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Special Articles For Health And Quarantine Of Entry And Exit Regulations

Original Language Title: 出入境特殊物品卫生检疫管理规定

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  Chapter I General provisions article in order to regulate the entry and exit health quarantine and supervision of special goods management, inbound, outbound, prevent infectious diseases, prevention and control of bio-security risks, the protection of human health, according to the People's Republic of China on frontier health and quarantine law and its implementing rules, the AIDS prevention and control regulations and the pathogen laboratory biosafety regulations and the interim measures for the management of human genetic resources, such as laws and regulations, this provision is enacted.

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 Bureau (hereinafter referred to as the inspection and quarantine departments) responsible for the area of the special supervision and management work of health and quarantine of entry and exit.

The fourth entry-exit health quarantine and supervision of special goods management follow the principles of risk management, according to risk levels based on implementation of the risk assessment and approval of quarantine inspection, quarantine, and supervision and management.

AQSIQ to the exporting country or region assessment of the bio-safety control system.

Article fifth immigration special articles of the owner or his agent, shall, in accordance with the requirements of laws and regulations and related standards, inputs, outputs, as well as production, distribution, use, special articles, be accountable to society and the public, ensure the safety of special goods, subject to public supervision, and social responsibility.

Chapter II examination and approval article sixth directly under import/export special items in the inspection and Quarantine Bureau, responsible for sanitation quarantine examination and approval (hereinafter referred to as special items for approval).

Seventh special items for approval the applicant shall satisfy the following conditions: (a) the laws and regulations of the documents to be approved by the relevant departments, should be approved by the appropriate documents; (b) immigration-special items suitable for bio-security control.

Article eighth entry special items of the owner or his agent shall, before special items shipped to destination inspection and Quarantine Bureau to apply for special approval.

Exit special articles of the owner or his agent shall, before special items delivered to the local inspection and Quarantine Bureau to apply for special approval.

Nineth article application special items approval of, owner or its agent should according to following provides provides corresponding material: (a) into/exit special items health quarantine approval application table; (ii) immigration special items description sex material, including special items in the English name, and category, and components, and source, and uses, and main sales channel, and output entered of national or area, and producers,; (three) entry human blood, and plasma, and organization, and organ, and cell, and bone marrow,, should provides health competent sector of approved file; (Four) entry, and exit for transplant with human organization, and cell, and organ, and bone marrow, should provides medical institutions issued of for body health proved and related test report; (five) entry for prevention, and diagnosis, and treatment human disease of biological products, and human blood products, should provides State drug supervision management sector to of imports drug registered certificate; (six) entry, and exit special items contains or may contains disease original microbial of, should provides disease original microbial of scientific name (Chinese and Latin), and

Biology characteristics of description sex file (in the English control pieces) and production operators or using who has corresponding biological security control level of proved file; (seven) exit for prevention, and diagnosis, and treatment of human disease of biological products, and human blood products, should provides drug supervision management sector issued of sales proved; (eight) exit special items involved human genetic resources management category of, should provides human genetic resources management sector issued of approved file;

(Nine) using contains or may contains disease original microbial of immigration special items of units, should provides and biological security risk grade phase adapted of biological security laboratory qualification proved, BSL-3 level above laboratory must get national recognized institutions of recognized; (ten) immigration high pathogenic STD original microbial bacteria (HIV) species or sample of, should provides provincial above government health competent sector of approved file. X article applicants for units of, first application special items approval Shi, except provides this provides Nineth article by provides of material yiwai, also should provides following material: (a) units license, and organization institutions code card, documents copies, while inspection original; (ii) units basic situation, as units management system certification situation, and units address, and production places, and laboratory set, and warehouse facilities equipment, and products processing situation, and production process or process, and plane figure,; (three) biological security system file,

Special goods storage management system, management system, waste disposal management system, professional management system, emergency handling procedures and so on.

The applicant is a natural person shall provide photocopies, and submit the originals.

Immigration of pathogenic microorganisms, or may contain pathogenic microorganisms of special goods, the applicant must not be a natural person. 11th article directly under the test quarantine Council on applicants proposed of special items approval application, should according to following situation respectively made processing: (a) application matters law not need made special items approval of, should rates told applicants not accepted; (ii) application matters law not belongs to this units terms range of, should rates made not accepted of decided, and told applicants to about administrative organ or other directly under the test quarantine Council application; (three) application material exists can spot corrections of errors of, Should permit the applicant to be corrected on the spot; (d) the application materials are incomplete or not in compliance with the statutory form, shall, on the spot or from the date of receipt of the application materials at once inform all applicants need to supplement the content within the 5th.

Fails to inform the, shall be accepted as of the date of receipt of the application materials; (v) applications belong to the terms of reference of the unit, application materials are complete and comply with the statutory format, or the applicant in accordance with the requirements of this unit all corrected application materials submitted, shall accept administrative licensing applications. Immediate inspection and Quarantine Bureau of the 12th written application materials should be carried out promptly.

And, according to expert review, on-site assessment, laboratory tests and other means to verify the substance of the application materials.

13th of the applicant's application meets the legal conditions and standards, inspection and Quarantine Bureau shall from the date of acceptance of the 20th/exit special articles issued by the health and quarantine examination and approval form (hereinafter referred to as the special approval).

Applicant's application does not meet the legal conditions and standards, inspection and Quarantine Bureau should be made effective as of the date of acceptance in the 20th no approval a written decision with reasons, advise the applicant have the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law.

Inspection and Quarantine Bureau in the 20th not to approve or not to approve a decision, approved by the head of the administrative organ, you can extend the 10th, and shall inform the applicant of the reasons for such further period.

Expert review, on-site assessment, laboratory testing and other time without the approval of the review period, but shall be required to inform the applicant in writing of the time.

14th the validity of the approval of special items was as follows: (a) contains or could contain highly pathogenic microorganisms of special items, will be valid for 3 months.

(B) contain or may contain pathogenic microorganisms of special items, will be valid for 6 months.

(C) in addition to special items other than the above, valid for 12 months. The special items in the period of validity of the approval you can batch verification.

Expired, shall apply.

Chapter 15th special items upon arrival at the port of entry quarantine inspection, the owner or his agent shall with the approval of special items and other materials to the port of entry inspection and quarantine Department inspection.

Exit special articles of the owner or his agent shall before leaving with the approval of special items and other materials to the local inspection and quarantine Department inspection.

Inspection application materials are incomplete or do not comply with the statutory format, no entry or exit inspection and quarantine departments. 16th article accepted reported check of test quarantine sector should 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 components, and batch, and specifications, and number, and validity, and transport store conditions, and output/entered country and production manufacturers, project whether and special items approval single of content match; (ii) check immigration special items packaging whether security no damaged, not infiltration, and not leak,

Bio security risk exists with dangerous goods, in conformity with the relevant requirements of biological identification.

Port of entry inspection of the site does not have the security conditions required for any special articles, special items should be shipped to meet bio-safety level criteria are designated places of inspection. 17th against entry from laboratory testing, special articles, the owner or his agent shall, in accordance with the port inspection and quarantine departments to request special items stored in an eligible storage site, pass the quarantine inspection before they can move or use.

Port inspection and quarantine departments do not have detection capability shall entrust a qualified testing laboratory. Contains or may contain pathogenic microorganisms, toxins, biological safety factor of the immigration special items, port inspection and quarantine Department after implementation of the on-site inspection shall electron transfer to destination inspection and quarantine departments in a timely manner.

Destination inspection and quarantine departments should implement follow-up supervision.

18th article immigration special mailing, carrying goods, does not provide the special items of the approval, rejection issued by the inspection and quarantine departments should be withheld and vouchers, retention period not exceeding 7 days.

Mail or couriers during the retention period after approval to pay the special goods, inspection and quarantine departments in accordance with the provisions of this article 16th identification, pass the quarantine release.

19th carry for personal use and is limited to the prevention or treatment of diseases of the blood products or bio-product entry and exit, do not need to go through sanitation quarantine examination and approval procedures, entry-exit inspection and quarantine departments should show the hospital's relevant certificates; your prescription or instructions to determine a course of treatment are limited.

20th for transplant tissue due to special reasons do not provide the special items of approval, entry and exit inspection and quarantine departments to perform quarantine inspection after the first release, the owner or his agent shall be replacement in the 10th after the release of special items and approval procedures. 21st port inspection and quarantine departments to meet the requirements of the immigration special items subject to quarantine health releases them. Has following situation one of of, by port test quarantine sector issued test quarantine processing notice, be back shipped or destroyed: (a) name, and batch, and specifications, and biological activity components, and special items approval content not match of; (ii) beyond health quarantine approval of number range of; (three) packaging not meet special items security management requirements of; (four) by quarantine identification not meet health quarantine requirements of; (five) was interception mailing, and carry special items since interception of day up 7th within not fill make special items approval single

Or submitted after the approval of special items, quarantine failed.

Port inspection and quarantine departments to process the results shall be recorded, archived.

Fourth chapter, supervision and management of the 22nd and exit special goods unit, special items the safety management system should be established, strictly in accordance with the special approval purposes manufacture, use or sale of special items. Immigration special units shall establish a special-use goods production, use and sale of records.

Records shall be true to the retention period shall be not less than 2 years.

23rd to entry-exit inspection and quarantine departments article special items to implement risk management, according to the exit-entry special items may be risk of transmitting human diseases of different risk levels of special items divided into different risk levels and adopt different sanitary or phytosanitary regulation.

Immigration special items of risk levels and their corresponding sanitary and phytosanitary regulation published by the State administration of quality supervision.

24th need to implement follow-up supervision of the immigration special items, special items in the 30th after using the unit shall, to the destination inspection and quarantine departments, the destination inspection and quarantine departments to implement follow-up supervision, inspection and quarantine Department, are not allowed to use.

25th inspection and quarantine departments to implement follow-up supervision of the immigration special goods include: (a) the use is consistent with the special approval of the laboratory; (b) the immigration special items are consistent with the special approval of certificate of domestic.

26th discovered during follow-up supervision of the following situations, the approval by the inspection and quarantine departments to withdraw the special goods, ordered to return or destroy: (a) use inconsistent with the special approval of the laboratory; (b) the immigration special items goods with the approval of special items to match the certificates. Inspection and quarantine departments on issues found during follow-up supervision, shall inform the original approval of the inspection and Quarantine Bureau.

Serious cases shall be reported to the State administration of quality supervision.

27th staff should enforce inspection and quarantine departments, loyalty, in carrying out its functions, within the knowledge of the trade secret confidential. Fifth chapter legal responsibility 28th article violation this provides, has following case one of of, by test quarantine sector according to People's Republic of China border health quarantine method implementation rules 110th article provides sentenced warning or 100 Yuan above 5000 Yuan following of fine: (a) refused to accept quarantine or boycott health quarantine supervision management of; (ii) forged or altered health quarantine single, and card of; (three) concealed carry ban imports of microbial, and human organization, and biological products, and

Blood and its products, or other possible causes of the spread of infectious diseases of animals and objects.

29th article violation this provides, has following case one of of, has illegal proceeds of, by test quarantine sector sentenced 30,000 yuan following of fine: (a) to cheat, and bribery, not due means made special items approval of; (ii) without test quarantine sector license, unauthorized moved shipped, and sales, and using special items of; (three) not to test quarantine sector reported check or provides false material, cheat test quarantine card single of;

(Four) not in corresponding of biological security grade laboratory on special items carried out operation of or special items using units not has corresponding grade of biological security control capacity of; not established special items using, and sales records or records and actual inconsistent of; (five) without test quarantine sector agreed, unauthorized using needed follow-up regulatory of entry special items of; (six) first to release of for transplant with human organization, its application people not in release Hou 10th within replacement special items approval procedures of.

Article 30th immigration special articles of the owner or his agent refuses or obstructs the inspection and quarantine departments and their staff to perform their duties according to law, transferred to relevant departments according to law.

31st inspection and quarantine Department functionary, abuse their powers, neglect their duties, violation of relevant laws and regulations, shall be given administrative sanctions in serious cases, constitute a crime, criminal responsibility shall be investigated according to law.

Articles 32nd to violation of these measures, 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.

The sixth chapter supplementary articles the 33rd article of the rules the following terms shall have the meanings: microorganisms are viruses, bacteria, fungi, actinomycetes, rickettsia, and Treponema pallidum, chlamydia, Mycoplasma and other medicine bacteria (HIV) species and samples as well as parasites, environmental microbial agents.

Refers to cells of human tissues, cells, embryos, organ, tissue, bone marrow, secretions, excretions, and so on.

Human genetic resources refers to the human genome, genes and their products, organs, tissues, cells, blood, preparations and recombinant deoxyribonucleic acid (DNA) building, as well as genetic material and related information.

Biological products are used for human medicine, life sciences related areas of vaccines, antitoxins, diagnostic reagents, cytokines, enzymes and their preparations, Antigen and toxins, allergens, antibody, Antigen-antibody complexes, nucleic acids, immune modulators, probiotics and other bioactive agents.

Blood is human blood, plasma composition and specific blood components.

Refers to a variety of human blood products plasma protein products.

Immigration special items are special items produced, used, sales, scientific, medical, testing, pharmaceutical research outsourcing of legal persons or other organizations.

Article 34th microbial agent for import and export of environmental health and quarantine supervision and administration in accordance with the import and export of microbial agents for environmental management measures of environment security (Ministry of environmental protection and the State administration of quality supervision, 10th) regulations.

Special 35th article turnover boundary goods should be put in quarantine, in accordance with the provisions of the entry and exit animal and plant quarantine laws and regulations.

36th article of the regulation by the AQSIQ to interpret. 37th article of the regulations come into force on March 1, 2015, AQSIQ released on October 17, 2005, of the immigration special items of sanitary and phytosanitary regulations (AQSIQ, 83rd) repealed simultaneously.