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Hainan to promote drug import facilitation

2022-11-15

Recently, the thirty-eighth meeting of theStanding Committee of the Sixth People's Congress of Hainan Province consideredand adopted the "Hainan Free Trade Port drug import facilitation provisions.

 

  First, it is clear that the import ofdrugs from the designated import port of Hainan Free Trade Port drug imports,should be filed to the port of drug supervision and management departments,without the "import drug clearance".

 

  Second, the port location of drugsupervision and management departments received the application materials forthe record of imported drugs, after review that the materials submitted by theimported drug companies meet the filing requirements, the same day to completethe import filing procedures, and the filing of electronic information exchangeto the Customs and Excise Department, while informing imported drug companiesof the record results. Approved for the record of imported drug companiesshould be customs clearance procedures.

 

  Third, the provisions of the portlocation of drug supervision and management departments should be based on theneeds of imported drug enterprises, free of charge for enterprises to providecustoms clearance certificates for imported drugs.

 

  Fourth, drug supervision and managementdepartments should strengthen the circulation of imported drugs, the use ofsupervision and management, sampling and inspection, the establishment ofimported drugs, corporate credit files, bad credit records of imported drugcompanies, increase the frequency of supervision and inspection, and relevantdepartments to implement joint discipline according to law.

 

  Fifth, emphasizing the mainresponsibility of the enterprise, the enterprise of imported drugs shouldestablish and implement the management system of imported drug informationtraceability, pharmacovigilance, etc., to comply with the requirements of theCode of Good Manufacturing Practice, to ensure the quality and safety ofimported drugs and traceability.

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