic of Kazakhstan “Requirements for the safety of feed and feed additives.” Veterinary regulations and the standards developed in 2003 were never approved. There are no documents containing definitions of the basic concepts and terms “feed” and “feed additives”.
-WITH Now manufacturers and businesses are concerned about changes in the conduct of scheduled inspections. Can you shed more light on this issue?
- Indeed, in In the coming year, we will be affected by amendments regarding scheduled inspections. In these amendments, the government will apply a risk-based approach, according to which feed industry enterprises are classified as moderate-risk industries and are subject to inspection once every five years. But there is one “but”: if the control body receives a consumer complaint about a minor violation of mandatory requirements, and the culprit has not previously been brought to justice, then the control body will have the right not to conduct an inspection, but to issue a warning. A consumer’s appeal regarding a violation of his rights will entail an unscheduled inspection only if the consumer filed a complaint with the organization, but his appeal was not considered or the demands were not satisfied.
If it is impossible to carry out an inspection due to the absence of the head of the organization on site, a special report is drawn up about this. In this case, the supervisory authority will have another three months to decide whether to conduct a scheduled or unscheduled on-site inspection without prior notice.
When conducting inspections, an innovation will be introduced - the use of verification checklists by type of activity, where it will be clearly stated what exactly is subject to inspection, as well as in which paragraph and in which regulatory act this requirement is contained. When inspecting feed manufacturers, inspectors refer to individual clauses of the technical regulations “Requirements for the safety of feed and feed additives.” Knowing the contents of checklists will help entrepreneurs prepare for the check in a timely manner.
- Tatyana Nikolaevna, The Ministry of Agriculture is developing guidelines for assessing biological safety use of genetically engineered modified (GM) organisms for the production of feed and feed additives and guidelines on conducting molecular genetic research on genetically modified organisms for the production of feed and feed additives . How will this affect the state registration procedure for this type of feed and what risks do producers of feed with GM products have?
- Yes, such a process is underway. The absence of these guidelines is the main reason why Rosselkhoznadzor stopped the procedure for state registration of GM feed. At the beginning of 2018, changes were made to Resolution No. 839, according to which the Sodrugestvo Group of Companies registered GM soybean meal for 5 years.
Feed products containing registered GM components are not subject to registration. The content of GM components of more than 0.9% is subject to declaration and labeling in accordance with the law on the protection of consumer rights (valid for sales of packaged feed through stores for the population and farmers), as well as with the 22nd technical regulation on the labeling of food products. There is no such regulatory document for feed, but this does not prevent supervisory authorities from applying food regulations.
There are controversial cases when soybean meal is not included in mixed feed and these products, accordingly, are not declared, but during control tests in the laboratory, a GMO content of more than 0.9% is detected. It is possible that GM soybean meal may enter as an accidental impurity in negligible quantities from the occurrence zones technological equipment. But the methodology used determines the percentage of GM soybeans as the ratio of the amount of DNA of genetically modified soybeans of a certain line to total number The DNA of all soybeans contained in the feed, i.e. in relation to herself.
This leads to an unreliable result: test reports indicate that more than 0.9% GMOs were detected, although the manufacturer did not introduce GM components and, accordingly, did not declare (label) its products as containing GMOs. As a result, penalties are applied to him, including the destruction of products, although the content of GM soybean meal approved for use in compound feed does not pose a danger. While work is underway on the laboratory methodology, feed mills remain at risk of sanctions.
- IN In March, the Ministry of Justice registered the order of the Federal Service for Veterinary and Phytosanitary Surveillance dated January 30, 2018 No. 53 “On approval Guidelines to ensure the functioning of the Federal State information system(FSIS) in the field of veterinary medicine." Tell our readers about this system.
- Yes, such a p The order has been accepted. It determines the operation of the veterinary information system (VetIS), which includes the Cyrano, Argus, Mercury, Vesta, Cerberus and Irena systems. The document prescribes the functions of the systems, user access and identification, establishes the types of users, the composition of the entered information, etc. VetIS must ensure traceability of controlled goods. With its help, permits for import, export and transit to the Russian Federation will be issued. This system is also intended for recording the results of laboratory tests and collecting samples for them. VetIS will be used to collect, process and store information about subjects of veterinary supervision (subjects, objects, processes) and state control over the circulation of medicines for veterinary use. Another area of application of the system - monitoring of key industry indicators and notification of their exceedance and other tasks in the field of veterinary medicine.
- It is known that there are cases when feed mills become hostages in relations with unscrupulous grain suppliers. And they are often fined. Is it possible to change this situation?
- Yes, we hope so, and and The initiative to change the rules of the game in the grain market comes from the Federal Tax Service.
Indeed, the market for domestic grain processing has not yet been restructured. In order to intensify the processes of “whitewashing” the market, the Federal Tax Service plans to carry out on-site tax audits with the involvement of law enforcement. Feed mills work directly with agricultural producers or traders in non-grain regions. Unscrupulous suppliers who have no assets buy from agricultural producers without VAT, but at a higher price than processors would buy, and sell to feed mills with VAT, thereby stealing from the state. The processor submits VAT for reimbursement, but the Federal Tax Service does not accept the documents, as it sees a gap in the payment of VAT. Legal proceedings begin. Feed mills are under threat because they really exist, they have assets, and their managers are real people. Tax authorities When carrying out tax control activities, they look for the beneficiary, that is, a real company from which, in the event of additional assessments, it will be possible to recover accrued tax payments. The “Charter of a Conscientious Taxpayer” is currently being developed. Enterprises that have signed this document undertake not to participate in illegal VAT refund schemes and not to receive competitive advantages due to non-payment of taxes. When selecting a supplier, members of the Charter will require that the supplier comply with the rules of the taxation system, such as: no gaps in the payment of VAT in the supply chain, the book value of the supplier’s fixed assets is at least 50 million rubles, and documentary confirmation from the supplier that the founder is an individual. A Charter member website is currently being created where members will inform others that certain suppliers are using tax schemes. Then such a supplier will either want to work correctly so as not to be at risk, or they will not buy products from him. Companies that have chosen these counterparties will not be able to prove to the tax inspectorate that due diligence has been exercised, which will serve as the basis for inspections. This will help remove dishonest intermediaries in the chain.
- Tatyana Nikolaevna, Thanks a lot for spending time with us. We will hope for the best for our feed industry and new meetings with you!
Number of impressions: 2230
Author: The conversation was conducted by V. Dubinskaya
Order of the Ministry of Agriculture of the Russian Federation dated April 1, 2005 N 48 “On approval of the Rules for state registration of medicines for animals and feed additives” (as amended on December 27, 2005, August 8, 2006)
In order to implement the requirements of the Law of the Russian Federation of May 14, 1993 N 4979-1 “On Veterinary Medicine” (Gazette of the Congress of People's Deputies of the Russian Federation and the Supreme Council of the Russian Federation, 1993, N 24, Art. 857; Collection of Legislation of the Russian Federation, 2002, No. 1 (Part I), Art. 2; 2004, No. 2711; 2004, No. 35, Art. 3607) and Federal Law of June 22, 1998 No. 86-FZ “On Medicines” Legislation of the Russian Federation, 1998, No. 3006; 2000, No. 126; 2003, No. 27 ( Part I), Art. 2700; 2004, No. 35, Art. 3607) I order:
1. Approve the Rules for state registration of medicines for animals and feed additives (attached).
2. Rosselkhoznadzor shall carry out state registration of medicines for animals and feed additives in accordance with the specified Rules.
3. Entrust control over the implementation of the order to Deputy Minister S.G. Mitina, Minister A.V. Gordeev Registered with the Ministry of Justice of the Russian Federation on April 14, 2005 Registration N 6510 By Order of the Ministry of Agriculture of the Russian Federation dated August 8, 2006 N 222, changes were made to this application See the text of the application in the previous edition Appendix to the order of the Ministry of Agriculture of the Russian Federation dated April 1, 2005 N 48
Rules for state registration of medicines for animals and feed additives (as amended on December 27, 2005, August 8, 2006)
1. The rules for state registration of medicines for animals and feed additives (hereinafter referred to as the Rules) were developed in accordance with the Law of the Russian Federation of May 14, 1993 N 4979-1 “On Veterinary Medicine”, Federal Law of June 22, 1998 N 86- Federal Law “On Medicines”, Regulations on the Ministry of Agriculture of the Russian Federation, approved by Decree of the Government of the Russian Federation dated March 24, 2006 N 164 and Regulations on the Federal Service for Veterinary and Phytosanitary Surveillance, approved by Decree of the Government of the Russian Federation dated June 30, 2004. N 327.
2. The rules establish a unified procedure for state registration of domestic and foreign medicines for animals (hereinafter referred to as medicines) and feed additives (hereinafter referred to as additives), with the exception of feed additives obtained from genetically modified organisms.
3. The procedure for state registration of medicines and additives established by the Rules is mandatory for legal entities and individuals engaged in the production, sale, use, as well as import of medicines and additives into the territory of the Russian Federation.
4. The following are subject to state registration: new medicines; new additives; new combinations of previously registered drugs; new combinations of previously registered additives; medicines registered earlier, but produced in other countries dosage forms, or with a new dosage, or with a different composition of excipients; additives registered previously, but produced in other forms, or with a new dosage, or with a different composition of excipients; generic medicines; generic supplements.
5. State registration of medicines and additives is carried out by Rosselkhoznadzor on the basis of the conclusion of the Federal State Institution “All-Russian State Center for Quality Control and Standardization of Medicines for Animals and Feeds” (hereinafter referred to as FGU “VGNKI”) within six months from the date of submission of registration documents and data provided for by these Rules.
6. For state registration of a medicinal product or additive, the Applicant submits to Rosselkhoznadzor the following registration documents and data: application for state registration of a medicinal product or additive (appendix to the Rules); legal address of the organization - manufacturer of the medicinal product or supplement; name of the drug or supplement, including international nonproprietary name, scientific name Latin, main synonyms; the original name of the medicinal product or supplement, if it is registered as a trademark in accordance with the legislation of the Russian Federation on trademarks, service marks and names of places of origin of goods; list of components included in the medicinal product or supplement, their quantity; instructions for the use of a medicinal product or additive, drawn up in accordance with the requirements of the Federal Law of June 22, 1998 N 86-FZ “On Medicines”; certificate of quality of a medicinal product or supplement; data on the production of the drug or supplement; methods for quality control of a medicinal product or supplement; results of preclinical studies of the drug or supplement; results of pharmacological and toxicological studies of the drug or supplement; results of veterinary research; samples of a medicinal product or additive for examination of its quality; drug or supplement price suggestions; documents confirming the registration of a medicinal product or supplement, if it is registered outside the Russian Federation.
7. Examination of medicines and additives is carried out by the Federal State Institution “VGNKI”* by agreement of the parties. Expertise of medicinal products and additives includes: a) specialized assessment of registration documents in order to draw a reasoned conclusion about the effectiveness, safety and quality of a medicinal product or additive; b) examination of samples of a medicinal product or additive for compliance with the requirements of regulatory and technical documentation for quality control of a medicinal product or additive and the reproducibility of the proposed research methods.
8. Based on the results of the examination, the Federal State Institution “VGNKI” sends to Rosselkhoznadzor a reasoned conclusion on the possibility or impossibility of registering a medicinal product or additive.
9. Based on the results of reviewing the documents and on the basis of the expert opinion of the Federal State Institution “VGNKI”, Rosselkhoznadzor makes a decision on registration or on a reasoned refusal to register a medicinal product or additive. If an incomplete set of registration documents and data is submitted, as well as if doubts arise about the quality and reliability of the submitted materials, the state registration procedure is suspended for a period not exceeding 3 months. If the Applicant fails to provide the missing materials about the medicinal product or supplement within the established time frame, as well as if the submitted materials are revealed to be unreliable, state registration of the medicinal product or supplement is refused. Based on the registration decision, Rosselkhoznadzor issues to the Applicant a standard document on state registration for each form (medicinal) of a medicinal product or additive for a period of 5 years, approved instructions for use of the medicinal product or additive and agreed upon regulatory and technical documentation.
10. Registration of a medicinal product or supplement may be suspended if a side effect is detected in the medicinal product or supplement or if data is received about it that was not known at the time of registration.
11. During the validity period of the state registration document, the Applicant is obliged to report any changes that are expected to be made to the registration documents and provide comprehensive information about the reasons for these changes and their impact on the effectiveness, safety and quality of the registered medicinal product or supplement, including about changes in technology and place of production.
12. Six months before the expiration of the state registration document, the Applicant has the right to submit an application for registration of a medicinal product or supplement for a new period.
13. The registered medicinal product or supplement is included in State Register medicines for animals and feed additives.
14. Rosselkhoznadzor, within 10 days after state registration of a medicinal product or additive, sends the following information to the Ministry of Agriculture of Russia for inclusion in the state register of medicinal products for animals and feed additives: a) name of the medicinal product or additive; b) the form of the drug or supplement; c) indications (area) of use of the medicinal product or supplement; d) Applicant (indicating the country or subject of the Russian Federation in which the Applicant is registered); e) manufacturing organization (indicating the country or subject of the Russian Federation in which the manufacturing organization is registered); f) registration number of the medicinal product or supplement; g) the accounting series of the Applicant (manufacturer organization); h) date of registration of the medicinal product or supplement; i) the validity period of the registration of the medicinal product or supplement.
15. If it is necessary to make changes to the state register of medicines for animals and feed additives, Rosselkhoznadzor sends the relevant information to the Ministry of Agriculture of Russia in the manner established by paragraph 14 of the Rules.
16. The Ministry of Agriculture of Russia enters the received information into the state register of medicines for animals and feed additives no later than 5 days from the date of receipt. No later than 5 days after entering the received information into the state register of medicines for animals and feed additives, the Ministry of Agriculture of Russia sends to Rosselkhoznadzor an extract from the state register of medicines for animals and feed additives for issuance to the Applicant.
17. Information contained in the state register of medicines for animals and feed additives is open to the public on the website of the Ministry of Agriculture of Russia on the Internet, and is also subject to publication by the Ministry of Agriculture of Russia.______________________________ * Article 16 of the Law of the Russian Federation of May 14, 1993 N 4979-1 “On veterinary medicine.” By Order of the Ministry of Agriculture of the Russian Federation dated December 27, 2005 N 236, these Rules are supplemented by the Appendix to the Rules for State Registration of Medicines for Animals and Feed Additives (SAMPLE) APPLICATION I request to register in the Russian Federation a medicine for animals/feed additive of domestic (foreign) production _____________________________________________________________________________________ ( trade name of the product - medicinal product for animals/feed additive) 1. Applicant _________________________________________________________________________ (full name legal entity in accordance with the constituent documents) 2. Location of the Applicant _________________________________________________________ _____________________________________________________________________________________ (location address, telephone/fax, TIN of the legal entity) 3. Representative of the Applicant _____________________________________________________________________________________ (full name, address, telephone, TIN (if available), power of attorney - date/N) 4. Information about the product (animal medicinal product/feed additive): 4.1. Product name ________________________________________________________________ (trade name/original name in Russian, scientific name in _________________________________________________________________________________ Latin, including international nonproprietary name of the animal medicinal product/feed additive) 4.2. Release form ___________________________________________________________________ 4.3. Composition __________________________________________________________________________ (component composition of the product by pharmaceutical group, active substance) __________________________________________________________________________________________ (presence of components of plant/animal origin that do not contain GMOs) 4.4. Purpose _____________________________________________________________________ 5. Availability of a patent, its number, owner _________________________________________________ 6. Product developer _________________________________________________________________ (name of legal entity, location address, phone number) _____________________________________________________________________________________ 7. Product manufacturer _________________________________________________________________ (location address, phone number) _____________________________________________________________________________________ (name of manufacturer/name of foreign manufacturer) 8. Information on product registration _________________________________________________ _____________________________________________________________________________________ (number and date of registration in the Russian Federation, expiration date of registration, registration abroad) Application submitted: " " ______________ 2005 ___________________________________________ (signature of the Applicant/representative of the Applicant) ___________________________________________ (F.I. .O., position held) Seal