Mongolia is a state in East Asia with a population of 3.1 million people. Mongolia was not a part of the USSR, but it had close historical, political and economic ties with the Union. The country’s economy is rapidly developing to a large extent due to mining.

Mongolian pharmaceutical market is represented by imported medicinal products for more than 70%, domestic production makes up less than 30%.

The circulation of pharmaceutical products is regulated by state health agencies and the Ministry of Health on the basis of relevant laws. Pharmaceutical market consists of privately-owned enterprises.

Import and sale of medicinal products are authorized after their registration. Medical devices are not subject to registration, except for medical devices for diagnostics. Special food products shall undergo the state registration following a procedure similar to the registration of medicinal products. Cosmetic products are not subject to registration.

Competent authorities:

The Ministry of Health of Mongolia.
The central executive authority in the area of health care. The department (division) on medicinal products and medical devices of the Ministry of Health carries out the expert examination and registration of medicinal products and medical devices for diagnostics.
Web-site: http://hdc.gov.mn/content3.php

Main legal acts:

1. The Law of Mongolia dated June 1, 2010 “On medicinal products and medical devices”;
2. Order of the Ministry of Health of Mongolia No. 13 dated January 15, 2015 “On Approval of the provision on registration of medicinal products and substances”;
3. Order of the Ministry of Health of Mongolia No. 415 dated July 11, 2013 “On approval of registration of data on the side effects of medicinal products and safety information and rules.”
4. Order of the Ministry of Health of Mongolia No. 13 dated January 15, 2015 “On approval of the provision on registration of biologically active products”.

“Cratia” professionally performs the activities of state registration of medicinal products in Mongolia. We have an excellent knowledge of national legislation, necessary experience and resources to carry out the work. We offer:

• registration of medicines in Mongolia;
• establishment and maintenance of the pharmacovigilance system in Mongolia;
• certification of medical devices in Mongolia;
• certification of special food products in Mongolia;
• certification of cosmetic products in Mongolia.

To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.