• Applicationfor making changes to the registration documents for a registered feed additive - 2 copies
• Instructions for use of the feed additive - 6 copies(4 signed copies with a seal + 2 unsigned copies without a seal);
  On the final sheet of the instructions for use, after the paragraph with the address of the organization producing the feed additive, you must place a paragraph with the following content:
  
  

With the approval of this instruction, the instruction on the use of the feed additive "name of the feed additive", approved by the Rosselkhoznadzor, becomes invalid......(date, month and year of approval of the previous instructions for use)

• Duly certified documents confirming the need to make changes to the registration documents for the registered feed additive - 1 copy;
  example: in case of changes in the term and / or storage conditions of a feed additive, as well as the introduction of new types of packaging-present the results of preclinical studies of the feed additive (confirmation of the declared shelf life of the feed additive (stability – - see the corresponding item from the section "registration of a feed additive"for more details
  
  example: if the scope of application of a feed additive is changed/expanded, animal species are added, etc – - the results of veterinary studies of the feed additive are presented;
  
  example: if a feed additive is renamed – a letter from the manufacturing organization and/or developer certified in accordance with the statutory procedure is submitted about the decision taken
  
  in case of renaming of the organization-producer of feed additives-the documents certified in accordance with the established procedure from official bodies of the country of the organization – producer confirming changes of the name of the organization – producer (with indication of the old and new names)are submitted
  
  if a feed additive manufacturing organization is replaced by another one (if this organization was not a developer of the additive), the developer and the applicant provide justification for the change of the manufacturing company, production certificates, stability reports, a letter from the manufacturer about contract production, samples of the additive.
• Draft notification of changes to the regulatory document (for domestic producers) - 3 copies;
  A draft notification of changes to a regulatory document is submitted if the changes made affect the regulatory document (changes in quality control methods, renaming the additive, changes in packaging, changes in the shelf life of the additive, etc.).
• Cover letter from the manufacturing organization / developer organization about the need to make changes - 1 copy.
  If the original letter prepared by a foreign manufacturing organization or developer organization is submitted, such a letter must also be issued in Russian
  
  If the original letter prepared by a foreign manufacturing or development organization is not written in Russian, such a letter must be translated into Russian and certified in accordance with the procedure established by law (notary, apostille).
  
  The letter is issued in any form with a detailed description of the planned changes to the registration documents for the registered feed additive
• A copy of the approved instructions for the use of feed additives-1 copy(seal certification is not required);
• Copy of the certificate of state registration of the feed additive-1 copy(seal certification is not required);
• A copy of the regulatory document (TU, SRT) -1 copy(seal certification is not required);
• Power of attorney - 2 copies each.
  Please note that there are 4 legal entities listed in the application for registration or making changes, namely::
  
  1-applicant,
  
  2- representative of the applicant,
  
  3-developer
  
  4-manufacturer
  
  Based on this information, a chain of powers of attorney is formed:
  
  If 1,3 and 4 are one legal entity, then one power of attorney for the applicant's representative is sufficient in the form attached on the site, without the right of transfer.
  
  If 3 and 4 are the same legal entity, and 1 and 2 are different persons, then a power of attorney for the applicant with the right of transfer (notarized!)is required. and then from the applicant to the applicant's representative (according to the dates of issue and validity periods, it cannot overlap the main power of attorney).
  
  If the developer and the applicant are different legal entities, and production takes place on a contract basis, then you will need to provide a letter/power of attorney from the manufacturer on letterhead signed by the legal entity that this product is produced on a contract basis only by order and for the developer's organization.
• Inventoryof submitted registration documents - 2 copies;
  In accordance with paragraph 11 of the Rules for State Registration of Medicinal Products for Animals and Feed Additives approved by Order No. 48 of the Ministry of Agriculture of the Russian Federation dated 01.04.2005 " On Approval of the Rules for State Registration of Medicinal Products for Animals and Feed Additives "(registered by the Ministry of Justice of the Russian Federation on April 14, 2005 registration number 6510), 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 changes in the technology and place of production.

• Terms of service delivery: from 3 to 6 months, depending on the nature of changes.

• Documents for registration of animal vaccines (PDF);
  
  
• Submitting an application to the Rosselkhoznadzor;

Review of documents;

Transfer of documents to an Expert organization and expert examination;

Providing samples if necessary;

Making a decision;

Registration of the certificate.

Within 10 days after the state registration of a feed additive, the Rosselkhoznadzor sends the following information to the Ministry of Agriculture of the Russian Federation for inclusion in the state register of feed additives::

1. a) name of feed additives;
   
   
2. b) form of feed additives;
   
   
3. c) indications (scope) for the use of feed additives;
   
   
4. d) The Applicant (indicating the country or subject of the Russian Federation in which the Applicant is registered);
   
   
5. e) manufacturing organization (indicating the country or subject of the Russian Federation in which the manufacturing organization is registered);
   
   
6. f) registration number of feed additives;
   
   
7. g) accounting series of the Applicant (manufacturing organization);
   
   
8. h) date of registration of feed additives;
   
   
9. i) the validity period of registration of feed additives.

The Ministry of Agriculture of the Russian Federation enters the received information in the state register of feed additives no later than 5 days after receiving it.

No later than 5 days after entering the received information in the state register of feed additives, the Ministry of Agriculture of the Russian Federation sends an extract from the state register of feed additives to the Rosselkhoznadzor for issuing it to the Applicant.