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Procedure Name

Export License issuing procedure for medicines and medical devices

Description

Category	LICENSE
Responsible Agency	Name: MINISTRY OF HEALTH Address: Mongolia, Ulaanbaatar 14210 Sukhbaatar District 14210 Olympic Street - 2 Government Building VIII, E-mail: info@moh.gov.mn Web: https://www.mohs.mn/home Phone: (976) 51-263695 Fax: 11-320916
The legal base of the Procedure	Order No. A/407 of the Minister of Health of 2017
Fee	N/A
Processing time	5 working days

Required Documents

No.	Type of information	Note
1	Trade agreement concluded with the organization importing drugs and medical devices	Documents necessary for the application
2	Invoice for goods imported in accordance with the contract
3	Conclusion of the accredited laboratory test

Process Steps

Step1	The applicant shall obtain the access code to the electronic system from the Health Development Center
Step2	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 (www.moh.mn/Licemed/)
Step3	Documents submitted by the applicant shall be reviewed by the Center for Health Development
Step4	The applicant shall receive information on the process of processing the application for a license in electronic form
Step5	If the application is approved by the Director of the Drugs Department of the Ministry of Health, Applicant receives the license to Export medicines and medical devices

NOTE;

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.
The license shall be issued for a period of up to six months.
It is prohibited to transfer, sell, gift or pledge the license
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
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

Category

Export

The following form/s are used in this procedure

Title	Description	Created Date	Updated Date	Issued By
Import/Export License for medicines and medical devices, 2017 Annex 2 to Order A / 407	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 devices	30-07-2020	08-10-2020

This procedure applies to the following measures

Name	Measure Type	Agency	Description	Comments	Legal Document	Validity To	Measure Class
License requirement for exporting medicines and medical devices	Licensing Requirement		As per the Order on Import and export of medicines and medical devices, this measure applies to traders who want to export medicines and medical devices any other country from Mongolia.	A License applicant shall have a license to engage in professional activities in the field of import and export of medicines and medical devices. 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 shipment.	On Approval of Procedure/Issuing import and export licenses for medicines and medical devices/, 2017	31-12-9999	Good