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Procedure NameSpecial permit for manufacturing, importing a veterinary drug and medical devices
Description

Category

Special Permit (import)

Responsible Agency         

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

Legal base of the Procedure

Law on Business Licensing, 2001

Time to be spent

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.

Fee registration and service fee

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

Required documents:

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Type of Information 

Note

1

Application for a license / specify the type and duration of production and services /

2

If the license applicant is a legal entity, a state registration certificate;

3

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;

4

Receipt of state stamp duty payment;

5

Тухайн үйлдвэрлэл, үйлчилгээний онцлогоос шалтгаалан хуульд заасан бусад баримт бичиг;

6

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).

7

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;

8

Drug samples;

9

Drug registration certificate issued by the competent authority of the country

10

Certificate of origin of the drug / Product certified by the competent authority, certificate of industrial registration and free trade, analysis, etc./;

11

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;

12

In addition to the above-mentioned documents for registration of bio preparations, the conclusion of the international reference laboratory test;

13

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.

14

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.

Process step

Step 1

Submit to the GAVS clerk

Step 2

The Chairman or Head of the unit shall appoint to the relative specialist

Step3

The specialist will present to the head of the unit and the chairman of the General Department

Step 4

After signed and stamped by the Chairman

The permit will be issued

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 /

 

CategoryImport

The following form/s are used in this procedure
TitleDescriptionCreated DateUpdated DateIssued By
This application form applies to the proceudre to request special permit from Mofali and Gavs13-12-202013-12-2020 This is Dowload File
This procedure applies to the following measures
NameMeasure TypeAgencyDescriptionCommentsLegal DocumentValidity ToMeasure Class
Special Permit to importing and manufacturing a veterinary drugs and medical equipmentLicensing Requirement Special Permit is required prior to importing and manufacturing the veterinary drug and medical devicesSpecial Permit is required prior to importing and manufacturing the veterinary drug and medical devicesLaw on Licensing of Business Activities09-09-9999Good