Provisions of the Customs of the People's Republic of China on the Administration of Health and Quarantine for Special Goods and Articles Entering and Exiting China

Chapter I General Provisions

Article 1 These Provisions are formulated in accordance with the Frontier Health and Quarantine Law of the People's Republic of China and the detailed rules for its implementation, the Biosecurity Law of the People's Republic of China, the Regulation on the Prevention and Treatment of HIV/AIDS, the Regulation on the Bio-safety Management of Pathogenic Microbe Labs, and other laws and administrative regulations for the purposes of regulating the supervision and administration of health quarantine for special goods and articles entering and exiting China, preventing the cross-border transmission of infectious diseases, safeguarding the life and health of the public, and preventing and mitigating public health risks.

Article 2 These Provisions apply to the supervision and administration of health quarantine for special goods and articles entering and exiting China that are related to public health safety, including human tissues such as blood, pathogenic microorganisms, and biological products, excluding those regulated as pharmaceuticals, veterinary drugs, or medical devices.

Article 3 The General Administration of Customs shall be responsible for the unified administration and supervision of health quarantine for special goods and articles entering and exiting China; the competent Customs offices shall be responsible, within their respective jurisdictions, for the administration and supervision of health quarantine for special goods and articles entering and exiting China.

Article 4 The supervision and administration of health quarantine for special goods and articles entering and exiting China shall be conducted in accordance with the principle of risk management and, on the basis of risk assessment, be subject to health quarantine approval, quarantine inspection, and supervision according to the resulting risk levels.

The risk levels of special goods and articles entering and exiting China and the corresponding health quarantine regulatory approaches shall be dynamically adjusted and published by the General Administration of Customs.

Article 5 The General Administration of Customs shall apply health quarantine access control to high-risk special goods and articles entering China for the first time or resuming entry following a suspension. The specific requirements shall be prescribed separately by the General Administration of Customs.

Article 6 An entity engaged in activities involving special goods and articles entering or exiting China, or a consignor, a consignee, a sender or recipient, a person carrying such goods and articles, a carrier, or an agent of any of the foregoing, shall, when engaging in the importation, exportation, production, sale, or use of special goods and articles, comply with the requirements of laws and regulations and relevant standards, be responsible to society and the public, ensure the safety of special goods and articles, accept public supervision, and assume social responsibility.

Chapter II Approval of Health Quarantine Matters

Article 7 Customs offices directly under the General Administration of Customs shall be responsible, within their respective jurisdictions, for the health quarantine approval of special goods and articles entering and exiting China ("approval of special goods and articles").

Article 8 An applicant for the approval of special goods and articles shall satisfy the following conditions:

(1) Where laws and regulations require approvals from relevant departments, the applicant shall have obtained the required approvals.

(2) The applicant shall possess biosafety control capacity commensurate with the special goods and articles entering and exiting China.

Article 9 An entity or natural person engaged in activities involving special goods and articles entering or exiting China (collectively, "applicant") shall, before the commencement of shipment of such special goods and articles, apply for approval to the Customs District at the place where the applicant is located.

Article 10 An applicant applying for the approval of special goods and articles shall, in accordance with the applicable provisions, submit the following relevant materials:

(1) An application form for the approval of special goods and articles.

(2) Descriptive materials for special goods and articles entering and exiting China (including their Chinese and English names, categories, components, sources, manufacturing processes, intended uses, intended distribution, countries or regions of export and import, manufacturers, and other relevant information), product safety certificates, and biosafety risk self-assessment materials.

(3) Where special goods and articles entering and exiting China contain or may contain pathogenic microorganisms, supporting documents shall be provided specifying the scientific names of the pathogenic microorganisms (in Chinese, English, or Latin, as applicable), explanatory documents on their biological characteristics (in both Chinese and English), and documents evidencing the corresponding biosafety control levels.

(4) Where an entity using special goods and articles entering and exiting China that contain or may contain pathogenic microorganisms conducts pathogenic microorganism experimental activities in biosafety level 1 or level 2 laboratories, the applicant shall provide laboratory filing materials filed with the health department of a people's government at the districted city level; where such experimental activities are conducted in biosafety level 3 or level 4 laboratories, the applicant shall provide documents evidencing approval of experimental activities involving highly pathogenic microorganisms by the health departments of the people's government at or above the provincial level.

(5) Where highly pathogenic microorganism strains or samples entering or exiting China are involved, the applicant shall provide transport-related supporting documents approved by the health departments of the people's government at or above the provincial level.

Article 11 Where the applicant is an entity, upon applying for the approval of special goods and articles for the first time, the applicant shall, in addition to the materials specified in Article 10, submit the following materials as required by the Customs:

(1) Basic particulars of the entity, including the status of the entity's management system certifications, the entity's address, production sites, laboratory setups, storage facilities and equipment, product processing information, manufacturing processes or process flows, layout plans, and other relevant information.

(2) Materials evidencing biosafety control capabilities.

Where the applicant is a natural person, identity documents shall be provided.

An applicant for pathogenic microorganisms entering or exiting China, or for special goods and articles that may contain pathogenic microorganisms, shall not be a natural person.

Article 12 The Customs District shall, in the following circumstances, process an application for the approval of special goods and articles submitted by an applicant:

(1) Where the application does not, under applicable laws, require the approval of special goods and articles, the applicant shall be notified immediately that the application shall not be accepted.

(2) Where, under applicable laws, the application does not fall within the authority of the Customs District, it shall make a decision immediately not to accept the application, and advise the applicant to apply to another Customs District or to the relevant administrative authority.

(3) Where the application materials contain errors that can be corrected on the spot, the applicant shall be permitted to correct them on the spot.

(4) Where the application materials are incomplete or do not conform to the statutory form, the Customs District shall notify the applicant, on the spot or, in a single notice, within five working days, of all contents requiring supplementation; where such notification is not provided within the prescribed time limit, the application shall be deemed accepted as of the date on which the application materials are received.

(5) Where the application falls within the authority of the Customs District and the application materials are complete and conform to the statutory form, or where the applicant has submitted all supplemented materials as required by the Customs District, the application for an administrative license shall be accepted.

Article 13 The Customs District shall examine the application materials. Where appropriate, the Customs District may verify the application materials by means of expert documentary review, on-site assessment, or other methods.

Article 14 Where an applicant's application meets the statutory conditions and standards, the Customs District shall, within 20 working days from the date of acceptance, issue an approval document for special goods and articles.

Where an applicant's application does not meet the statutory conditions and standards, the Customs District shall, within 20 working days from the date of acceptance, make a written decision not to approve the application, state the reasons therefor, and inform the applicant of the right, in accordance with the law, to apply for administrative reconsideration or to file an administrative lawsuit.

Where the Customs District is unable to make a decision to approve or not to approve the application within 20 working days, the time limit may, upon approval by the head of the Customs District, be extended by ten working days, and the reasons for the extension shall be notified to the applicant.

Article 15 The validity period of an approval document for special goods and articles shall be determined based on the risk profile and shall not exceed twelve months.

The Customs shall implement verification and write-off administration with respect to approval documents for special goods and articles.

Chapter III Quarantine Inspection

Article 16 A consignor, a consignee, a sender or recipient, a person carrying special goods or articles entering or exiting China, a carrier, or an agent of any of the foregoing shall make a declaration to the Customs upon presentation of the approval document for special goods and articles and other required materials. The Customs shall conduct verification of the approval document for special goods and articles and other relevant documents by cross-checking. Where the declaration materials are incomplete or do not conform to the statutory form, the Customs shall not permit the entry or exit of such goods or articles.

For special goods and articles exiting China, an application for quarantine shall be submitted to the Customs at the place of production or at the place where the applicant is located.

Article 17 The Customs shall, in accordance with the following requirements, conduct quarantine inspection of special goods and articles entering or exiting China and complete quarantine inspection records:

(1) Verifying that the name, components, batch number, specifications, quantity, validity period, transportation and storage conditions, exporting or importing country, manufacturer, and other relevant particulars of special goods and articles entering or exiting China are consistent with the contents of the approval document for special goods and articles.

(2) Inspecting whether the packaging of special goods and articles entering or exiting China is secure and free from damage and leakage or seepage, and, where biosafety risks are involved, whether the packaging bears biosafety labels that comply with relevant requirements.

Where the inspection site at the port of entry lacks the necessary safety protection conditions for conducting quarantine inspection of special goods or articles, such goods or articles shall be transported to a designated site that meets the relevant requirements for quarantine inspection.

For special goods or articles entering China that contain highly pathogenic microorganisms, the Customs District at the destination shall, in a timely manner, notify the health department of the people's government at the place where the entity using such goods or articles is located.

Article 18 Where a person carries special goods or articles entering or exiting China without having obtained the approval document for special goods and articles, the Customs shall temporarily deny clearance and issue relevant written documentation therefor.

Where the person carrying such goods or articles obtains the approval document for special goods and articles within seven days, the Customs shall, in accordance with Article 17 of these Provisions, conduct quarantine inspection, and shall grant clearance upon the goods or articles passing such quarantine inspection.

Article 19 The Customs shall grant clearance to special goods and articles entering or exiting China that pass quarantine inspection. Under any of the following circumstances, special goods and articles exiting China shall not be permitted to exit, and special goods and articles entering China shall be returned or destroyed in accordance with the law, and shall be subject to supervision by the Customs:

(1) The name, batch number, bioactive components, specifications, manufacturer, or other relevant particulars do not match the contents of the approval document for special goods and articles.

(2) The approval document for special goods and articles has not been obtained, or the quantity exceeds the approved quantity.

(3) The packaging fails to meet the safety management requirements for special goods and articles.

(4) Other circumstances in which the goods or articles fail to pass quarantine inspection.

Where special goods or articles entering China would pose public health risks if returned due to packaging damage, leakage, or seepage, they shall be destroyed in accordance with the law, subject to supervision by the Customs.

Chapter IV Supervision and Administration

Article 20 An entity engaged in activities involving special goods and articles entering or exiting China shall establish a biosafety management system for such goods and articles, and shall produce, sell, and use such goods and articles strictly according to the approved purposes.

An entity engaged in activities involving special goods and articles entering or exiting China shall establish records of the production, sale, and use of such goods and articles. Such records shall be true and accurate and shall be retained for a period of not less than three years.

Article 21 The Customs shall conduct biosafety risk monitoring of special goods and articles entering or exiting China that may pose risks to public health safety within the territory of China.

For special goods and articles entering or exiting China, whose samples need to be collected for testing due to biosafety risk monitoring, an entity engaged in activities involving special goods and articles entering or exiting China shall cooperate in sample collection, as required by the Customs.

Article 22 The Customs shall, according to the approval document for special goods and articles, supervise and administer the production, sale, and use of special goods and articles by an entity engaged in activities involving special goods and articles entering or exiting China.

Where any of the following circumstances is discovered in the course of supervision and administration, the special goods and articles shall be returned or destroyed in accordance with the law, subject to supervision by the Customs:

(1) The laboratory using the special goods and articles is inconsistent with that specified in the approval document for special goods and articles, except as approved by the Customs.

(2) There is an inconsistency between special goods and articles entering China and the approval document for special goods and articles.

Article 23 Customs officers shall enforce the law impartially and perform their duties faithfully, and shall be obligated to maintain confidentiality with respect to commercial secrets, personal privacy, and personal information that they become aware of in the course of performing their duties.

Chapter V Legal Liability

Article 24 Whoever, in violation of these Provisions, commits any of the following acts shall be fined not more than 100,000 yuan by the Customs:

(1) Obtaining the approval document for special goods and articles by fraud, bribery, or other improper means.

(2) Selling or using special goods and articles without the consent of the Customs.

(3) Failing to return or destroy special goods and articles as required by these Provisions.

(4) Failing to handle special goods and articles in laboratories of the corresponding biosafety level.

(5) Failing to establish records of the production, sale, or use of special goods and articles, or maintaining records that are inconsistent with actual conditions.

Article 25 Whoever, in violation of these Provisions, refuses to cooperate with or obstructs the Customs or its officers in the lawful performance of their duties shall be transferred to the relevant authorities for disposition in accordance with the law.

Article 26 Where a Customs officer practices favoritism, abuses power, commits dereliction of duty, or otherwise violates relevant laws and regulations, the Customs officer shall be subject to disciplinary sanctions in accordance with the law; where the circumstances are serious and a crime is constituted, the violator shall be held criminally liable in accordance with the law.

Article 27 Where a violation of these Provisions constitutes a crime, the violator shall be held criminally liable in accordance with the law.

Chapter VI Supplemental Provisions

Article 28 As used in these Provisions, the following terms shall have the following meanings:

The term "human tissues such as blood" means human whole blood, plasma, serum, other blood components, cells, cell lines, embryos, organs, tissues, and bone marrow, as well as other secretions, excretions, and bodily fluids that may transmit infectious diseases, including cerebrospinal fluid, pleural fluid, and peritoneal fluid.

The term "pathogenic microorganisms" means microorganisms that may invade the human body and cause infection and, in some cases, infectious diseases, including viruses, bacteria, fungi, actinomycetes, rickettsiae, spirochetes, chlamydiae, mycoplasmas, prions, and parasites.

The term "biological products" means biologically active agents derived from humans or used in human medicine or related fields, including proteins, cytokines, enzymes and their preparations, toxins, antigens, antibodies, antigen-antibody complexes, nucleic acids, and other biotechnology products.

The term “entity engaged in activities involving special goods and articles entering or exiting China” means a legal person or other organization that engages in the production, sale, or use (including scientific research, medical treatment, testing, and pharmaceutical research and development outsourcing) of such special goods and articles.

Article 29 Where special goods or articles entering or exiting China are subject to other regulatory requirements, including animal and plant quarantine, such matters shall be governed by the relevant laws and regulations.

Article 30 These Provisions shall be subject to interpretation by the General Administration of Customs.

Article 31 These Provisions take effect on August 1, 2026, upon which the Provisions on the Administration of Health Quarantine for Special Articles Entering or Exiting China, as issued by Order No. 160 of the former General Administration of Quality Supervision, Inspection and Quarantine on January 21, 2015, and as amended by Order No. 184 of the former General Administration of Quality Supervision, Inspection and Quarantine on October 18, 2016, Order No. 238 of the General Administration of Customs on April 28, 2018, Order No. 240 of the General Administration of Customs on May 29, 2018, and Order No. 243 of the General Administration of Customs on November 23, 2018, shall be repealed.