(October 17, 2005 State General Administration of quality supervision, inspection and quarantine, the 83rd reported as of January 1, 2006) Chapter I General provisions article to regulate the entry and exit health quarantine supervision and administration of special items, according to the People's Republic of China on frontier health and quarantine law and the detailed rules for the implementation of the relevant provisions, these provisions are formulated.
    Provisions of this article apply to the entry or exit of micro-organisms, tissues, biological products, blood products and other sanitary and phytosanitary supervision of special items.
    Third State administration of quality supervision, inspection and quarantine (hereinafter referred to as AQSIQ) unified management over entry and exit health quarantine supervision and administration of special items; the national quality watchdog based in local entry-exit inspection and quarantine institutions (hereinafter referred to as the inspection and quarantine institutions) on the area of special sanitary and quarantine supervision of entry and exit.
    Fourth special items of health and quarantine of entry and exit health quarantine management approval, on-site inspection and follow-up supervision and management system.
    Fifth/exit special articles section of the health and quarantine examination and approval form (hereinafter referred to as the sanitation quarantine examination and approval form for), special items and approved by the health and quarantine of entry and exit, entry or exit.
    Sixth immigration special items designated by the State General Administration of quality supervision and released ports of entry and exit.
    Sanitation quarantine examination and approval article seventh chapter II inspection and Quarantine Bureau is responsible for areas within the entry-exit health and quarantine of special objects for examination and approval.
    Article eighth entry, exit special items of the owner or his agent shall, before delivery to the port of entry and exit inspection and Quarantine Bureau submitted the entry/exit approval application form for special items of health quarantine (hereinafter of the approval request form).
    The owner or his agent shall, according to immigration classification of fill in the application form for approval of special, fill in each category. Nineth article application handle immigration microbial, and human organization, and blood of health quarantine approval procedures of, should provides following material: (a) related competent sector issued of allowed immigration proved (original and copies); (ii) special items by containing disease original microbial of scientific name (Chinese and Latin) and biology characteristics (in the English control pieces) of description sex file; (three) contains or may contains 3 to 4 level disease original microbial of entry special items,
    And the contains or may contains yet grading disease original microbial of entry special items, using units should has BSL-3 level (P3 level) laboratory, and provides corresponding qualification of proved; (four) research with special items should provides research project approved file original or research project application people and both at home and abroad cooperation institutions agreement (original and copies, in the, and English control pieces); (five) for transplant with organ should provides has qualification hospital issued of for body health proved and related test report. Tenth Article application handle biological products, and blood products of health quarantine approval procedures of, owner or its agent should provides following material: (a) for treatment, and prevention, and diagnosis of entry biological products, and blood products, should provides national drug supervision management sector issued of imports registered proved; (ii) for treatment, and prevention, and diagnosis of exit biological products, and blood products, should provides drug supervision management sector issued of drug sales proved; (three) for other field of immigration biological products, and blood products
    , The import documents issued by competent authorities should be provided.
    11th entry inspection and Quarantine Bureau on application materials are complete, applications for compliance with the statutory form, shall be admissible.
    12th Bureau of inspection and quarantine for accepting applications for substantive review of application materials, and within 20 working days to approve the license or disapproving the licensing decision, did not take a decision within 20 working days, approved by the owner can be extended by 10 working days, and shall inform the applicant of the reasons for such further period.
    Permission is granted shall be issued by the health and quarantine examination and approval form for, are not allowed to leave, shall state the reasons in writing. Not cognitive of its infectious special articles, shall be submitted to the State administration of quality supervision inspection and quarantine technical analysis.
    Excluding the time required for approval of technical analysis terms, shall notify the owner or his agent.
    13th special articles for health and quarantine of entry and exit of approval can only be used once, valid for 90 days.
    14th for transplant organs due to special reasons do not go through sanitation quarantine examination and approval procedures, entry and exit inspection and quarantine authorities can be released, the owner or his agent shall be released after applying for health and quarantine examination and approval procedures in the 10th. Chapter III health and quarantine 15th entry, exit before special items upon arrival at the port, or leave the port, the owner or his agent shall be in accordance with the port inspection and quarantine Agency inspection.
    Any of the following circumstances, the inspection and quarantine agency shall not accept inspection: (a) do not provide the sanitation quarantine examination and approval form for, (ii) the sanitation quarantine examination and approval form for expired, (iii) forged or altered documents or documents; (iv) does not comply with the inspection and quarantine requirements. 16th article accepted reported check of port test quarantine institutions according to following requirements on immigration special items implementation site identification, and fill in into/exit special items health quarantine site identification records: (a) check immigration special items name, and batch, and specifications, and number, and output/entered country and production manufacturers, project whether and approval single ming of content match; (ii) check immigration special items packaging whether security no damaged, not infiltration, and not leak; (three) on exit of special items should verification factory test qualified report,
    Review production records and sources of raw materials, production processes and compliance with health requirements. Article 17th entry special items to be random testing, licensed by the port inspection and quarantine institutions, the owner or his agent to transport to the storage place, qualified before the move you want to test or use.
    Port inspection and quarantine institutions did not have testing capacity, shall entrust the AQSIQ specified laboratories for testing.
    18th article immigration special mailing, carrying goods, due to special conditions without sanitation quarantine examination and approval procedures, the inspection and quarantine authorities shall retain, in accordance with provisions of health and quarantine examination and approval procedures, and inspection in accordance with section 16th, qualified before they have passed quarantine before release. 19th port inspection and quarantine institutions to meet the requirements of the immigration special items subject to quarantine health releases them.
    Found has following situation one of of, issued test quarantine processing notice, and be sealed, and returned or destroyed: (a) name, and batch, and specifications, and number, and approval content not match of; (ii) packaging or save conditions not meet requirements of; (three) over effective using term of; (four) by test not meet health quarantine requirements of; (five) was interception items since interception of day up 60 days not allowed license of.
    Port inspection and quarantine agencies to process the results shall be recorded, archived and reported to the State administration of quality supervision.
    20th chapter fourth follow-up supervision, inspection and quarantine institutions within the jurisdiction contains or may contain pathogenic microorganisms of special articles of subsequent supervision of entry.
    Need follow-up supervision of the immigration special articles, without the consent of inspection and quarantine institutions, are not allowed to use. Article 21st on the need to implement offsite follow-up supervision of the immigration special articles, port inspection and quarantine agencies shall issue out of entry of goods and electron transfer to destination inspection and quarantine authorities in a timely manner.
    Special items in the 30th after using the unit should, entry of goods transferred to destination inspection and quarantine institutions Declaration and receive follow-up supervision.
    22nd article test quarantine institutions on entry special items implementation follow-up regulatory of content including: (a) contains or may contains disease original microbial entry special items of using units whether has corresponding grade of biological security laboratory, P3 level above laboratory must get national recognized institutions of recognized; (ii) using units laboratory operation personnel whether has corresponding of qualification; (three) entry special items using situation records, whether according to approval uses using.
    To inspection and quarantine agencies shall promptly provide usage instructions. 23rd discovered during follow-up supervision and inspection and quarantine institutions does not meet the requirements, shall order the rectification, and the entry of special goods for storage until corrective action to meet the requirements.
    If rectification does not meet the requirements, ordered to return or destruction.
    24th discovered during the inspection and quarantine agencies for follow-up supervision problems, shall immediately report to AQSIQ, and inform the original examination and approval of inspection and Quarantine Bureau.
    Fifth chapter schedule 25th article violation this provides, has following behavior one of of, test quarantine institutions can give warning or sentenced 5000 Yuan following of fine: (a) concealed or omitted ban imports of microbial, and human organization, and biological products, and blood and products, special items of; (ii) without test quarantine institutions license, unauthorized moved shipped, and sales and using special items of; (three) in provides time within not to test quarantine institutions declared or refused to accept special items health quarantine follow-up regulatory of;
    (D) forge or alter the quarantine and permits.
    26th violations of the provisions of this article, which caused quarantine diseases spread or a grave danger of the spread of infectious diseases, in accordance with the People's Republic of China Criminal Code relating to criminal responsibility shall be investigated. 27th article this provides following terms of meaning: (a) microbial is refers to virus, and bacteria, and fungi, and Actinomycetes, and Mill Creek times's body, and pallidum, and clothing original body, and support original body, medical microbial; (ii) human organization is refers to human embryos, and organ, and organization, and cell, and human secretion real, and waste; (three) biological products is refers to: bacteria class vaccine, and virus class vaccine, and anti-toxins, and various diagnosis with reagents, and interferon, and hormone, and enzyme and preparations and other activity preparations (toxins, and Antigen, and allergy original, and single clone antibody , Recombinant DNA products, Antigen-antibody complexes, immune modulators, micro-ecology preparation, nucleic acid preparation, etc), as well as other related products produced by biological material;

    (D) refers to blood and its products in whole blood, plasma, serum, blood and blood separation, purification or bio-technology made of plasma protein fraction blood cell components or products.
    28th out of the bonded area, export processing zone management of entry-exit health and quarantine of special objects, in accordance with this regulation.
    Article 29th of this provision by the AQSIQ to interpret.
                                                                  30th article of the regulations come into force on January 1, 2006.