Promulgation Authorities:  General Administration of Customs

Promulgation Date:  2018.11.23

Effective Date:  2018.11.23

Validity Status:  valid

Administrative Provisions on Entry-Exit Health Quarantine for Special Articles (Revised in November 2018)

Administrative Provisions on Entry-Exit Health Quarantine for Special Articles (Revised in November 2018)

Chapter I General Provisions

Article 1    In order to regulate the supervision and administration of health quarantine for entry or exit of special articles, prevent the spread of infectious diseases, prevent and control biosecurity risks, and protect human health, these Provisions are enacted in accordance with the Entry-Exit Health Quarantine Law of the People's Republic of China and its implementing rules, the Regulations on AIDS Prevention and Treatment, the Regulations on the Administration of Biosecurity of Pathogenic Microbe Laboratories, the Interim Measures for the Administration of Human Genetic Resources and other laws and regulations.

Article 2    These Provisions apply to the supervision and administration of health quarantine for entry or exit of special articles such as microbes, human tissues, biological products, blood and blood products, etc.

Article 3    The General Administration of Customs uniformly administers the nationwide supervision and administration of health quarantine for entry or exit of special articles; the competent customs are responsible for the supervision and administration of health quarantine for entry or exit of special articles in their own jurisdictions.

Article 4    The supervision and administration of health quarantine for entry or exit of special articles follow the principle of risk management, and quarantine approval, quarantine checking and examination, and supervision and administration are conducted according to the risk level on the basis of risk assessment.

The General Administration of Customs may assess the biosecurity control system of the exporting countries or regions.

Article 5    The owner of entry or exit of special articles or its agent shall, in accordance with the provisions of laws and regulations and requirements of relevant standards, import, export, produce, operate and use the special articles, take responsibility for the society and the public, ensure the safety of the special articles, accept social supervision, and undertake social responsibilities.

Chapter II Quarantine Approval

Article 6    The Customs districts directly subordinate to the General Administration of Customs ("GACC") are responsible for the approval of health quarantine for entry or exit of special articles (hereinafter referred to as the "approval of special articles") within their respective jurisdictions.

Article 7    To apply for the approval of special articles, the following conditions shall be met:

(I) If approval documents from relevant authorities are required by laws and regulations, the corresponding approval documents shall be obtained; and

(II) Having the biosecurity control ability that is appropriate for the entry or exit of special articles.

Article 8    The owner of the inbound special articles or its agent shall apply to the Customs district directly subordinated to the GACC at the destination for the approval of the special articles before they are delivered for transportation.

The owner of the outbound special articles or its agent shall apply to the local Customs district directly subordinated to the GACC for the approval of the special articles before they are delivered for transportation.

Article 9    To apply for the approval of special articles, the owner of the special articles or its agent shall provide corresponding materials in accordance with the following provisions:

(I) the Application Form for Approval of Entry/Exit Health Quarantine for Special Goods;

(II) the descriptive materials on the entry or exit of special articles, including the Chinese and English names, types, ingredients, sources, uses and main sales channels of the special articles, import and export countries or regions, and manufacturers, etc. of the special articles;

(III) for the inbound biological products and human blood products used for the prevention, diagnosis, and treatment of human diseases, the registration certificate of imported drugs issued by the Department of Drug Supervision and Administration under the State Council shall be submitted;

(IV) for the entry or exit of special articles that contain or may contain pathogenic microbes, the scientific names of pathogenic microbes (both in Chinese and Latin), biological characteristics description documents (bilingual versions in both Chinese and English) and the documents proving that the producers, operators or users possess corresponding biosecurity prevention and control capacity shall be submitted;

(V) for outbound biological products and human blood products used for the prevention, diagnosis, and treatment of human diseases, the sales certificate issued by the department of drug supervision and administration shall be submitted;

(VI) for outbound special articles that are involved in the administration of human genetic resources, the approval documents issued by the department of human genetic resources shall be obtained, and the Customs house shall automatically verify and examine through system the electronic data of relevant approval documents;

(VII) any organization using entry or exit of special articles that contain or are likely to contain pathogenic microbes shall provide the qualification certificates of biosecurity laboratories corresponding to the biosecurity risk level, and a laboratory above Grade BSL-3 shall be accredited by an agency recognized by the State; and

(VIII) for inbound or outbound highly pathogenic microbe (virus) strains or samples, the approval documents issued by the department in charge of health of the people's government at or above the province level are required.

Article 10    In the case of an organization as applicant for the examination and approval of special articles for the first time is an organization, the following materials shall be submitted in addition to the materials provided in Article 9 hereof:

(I) basic information of the organization, such as the certification of the management system of the organization, its address, production site, laboratory setup, warehousing facilities and equipment, product processing conditions, production process or process flow, and plan, etc.; and

(II) Laboratory biosafety qualification certificate.

In the case of a natural person as applicant, the copy of his/her ID card shall be submitted.

For inbound or outbound pathogenic microbes or special articles that may contain pathogenic microbes, the applicant shall not be a natural person.

Article 11    A Customs district directly subordinated to the GACC shall handle the application for the examination and approval of special articles filed by an applicant respectively according to the following circumstances:

(I) for the items applied for that are not subject to the examination and approval of special articles according to the law, the applicant shall be informed of the rejection immediately;

(II) for items applied for that are not within the scope of authority of the Customs district directly subordinated to the GACC according to the law, the decision of rejection shall be made immediately, and the applicant shall be informed to apply to the relevant administrative authorities or other Customs district directly subordinated to the GACC;

(III) for errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot;

(IV) for the application materials that are incomplete or do not conform to the legal form, the applicant shall be informed of all the items that need to be supplemented on the spot or within 5 days after receiving the application materials once for all. If the applicant has not been informed within the time limit, the date of receiving the application materials shall be deemed as the date of acceptance; and

(V) for the items applied for that are within the scope of authority of the Customs district directly subordinated to the GACC, and the application materials are complete and conform to the legal form, or the applicant has supplemented and corrected all the items according to the requirements of the Customs district directly subordinated to the GACC, the application for administrative license shall be accepted.

Article 12    The Customs district directly subordinated to the GACC shall timely conduct the written examination on the application materials. The substantive contents of the application materials may be verified by means of expert information review, on-site assessment, and laboratory testing, etc. as the case may be.

Article 13    For the applications that meet the legal conditions and standards, the Customs district directly subordinated to the GACC shall issue a Certificate of Approval of Entry/Exit Health Quarantine for Special Goods (hereinafter referred to as the Certificate of Approval for Special Goods) within 20 days after accepting the application.

If the application does not meet the legal conditions and standards, the Customs district directly subordinated to the GACC shall make a written decision of disapproval and explain the reasons within 20 days after accepting the application, and inform the applicant of its/his rights to apply for administrative reconsideration or bring an administrative lawsuit according to law.

If the Customs district directly subordinated to the GACC is unable to make a decision of approval or disapproval within 20 days, an extension of 10 days may be granted upon the approval of the person in charge of the administrative organ, and the applicant shall be notified of the reasons for the extension.

Article 14    The period of validity of a Certificate of Approval for Special Goods is as follows:

(I) three months for the special articles that contain or are likely to contain highly pathogenic microbes;

(II) six months for the special articles that contain or are likely to contain other pathogenic microbes; or

(III) 12 months for the special articles other than those specified above.

The Certificate of Approval for Special Goods can be used for writing off in batches within the period of validity. If the period of validity expires, a new application shall be filed.

Chapter III Quarantine Examination

Article 15    After the inbound special articles arrive at the port of entry, the owner or its agent shall apply for inspection to the Customs house at the port of entry on the strength of the Certificate of Approval for Special Goods and other materials.

The owner of the outbound special articles or its agent shall apply for inspection to the local Customs house on the strength of the Certificate of Approval for Special Goods and other materials before the exit.

If the application materials are incomplete or do not meet the statutory forms, the Customs house will not allow the entry or exit.

Article 16    The Customs house that accepts an application for inspection shall conduct on-site examination on the entry or exit of special articles according to the following requirements, and fill in the Record of On-site Examination for Entry/Exit Health Quarantine for Special Goods:

(I) checking whether the name, composition, batch number, specifications, quantity, validity period, transportation and storage conditions, export/import countries and manufacturers of the entry or exit of special articles are consistent with the contents of the Certificate of Approval for Special Goods;

(II) checking whether the package of the entry or exit of special articles is safe and without damage, seepage and leakage, and whether the special articles with biosecurity risks have marks of bio-hazardous goods that meet the relevant requirements.

If the inspection site at the port of entry does not have the safety protection conditions necessary for the examination and inspection of the special articles, the special articles shall be transported to a designated place that meets the biosecurity level conditions for inspection.

Article 17    For the inbound special articles are subject to laboratory testing, the owner or its agent shall store the special articles in a qualified storage place according to the requirements of the Customs house at the port of entry, and shall not move or use the special articles until they pass the quarantine inspection. If the Customs house at the port of entry has no testing capability, it shall entrust a laboratory with corresponding qualification to conduct the testing.

For the inbound special articles that contain or may contain pathogenic microbes, toxins and other biosecurity hazard factors, the Customs house at the port of entry shall promptly transmit the electronic form to the Customs house at the destination after the on-site examination and inspection. The Customs house at the destination shall implement follow-up supervision.

Article 18    For the entry or exit of special articles that are posted or carried with no Quarantine Approval Certificate for Special Articles obtained, the Customs house shall detain them and issue a detainment voucher, and the detainment period shall not exceed 7 days.

After the postman or the carrier obtains the Quarantine Approval Certificate for Special Articles within the detainment period, the Customs house shall conduct the inspection according to the provisions of Article 16 hereof, and the special articles shall be released if they pass the quarantine inspection.

Article 19    A person who carries blood products or biological products for personal use which is limited to prevention or treatment of diseases when entering/exiting the country is not required to go through the formalities for health quarantine approval, but shall present relevant proof issued by the hospital to the Customs house when entering/exiting the country; and the permissible carrying quantity shall be limited to a course of treatment determined on the prescription or instructions.

Article 20    The Customs house at the port shall give clearance to the entry or exit of special articles that meet the requirements of health quarantine. The Customs house at the port shall issue a Notice of Inspection and Quarantine, and return or destroy the articles under any of the following circumstances:

(I) the name, batch number, specifications, bioactive ingredients, etc. of such articles do not conform to the contents of the health quarantine approval for the special articles;

(II) exceeding the quantity scope of health quarantine approval;

(III) the packing does not conform to the requirements for safety management of special articles;

(IV) failure to meet the requirements of health quarantine after the quarantine inspection; or

(V) failure to obtain the Approval Certificate for Special Articles for the special articles detained, posted or carried within 7 days from the date of detainment, or the special articles fail to pass the quarantine inspection after obtaining the Approval Certificate for Special Articles.

The Customs house at the port shall make records and files for the handling results.

Chapter IV Supervision and Administration

Article 21    The organizations involving entry or exit of special articles shall establish a safety management system for the special articles, and produce, use or sell the special articles strictly according to the purposes of the examination and approval of special articles.

The organizations involving entry or exit of special articles shall establish records on the production, use and sale of the special articles. The records shall be authentic and kept for at least 2 years.

Article 22    Customs houses shall implement risk management on inbound and outbound special articles, classify the special articles into different risk levels according to the risks that inbound and outbound special articles may spread human diseases, and adopt different supervision and administration methods of health quarantine.

The risk levels of inbound and outbound special articles and the corresponding supervision and administration methods of health quarantine shall be announced by the GACC in a unified manner.

Article 23    For the inbound special articles that are subject to follow-up supervision, the organization to use such articles shall declare to the Customs house at destination within 30 days after the entry of the special articles, and the Customs house at destination shall implement the follow-up supervision and administration.

Article 24    The contents of the follow-up supervision and administration conducted by a Customs house for entry or exit of special articles include:

(I) whether the laboratory of the organization that uses the special articles are consistent with that indicated on the Approval Certificate for Special Articles; and

(II) whether the entry or exit of special articles are consistent with those indicated on the Approval Certificate for Special Articles.

Article 25    If either of the following circumstances is found during the follow-up supervision and administration, the Customs house shall withdraw the Approval Certificate for Special Articles and order the special articles to be returned or destroyed:

(I) the laboratory of the organization that uses the special articles are inconsistent with that indicated on the Approval Certificate for Special Articles; or

(II) the entry or exit of special articles are inconsistent with those indicated on the Approval Certificate for Special Articles.

The Customs house shall notify the problems found during the follow-up supervision and administration to the Customs district directly subordinated to the GACC that made the original approval. If the case is serious, it shall be reported to the GACC in a timely manner.

Article 26    The customs staff shall enforce the law impartially, be devoted to their duties, and keep the trade secrets known to them during the performance of their duties.

Chapter V Legal Liability

Article 27    If any of the following circumstances occurs in violation of the present Provisions, the Customs house may give a warning or impose a fine of not less than 100 yuan but not more than 5,000 yuan in accordance with the provisions of Article 110 of the Implementing Rules for the Entry-Exit Health Quarantine Law of the People's Republic of China:

(I) refusing to accept quarantine inspection or resisting the supervision and administration of health quarantine;

(II) forging or altering the health quarantine forms or certificates; or

(III) concealing the fact of carrying microbes, human tissues, biological products, blood and products thereof that are prohibited from import or other animals and articles that may cause the spread of infectious diseases.

Article 28    If any of the following circumstances occurs in violation of the present Provisions, and there are illegal gains, the Customs house may impose a fine of not more than 30,000 yuan:

(I) the approval of special articles is obtained by improper means such as fraud or bribery;

(II) moving, selling or using the special articles without the permission of the Customs house;

(III) failure to apply for inspection to the Customs house or providing false materials to obtain the inspection and quarantine documents by fraud;

(IV) failure to operate special articles in the laboratory with corresponding biosecurity level, or the organization using the special articles does not have corresponding level of biosecurity control capability; or failure to establish records on use and sale of the special articles or the records do not conform to the actual conditions; and

(V) unlawfully using the inbound special articles that are subject to follow-up supervision and administration without the approval of the Customs house.

Article 29    If the owner of the special articles that enter or exit the country or its agent refuses or obstructs a Customs house and its staff from performing their functions, the case shall be referred to relevant departments for handling.

Article 30    If any staff member of a Customs house violates the relevant laws and regulations by practicing favoritism, abuse of his/her power or neglection of his/her duty, he/she will be given an administrative sanction according to law; if the circumstance is serious and a crime is constituted, he/she will be prosecuted for criminal liability according to law.

Article 31    Whoever violates the present Provisions and causes the spread of a quarantinable infectious disease or causes great danger of spreading a quarantinable infectious disease will be prosecuted for criminal liability according to the relevant provisions of the Criminal Law of the People's Republic of China.

Chapter VI Supplementary Provisions

Article 32    For the purpose of the present Provisions, the following terms shall have the meanings as follows:

Microbes shall refer to viruses, bacteria, fungi, actinomyces, rickettsiae, spirochaeta, chlamydia, mycoplasma and other medical microorganisms (virus) strains and samples, parasites, and environmental microbial agents.

Human tissues shall refer to human cells, cell lines, embryos, organs, tissues, bone marrow, secretions, and excrement, etc.

Human genetic resources shall refer to the genetic materials and related information and data of organs, tissues, cells, blood, preparations, recombinant deoxyribonucleic acid (DNA) constructs containing human genomes, genes and their products.

Biological products shall refer to vaccines, antitoxins, diagnostic reagents, cytokines, enzymes and their preparations used in related fields of human medicine and life sciences, as well as toxins, antigens, allergens, antibodies, antigen-antibody complexes, nucleic acids, immunomodulators, microecological preparations and other bioactive agents.

Blood shall refer to human whole blood, plasma components and special blood components.

Blood products shall refer to various human plasma protein products.

Organizations involving inbound or outbound special articles shall refer to legal persons or other organizations engaged in the production, use, sales, scientific research, medical treatment, inspection, and pharmaceutical research and development outsourcing of special articles.

Article 33    The supervision and administration of health quarantine of imported and exported microbial agents for environmental protection shall be subject to the Measures for the Administration of Environmental Safety of Imported and Exported Microbial Agents for Environmental Protection (Decree No. 10 of the Ministry of Environmental Protection, and the General Administration of Quality Supervision, Inspection and Quarantine).

Article 34    Where the entry or exit of special articles is subject to the quarantine for animals and plants, the provisions of laws and regulations on the entry and exit quarantine for animals and plants shall be followed.

Article 35    The GACC shall be responsible for the interpretation of the present Provisions.

Article 36    The present Provisions shall come into force on March 1, 2015, repealing simultaneously the Administrative Provisions on Entry-Exit Health Quarantine for Special Articles (Decree No. 83 of the General Administration of Quality Supervision, Inspection and Quarantine) promulgated by the General Administration of Quality Supervision, Inspection and Quarantine on October 17, 2005.