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Category
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Special Permit (import)
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Responsible Agency
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Name: General Authority for Veterinary Services
Address: Mongolia, Ulaanbaatar 13381
Bayanzurkh district,
Peace avenue 16a,
Government building IXa
E-mail: vetsermongolia@magicnet.mn info@dvab.gov.mn
Web: http://vet.gov.mn/
Phone: 51-262271
Fax: 51-263237
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Legal base of the Procedure
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Law on Business Licensing, 2001
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Time to be spent
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The application shall be resolved within 21 working days of the postponement / unless the licensing authority submits an application for a license, submits an application and other relevant documents, and resolves the issue of issuing a license /
If a license is refused, a written response shall be provided stating the reasons for the refusal.
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Fee registration and service fee
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State stamp duty. Once the decision to grant a license is clear, the following fees must be paid. Payments will be made once the decision is made
1. UB Bank Bayanzurkh district tax department, Ministry of Food and Light Industry, Account № 2609006065 license stamp duty 600,000 MNT
2. The price of the certificate shall be 5,000 MNT to the Treasury account number 100900019039
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Required documents:
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#
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Type of Information
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Note
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1
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Application for a license / specify the type and duration of production and services /
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2
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If the license applicant is a legal entity, a state registration certificate;
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3
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If the license applicant is a citizen, a copy of the ID card / the authorized person receiving the document shall verify the copy with the original and make a note on the authenticity of the copy free of charge /, if submitted by mail, a notarized copy;
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4
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Receipt of state stamp duty payment;
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5
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Тухайн үйлдвэрлэл, үйлчилгээний онцлогоос шалтгаалан хуульд заасан бусад баримт бичиг;
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6
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Published materials on pharmacology and clinical trials, main agents, excipients, stability test results, drug toxicity, activity, composition, safety, interactions, drug label (certified in Mongolian and English).
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7
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In order to ensure the safety of the external environment of the building to be operating, video equipment and devices shall be installed and the proposal of the policy shall be obtained;
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8
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Drug samples;
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9
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Drug registration certificate issued by the competent authority of the country
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10
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Certificate of origin of the drug / Product certified by the competent authority, certificate of industrial registration and free trade, analysis, etc./;
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11
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When registering drug raw materials in the state registry, the manufacturer's GMP certificate, product certificate, test results, methodology, laboratory test results, the conclusion of the environmental assessment of the state central administrative body in charge of nature and environment, and other relevant materials with translation;
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12
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In addition to the above-mentioned documents for registration of bio preparations, the conclusion of the international reference laboratory test;
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13
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A person wishing to register a product in the State Veterinary Drug Registry shall be a legal entity that officially represents the manufacturer in our country and shall submit the original, documents and materials certified by the seal and stamp to the Veterinary Drug Sub-Council.
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14
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Domestic drug labels are written in Mongolian, and imported drug labels are written in English. Instructions for use of the drug are written in Mongolian.
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Process step
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Step 1
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Submit to the GAVS clerk
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Step 2
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The Chairman or Head of the unit shall appoint to the relative specialist
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Step3
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The specialist will present to the head of the unit and the chairman of the General Department
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Step 4
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After signed and stamped by the Chairman
The permit will be issued
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NOTE:
- The licensing authority has the right to have the applicant's documents reviewed by the relevant authority, if necessary. Within 14 days after the decision to register a drug, a registration certificate shall be issued and signed by the chairman and secretary of the drug council.
- In the case of verification, the application processing time can be extended by 14 days.
- The license specified in 15.10.17 of this Law shall be issued to a legal entity member of the relevant professional association. / This section was added by the law in 7 February 2013 /
Suspension of the license
- In case of violation of the term, conditions and requirements of the license, the licensing authority may suspend it for up to 3 months based on the conclusion of the specialized inspection agency.
- The licensing authority shall notify the license holder and the relevant tax authority in writing of the decision to suspend within 3 days.
- The licensing authority shall renew the license if the conditions for suspension of the license cease to exist.
Revocation of a permit / The licensing authority shall revoke the license in the following cases /
- at the request of the licensee;
- the legal entity is liquidated;
- False documents were found to obtain a license;
- repeated or serious violation of the terms and conditions of the license; / This part was amended according to the law dated November 20, 2003,/
- non-compliance with the requirements for elimination of violations during the period of suspension of the license.
- / This provision was added by the law in 5 May 2012 and repealed by the law in 3 October 2013 /

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