|
Welcome Guest
|
|
You are using Guest Account
|
|
||||||||||||||||||||||||||||||||||
|
TABLE OF CONTENTS CHAPTER I GENERAL PROVISIONS CHAPTER II VERIFICATION FOR SANITATION AND QUARANTINE CHAPTER III SANITATION AND QUARANTINE CHAPTER IV FOLLOW-UP SUPERVISION CHAPTER V SUPPLEMENTARY PROVISIONS CHAPTER I GENERAL PROVISIONS Article 1. The present Provisions are formulated in accordance with the relevant provisions of the Frontier Sanitation and Quarantine Law of the People's Republic of China and the relevant provisions of its detailed implementation rules for the purpose of regulating the supervision and administration of sanitation and quarantine on entry/exit special articles. Article 2. The present Provisions shall be applicable to the supervision and administration of sanitation and quarantine on entry/exit microorganism, human tissue, biological products, blood and its products, and other special articles. Article 3. The General Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as the GAQSIQ) shall administer uniformly the work for the supervision and administration of sanitation and quarantine of entry/exit special articles countrywide; and the entry/exit inspection and quarantine organ established by the GAQSIQ at each locality (hereinafter referred to as the inspection and quarantine organ) shall conduct supervision and administration of heath and quarantine on entry/exit special articles within its own jurisdiction. Article 4. The systems of examination and approval for sanitation and quarantine, on-site checking, and follow-up supervision and administration shall be implemented for the administration of heath and quarantine on entry/exit special articles. Article 5. No entry/exit special articles may be allowed to enter and exit the territory until after they have obtained the Approval of Entry/Exit Special Articles for Verification of Sanitation and Quarantine (hereinafter referred to as the Approval for Verification of Sanitation and Quarantine), and are checked to be qualified after the heath and quarantine inspection. Article 6. The entry/exit special articles shall enter and exit the territory from the ports as designated and announced by the GAQSIQ. CHAPTER II VERIFICATION FOR SANITATION AND QUARANTINE Article 7. The inspection and quarantine bureau directly under the GAQSIQ shall be responsible for the verification of the sanitation and quarantine on entry/exit special articles. Article 8. The consigners of the entry/exit special articles or their agents shall submit the Application of Entry/Exit Special Articles for Verification of Sanitation and Quarantine (hereinafter referred to as the Application for Verification) to the inspection and quarantine bureaus directly under the GAQSIQ at the entry/exit ports before delivering the special articles for shipment. The consigners or their agents shall fill in the Application for Verification according to the classification of entry/exit special articles, with one copy for each category. Article 9. The following materials shall be provided when applying for going through the formalities for the verification of heath and quarantine on entry/exit micro-organism, human tissue, and blood: (1) The certificate of entry and exit license (the original and photocopy) issued by the relevant competent departments; (2) The descriptive documents on the name of the pathogenic microbes contained in the special articles (both in Chinese and in Latin) and the biological characters (with both Chinese and English versions); (3) With regard to the entry special articles that contain or are likely to contain the pathogenic microbes of Grades Three to Four, and the entry special articles that contain or are likely to contain the pathogenic microbes that have not been graded, the entity using them shall have the BSL- Grade Three (Grade P3) laboratories, and shall provide the certificate of corresponding qualification; (4) With regard to the special articles for the use of scientific research, the original of the document of approval for the scientific research project or the agreement between the applicant of the scientific research project and the cooperative institutions both home and abroad (the originals and photocopies, with both Chinese version and English version) shall be provided; and (5) With regard to the organs for the use of transplanting, the sanitation certificate of the provider and the relevant inspection report that are issued by the hospital that has the qualification shall be provided. Article 10. The consigners or their agents shall provide the following materials when they apply for going through the formalities for the verification of sanitation and quarantine on biological products and blood products: (1) For the entry biological products and blood products for treatment, prevention, and diagnosis, the import registration certificate issued by the department of state drug supervision and administration shall be provided; (2) For the exit biological products and blood products for treatment, prevention, and diagnosis, the Certificate of Drug Sale issued by the department of drug supervision and administration shall be provided; and (3) For the entry/exit biological products and blood products for the use in other fields, the import documents of approval issued by the relevant competent departments shall be provided. Article 11. The inspection and quarantine bureaus directly under the GAQSIQ shall accept the application with complete application materials and complies with the legal form. Article 12. The inspection and quarantine bureau directly under the GAQSIQ that accepts an application shall make material examination on the application materials, and make a decision on whether to grant license or not within 20 workdays. If it is impossible to make a decision within 20 workdays, another 10 workdays may be granted upon the approval of the person-in-charge, and the applicant shall be notified of the reasons for the extension. If a license is granted, the Approval for Verification of Sanitation and Quarantine shall be issued; if a license is not granted, the said bureau shall explain the reasons for it in written forms. The inspection and quarantine bureau directly under the GAQSIQ shall report to and request the GAQSIQ to carry out technical analysis on the special articles whose epidemic nature has not been known. The time needed for technical analysis shall not be computed into the time limit for verification, but the consigners or their agents shall be informed of the time limit in written forms. Article 13. The Approval for Verification of Sanitation and Quarantine on entry/exit special articles may only be used for once, and its valid period shall be 90 days. Article 14. In case the formalities for the verification of sanitation and quarantine on any organ for the use of transplanting have not been gone through, the inspection and quarantine organ may discharge it in advance when it enters and exits the territory, and the consigner or its agent shall apply for making up the formalities of verification for sanitation and quarantine within 10 days after it is discharged. CHAPTER III SANITATION AND QUARANTINE Article 15. After any entry/exit special articles reach a port or before they leave a port, the consigner or its agent shall apply to the port inspection and quarantine organ for inspection according to law. Under any of the following circumstances, the inspection and quarantine organ shall not accept the application for inspection: (1) The consigner or its agent fails to provide the Approval for Verification of Sanitation and Quarantine; (2) The Approval for Verification of Sanitation and Quarantine exceeds the valid period; (3) The consigner or its agent forges or alters the relevant documents or documentations; or (4) Other circumstances that do not comply with the requirements of inspection and quarantine. Article 16. The port inspection and quarantine organ that accepts the application for inspection shall conduct on-site checking on the entry/exit special articles in light of the following requirements, and fill in the Records of On-site Checking of Sanitation and Quarantine on Entry/Exit Special Articles: (1) Inspecting whether the name, batch number, specification, quantity, export/import country, and manufacturer of the entry/exit special articles, and other items thereof comply with the contents listed in the approval for verification; (2) Inspecting whether the package of the entry/exit special articles is safe and without damage, and does not leak; (3) Verifying the ex-factory inspection conformity report on the exit special articles, inspecting the production records and sources of the raw materials, and whether the production flow complies with the sanitation requirements. Article 17. For the entry special articles that need to be inspected by sampling, the consigners or their agents may transport them to the place that have storage conditions upon the approval of the port inspection and quarantine organs, and may not move or use them until they are checked to be qualified. If a port inspection and quarantine organ has no inspection capacity, it shall entrust the laboratories designated by the GAQSIQ for inspection. Article 18. In case the entry/exit special articles that are mailed or carried have not gone through the formalities for verification of sanitation and quarantine due to special circumstances, the inspection and quarantine organs shall detain them, and request that they go through the formalities for verification of sanitation and quarantine, and the articles shall not be discharged until after they have been inspected as qualified in accordance with Article 16 of the present Measures. Article 19. The port inspection and quarantine organs shall discharge the entry/exit special articles that comply with the requirements after sanitation and quarantine. In case the port inspection and quarantine organs discover any of the following circumstances, they shall issue the Notice on Inspection and Quarantine Disposal, and seal, return, or destroy the entry/exit special articles: (1) The name, batch number, specification, and quantity, and etc. do not comply with those verified; (2) The conditions for packaging or preservation do not comply with the requirements; (3) They exceed the valid period for utilization; (4) They do not comply with the requirements of sanitation and quarantine after inspection; or (5) The detained articles fail to obtain the license within 60 days from the day of detention. The port inspection and quarantine organs shall keep a good record and file on the handling result, and report them to the GAQSIQ. CHAPTER IV FOLLOW-UP SUPERVISION Article 20. The inspection and quarantine organs shall conduct follow-up supervision on the entry special articles that contain or are likely to contain the pathogenic microbes within their jurisdictions. The entry special articles that need follow-up supervision may not be used without the consent of the inspection and quarantine organs. Article 21. For the entry special articles over which follow-up supervision shall be conducted at other places, the port inspection and quarantine organs shall issue the Notice on Transferring Entry Goods, and forwarding the Notice by electronic ways to the inspection and quarantine organ at the place of destination in a timely manner. The entity using the articles shall, within 30 days after the special articles enter the territory, declare at the inspection and quarantine organ at the place of destination upon the strength of the Notice on Transferring Entry Goods, and accept follow-up supervision. Article 22. The contents of follow-up supervision over entry special articles by an inspection and quarantine organ shall include: (1) Whether the entity using the entry special articles that contain or are likely to contain pathogenic microbes has the corresponding level of bio-safety laboratory, the laboratory of Grade P3 or above shall be certified by the state certification organs; (2) Whether the operators in the laboratories of the using entity have the corresponding qualification; and (3) As to the records on the use of the entry special articles, whether they are used in light of the usage having been verified. The using entities shall provide specifications on their use to the inspection and quarantine organs. Article 23. In case an inspection and quarantine organ discovers any incompliance during follow-up supervision, it shall order that the incompliance be rectified within a prescribed time limit, and seal the special articles that have entered the territory, until they comply with the requirements after rectification. If they still do not comply with the requirements after rectification, the inspection and quarantine organ shall order to return or destroy them. Article 24. An inspection and quarantine organ shall, for the problem discovered in the follow-up supervision, immediately report to the GAQSIQ, and circulate a report to the inspection and quarantine bureau directly under the GAQSIQ that approves the verification. CHAPTER V SUPPLEMENTARY PROVISIONS Article 25. In case anyone violates the present Provisions, and has any of the following acts, the inspection and quarantine organ may give it/him a warning or impose a fine of less than RMB 5,000 Yuan: (1) Disguising or missing the report of microorganism, human tissue, biological products, flood and its products whose import is prohibited, and other special articles; (2) Moving, selling, or using the special articles without the approval of the inspection and quarantine organ; (3) Failing to apply for inspection to the inspection and quarantine organ within the prescribed time limit or refusing to accept the follow-up supervision of sanitation and quarantine on special articles; or (4) Forging or altering the quarantine documentations. Article 26. Anyone that violates the present Provisions and results in the spread of quarantine epidemic diseases or brings about grave danger of the spread of quarantine epidemic diseases, he/it shall be subject to criminal liabilities according to the relevant provisions of the Criminal Law of the People's Republic of China. Article 27. The following terms in the present Provisions shall have the following meanings: (1) Microorganisms shall refer to Vvruses, bacteria, fungi, actinomycetes, rickettsia, spirochetes, chlamydia, mycoplasma and other medical microbiology; (2) Human Tissue shall refer to the human embryos, organs, tissue, cells, human secretions and human excrement; (3) Biological Products shall refer to: bacterium vaccine, virus vaccine, antitoxin, various reagents for diagnosis, interferon (IFN), hormone, enzyme and its preparations, and other active preparations (toxins, antigens, allergens, monoclonal antibodies, recombinant DNA products, antigen-antibody complex one, immunomodulatory agents, probiotics, nucleic acid preparation, etc.), and the relevant products produced with other biological materials; and (4) Blood and Its Products shall refer to the whole blood, plasma, amylase, blood cell, and plasma protein composition or the blood cell composition products, which are separated, purified from blood or made by applying biological technology. Article 28. The present Provisions shall be followed for the administration of sanitation and quarantine of entry/exit special articles that are transported in and out of the bonded zones and export processing zones. Article 29. The power to interpret the present Provisions shall remain with the GAQSIQ. Article 30. The present Provisions shall be implemented as of January 1, 2006. |
||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
|
Copyright 2002 NovexCn.com
|