Decree of State Food and Drug Administration

Decree of State Food and Drug Administration

No.4

The Provisions for Drug Importation, adopted by the State Food and Drug Administration and the General Administration of Customs of the People's Republic of China, is hereby promulgated and shall go into effect as of January 1, 2004.

Commissioner:  State Food and Drug  Administration

General  Administration of Customs of the People's Republic of China

Minister:MouXinsheng

                                                                                                                                                                                               August 18, 2003

Provisions for Drug Importation

(Promulgated on August 18, 2003 by the Decree No. 4 of the State Food and Drug Administration, the General Administration of Customs, and amended in accordance with the Decision on Amending the Provisions for Drug Importation by the Ministry of Health, General Administration of Customs (Decree No. 86 of Ministry of Health and General Administration of Customs) on August 24, 2012.)

Chapter I General Provisions

Article 1 The Provisions is formulated to regulate the drug importation record filing, customs declaration and port testing,to ensure the quality of drugs to be imported, in accordance with the Drug Administration Law of the People's Republic of China, the Customs Law of the People's Republic of China and the Regulations for Implementation of the Drug Administration Law of the People's Republic of China (hereinafter referred to as Drug Administration Law, Customs Law and Regulations for Implementation of Drug Administration Law, respectively) as well as other relevant laws and regulations.

Article 2 The Provisions shall apply to the importation record filing, customs declaration, port testing and drug importation.

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

Article 4 Importation record filing in the Provisions refers to the process that drug importers apply for the Drug Import Note to the local drug regulatory department at ports of entry where drug importation is permitted (hereinafter referred to as the drug regulatory department at ports of entry). Importation record filing of narcotic drugs and psychotropic substances in the Provisions refers to the process that drug importers apply for the Notice of Port Testing for Import Drugs from the drug regulatory department at ports of entry.

Port testing in the Provisions refers to the testing of drugs to be imported upon the arrival at port, conducted by a drug control institute designated by the State Food and Drug Administration (hereinafter referred to as the drug control institute of port) in accordance with laws.

Article 5 An importer may go through the formalities of importation record filing and port testing of drugs to be imported only after it has obtained the Import Drug License (or Pharmaceutical Product License) or Import Drug Approval issued by State Food and Drug Administration.

In addition, to import narcotic drugs and psychotropic substances, an importer shall obtain the Import License for narcotic drugs and psychotropic substances issued by the State Food and Drug Administration.

Article 6 An importer shall apply to the customs by presenting the Drug Import Note, while the customs shall perform customs clearance of the drug imports based on the Drug Import Note issued by the drug regulatory department at ports of entry.

To import narcotic drugs and psychotropic substances, the customs shall perform customs clearance on the basis of the Import License for narcotic drugs and psychotropic substances issued by the State Food and Drug Administration.

Article 7 The State Food and Drug Administration shall, together with the General Administration of Customs, formulate, revise and publish the import drugs list.

Chapter II Importation record filing

Article 8 Drug regulatory departments at ports of entry are responsible for the importation record filing of drugs. A drug regulatory department at ports of entry shall, under the leadership of the State Food and Drug Administration, carry out importation record filing, specific responsibilities of which include:

(I)  to accept applications for importation record filing and to examine the materials for importation record filing;

(II) to deal with matters relevant to approving or refusing importation record filing application;

(III) to contact with the customs for matters relevant to importation record filing;

(IV) to notify the drug control institute of port to impose port testing on drugs to be imported;

(V) to supervise and handle the issues found during importation record filing and port testing; and

(VI) other matters stipulated by State Food and Drug Administration

Article 9 An entity which applies for port testing shall be an independent legal entity and hold the Drug Supply Certificate. A drug manufacturer shall hold the Drug Manufacturing Certificate to import the active pharmaceutical ingredients and intermediate (including pharmaceutical preparations for re-packaging within China) used for its own manufacture.

Article 10 In any of the following cases, the importation record filing of drugs to be imported shall proceed only after they have been tested and confirmed by the drug control institute of port that they meet the prescribed standards. If they do not meet the prescribed standards based on testing, the drug regulatory department at ports of entry shall not approve the importation record filing.

(I) biological products specified by the State Food and Drug Administration;

(II) drugs to be marketed in China for the first time; and

(III) other drugs specified by the State Council.

Article 11 An importer shall choose a port where drug importation is permitted as the port of delivery when signing a purchase contract. Drugs specified in Article 10 of the Provisions shall be imported via a port that is specially permitted by the State for such importation.

Article 12 An application for importation record filing shall be made to the drug regulatory department at ports of entry where goods arrive, and drugs to be imported shall be tested by the drug control institute of port which is responsible for port testing of drugs at that port.

Article 13 An applicant for importation record filing shall fill in the Application for Testing of Import Drugs, present the original Import Drug License (or Pharmaceutical Product License) (in original or duplicate), additionally the original Import License for narcotic drugs and psychotropic substances when importing them, and submit other relevant materials (with two photocopies each) of the drug to be imported to the local drug regulatory department at ports of entry:

(I) photocopies of the Import Drug License(or Pharmaceutical Product License) (in original or duplicate); copies of Import License of narcotic drugs and psychotropic substances;

(II) photocopies of Drug Supply Certificate and Business License for Legal Person of the applicant for testing;

(III) photocopies of the Certificate of Origin;

(IV) photocopies of the purchase contracts;

(V)  photocopies of the packing list, bill of lading and shipping invoice;

(VI)  photocopies of the Certificate of Analysis for release;

(VII) insert sheet, patterns of its packaging and labeling(except for drug substances and intermediate preparations);

(VIII) in the case of biological products subject to lot release specified by the State Food and Drug Administration, photocopies of the summary of production control test records, and the original certificate of lot release issued by the drug regulatory department of the country or region of origin; and

(IX) in the case of drugs other than those specified in Article 10 of the Provisions, photocopies of the last time Report of Testing for Import Drugs and the Drug Import Note.

When a drug manufacturer applies for importation record filing for drug substances and intermediate preparations used for its own manufacture, photocopies of the Drug Manufacturing Certificate and the Business License for Legal Person shall be submitted corresponding to the materials specified in subparagraph (II) of this Article.

When a drug to be imported has been transited from other countries or regions, all of its purchase contracts, packing lists, bills of lading and shipping invoices of the country or region of origin and of every transit country or region shall be submitted.

Each photocopy of the above-mentioned documents shall be affixed with the seal of the importer.

Article 14 Drug regulatory departments at ports of entry shall carry out examination in accordance with the following procedures after receiving the Application for Testing of Import Drugs and relevant materials:

(I) to verify, item by item, whether the materials submitted are complete and true;

(II) to examine the authenticity of the original Import Drug License (or the Pharmaceutical Product License) (in original or duplicate) or the original Import License for narcotic drugs and psychotropic substances; and

(III) if the materials pass examination, the original Import Drug License (or the Pharmaceutical Product License) (in original or duplicate) or the original Import License for narcotic drugs and psychotropic substances shall be returned to the applicant for testing, and relevant formalities of importation record filing shall be completed within that day.

Article 15 In the case of drugs as specified in Article 10 of the Provisions, drug regulatory department at ports of entry shall, if all the materials pass examination, issue a Notice of Port Testing for Import Drugs to the relevant drug control institute of port with one set of materials specified in Article 13 of the Provisions attached, and shall at the same time send a Notice of Sampling for Import Drugs to the customs. The rules for sampling by drug control institute of port within customs surveillance area shall be separately formulated by the State Food and Drug Administration and the General Administration of Customs.

A drug control institute of port shall take sample sat the sampling place specified in the Notice of Port Testing for Import Drugs, test the quality, and deliver the testing result to the local drug regulatory department at ports of entry. If the testing result is in conformity with relevant standards, the importation record filing shall be approved, and the drug regulatory department at ports of entry shall issue the Import Drug Note; if the testing result is not in conformity with relevant standards, the importation record filing shall not be approved, and the drug regulatory department at ports of entry shall issue the Notice of Non-Acceptance of Drug Import Filing.

Article 16 In the case of drugs other than those specified in Article 10 of the Provisions, a drug regulatory department at ports of entry shall, if all the materials pass examination, approve the importation record filing and issue the Import Drug Note. At the same time, it shall issue the Notice of Port Testing for Import Drugs to the relevant drug control institute of port with one set of the materials specified in Article 13 of the Provisions attached.

In the case of narcotic drugs and psychotropic substances, a drug regulatory department at ports of entry shall, if all the materials pass examination, only issue a Notice of Port Testing for Import Drugs to the relevant drug control institute of port with one set of the materials specified in Article 13 of the Provisions attached, where no Import Drug Note is required.

The drug control institute of port shall take sample sat the sampling place specified in the Notice of Port Testing for Import Drugs, test the quality, and deliver the testing result to the local drug regulatory department at ports of entry. If the testing result is not in conformity with relevant standards, the drug regulatory department at ports of entry shall dispose with it in accordance with Drug Administration Law and relevant rules.

Article 17 Importation record filing of drugs to be imported shall not be approved in any of the following cases, and the drug regulatory department at ports of entry shall issue the Notice of Non-Acceptance of Drug Importation record filing; in the case of narcotic drugs and psychotropic substances, the drug regulatory department at ports of entry shall not issue the Notice of Port Testing for Import Drugs:

(I) the importer fails to provide the original Import Drug License (or the Pharmaceutical Product License) (in original or duplicate), or the Import Drug Approval, or the original Import License for narcotic drugs and psychotropic substances;

(II) the Import Drug License (or the Pharmaceutical Product License), or the Import License for narcotic drugs and psychotropic substances has expired at the time of importation record filing;

(III) drugs to be imported will be expired less than 12 months at the time of importation record filing. (drugs to be imported of which the date of expiry is less than 12 months shall not be expired at least 6 months at the time of importation record filing);

(IV) the actual place of production indicated in the Certificate of Origin is not in conformity with the place of origin specified in the Import Drug License (or the Pharmaceutical Product License), or the Certificate of Origin issued by a regional organization fails to indicate the place of origin as specified in the Import Drug License (or the Pharmaceutical Product License);

(V) the importer has not obtained the Drug Supply License (in the case of a drug manufacturer, Drug Manufacturing Certificate shall be obtained) and the Business License for Legal Person;

(VI) the packing and labeling of drugs upon arrival at port are not as specified by the State Food and Drug Administration;

(VII) there is no Chinese insert sheet for the pharmaceutical preparation or the Chinese insert sheet is inconsistent with the approved one;

(VIII) drugs are not imported through the ports where drug importation is permitted by the State Council, or the port of delivery does not fall within the jurisdiction of the local drug regulatory department at ports of entry;

(IX) in the case of biological products subject to lot release specified by the State Food and Drug Administration, no effective certificate of lot release issued by the drug administration of country or region of origin is provided;

(X) relevant documents, invoices or vouchers are falsified or altered;

(XI) the Import Drug License (or the Pharmaceutical Product License) has been revoked;

(I)  in the case of drugs as specified in Article 10 of the Provisions, the drug control institute of ports hall not take samples in accordance with the regulations of Article 25 of the Provisions;

(II) in the case of drugs as specified in Article 10 of the Provisions fail to meet relevant standards based on port testing; or

(III) the drug regulatory department has other evidence proving that the drug to be imported may damage people’s health.

Article 18 when importation record filing of drugs to be imported is not approved, the importer shall withdraw the cargo. Drugs which cannot be withdrawn shall be handed over by the customs to the drug regulatory department at ports of entry for supervision and handling.

Article 19 The importation of drugs in urgent clinical needs, drugs for donation purpose, samples or comparator products required for new drug research and drug registration and so on shall apply for approval from the State Food and Drug Administration, and shall go through the formalities of importation record filing in accordance with Article 16 of the Provisions by presenting the Import Drug Approval issued by the State Food and Drug Administration.