| Description |
Required Documents
|
No.
|
Type of information
|
Note
|
|
1
|
A copy of the official request of the registrant.
|
|
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2
|
State registration certificate of legal entity
|
|
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3
|
An application for registration of animal feed additives in the state registry
|
|
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4
|
A free trade document for the animal feed supplement issued by the official contracted distributor
|
In the case of a feed additive produced by a manufacturer or an imported animal feed supplement |
|
5
|
A manufacturer's certified document confirming that the manufacturer meets the requirements of good manufacturing practice (GMP), international (IS0: 9001, IS0: 22000) and similar standards of the country, and a description of the plant
|
|
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6
|
A document certified by the manufacturer confirming that the animal feed supplement is registered in the country of origin and used in that country
|
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7
|
Manufacturer's statement that the mixture has been genetically modified and does not belong to the stimulant group
|
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|
8
|
A description of the manufacturer specifying their surnames and types in Latin names, and a Mongolian translation of the Latin name
|
If the composition of the product includes live microorganisms and plants |
|
9
|
A draft instructions for the use discussed by the Pharmacopoeia Committee under the State Administrative Body;
Developed in Mongolian language the composition, properties, action, purpose, method of application, dosage, amount, side effects, prohibitions, storage, transportation conditions and warnings of animal feed additives and is in charge of animal health issues
|
|
|
10
|
Color pictures of primary and secondary packaging of animal feed additives
|
Submit a sample to the Veterinary Drug Sub-Council with the condition to return it if necessary |
In addition to the items specified above, the following documents shall be required for registration of animal feed additives included in these categories;
Required Documents for animal feed additives included in the category of feed mixture
|
No.
|
Type of Information
|
Note
|
|
1
|
Information on adverse side effects of feed mixture on humans, livestock, animals and the environment
|
|
|
2.
|
Safety indicators of feed mixtures and laboratory test methods to check them
|
|
|
3.
|
Results of the State Veterinary Drug Testing and Certification Laboratory of Mongolia
|
|
|
4
|
Draft instructions for use shall include instructions for disposal and disposal of feed additives and waste
|
|
|
5.
|
License certificate of the business entity
|
|
Required Documents for domestically produced feed additives
|
No.
|
Type of Information
|
Note
|
|
1
|
Test results of the State Laboratory for Veterinary Drug Testing and Certification of Mongolia
|
|
Process Steps
|
Step 1
|
The Applicant submits a required document to the GAVS clerk
|
|
Step 2
|
The Veterinary Sub-Council shall review the application
|
|
Step 3
|
Head of GAVS will review
|
| Step4 |
Grant a Registration certificate |
NOTE
- In case of change of composition, instructions for use, dosage, form, label, official name and address of the animal feed additive, the state registration shall be changed and a new certificate shall be issued.
- In case a business entity imports animal feed additives previously registered in the state registry from another source under the same trade name, it shall submit a new registration. A new registration number shall be assigned to another product with the same trade name, composition, label, and packaging
- The applicant shall submit a written request to the Veterinary Drug Sub-Council at least 1 month prior to the expiration of the state registration of feed additives. The request shall clearly state the total amount and scope of use of the animal feed supplement.
- The registration shall be canceled if;
- No request has been submitted to extend the state registration period for animal feed additives and the validity period has expired
- The poisoning and death of livestock due to its side effects during the use of animal feed additives has been determined by a professional veterinary and law enforcement agency.
- It has been proven that the animal feed additive was forged or the documents were forged
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