AKVET Consulting is a leading company providing comprehensive services in registration, licensing, promotion and sales of veterinary drugs and feed additives for agricultural industry on the territory of the Russian Federation and other EEU Member states. One of our company’s areas of business – registration of feed additives on Russia.
We are ready to develop and implement a strategy to promote your product in EEU Countries, using the legal, technical and scientific potential. All our actions are directed to ensure that your product has taken a worthy place in the domestic and foreign markets.
Our range of services includes the initial GAP analysis, development of registration dossier, complete control of the registration process, expert advice, etc. After successful registration, our specialists will prepare the most efficient promotion and sales plan for your product on the territory of Russia and EEU Countries.
Nowadays such agricultural areas as poultry, livestock, fish farming, almost cannot do without introduction of advances technologies and use of veterinary drugs to promote growth and productivity of poultry, livestock and fish. The most important and popular product in agricultural industry is a feed additive. It is in a great demand among farmers and producers, but requires mandatory registration to enter the market. If your company manufactures veterinary products, then you will definitely need to register animal feed additives. Please contact us for quick and successful registration process.
Registration of feed additives
Compulsory state registration of feed additives in Rosselkhoznadzor is required.
There is a list of feed additives and veterinary medicinal products that subject to compulsory state registration:
- New (not previously produced) feed additives and medicinal products;
- Drugs and feed additives created on the basis of already existing ones;
- Feed additives and medicines, previously created, but with modified dose, dosage form, and another set of additional components;
- Generic medicines and feed additives.
In fact, every new product needs to get registered before it enters the market. These can be totally new products with completely original composition and set of substances or generic products with changes name. In any case you will need to obtain state registration.
The process of obtaining the certificates confirming the state registration can be called multi-step and time-consuming. This is due to the fact that the competent authorities require collecting a huge package of documents, without which it is impossible to obtain a permit.
List of documents for submission to Rosselkhoznadzor
To obtain the registration certificate, you must provide the following documents:
- Application form from the applicant for the state registration of feed additive or medicinal product (two copies);
- The registration dossier, which includes the following types of documents:
- Mock-ups of initial and consumer package (three copies);
- Document in Russian, which confirms the compliance of the manufacturer of the feed additive or the drug to the rules of production and quality of drugs, issued by the competent authority of the production country of the feed additive or the drug that subject to registration, and certified as required by the prescribed procedure(for Russian manufacturers – manufacturing license, and for the foreign – GMP, CCP or ISO).
- Draft of regulations or regulatory documents for the medicine or feed additive, or an indication of a specific pharmacopoeial monograph.
- Technological production flow diagram for the feed additive and its description.
- The document, which includes information on product name, manufacturer’s name and address, expiration date of the product under registration.
- Document with the details on the quality parameters of the feed additive, veterinary medicine of pharmaceutical substance.
- Information about the conditions of transportation, storage and other related information.
- Report on the results of pre-clinical studies of the feed additive or the drug, the studies on laboratory animals, the toxicity studies, detection of veterinary drug residues and other studies confirming the quality and safety of products.
- Instructions for use.
- A copy of the document, translated into Russian and supporting product registration in the case of the product registration outside the Russian Federation;
- The document confirming payment of the State fee for the examination of product quality.
The registration process requires strict compliance with the requirements of the existing legal documents as well as methods for evaluating safety and efficacy of feed additives and medicinal products.
AKVET Consulting offers you significantly reduce the time required for registration and to shift most of the work on our staff. We will help you to build a complete package of necessary documents and successfully undergo the procedure of state registration of feed additives. We also carry out the registration of premixes.
Our experts will conduct effective consultations and help you bring your products to the domestic and foreign markets. We have extensive experience in working with government institutions and know perfectly well how to negotiate with them.
Our company cooperates with leading laboratories, veterinarians and scientists, so we can guarantee an excellent result.