Pharmaceuticals imported to be sold within Mongolia are required to be registered with the Ministry of Health prior to import. The law provides for an “Express” registration process, as well as a “Regular” track. Express registration includes a sub-track “A” and “B”.
To be eligible for Track A Express registration, a pharmaceutical product must already have approval from a national regulator from a country recognized internationally as having effective pharmaceutical review and control processes, and must be sold on the market in that country. Such recognized bodies include the FDA in the USA, The European Medicines Agency (EMA), European Free Trade Association (EFTA) and the Ministry of Health, Labour, and Welfare in Japan. Track A Express registration provides for formal registration of the product within 30 days of the filing of the application for registration.
Track B Express registration provides for formal registration within 60 days of the filing of the application for pharmaceuticals which have been previously approved by relevant authorities of states which are party to Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme–PIC/S.
If a pharmaceutical product does not meet the requirements for Express Track A or B, it will be required to proceed with a regular registration process. The regular approval process will take 3-5 months, however this time may be extended if required.
Applications for pharmaceutical approvals in Mongolia are submitted to the “Human Medicine Board” which will make a decision as to registration of the pharmaceutical for sale within Mongolia. Products approved under the Express process are granted approval for 3 years, while products registered via regular process will receive approval valid for 5 years, after which the registration is required to be renewed.
If you are seeking to import a medicine product to Mongolia, our Mongolian lawyers are able to assist with all required registration actions.