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TABLE OF CONTENTS CHAPTER I GENERAL PROVISIONS CHAPTER II IMPORT RECORD KEEPING CHAPTER III PORT INSPECTION CHAPTER IV SUPERVISION CHAPTER V SUPPLEMENTARY PROVISIONS CHAPTER I GENERAL PROVISIONS Article 1. 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. Article 2. The present Measures shall be applicable to the work of record keeping, customs declaration and port inspection relating to the import of drugs. Article 3. The Drugs shall be imported through ports, which permit the entry of imported drugs upon the approval of the State Council. Article 4. The term "import record keeping" mentioned in the present Measures refers to the process, in which the import entities file applications to the administrative departments for drugs of the 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 (hereinafter referred to port drug inspection institutions) conduct examination on the imported Drugs, which have arrived at the ports, in accordance with the law. Article 5. 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. Article 6. 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. As to the narcotics and psychotropic drugs, the customs shall handle the procedures for the customs declaration and clearance upon the strength of the Import Permit issued by State Food and Drug Administration. Article 7. The catalogue of drugs to be imported shall be formulated, amended, and announced by the State Food and Drug Administration jointly with the General Administration of Customs. CHAPTER II IMPORT RECORD KEEPING Article 8. The port drug administrations shall be responsible for the work of drug import record keeping, which shall be subject to the guidance of the State Food and Drug Administration. Their duties and functions include: (1) To accept the applications for import record keeping, and examine relevant materials; (2) To handle relevant matters related to import record keeping; (3) To contact with the customs for handling matters relating to import record keeping; (4) To notify the port drug inspection offices to make port inspections over the imported drugs; (5) To supervise and address the problems found in import record keeping and port inspection; and (6) Other matters provided for by the Sate Food and Drug Administration. Article 9. Only as an independent legal person holding a Drug Business License may an entity apply for drug inspection. When a pharmaceutical production enterprise has to import crude drugs and intermediate preparations (including those repackaged within China) needed by this enterprise itself, it shall hold a Pharmaceutical Production License. Article 10. Under any of the following circumstances, the import record keeping procedures shall not be handled until the imported drugs have been inspected by the port drug inspection offices and have been confirmed meeting the prescribed standards. For the imported drugs not meeting the prescribed standards, the port drug administrations shall not make import record keeping. (1) The biological products prescribed by the State Food and Drug Administration; (2) The drugs sold within China for the first time; (3) Other drugs prescribed by the State Council. Article 11. When an import entity signs a purchase contract, it shall select a port from those permitting the entry of imported drugs as the destination of cargo. The drugs listed in Article 10 shall pass through the ports with a special approval of the state, permitting the entry of imported drugs. Article 12. An application for import record keeping shall be filed to the destination port drug administration. The imported drugs shall be inspected by the port drug inspection office responsible for the inspection of drugs at the port. Article 13. When applying for import record keeping, an applicant shall fill in the Imported Drugs Inspection Application Form and submit other relevant materials of the imported drugs (in duplicate) to the local port drug administration upon the strength of the original Drug Import Registration Certificate (or Pharmaceutical Product Registration Certificate (original or duplicate)), and the original Import Permit of narcotics and psychotropic drugs when importing such drugs: (1) Copy of Drug Import Registration Certificate (or Pharmaceutical Product Registration Certificate (original or duplicate)), the Import Permit of narcotics and psychotropic drugs; (2) Copy of the applicant's Drug Business License or Enterprise Legal Person Business License; (3) Copy of certificate of origin; (4) Copy of the purchase contract (5) Copies of the packing lists, bills of lading, and invoices of freight; (6) Copy of the report about the factory inspection; (7) Drug directions and the package and label styles (except for the crude drugs and intermediate preparations); (8) For a biological product within the range of examination, approval and issuance specified by the State Food and Drug Administration, the summary of the production examination records and the original approval issued by the administrative department for drugs of the country or region of origin shall be submitted; and (9) For the drugs listed in Article 10, a copy of the recent Report on the Inspection of Imported Drugs and the Customs Clearance Form for Imported Drugs shall be submitted. When a pharmaceutical production enterprise applies for import record keeping for the crude drugs and intermediate preparations needed by itself, it shall submit a copy of both the Pharmaceutical Production License and the Enterprise Legal Person Business License as the materials specified in Item (2) of the present Article. For the imported drugs transited from other countries or regions, the complete set materials including the purchase contract, packing list, bills of lading, and freight invoices from the place of origin to all the transit places shall be submitted at the same time. Each of the copies of the above-mentioned materials shall be affixed with the seal of the import entity. Article 14. After a port drug administration has accepted an Imported Drugs Inspection Application Form and other relevant materials, it shall examine them in compliance with the requirements as below: (1) To examine the above-mentioned materials item by item to see whether they are complete and authentic; (2) To examine the authenticity of the original Drug Import Registration Certificate (or the Pharmaceutical Product Registration Certificate (original or duplicate)), or the original Import Permit for narcotics and psychotropic drugs; and (3) If there is no discrepancy upon examination, the original Drug Import Registration Certificate (or the Pharmaceutical Product Registration Certificate (original or duplicate)), or the original Import Permit for narcotics and psychotropic drugs shall be returned to the applicant, and the relevant procedures for import record keeping shall be completed within the same day. Article 15. For the drugs listed in Article 10 of the present Measures, after the port drug administration has confirmed, upon examination, that there is no discrepancy in the complete set of materials, it shall send an Imported Drugs Port Inspection Notice, attaching a set of the materials specified in Article 13 of the present Measures, to the competent port drug inspection office, and shall send an Imported Drugs Sampling Notice to the customs office at the same time. The pertinent administrative provisions on the port drug inspection offices' sampling by entering into the supervisory area of the customs office shall be separately formulated by the State Food and Drug Administration and the General Administration of Customs. The port drug inspection office shall fetch the inspection samples at the sampling place specified in the Imported Drugs Port Inspection Notice, conduct quality inspection on them and shall send the inspection result to the local port drug administration. If the inspection result shows that the imported drugs meet the prescribed standards, the import record keeping shall be approved and a Customs Clearance Form for Imported Drugs shall be issued by the port drug administration; if the inspection shows an adverse result, the import record keeping shall not be approved, and a Notice of Disapproval of Drug Import record keeping shall be issued by the port drug administration. Article 16. For the drugs other than those listed in Article 10 of the present Measures, after the port drug administration has confirmed that, upon examination, there is no discrepancy in the complete set of materials, it shall approve of the import record keeping and issue a Notice of Customs Clearance for Imported Drugs. At the same time, it shall be responsible for the issuance of Imported Drugs Port Inspection Notice to the port drug inspection office in charge of inspection, and attach to the Notice a complete set of materials required in Article 13. For narcotics and psychotropic drugs, after the port drug administration has confirmed, upon examination, that there is no discrepancy in the complete set of materials, it shall issue an Imported Drugs Port Inspection Notice to the port drug inspection office in charge of inspection, and attach to the Notice a complete set materials required in Article 13 of the present Measures, it needn't issue a Notice of Customs Clearance for Imported Drugs. The port drug inspection office shall fetch the inspection samples at the sampling place specified in the Imported Drugs Port Inspection Notice, conduct quality inspection on them, and shall deliver the inspection result to the local port drug administration. The drugs confirmed not meeting the prescribed standards upon inspection shall be dealt with by the port drug administration in accordance with the Pharmaceutical Administration Law and other relevant regulations. Article 17. Under any of the following circumstances, the imported drugs shall be rejected to be put on import record keeping and a Notice of Disapproval of Putting the Imported Drug on Import Record Keeping shall be issued by the port drug administration; for narcotics and psychotropic drugs, the port drug administration shall not issue an Imported Drugs Port Inspection Notice: (1) An applicant fails to provide the original Drug Import Registration Certificate (or Pharmaceutical Product Registration Certificate (original or duplicate)) or the Import Permit for narcotics and psychotropic drugs; (2) When an applicant goes through the formalities for import record keeping, the valid term of the Drug Import Registration Certificate (or Pharmaceutical Products Registration Certificate) or the Import Permit for narcotics and psychotropic drugs has expired; (3) When an applicant goes through the formalities for import record keeping, the valid term of the drugs is less than 12 months. (For a drug whose valid term is less than 12 months, the valid term of the drugs shall not be less than 6 months when the import record keeping application is handled); (4) The actual production place indicated in the Origin Certification is inconsistent with that specified in the Drug Import Registration Certificate (or in the Pharmaceutical Products Registration Certificate), or the Origin Certification issued by regional international institutions fails to give a clear indication of the production place specified in the Drug Import Registration Certificate (or in the Pharmaceutical Products Registration Certificate); (5) The import entity fails to obtain a Drug Business License (For the production enterprise, it shall have obtained Pharmaceutical Production License and Enterprise Legal Person Business License); (6) The packages and labels of the drugs that have arrived at the port are inconsistent with the requirements of the State Food and Drug Administration; (7) There is no Chinese language directions for the drug preparations or the Chinese directions is inconsistent with the approved ones; (8) The applicant fails to organize the import at a port permitting the entry of imported drugs upon the approval of the State Council; the destination place of the cargo doesn't fall within the jurisdiction of the local port administration; (9) The applicant fails to provide any evidential document for the biological products within the range of examination, approval and issuance specified by the administrative department for drugs in the production country or region; (10) An applicant forges or alters the relevant documents and vouchers; (11) The Drug Import Registration Certificate (or the Pharmaceutical Registration Certificate) has been canceled; (12) The drugs fall within the scope specified in Article 10 of the present Measures and shall not be sampled by the port drug inspection office in accordance with Article 25 of the present Measures; (13) The drugs fall within the scope specified in Article 10 of the present Measures and have confirmed not meeting the prescribed standards upon port inspection; or (14) Other circumstances contrary to the relevant regulations of our country on drug administration. Article 18. For the imported drugs rejected to be put on import record keeping, they shall be returned to the consignor by the import entity. If unable to be returned, they shall be delivered to and dealt with by the port drug administration. Article 19. The import of clinical drugs in urgent need, the donated drugs, the samples or comparative drugs needed for the research on new drugs and drug registration shall be subject to the approval of the State Food and Drug Administration, and the import record keeping formalities shall be gone through upon the strength of the Drug Import Approval Document issued by the State Food and Drug Administration in accordance with Article 16 of the present Measures. CHAPTER III PORT INSPECTION Article 20. The port drug inspection offices shall be established by the State Food and Drug Administration in light of the port inspection work related to the imported drugs. A port drug inspection office shall exercise the following functions: (1) To conduct spot inspection on the cargos arrived at the port; (2) To examine the factory inspection report and the Certificate of Origin; (3) To fetch samples under the relevant requirements; (4) To conduct port inspection on the imported drugs; (5) To conduct re-inspection on a disputed inspection result; and (6) Other matters provided for by the State Food and Drug Administration. Article 21. The National Institute for the Control of Pharmaceutical and Biological Products shall be responsible for the guidance and cooperation of the port inspection on the imported drugs. The standard and comparative samples needed by the port inspection offices shall be examined and labeled by the National Institute for the Control of Pharmaceutical and Biological Products. Article 22. The port drug inspection offices shall conduct inspections on the imported drugs according to the standards specified in the Drug Import Registration Certificate (or the Pharmaceutical Products Registration Certificate). Article 23. A port inspection office shall contact with the import entity within 2 days from the day it receives the Imported Drugs Port Inspection Notice, and shall fetch samples in the specified storage place of the cargos. Before sampling, the import entity shall provide the factory inspection report and the original origin certification. If the port drug inspection office has to fetch samples in the supervisory area of the customs, the port drug inspection office shall, at the same time, contact the customs about the matters related to the sampling, and shall obtain the consent of the customs. When sampling, the personnel of the import entity and those of the customs shall be on the spot at the same time. Article 24. When a port drug inspection office fetches samples on the spot, it shall pay attention to the imported drugs actually arrived, shall carefully record the samples and fill in the Imported Drugs Sampling Record Form. For the drugs other than those specified in Article 10, after the port drug inspection office has completed the sampling, it shall give an clear indication of "Sampled" on the original Customs Clearance Permit for the Imported Drugs, and to which it shall affix its official seal. For narcotics and psychotropic drugs, after the port drug inspection office has completed the sampling, it shall give a clear indication of "Sampled" on the original Import Permit, and to which it shall affix its official seal. Article 25. A port inspection office shall not fetch samples from the imported drugs under any of the following circumstances: (1) No original factory inspection report or origin certificate has been provided, or the original certificates are inconsistent with the photocopies, which are submitted when the application for import record keeping is filed; (2) The shipping mark is inconsistent with the documents; (3) The batch number or quantity of the imported drugs is inconsistent with that in the documents; (4) The package and the label of the imported drugs are inconsistent with those in the documents; or (5) Other circumstances not meeting the laws, regulations and rules of the state concerning the control of food and drug. With regard to the drugs that are exempt from sampling, the drug inspection office of the port shall, within two days, deliver the Imported Drugs Sampling Record Keeping Form to the drug supervision and regulation administration of the port where it is located. Article 26. The port drug inspection office shall conduct inspection on the samples it fetched in good time, complete the inspection within 20 days from the day when the sampling is done, and shall issue an Imported Drug Inspection Report. If it is unable to complete the inspection within the time limit for special drugs or under special circumstances, it may extend the time limit reasonably, and shall notify the import entity and port drug administration. The inspection conclusions of "Meeting the Prescribed Standards" or "Not Meeting the Prescribed Standards" shall be clearly specified in the Imported Drug Inspection Report. In terms of the biological products within the range of examination, approval and issuance specified by the State Food and Drug Administration, for those meeting the prescribed standards upon port inspection and meeting the requirements upon examination, a certification shall be issued at the same time. Article 27. For the imported drugs that are found, upon inspection, to meet the prescribed standards, the port drug inspection office shall submit the Imported Drug Inspection Report to both the local port drug administration and the import entity. For those not meeting the prescribed standards, the port drug inspection office shall timely send the Imported Drug Inspection Report to the port drug administration and the port drug inspection offices, and shall simultaneously submit it to both the State Food and Drug Administration and the National Institute for the Control of Pharmaceutical and Biological Products. Article 28. The inspection samples fetched from the imported drugs shall be preserved until their valid term expires. For those difficult to preserve, the preservation period shall depend on the actual circumstances. The samples in case of claim or rejection of goods shall be preserved until the case is settled. The samples exceeding the preservation period shall be handled and put on record keeping by the port drug inspection office. Article 29. Where an import entity raises an objection to the inspection result, it may file an application for re-inspection to the original port drug inspection office within 7 days from the day it accepts the inspection result, or directly file an application for re-inspection to the National Institute for the Control of Pharmaceutical and Biological Products. For the re-inspection on biological products, an applicant may directly file an application to the National Institute for the Control of Pharmaceutical and Biological Products. After a port drug inspection office accepts a re-inspection application, it shall timely notify the port drug administration, come to a conclusion upon re-inspection within 10 days from the day when it accepts the application, and notify the port drug administration, other port drug inspection offices, and shall report to the State Food and Drug Administration and the National Institute for the Control of Pharmaceutical and Biological Products. CHAPTER IV SUPERVISION Article 30. For the drugs that the port drug inspection office decides not to sample in accordance with Article 25 of the present Measures, but the customs clearance procedures have been completed, the port drug administration shall adopt mandatory administrative measures to seal up and detain all the drugs. Article 31. As to the drugs other than those specified in Article 10 of the present Measures, those not meeting the prescribed standards upon the inspection of the port drug inspection office, the import entity report the detailed information about the circulation and use of all the imported drugs to the local port drug administration. After the local drug administration has accepted the Imported Drug Inspection Report, it shall adopt mandatory measures to seal up and detain all the drugs in time, and shall make a decision of administrative handling within 7 days. For a re-inspection application, it shall make a decision of administrative handling within 15 days from the day the self-inspection report is sent. It shall report the relevant information to the State Food and Drug Administration in time, and notify the drug administrations of all provinces, autonomous regions, and municipalities directly under the Central Government and other port drug administrations at the same time. Article 32. If the import entity fails to file a re-inspection application, or the drugs are confirmed not meeting the prescribed standards upon re-inspection, the port drug administration shall make a decision of administrative sanctions in accordance with the Pharmaceutical Administration Law and other relevant regulations. The relevant information shall be reported to the State Food and Drug Administration in time, and notified to the drug administrations of all provinces, autonomous regions, and municipalities directly under the Central Government and other port drug administrations at the same time. If the imported drugs meet the prescribed standards upon re-inspection, the port drug administration shall lift the mandatory administrative measures of sealing up and detainment, report the relevant information to the State Food and Drug Administration in time, and notify the drug administrations of all provinces, autonomous regions, and municipalities directly under the Central Government and other port drug administrations at the same time. Article 33. The other problems found in the process of drug import record keeping shall be dealt with by the port drug administration in accordance with Pharmaceutical Administration Law and other relevant regulations. Article 34. When a domestic pharmaceutical production enterprise, commercial enterprise or medical institution purchases imported drugs, the supplier shall provide the following materials simultaneously: (1) Photocopy of the Drug Import Registration Certificate (or the copy of Pharmaceutical Product Registration Certificate) and photocopy of the Drug Import Approval; and (2) Photocopy of the Imported Drug Inspection Report, or photocopy of the Imported Drug Customs Clearance Form with a clear indication of "Sampled" and the official seal. For the biological products within the range of examination, approval and issuance specified by the State Food and Drug Administration, the examination, approval and issuance certification issued by the port drug inspection office shall be presented at the same time. For a supplier of narcotics and psychotropic drugs, it is required to submit simultaneously the photocopy of Drug Import Certificate (or copy of Pharmaceutical Products Registration Certificate), photocopy of Import Permit and photocopy of Imported Drug Inspection Report. All the above-mentioned copies shall bear the seal of the supplier. Article 35. The port drug administration and port drug inspection office shall establish a strict management system for the import record keeping materials and port inspection materials, and shall keep secret the materials submitted by the import entities to themselves. Article 36. For a port drug administration or a port drug inspection office that violates any of the relevant requirements for import record keeping or those for port inspection, the State Food and Drug Administration shall give it a criticism, a criticism by circulating a notice; if the circumstance is serious, it shall be disqualified from import record keeping and port inspection. Article 37. Those in violation of the relevant regulations concerning the customs shall be dealt with by the customs in accordance with the Customs Law and the Detailed Rules for the Administrative Punishments of the Customs Law of the People's Republic of China. CHAPTER V SUPPLEMENTARY PROVISIONS Article 38. The term "import entity" mentioned in the present Measures may be a commercial operating entity, or recipient entity, or inspection application entity. An operating entity refers to an enterprise or entity that signs and performs import and export contracts. A recipient entity refers to the consignee or consignor specified in the purchase contract and shipping invoice. An Inspection application entity refers to the actual consignor or domestic distributor of a batch of imported drugs, who shall be responsible for the import record keeping and port inspection formalities. The recipient entity and the inspection application may refer to the same unit. Article 39. The drugs that enter into the bonded warehouses, bonded areas and export processing areas from abroad shall be exempt from the formalities, and which shall be supervised by the customs in accordance with the relevant regulations. For the drugs that enter into China from the bonded warehouses, export supervision warehouses, bonded areas and export processing areas, the procedures for import record keeping and port inspection shall be handled in accordance with the present Measures. The crude drugs, medicinal drugs imported in the form of processing trade shall be exempt from the formalities for import record keeping and port inspection, and the crude drugs and finished products shall not be sold in domestic market. Those unable to be exported for special reasons shall be delivered to the local administrative department for drugs in accordance with the relevant regulations, and shall be verified and written off by the customs office. Small quantity of drugs carried by the persons at the entry and exit shall be limited to self-use and reasonable amount, and shall be subject to the supervision of the customs. Article 40. The crude drugs unlisted in the catalogue of the import catalogue of drugs shall be in line with the present Measures, shall be subject to the import record keeping formalities in accordance with the law. Article 41. The regulations for import record keeping and port inspection shall be separately formulated by the State Food and Drug Administration. Article 42. An importer of narcotics and psychotropic drugs shall go through the formalities for obtaining of Import Permit upon the strength of the Imported Drug Registration Certificate (or Pharmaceutical Products Registration Certificate) in accordance with the relevant regulations of the State Council concerning the control of narcotics and psychotropic drugs. Article 43. The nartotics and psychotropic drugs mentioned in the present Provisions refer to clinical drugs. The import of narcotics and psychotropic drugs used for scientific research, teaching and animals shall be in line with the relevant regulations of the State Council on the management of narcotics and psychotropic drugs. Article 44. The power to interpret the present Measures shall remain with the State Food and Drug Administration and the General Administrations of Customs. Article 45. The present Measures shall be implemented as of January 1, 2004. The Administrative Measures for the Import of Drugs shall be abolished at the same time. Attachment: 1. Provisions on the Sampling of Imported Drugs ATTACHMENT 1: PROVISIONS ON THE SAMPLING OF IMPORTED DRUGS 1. The present Provisions are formulated in order to improve the management of sampling of the imported drugs, to ensure that the port inspection sampling shall be representative and scientific and the inspection results shall be accurate. 2. The sampling of imported drugs shall be conducted by a port inspection office that undertakes such inspection. An applicant shall be responsible for the preparation of the tools and place for the sampling, and the move, stack transfer, opening, repackage, etc. 3. The drugs with the same name, country of production, manufacturer, package, batch number, dosage form, specifications, mark and contract number shall be sampled as the same batch of drugs; for the drugs under a contract that arrive not once and for all, the drugs that arrive each time shall be sampled. 4. For the sampling from the imported drugs and preparations, the import entities provide the Drug Import Registration Certificate for large-scale packing and the approval document for the repackaging of imported drugs, and the sampling shall be conducted on the basis of the repackaged specifications and quantity by referring to the relevant preparation. 5. Sampling quantity Except for the special regulations and requirements, it is the general rule that 3 times of the inspection quantity of drugs shall be sampled. After inspection, the remained samples except for those that shall be preserved for examination shall be returned to the inspection application entities. 6. Sampling method (1) Crude drugs (a) For the drugs more than 10 kilograms per package Those not exceeding 10 pieces, one shall be fetched as a sample; 11-50 pieces, one shall be fetched as a sample for each additional 10 pieces, those less than 10 pieces shall be considered as 10 pieces; 51-100 packages, one shall be fetched as a sample for each additional 20 pieces, those less than 50 pieces shall be considered 50 pieces; no less than 1000, one shall be fetched as a sample for each additional 100 pieces, those less than 100 pieces shall be considered 100 pieces; (b) For the 5-10 kilograms (including 5 kilograms) of drugs per package, one piece shall be fetched as a sample every 100 kilograms, those less than 100 kilograms shall be considered 100 kilograms; (c) For the 1-5 kilograms (including 1 kilogram) of drugs per package, one piece shall be fetched as a sample every 50 kilograms, those not more than 50 kilograms shall be considered 50 kilograms; (d) For those not exceeding 1 kilogram, 1 shall be fetched as a sample every 20 kilograms, those not exceeding 20 kilograms shall be considered 20 kilograms (the samples shall be fetched from the original packages). (2) Injection (a) Small capacity injection If not exceeding 20,000 bottles (including 20,000 bottles), one shall be fetched as a sample; if not more than 50,000 bottles (including 50,000 bottles)£¬two shall be fetched as samples; if not more than 10,000 bottles (including 10,000 bottles), three shall be fetched as samples; if more than 10,000 bottles, one shall be fetched as a sample for each additional 10,000 bottles, those less than 10,000 bottles shall be considered 10,000 bottles. (b) Injection of large capacity For the injection of 100-1000 ml (including 1000 ml), one piece shall be fetched as a sample from every 10,000 bottles, if not more than 10,000 bottles, one shall be fetched as a sample. The injections of no less than 1,000 ml (including dialysate) per bottle (bag), one bottle (bag) shall be fetched as a sample every 5,000 bottles (bags), those not more than 5,000 bottles (bags) shall be considered 5,000 bottles (bags). (3) All the other types of preparation One shall be fetched as a sample each 20,000 boxes (bottles), those less than 20,000 boxes (bottles) shall be considered 20,000 boxes (bottles). 7. Sampling requirements (1) Before opening the external package for fetching samples, the external packages, the shipping mark number or contract number, name of goods and quantity shall be verified against the inspection application materials. After external package is opened, the drug or preparation name, factory name and batch number on the small package shall be verified, and attention shall be paid to the integration and cleanness of the package to see if there is any water stain, mildew and rot or other pollutants. If some of the packaged drug has gone bad, the sampling and inspection shall be re-conducted. (2) After the package of crude drug has been opened, the samples shall be fetched from different parts, making the total quantity reach the sampling one, then the samples shall be directly poured into the sample bottle and be mixed. (3) After the sampling is completed, the packages that have been opened shall be sealed up and be given a clear indication of the sampled quantity and date. 8. Points of attention for sampling (1) The sampling environment shall be clean, the sampling tools shall be clean and dry, and shall meet the requirements of the drug to be sampled. (2) When sampling, the drug shall be prevented from going bad because of pollution, absorption of moisture and weathering. The inspection samples shall be put in airtight containers (plastic bags, cans or ground glass bottles) as soon as they are fetched. (3) As to a drug in liquid, the liquid shall be shaken to uniformity before samples are fetched. If it contains crystals, under the precondition of not affecting the quality, the crystals shall be dissolved before a sample is fetched. (4) For toxic, corrosive and explosive drugs, pertinent protective measures shall be taken in sampling, the drugs shall be moved carefully and shall not be vibrated, and the sample bottles shall marked "Dangerous Articles". (5) No metal tool may be used in fetching samples from corrosive drugs. (6) For the drugs that easily get bad when exposed to light, the sampling shall be conducted in darkness, and the samples shall be put in colored bottles, and the colored bottles may be wrapped in black paper where necessary. (7) Where it is necessary to make axenic or pyrogen experiment, animalcule limit inspection on a crude drug, or it is necessary to vaccumize and fill in nitrogen gas for a crude drug, the sampling shall be done in line with the aseptic technique or the special requirements. (8) The sampling shall be conducted by (two or more) professionals who have accepted special training, and the relevant personnel of the sampled entity shall be present at the scene. (9) Where it is necessary to change the sampling methods and quantity according to the quality of the goods and the abnormal circumstance in the packages, the port drug inspection office shall determine the methods jointly with the inspection application entity upon discussion in order to get representative samples. The information concerning the changes of the sampling methods shall be recorded in the Imported Drugs Sampling Record Keeping Form. |
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