View Procedure

Category

Registration(Veterinary drug importation)

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

Resolved within 3 months of receipt of application Issuance of registration certificate within 14 days after the decision to register the drug

Fee for registration

The registration fee (hereinafter referred to as the "registration fee") shall be paid regardless of the form of ownership. The registrant shall be responsible for the costs of work and services related to the registration of drugs, bio-preparations, disinfectants and feed additives. The registration fee shall not be refunded.

Registration and service fee:

• 250,000 tugrugs for the registration of imported drugs, bio-preparations and substances for vaccination, deworming, washing, processing, disinfection and disinfection for animal diseases, and 150,000 tugrugs for renewal;
• Registration of other imported drugs MNT 200,000, extension MNT 100,000;
• 100,000 MNT for registration and 50,000 MNT for renewal of national industrial drugs;
• 100,000 MNT for registration and renewal of drug raw materials;
• The registration fee for the same drug form registered by more than 8 drug supply organizations is twice as high.

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Type of Information 

1

Trade agreement and power of attorney with the manufacturer

2

Pharmacopoeia article

3

Documents issued in accordance with the application form for drug registration in the state registration specified in paragraph 8 of this regulation; (must be written and certified in Mongolian)

4

Profile of the pharmaceutical company and proof that the plant meets international standards and quality requirements (GMP);

5

Test results from an authorized laboratory in the country of origin of the drug or in its own country;

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

Instructions for use written in accordance with the approved model, which includes the composition of the drug, its chemical properties, indications for use, contraindications, side effects, drug interactions, dosage conditions, and warnings;

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.

Step 1

Submit to the organization's file

Step 2

The Chairman of the Board shall review and approve the application

Step 3

Go to a specialist

The registration certificate will be issued