Measures for the Administration of Health and Quarantine Access for High-risk Special Items
GACC
December 26, 2023
Measures for the Administration of Health and Quarantine Access for High-risk Special Items
Chapter I: General Provisions
Article 1: These Measures are formulated on the basis of the "Biosecurity Law of the People's Republic of China", the "Frontier Health and Quarantine Law of the People's Republic of China" and its implementation rules, the "Provisions on the Administration of Health and Quarantine of Special Items Entering and Exiting Territory", and other laws and regulations, so as to prevent and respond to biosecurity risks for special items entering the country.
Article 2 These Measures shall apply to the administration of health and quarantine access of high-risk special articles entering the country for the first time or resuming entry after suspension, unless otherwise provided by the State.
Article 3 The management of health and quarantine access for high-risk special items adheres to the principles of risk prevention, classified management, and openness and transparency.
Article 4 The General Administration of Customs shall uniformly manage the health and quarantine access of high-risk special articles.
Article 5 The General Administration of Customs shall be responsible for formulating and promulgating the List of High-Risk Special Items for the Implementation of Access Administration (hereinafter referred to as the "Access Management List") and shall make dynamic adjustments.
Article 6 High-risk special items included in the "Access Management List" shall obtain access qualifications before going through the examination and approval of entry health quarantine.
Article 7 Customs shall use information technology to enhance the level of access management of high-risk special items.
Chapter II: Access Conditions and Procedures
Article 8 The high-risk special articles applying for access shall comply with the laws and regulations of China, and shall also comply with the requirements of international treaties and agreements concluded or acceded to if there are special requirements.
Article 9 The applicant shall designate an agent within the territory of China to handle matters related to the access of high-risk special items. The agent shall hold the applicant's proof of entrustment and perform the applicant's obligations.
Neither the applicant nor the agent shall be a natural person.
Article 10 After the implementation of these Measures, the applicant shall apply to the General Administration of Customs for the first time to export high-risk special articles listed in the "Access Management Directory" to China and submit the following application materials:
(1) Application form for access to high-risk special items;
(2) The applicant's legal production and operation certificate, such as the business license issued by the competent department of the country (region);
(3) Product manuals, safety data sheets, or other supporting materials containing biosafety information for high-risk special items for which access is being applied. For high-risk special items that have been marketed overseas, relevant supporting materials such as listing or sales shall be provided.
Article 11 The General Administration of Customs shall issue an assessment questionnaire to the applicant. Applicants should provide feedback on the assessment questionnaire within 6 months and attach the documents required by the questionnaire.
Article 12 The application materials, assessment questionnaire and documents and materials required by the accompanying questionnaire (hereinafter collectively referred to as the admission materials) shall be expressed in Chinese. Where the original admission materials are in a foreign language, a Chinese translation shall be provided.
The applicant is responsible for the authenticity, completeness and validity of the admission materials.
If the admission materials do not meet the requirements, the applicant may modify or supplement the relevant materials.
Article 13 The General Administration of Customs shall organize experts to carry out access assessment through data review, on-site inspection, video inspection and other forms and combinations.
The admission assessment includes:
(1) The biosecurity status of the applicant and the country (region) where they are located;
(2) The biosecurity management system and operation of the applicant and the country (region) where they are located;
(3) The biosecurity risk characteristics of high-risk special items;
(4) The biosecurity risks and historical compliance of high-risk special items in areas such as the production, preservation, storage, packaging, transportation, sales, use, import, and export of high-risk special items;
(5) Other biosecurity risks related to high-risk special items.
The applicant shall provide the necessary assistance for the admission assessment. During the admission assessment process, the General Administration of Customs may, as needed, require the applicant to provide necessary supplementary materials.
Article 14 Under any of the following circumstances, the General Administration of Customs shall terminate the admission assessment and notify the applicant:
(1) The applicant does not give feedback within 6 months from the date of receipt of the assessment questionnaire;
(2) The applicant fails to provide the required materials within 3 months from the date of receipt of the notice of the General Administration of Customs requesting supplementary materials;
(3) The applicant does not cooperate with the completion of the on-site inspection or video inspection;
(4) The applicant takes the initiative to apply for termination of the admission assessment;
(5) Other circumstances that require termination.
In the circumstances of items 1 and 2 of the preceding paragraph, where the applicant applies for an extension for reasonable reasons, the relevant materials shall be submitted in accordance with the time limit re-determined by the General Administration of Customs with the consent of the General Administration of Customs.
Article 15 After the completion of the access assessment, the General Administration of Customs shall inform the applicant of the results of the access risk assessment. If rectification is required, the General Administration of Customs shall also notify the rectification matters.
The applicant shall submit a rectification report to the General Administration of Customs within the prescribed time limit. The General Administration of Customs shall review the rectification situation and notify the results of the review.
Article 16 The General Administration of Customs shall decide whether to grant access qualifications based on the results of the access assessment. For high-risk special items that have obtained access qualifications, the General Administration of Customs will give the corresponding high-risk special items and their applicants' access numbers, and include them in the List of High-risk Special Items Eligible for Access (hereinafter referred to as the "Access List"), and the access qualifications will be valid for 5 years.
The Access List is promulgated by the General Administration of Customs and dynamically adjusted.
For high-risk special items that have obtained access qualifications, units with import needs may apply to the Customs for health quarantine approval with the corresponding access number, and the Customs will verify and verify the access results when accepting the health quarantine approval.
Chapter III: Dynamic Management
Article 17 In any of the following circumstances, the General Administration of Customs shall conduct a retrospective review:
(1) A biosecurity incident occurs in the country (region) where the applicant for high-risk special items has obtained access qualifications, which might impact the biosecurity of the high-risk special items entering the country;
(2) There are major changes in the biosecurity management system of the applicant for high-risk special items or the country (region) where they are located, which might impact the biosecurity of high-risk special items entering the country;
(3) It is discovered that there might be a serious biosecurity risk for high-risk special items entering the country;
(4) Changes in our nation's biosecurity laws and regulations, and so forth, that put forward higher or special requirements for the biosecurity of high-risk special items entering the country;
(5) Other situations where a retrospective review is required.
Article 18 If there is a change in the access information of high-risk special items during the validity period of the access qualifications, the applicant shall handle it in a timely manner in accordance with the following methods:
(1) Where there are major changes in the production process or production environment of high-risk special items, a new application for access shall be made through the access application channel;
(2) Where the description of high-risk special items adds content related to safety risks, changes in the name or legal representative of the applicant, the name of the high-risk special items or the content of the packaging label, etc., and changes in the information directly related to the biosecurity of high-risk special items in the access materials, the General Administration of Customs shall submit to the General Administration of Customs a comparison table of information on changes in access matters and supporting materials related to the change of information to apply for changes. The General Administration of Customs shall conduct an assessment of the changes and make changes if the assessment finds that they should be changed, and if the assessment finds that they should not be changed, they may re-apply for access through the access application channel;
(3) If there is any change in the applicant's contact information, agent entity, and other information in the access materials, the changed information shall be submitted, and the change shall be made after confirmation by the General Administration of Customs.
Article 19 Where access to high-risk special items needs to be renewed, an application for renewal of access shall be submitted to the General Administration of Customs within 3 to 6 months before the expiration of the validity period of access.
The application materials for renewal of admission include:
(1) Application form for continued access to high-risk special items;
(2) A statement of commitment to continue to meet the access requirements.
The General Administration of Customs (GACC) will renew the access qualifications for high-risk special items that meet the access requirements, extend the validity period by 5 years, and may carry out retrospective reviews as needed.
Article 20 In any of the following circumstances, the General Administration of Customs shall, in accordance with laws and regulations, adopt control measures to suspend the entry of the relevant high-risk special items and make them public:
(1) A major biosecurity incident occurs in the applicant or the country (region) where the applicant is located, which might cause a biosecurity risk for high-risk special items entering the country;
(2) High-risk special items are found to not meet the access requirements;
(3) Failing to submit materials in a timely manner to apply for changes as required.
If it is necessary to resume the export of high-risk special items to China, the applicant shall submit an application to the General Administration of Customs and provide a rectification report according to the reason for the suspension. The General Administration of Customs shall assess the rectification situation, and if the requirements are met, the suspension of entry may be lifted.
Article 21 In any of the following circumstances, the General Administration of Customs shall remove the high-risk special items that have obtained access qualifications from the Access List and publish them:
(1) Where there are non-conforming situations for high-risk special items entering the country due to the applicant's reasons, causing biosecurity hazards;
(2) There is a serious biosecurity risk for high-risk special items entering the country due to the applicant's reasons;
(3) Where the validity period of access has expired, and no application has been made for the renewal of the access qualifications, or the application has not been obtained for the renewal of the access qualifications;
(4) The applicant's qualifications as entities are terminated in accordance with law;
(5) Other situations that shall be transferred.
If the applicant or agent deliberately provides false materials or obtains access qualification by other fraudulent means, the General Administration of Customs will remove the high-risk special items that have obtained the access qualification from the Access List, and will not accept the application for access of the high-risk special items of the applicant or agent for three years.
Article 22 The General Administration of Customs may, in accordance with the needs of risk management, require the entry of high-risk special goods from designated ports.
Chapter IV: Supplementary Provisions
Article 23 For the purposes of these Measures, "high-risk special items" refer to special items that contain or may contain pathogenic microorganisms and have the risk of transmission of infectious diseases.
For the purposes of these Measures, "applicant" refers to an overseas production and preservation entity that applies for the export of high-risk special items within the territory of China.
Article 24: For humanitarian purposes, life-saving and wounded-up purposes, the entry and exit of special blood for patients and urgently needed clinical needs shall be implemented in accordance with relevant provisions.
Article 25 Where the General Administration of Customs and the competent authority of the country (region) where the applicant is located sign a protocol, the relevant protocol shall be followed.
Article 26 Where the access materials involve commercial secrets, undisclosed information or confidential commercial information, the Customs shall bear the obligation of confidentiality in accordance with the relevant provisions of the State.
Article 27 The General Administration of Customs shall be responsible for the interpretation of these Measures.
Article 28: These Measures shall establish a one-year transition period from the date of implementation. During the transition period, before the high-risk special items included in the "Access Management List" are eligible for access, they can directly go through the entry health and quarantine approval procedures in accordance with the current regulations of the Customs.
Article 29: These Measures take effect on January 1, 2025.
List of high-risk special items subject to access management
| NO. |
Inspection and quarantine code |
Name of inspection and quarantine |
|
1 |
3002909001410 |
Human blood (whole human blood commercialized containing Class III pathogenic microorganisms in the List of Human-to-Human Pathogenic Microorganisms) |
|
2 |
3002909001411 |
Human blood (whole human blood commercialized containing Class 4 pathogenic microorganisms in the List of Human-to-Human Pathogenic Microorganisms) |
|
3 |
3002909001412 |
Human blood (commercialized human whole blood screened negative for blood-borne pathogens) |
Remark:
1. The above are the first batch of high-risk special items to be included in the List of High-risk Special Items for the Implementation of Access Management, and the General Administration of Customs will dynamically adjust the list according to the actual situation.
2. The products included in the List of High-Risk Special Items for Access Management do not include human blood, plasma, tissues, organs, cells, bone marrow, etc., imported for clinical treatment.
