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Procedure Name

Procedure for granting import license for Veterinary medicine and medical equipment, A/212

Description

Category	Import License
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 Web: http://vet.gov.mn/ Phone/ Fax: (976-51) 26-16-35
The legal base of the Procedure	Approval of procedure for veterinary medicine and medical equipment license,2010 Number A / 212
Fee	N/A

Required Documents

No.	Type of information	Note
1	Notarized copy of the state registration certificate of the business entity of the legal entity	Documents necessary for the application
2	A copy of the license for importing drugs and medical devices
3	Evidence that the importer is a trade agreement, power of attorney or official representative of a foreign supplier of medicines and medical devices
4	A copy of the certificate registered in the state drug registry (not applicable to medical devices and diagnostics
5	Certificate of origin, quality certificate, and conformity of drugs and drug raw materials
6	Quality assurance of drug series of exporting countries
7	International and national quality assurance and origin certificates and instructions for use of medical devices, diagnostics, instruments, and equipment
8	Certificate of manufacturer or supplier (GMP, ISO) that meets international quality standards

When importing drugs and bio preparations:

1. Customs Original Registered Copy (AWB)

2. detailed registration of the package and a copy of the invoice

3. certificate issued by the manufacturer

Process Steps

Step 1	The Applicant submits a request to the General Veterinary Department along with all required documents
Step 2	The General veterinary Department reviews the application
Step 3	If the application gets approved, the applicant receives the Veterinary Certificate

NOTE:

1. Medicines and medical supplies supplied through international projects, programs, aid, donations and loans under government agreements and used for disasters and emergencies shall be provided by the Ministry of Food, Agriculture and Light Industry and the Ministry of Finance's Credit and Assistance Policy and Cooperation Department. have an official letter and page

2. The import license shall include the name, form, dosage, quantity of the drug or medical device, the name of the manufacturer (packaging), the time of crossing the border, and information on the border crossing point.

3.Within 100 working days after receiving the documents specified in 2.2 of this regulation, the Veterinary and Breeding Department shall review and decide and issue the import license for at least 1 month.

4. days prior to the expiration of the import license, the drug supply organization shall submit an official letter to the Veterinary and Breeding Department stating the reasons for the extension.

5. Application for extension of import license shall be extended for up to 1 month and the license shall be revoked if it is found to be late or in violation.

6. Licenses for the import of veterinary drugs and medical devices shall use an approved template with a unified code, number, special security and printed form.

7. If a drug supplier uses a license and is not registered at the state border, does not have a quality assurance or conformity certificate, submits false documents, obtained from a pharmaceutical company or a drug supply contractor, expires, or attempts to introduce drugs or medical devices, license will be revoked.

8. The Ministry of Food, Agriculture, and Light Industry shall monitor the registration and disbursement of import licenses and establish a unified registration database and network.

Category

Import

The following form/s are used in this procedure

Title	Description	Created Date	Updated Date	Issued By
Import license of veterinary medicine and medical Equipment	This form applies to the procedure related to importation of Veterinary Medicine and Medical Equipment	03-06-2020	17-12-2020	General Authority for Veterinary Services

This procedure applies to the following measures

Name	Measure Type	Agency	Description	Comments	Legal Document	Validity To	Measure Class
Import License requirement for Veterinary Medicine and Medical Equipment	Licensing Requirement	General Authority for Veterinary Services	As per the Order on Veterinary Medicine and Medical Equipment License , this measure applies to traders who want to import Veterinary medicine and medical equipment from any other country to Mongolia.	In order to import for veterinary drugs, bio-preparations (vaccines, serums, test kits), raw materials, medical devices, disinfectants (hereinafter "drugs and medical devices") in the territory of Mongolia, a person must in possession of import license permit.	On Approval of Procedure/Issuance of License for Importing Veterinary Medicine and Medical Equipment/, 2010 А 212	09-09-9999	Good