Mongolia
- Regulatory Authority:
Ministry of Health of Mongolia
Central executive body in the field of health
- Language of labeling and documentation:
Mongolian, English
- Authorized Representative:
country resident
- Import and sale of medicines in Mongolia requires mandatory registration
- Medical devices (except for diagnostic kits) and medical equipment are not subject to registrationю Import license required
- Diagnostic kits are subject to mandatory registration
- Specialty food products are subject to a registration procedure similar to registration of medicines
- Cosmetic products do not require mandatory registration
- Legislations:
Law of Mongolia dated 1 June 2010 on “Medicines and Medical Devices”
Order of the Ministry of Health of Mongolia dated 15 January 2015, No.13 “On Approval of Regulations on Registration of Medicines and Substances”
Order of the Ministry of Health of Mongolia dated 11 July 2013, No.415 “On approval of the procedure for registration of data on adverse effects of medicines and safety information and regulations”