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Laws & Regulations - Drugs - Provisions for Drug Importation
Provisions for Drug Importation
 
2012/3/20 14:26:07¡¡Source: ¡¡Hits:

Chapter 1 General Provisions

Article 1 The Provisions are formulated with a view of regulating importation filing, Customs declaration and port inspection for the importation of drugs and ensuring the quality of import drugs in accordance with the Drug Administration Law of the People¡¯s Republic of China, Customs Law of the People¡¯s Republic of China, Regulations for Implementation of the Drug Administration Law of the People¡¯s Republic of China (hereinafter referred to as the Drug Administration Law, Customs Law and Regulations for Implementation of the Drug Administration Law) and relevant laws and regulations.

Article 2 The Provisions are applicable to importation filing, customs declaration, port inspection and import of drugs.

Article 3 Drugs shall be imported via the ports where drug importation is permitted by the State Council.

Article 4 "Importation filing" mentioned in the Provisions refers to the process by which an importer applies for a Drug Import Note to the drug regulatory department of the place where the port permitted for importation is located (hereinafter referred to as the ¡°port drug administration¡±. The importation filing of narcotic and psychotropic drugs refers to the process by which an importer applies to the port drug administration for a Notice for Port Inspection of Import Drugs.
Port inspection mentioned in the Provisions refers to the inspection of import drugs arrived at a port, which is conducted by a drug testing institution designated by the State Food and Drug Administration (hereinafter referred to as the ¡°port drug testing institution¡±) in accordance with the law.

Article 5 Only after obtaining an Import Drug License (or Pharmaceutical Product License) or an Import Drug Approval issued by the State Food and Drug Administration, can an importer go through formalities of importation filing and port inspection.
For importation of narcotic and psychotropic drugs, an Import License for narcotic and psychotropic drugs issued by the State Food and Drug Administration must be obtained.

Article 6 An importer shall file a declaration with the Customs in the presence of a Drug Import Note. The Customs shall handle the customs declaration procedures for the import drug based on the Drug Import Note issued by a port drug administration.
The Customs shall handle the customs declaration procedures for a import narcotic and psychotropic drug based on the Import License for narcotic and psychotropic drugs issued by the State Food and Drug Administration.

Article 7 The State Food and Drug Administration shall formulate, amend and publish the catalogue of import drugs jointly with the General Administration of Customs.

Chapter 2 Importation Filing

Article 8 The port drug administrations are responsible for drug importation filing. The importation filing undertaken by port drug administrations shall be under the leadership of the State Food and Drug Administration. Their specific responsibilities include:
(1) Accepting applications for importation filing and examining relevant materials;
(2) Handling matters with respect to importation filing or rejection of importation filing;
(3) Contacting the Customs to handle matters with respect to importation filing ;
(4) Notifying the port drug testing institute to conduct port inspection of import drugs;
(5) Addressing problems arising from importation filing and port inspection ;
(6) Other matters specified by the State Food and Drug Administration.

Article 9 The applicant for inspection shall be an independent legal entity holding a Drug Supply Certificate. A drug manufacturer must hold a Drug Manufacturing Certificate to import drug substances and intermediate preparations (including preparations to be repackaged within China) for its own use.

Article 10 An import drug with any of the following circumstances must be confirmed in compliance with specifications after inspection by a port drug testing institute before undergoing the importation filing procedure. For an import drug found not in compliance with specifications, the port drug administration shall not approve its importation filing.
(1) A biological product specified by the State Food and Drug Administration;
(2) A drug sold in China for the first time;
(3) Other drugs specified by the State Council.

Article 11 Where a purchase contract is signed, the importer shall select a port of delivery from the ports permitted for drug importation. A drug specified in any of the circumstances prescribed in Article 10 of the Provisions must be imported via ports that are specially approved by the State for drug importation.

Article 12 An application for (drug) importation filing shall be submitted to the port drug administration of the port of delivery and inspection shall be carried out by the port drug testing institute responsible for testing drugs imported form this port.

Article 13 To apply for importation filing, an applicant shall fill in a Application Form for Inspection of Import Drugs and provide the original of the Import Drug License £Ûor Pharmaceutical Product License (formal edition or its counterpart)£Ý. To import a narcotic or psychotropic drug, the applicant shall provide the original of the Import License for the narcotic and psychotropic drug and submit materials relating to the import drug in duplicate to the local port drug administration.
(1) Copy of the Import Drug License £Ûor Pharmaceutical Product License (formal edition or its counterpart)£Ý; copy of the Import License for narcotic and psychotropic drugs;
(2) Copies of the Drug Supply Certificate and Corporate Business License of the applicant;
(3) Copies of the Certificate of Origin;
(4) Copies of the purchase contract;
(5) Copies of the packing list, bill of lading and freight invoice;
(6) Copies of the certificate of analysis for the release of the drug by the manufacturer;
(7) Prototypes of the drug insert sheet, package and label (except for a drug substance or an intermediate preparation);
(8) For a biological product subjected to lot release as required by the State Food and Drug Administration, a summary manufacturing protocol as well as the original of the lot release certificate issued by the drug regulatory authority of the country or region of origin shall be provided;
(9) For a drug other than those specified in Article 10 of the Provisions, copies of the latest Import Drug Testing Report and Drug Import Note shall be submitted.
Where a drug manufacturer imports a drug substance or an intermediate preparation for its own production, it shall provide copies of the Drug Manufacturing Certificate and Corporate Business License in replacement of what are required in Item (2) when applying for importation filing.
For an import drug transited via other countries or regions, all the purchase contracts, packing lists, bills of lading and freight invoices for transport from the place of origin to various transit places shall be submitted at the same time.
The copies above shall be affixed with the official seal of the importer.

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