The “Provisions on Facilitation of Drug Import in Hainan Free Trade Port,” released in September this year, will take effect as of December 1, 2022. These new regulations aim to streamline the import process for pharmaceuticals, enhancing efficiency and reducing administrative burdens.
Regulatory Changes
The Provisions specify that enterprises importing drugs from the designated drug import port of Hainan Free Trade Port shall file with the local drug regulatory department, without having to go through the Drug Import Customs Clearance. Customs will no longer check the Drug Import Customs Clearance when processing customs declaration and inspection formalities.
Implementation Process
According to the Provisions, after the shipment of imported drugs, enterprises can submit the required materials for import registration through the International Trade “Single Window.” Upon receiving the materials, the local drug regulatory department will complete the import filing procedures on the same day if the materials meet the requirements. The department will exchange electronic filing information with Customs and inform the importing enterprise of the filing results. Additionally, the local drug regulatory department will provide the enterprise with a free certificate for customs clearance of imported drugs, as needed.
Scope of Application
Notably, the drugs covered by the Provisions include those that have obtained a drug registration certificate from the State Council’s drug regulatory authority and have been sold in the domestic market. Excluded are drugs that require import inspection under laws and regulations, such as imported medicinal materials, vaccines, blood products, etc.-Fineline Info & Tech
