However, if the value of the drugs carried exceeds the ‘self-use’ limit prescribed by the Customs, or its nature cannot be judged as ‘reasonable for self-use’, the Customs will request the post consignee or carrier to provide evidence such as diagnostic instructions, prescriptions, purchase records, overseas marketing license and drug instructions etc., to prove the rationality of self-use. For non-prohibited articles, in general the Customs will inspect and release them directly.For the entry and exit of overseas drugs for self-use, the Customs department shall supervise them according to the principles of ‘reasonable, self-use and small amount’, and Customs clearance shall be conducted in accordance with personal articles without submitting the relevant import licenses, and duty-free release.Individuals who enter or leave China with a small amount of drugs for self-use shall follow the relevant regulatory provisions of the Customs. Imported drugs shall be used for particular medical purposes in designated medical institutions. When there is an urgent need to import a small amount of drugs for clinical purpose, they must get approval from the drug regulatory department of the State Council or the people’s government of a province, autonomous region, and municipality directly under the Central Government authorized by the State Council. Medical institutions shall not engage in drug import and export business in their daily operations. Moreover, enterprises must also obtain corresponding licenses for importing and exporting drugs and perform the specific import and export process. A pharmaceutical manufacture shall also hold the “Drug Manufacture License” when importing APIs and pharmaceutical intermediates (including domestic sub-packaging preparations) of their own. The enterprises of drug import and export must be independent legal person holding the “Drug Service License” and “Drug Manufacture (Service) Enterprise Certificate”. Special qualification for importing and exporting drugs In accordance with the provisions of the “Customs Law of the People’s Republic of China (revised in 2017)”, the consignee or consignor of import and export goods must register with the Customs according to the law when going through the Customs declaration formalities.According to the provisions of the “Foreign Trade Law”, foreign trade operators who engage in the import and export of goods or technology should file with the foreign trade department of the State Council or its authorized agencies.Qualification of general import and export trade subjectsįor drug import and export enterprises, they must obtain the general enterprise qualification to engage in import and export trade: The new law has made corresponding adjustment to the import and export regulations, which promotes the continuous improvement of China’s drug import and export supervision legal system.ġ.Qualification of the main body engaged in drug import and export activities This is the second major revision of the law since it was promulgated in 1984. On December 1 st, 2019, the new edition of “China Drug Administration Law” was implemented officially.
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