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.

　　Chapter III Port Testing

　　Article 20 Drug control institutes of port shall be designated by the State Food and Drug Administration according to the demand of port testing of drugs to be imported. The responsibilities of a drug control institute of port include:

　　(I) carrying out on-site examination of the goods arriving at port;

　　(II) verifying the original Certificate of Analysis for release and Certificate of Origin;

　　(III) taking samples as prescribed;

　　(IV) imposing port testing on drugs to be imported;

　　(V) carrying out a verification test when the testing result is objected; and

　　(VI) handling other matters specified by State Food and Drug Administration.

　　Article 21 The National Institute for the Control of Pharmaceutical and Biological Products shall be responsible for guiding and coordinating the port testing for drugs to be imported. The biological reference standard and chemical reference substance required for port testing shall be reviewed and characterized by the National Institute for the Control of Pharmaceutical and Biological Products.

　　Article 22 Drug control institutes of port shall test the import drugs in accordance with the registration standards as specified in the Import Drug License (or the Pharmaceutical Product License).

　　Article 23 Drug control institutes of port shall, within two days after receiving the Notice of Port Testing for Import Drugs, contact the importer, and carry out on-site sampling at the specified storage location in accordance with the Rules for Import Drugs Sampling.

　　The importer shall, before sampling, provide the original Certificate of Analysis for release and Certificate of Origin.

　　Where the sampling location is at customs surveillance area, the drug control institute of port shall contact the customs at the same time for sampling matters and ask for approval from the customs. When taking samples, both the importer and the customs officials shall be present on-site.

　　Article 24 When carrying out on-site sampling, the drug control institute of port shall impose close inspection on the actual condition of the imported drugs upon arrival, make sampling records, and fill in the Record of Sampling for Import Drugs.

　　In the case of drugs other than those specified in Article 10 of the Provisions, when sampling is completed, the drug control institute of port shall indicate "Sampled" on the original Import Drug Note held by the importer, and affix the seal of sampling entity.

　　In the case of the narcotic drugs and psychotropic substances, when sampling is completed, the drug control institute of port shall indicate "Sampled" on the Import License, and affix the seal of sampling entity.

　　Article 25 Drug control institutes of port shall not take samples on drugs to be imported in any of the following cases:

　　(I) the original Certificate of Analysis for release and Certificate of Origin is not provided, or the original copy provided is inconsistent with the photocopies submitted at the time of importation record filing;

　　(II) the shipping marks are not in conformity with the documents;

　　(III) the batch number or quantity of the drug to be imported is not in conformity with the documents;

　　(IV) the packaging and labeling of drugs to be imported is inconsistent with the documents; and

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

　　As to drugs from which no sample shall be taken, the drug control institute of port shall within 2 days deliver the Record of Sampling for Import Drugs to the local drug regulatory department at ports of entry.

　　Article 26 Drug control institutes of port shall test the samples taken without delay, complete testing within 20 days after sampling, and issue the Report of Testing for Import Drugs. If the testing cannot be completed on time due to special varieties or special circumstances, the time limit for testing may be appropriately extended, where the importer and the drug regulatory department at ports of entry shall be notified.

　　The Report of Testing for Import Drugs shall clearly indicate testing conclusion such as "up to relevant standards" or "not up to relevant standards".

　　In the case of biological products subject to lot release specified by the State Food and Drug Administration, if a batch of biological products meets relevant standards based on port testing and conforms to the requirements according to examination, a certificate of lot release for that batch shall also be issued at the same time.

　　Article 27 If drugs to be imported conform to relevant standards based on testing, the drug control institute of port shall deliver the Report of Testing for Import Drugs to the local drug regulatory department at ports of entry and the importer.

　　If drugs to be imported fail to meet relevant standards based on testing, the drug control institute of port shall promptly deliver the Report of Testing for Import Drugs to the local drug regulatory department at ports of entry and other drug control institutes of port, and shall, at the same time, report to the State Food and Drug Administration and the National Institute for the Control of Pharmaceutical and Biological Products.

　　Article 28 The samples for testing of drugs to be imported shall be kept until the expiry date. Retained samples which are not easy to be stored may be kept for a period of time according to the actual situation. Any retained sample of goods which are claimed for compensation or asked to be returned shall be kept until the end of the relevant case. Any reserved sample which pasts its date of expiry shall be disposed by the drug control institute of port and recorded for archiving.

　　Article 29 Where an importer has objections to the testing result, it may, within seven days since the day of receiving such testing result, apply to the original drug control institute of port for a verification test, or directly apply to the National Institute for the Control of Pharmaceutical and Biological Products for a verification test. The verification test of biological products shall be directly applied to the National Institute for the Control of Pharmaceutical and Biological Products.

　　The drug control institute of port shall promptly notify the drug regulatory department at ports of entry, and shall, within 10 days after accepting the application for verification test, draw a conclusion on the verification test, notify the drug regulatory department at ports of entry and other drug control institutes of port, and submit it to the State Food and Drug Administration and the National Institute for the Control of Pharmaceutical and Biological Products.

　　Chapter IV Supervision and Administration

　　Article 30 As to drugs which no samples shall be taken by the drug control institute of port in accordance with the regulations of Article 25 of the Provisions but having gone through the procedures of customs examination and release, the drug regulatory department at ports of entry shall take administrative enforcement measures to seize and detain all of such drugs to be imported.

　　Article 31 In the case of drugs other than those specified in Article 10 of the Provisions, if they fail to meet relevant standards based on testing by the drug control institute of port, the importer shall within 2 days after receiving the Report of Testing for Import Drugs, report the detailed information on the circulation and use of all such imported drugs to the local drug regulatory department at ports of entry.

　　Upon receipt of the Report of Testing for Import Drugs, the local drug regulatory department at ports of entry shall promptly take administrative enforcement measures to seize and detain all such drugs, and make an administrative handling decision within 7 days. In the case of applying for verification test, an administrative handling decision must be made within 15 days since the day of issuing the testing report. Relevant information shall be reported to the State Food and Drug Administration in a timely manner and at the same time to the drug regulatory department of each province, autonomous region and municipality directly under the central government and to other drug regulatory departments at ports of entry.

　　Article 32 Where no application for verification testis submitted within the prescribed time or the drug still fails to meet relevant standards based on the verification test, drug regulatory department at ports of entry shall make an administrative handling decision in accordance with the Drug Administration Law and relevant regulations. Relevant information shall be reported to the State Food and Drug Administration in a timely manner and at the same time to the drug regulatory department of each province, autonomous region and municipality directly under the central government and to other drug regulatory departments at ports of entry.

　　If the drug meets relevant standards based on verification test, the drug regulatory department at ports of entry shall lift the administrative enforcement measures such as seizure and detention, and report the handling situation to the State Food and Drug Administration and at the same time to the drug regulatory department of each province, autonomous region and municipality directly under the central government and to other drug regulatory departments at ports of entry.

　　Article 33 Other issues found in the record filing of drugs to be imported shall be disposed of by the drug regulatory departments at ports of entry in accordance with the Drug Administration Law and relevant regulations.

　　Article 34 Where a domestic drug manufacturer, distributor or medical institution purchases imported drugs, the supplier shall provide the following materials at the same time:

　　(I) photocopies of the Import Drug License (or the Pharmaceutical Product License) or photocopies of Import Drug Approval; and

　　(II) photocopies of the Report of Import Drug Testing or photocopies of the Import Drug Note marked with "Sampled" and affixed with the official seal.

　　In the case of the biological products subject to lot release specified by the State Food and Drug Administration, photocopies of the certificate of lot release examined and issued by drug control institutes of port shall also be provided at the same time.

　　When importing narcotic drugs and psychotropic substances, photocopies of the Import Drug License (or the Pharmaceutical Product License), photocopies of the Import License and photocopies of the Report of Testing for Import Drugs shall be provided at the same time.

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

　　Article 35 Drug regulatory departments at ports of entry and drug control institutes of port shall establish a strict management system for the materials of importation record filing and the materials of port testing, and shall be responsible for the confidentiality of the materials submitted by importers.

　　Article 36 The State Food and Drug Administration shall, based on the seriousness of the circumstances, criticize or circulate a notice of criticism to the drug regulatory department at ports of entry or the drug control institute of port which violates relevant provisions for importation record filing and port testing, and shall suspend its qualification with respect to importation record filing and port testing if the circumstances are serious.

　　Article 37 In the case of violating any relevant provisions related to customs as specified in the Provisions, the customs shall dispose the violation in accordance with the regulations of the Customs Law and the Regulations of the People’s Republic of China on Implementing Customs Administrative Penalty.

　　Chapter V Supplementary Provisions

　　Article 38 For the purpose of the Provisions, importer includes distribution enterprises, the consignee and the applicant for testing.

　　The distribution enterprise refers to enterprise or entity within China that has signed and performed import and export trade contracts with foreign counterparts.

　　The consignee refers to the consignee or the owner of the goods as specified in the purchase contract and the shipping invoice.

　　The applicant for testing refers to the actual owner or the domestic distributor of that batch of imported drugs who is specifically responsible for going through the formalities of importation record filing and port testing.

　　The consignee and the applicant for testing may be the same.

　　Article 39 Drugs entering bonded warehouses, bonded zones and export processing zones from abroad shall be exempted from importation record filing and port testing, and shall be supervised by the customs in accordance with relevant regulations. Drugs entering China from bonded warehouses, export supervised warehouses, bonded zones or export processing zones shall go through the formalities for importation record filing and port testing in accordance with the relevant regulations of the Provisions.

　　The drug substances and crude drugs that have been approved for importation through processing trade shall be exempted from importation record filing and port testing, while such drug substances and the resulting finished products made from that shall be prohibited for domestic sale. If they are indeed unable to be exported due to special circumstances, they shall be handed over to and disposed of by the local drug regulatory department in accordance with relevant regulations, and shall be written off by the customs after verification.

　　Small amount of drugs for personal use carried by individuals entering or leaving the territory of China shall be limited to reasonable quantities for personal use and shall be subject to the supervision of the customs.

　　Article 40 To import drug substances which have been imported but have not yet been included in the list of imported drugs for the time being, the importer shall go through the formalities of importation record filing with the drug regulatory department at ports of entry in accordance with the regulations of the Provisions.

　　Article 41 Measures governing the importation record filing and port testing of crude drugs shall be separately formulated by the State Food and Drug Administration.

　　Article 42 To import narcotic drugs and psychotropic substances, the importer shall, on the premise of obtaining the Import Drug License (or the Pharmaceutical Product License), apply for the Import License in accordance with the relevant regulations on the administration of narcotic drugs and psychotropic substances as specified by the State Council.

　　Article 43 The narcotic drugs and psychotropic substances as specified in the Provisions refer to the varieties of drugs for clinical use. The importation of narcotic drugs and psychotropic substances for scientific research, teaching and veterinary use shall follow the relevant regulations on the administration of narcotic drugs and psychotropic substances formulated by the State Council.

　　Article 44 The Provisions shall be interpreted by the State Food and Drug Administration and the General Administration of Customs.

　　Article 45 The Provisions shall come into force as of January 1, 2004. The Administrative Measures for the Import of Drugs, which came into effect on May 1, 1999, shall be repealed simultaneously.

　　Rules for Import Drugs Sampling

　　I. These Regulations are formulated to make sure the sampling management of drugs to be imported is well performed, guarantee the representativeness and scientificness of sampling for port testing and ensure the accuracy of testing results.

　　II. Sampling of drugs to be imported shall be carried out by the drug control institute of port which undertakes the testing for that variety of drugs. The applicant for testing shall be responsible for the preparation of the tools and sites necessary for sampling, as well as the matters such as to move, stack, open and restore packaging during sampling.

　　III. The drugs imported under the same contract may be sampled as the same batch only if the drug name, country of manufacture, manufacturer, package, batch number, dosage form, strength, shipping mark and contract number are identical. If drugs are imported under the same contract but shipped in different batches, they shall be sampled in different batches.

　　IV. In the case of taking samples of imported pharmaceutical preparations which will be sub-packaged in China, the importer shall provide the Import Drug License for the drugs in the original large package and the approval documents of sub-packaging for imported drugs, and samples shall be taken as per the strength and quantity after sub-packaging and in accordance with the sampling rules of corresponding preparations.

　　V. Sampling Quantity

　　Except for special regulations and requirements, the quantity of drug samples required for sampling generally shall be three times of the quantity required for testing. The remaining samples after testing, except for the retained samples for future reference, shall be returned to the applicant for testing.

　　VI. Sampling Method

　　(I) Drug substances

　　1. If the products within one package are at least 10 kg

　　If the quantity is less than 10, take 1 product for sampling; if the quantity is 11 to 50, take additional 1 product for sampling for every additional 10, and the odd less than 10 shall be counted as 10; if the quantity is 51 to 100, take additional 1 product for sampling for every additional 20, and the odd less than 20 shall be counted as 20; if the quantity is more than 101, take additional 1 product for sampling for every additional 50, and the odd less than 50 shall be counted as 50; if the quantity is more than 1001, take additional 1 product for sampling for every additional 100, and the odd less than 100 shall be counted as 100;

　　2. If the products within one package are 5 kg (including) to 10 kg, take 1 product for sampling for every 100 kg, and the odd less than 100 kg shall be counted as 100 kg;

　　3. If the products within one package are 1 (including) to 5 kg, take 1 product for sampling for every 50 kg, and the odd less than 50 kg shall be counted as 50 kg;

　　4. If the products within one package are less than 1 kg, take 1 product for sampling for every 20 kg, and the odd less than 20 kg shall be counted as 20 kg (taking samples from original package).

　　(II) Injections

　　1. Small volume injections

　　If the quantity is below 20,000 vials (including), take 1 product for sampling; if the quantity is below 50,000 vials (including), take 2 products for sampling; if the quantity is below 100,000 vials (including), take 3 products for sampling; if the quantity is more than 100,000 vials, take additional 1 product for sampling for every additional 100,000 vials, and the odd less than 100,000 shall be counted as 100,000.

　　2. Large volume injections

　　If the injection is 100 ml to 1000 ml (including), take 1 product for sampling for every 10,000 vials, and the odd less than 10,000 vials shall be counted as 10,000. If the injection (including dialysate) is more than 1000 ml, take 1 product for sampling for every 5,000 vials (bags), and the odd less than 5,000 vials (bags)shall be counted as 5,000.

　　(III) Other preparations

　　Take 1 product for sampling for every 20,000 boxes (vials), and the odd less than 20,000 boxes (vials) shall be counted as 20,000.

　　VII. Sampling Requirements

　　(I) Before unsealing the sample, the outer package, shipping mark number or contract number, and name and quantity of the product shall be checked against the materials submitted for testing. After unsealing, the name of drug, the name of factory and the batch number of the drugs in the sub-package shall be checked, and whether the package is intact and clean without water stain, mildew or other material pollution shall be determined. If the drugs within part of the packages deteriorate, samples shall be taken for testing separately.

　　(II) After unsealing the package of drug substances, samples shall be taken at different parts to make the total amount reach the sampling quantity, and then directly pour them into the sample bottle and mix well.

　　(III) After sampling, the opened package shall be sealed, and the quantity and date of sampling shall be indicated on the package.

　　VIII. Notes for Sampling

　　(I) The sampling environment shall be clean and hygienic, and the sampling tools must be clean and dry, up to the requirements for the drugs to be sampled.

　　When taking samples, the drugs shall be prevented from deterioration due to pollution, moisture absorption, weathering or oxidation. Samples taken for testing shall be promptly placed in sealed containers (plastic bags, cans or ground-glass flask).

　　(III) Shake the liquid sample well before sampling. Crystals contained shall be dissolved and extracted without affecting the quality.

　　(IV) For toxic, corrosive and explosive drugs, appropriate protective measures shall be taken during sampling. Handle with care without vibration during sampling, and mark "dangerous goods" on the outside of the sample bottle.

　　(V) Avoid taking samples with metallic sampling tools for corrosive drugs.

　　(VI) Light sensitive drugs shall be sampled in a dark place protected from light, and the samples shall be placed in colored bottles and when necessary covered with black paper.

　　(VII) If sterility test, pyrogen test, microbial limit test or vacuum supply or nitrogen filling is required for drug substances, then samples shall be taken according to sterility operation or special requirements.

　　(VIII) Sampling shall be carried out by two or more professionals who have received special training, and the relevant personnel of the entity of which products are sampled must be present.

　　(IX) When it is necessary to appropriately change the sampling method and quantity based on the quality and packing abnormalities of the goods arriving at port, the drug control institute of port shall, communicate with the applicant for testing, and seek agreement on the sampling method so as to take representative samples. Any change in the sampling method shall be recorded in the Record of Sampling for Import Drugs.

　　Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.