Tag Archives: Import

Customs Processing and Temporary Warehousing

Our Mongolian lawyers often work with foreign clients and local trading companies involved in import of product into Mongolia. Products entering Mongolia often require short term storage as the products are inspected by Customs. Importers are able to utilize temporary warehousing solutions for these goods for the duration the products are under Customs control yet not yet cleared.

Temporary Customs warehousing may be open for the public, or limited access. Goods are typically placed in temporary storage upon decision by Customs that the goods be stored pending the Customs inspection process. Goods seized by Customs or detained on suspicions of violations of import regulations are also stored in the temporary warehouse.

When goods are placed in temporary storage, a copy of the manifest and other documentation relating to the shipment is kept on file. In normal circumstances storage in temporary warehouses is permitted for a period of up to 2 months from the date of entry. Customs has the option to extent this period for an additional month. For perishable or hazardous goods, storage may be for 2 weeks, with a possible one week extension.

Storage of petroleum products is permitted in a limited access facility operated a licensed fuel importer. Third parties and those not having the necessary import license will not be permitted to store products in such facility.

A party with product in temporary storage may not transfer title to a third party until customs inspection and clearance is completed.

What You Need to Know About Registration of Foreign Pharmaceuticals in Mongolia

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.