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Procedure NameImport License procedure for medicines and medical devices, A/407



Responsible Agency       


Address: Mongolia, Ulaanbaatar 14210

Sukhbaatar District 14210

Olympic Street - 2

Government Building VIII,



Phone: (976) 51-263695

Fax: 11-320916

The legal base of the Procedure

On Approval of Procedure/Issuing import and export licenses for medicines and medical devices/, 2017



Processing time

5 working days

Amendments to the license shall be reviewed and resolved within 3 working days.


Required Documents


Type of information



A trade agreement concluded by an importer of drugs and medical devices with a foreign pharmaceutical company or its official authorized distributor

Documents necessary

for the application


Invoice for goods imported in accordance with the contract


A certificate confirming that the manufacturer and the product meet the requirements of international standards (ISO) for the import of medical devices


A proposal issued by the Public Health Department of the Ministry of Health for the import of a vaccine and a Lot Release certificate issued by the competent authority of the country exporting the vaccine


Process Steps


Imported drugs shall be registered in the Mongolian Drug Registry


The applicant shall obtain the access code to the electronic system from the Health Development Center


The application for a license shall be submitted in electronic form by entering the Internet-based electronic registration system for health sector licenses and import permits (

Step4 Documents submitted by the applicant shall be reviewed by the Center for Health Development  
Step5 The applicant shall receive information on the process of processing the application for a license in electronic form
Step6 If the application is approved by the Director of the Drugs Department of the Ministry of Health, the Applicant receives the license to import medicines and medical devices



1. The Licensor shall have the right to inspect, verify, and issue an opinion on the applicant's documents by the relevant authority, if necessary. In this case, the period shall be extended

until the conclusion of the relevant authority and the applicant shall be responsible for the costs incurred in this connection.

2. The license shall be issued for a period of up to six months.

3. It is prohibited to transfer, sell, gift, or pledge the license

4. If a request is made stating the reasons for making an amendment during the term of the license, the amendment may be made based on the relevant documents

5. If it is necessary to change the type and quantity of drugs and medical devices specified in the license, a new application shall be submitted to obtain a license

6. Log in to the electronic system at the following web address and submit a license application and import report.




The following form/s are used in this procedure
TitleDescriptionCreated DateUpdated DateIssued By
This License form applies to traders wishing to import/export of medicines and medical devices. License relates the Import License procedure for medicines and medical devices30-07-202008-10-2020Ministry of HealthThis is Dowload File
This procedure applies to the following measures
NameMeasure TypeAgencyDescriptionCommentsLegal DocumentValidity ToMeasure Class
License requirement for importing medicines and medical devicesLicensing RequirementMinistry of HealthAs per the Order on import and export of medicines and medical devices, this measure applies to traders who want to import medicines and medical devices any other country to Mongolia.The application for a license shall clearly indicate the type, dosage, packaging, name of the manufacturer, quantity and border crossing of the drugs and medical devices to be imported in the shipmentOn Approval of Procedure/Issuing import and export licenses for medicines and medical devices/, 2017 31-12-9999Good