Order of the State Food and Drug Administration
The Administrative Measures for the Import of Drugs have been adopted by the State Food and Drug Administration and the General Administration of Customs of the People’s Republic of China upon deliberation,
Administrative Measures for the Import of Drugs
In order to regulate the record keeping, customs declaration and port inspection work relating to the import of drugs, guarantee the quality of imported drugs,
the present Measures are formulated in accordance with the Pharmaceutical Administration Law of the People’s Republic of China,
the Customs Law, the Rules for the Implementation of the Pharmaceutical Administration Law of the People’s Republic of China and the other relevant laws and regulations.
The present Measures shall be applicable to the work of record keeping, customs declaration and port inspection relating to the import of drugs.
The Drugs shall be imported through ports, which permit the entry of imported drugs upon the approval of the State Council.
“Import record keeping” as mentioned in the present Measures refers to the process, in which import entities file applications to administrative departments for drugs of place where the ports are located for Customs Clearance Permit for Imported Drugs.
The import record keeping of narcotics and psychotropic drugs refers to the process that the import entities file applications to the drug administrations where the ports are located for Imported Drugs Port Inspection Notice.
The term “port inspection” means that the medicine inspection institutions determined by the State Food and Drug Administration conduct examination on the imported Drugs, which have arrived at the ports, in accordance with the law.
An import entity shall not go through the formalities for import record keeping and port inspection on imported drugs unless it has acquired the Drug Import Registration Certificate (or Pharmaceutical Products Registration Certificate).
In addition, an important entity shall have acquired the Import Permit for the import of narcotics and psychotropic drugs.
An import entity shall file a declaration to the customs upon the strength of Customs Clearance Permit for Imported Drugs, while the customs shall handle the procedures for the customs declaration and clearance of the imported drugs.