Provisions on the Administration of the Health and Quarantine of Entry/Exit Special Articles (2018 Third Amendment)

Provisions on the Administration of the Health and Quarantine of Entry/Exit Special Articles (2018 Third Amendment) Provisions on the Administration of the Health and Quarantine of Entry/Exit Special Articles (Promulgated by the Order No. 160 of the General Administration of Quality Supervision, Inspection and Quarantine on January 25, 2015; amended for the first time in accordance with the Decision of the Decision of the General Administration of Quality Supervision, Inspection and Quarantine on Amending and Repealing Some Rules by the Order No. 184 of the General Administration of Quality Supervision, Inspection and Quarantine on October 18, 2016; amended for the second time in accordance with the Decision of the General Administration of Customs to Amend Some Rules by the Order No. 238 of the Generation Administration of Customs on April 28, 2018; amended for the third time in accordance with the Decision of the General Administration of Customs to Amend Some Rules by the Order No. 240 of the Generation Administration of Customs on May 29, 2018; amended for the fourth time in accordance with the Decision of the General Administration of Customs to Amend Some Rules by the Order No. 240 of the Generation Administration of Customs on May 29, 2018) Chapter I General Provisions Article 1 To regulate the supervision and administration of the health and quarantine of entry/exit special articles, prevent the introduction and spreading of infectious diseases, prevent and control bio-safety risks, and protect human health, these Provisions are developed in accordance with the Frontier Health and Quarantine Law of the People's Republic of China and the Detailed Rules for the Implementation thereof, the Regulation on the Prevention and Treatment of HIV/AIDS , the Regulation on the Bio-safety Management of Pathogenic Microorganism Laboratories , the Interim Measures for the Administration of Human Genetic Resources, and other relevant laws and regulations. Article 2 These Provisions shall apply to the supervision and administration of health and quarantine of entry/exit microorganisms, human tissues, biological products, blood and its products, and other special articles. Article 3 The General Administration of Customs shall uniformly conduct the supervision and administration of the health and quarantine of entry/exit special articles across the country; and the competent customs offices shall conduct the supervision and administration of the health and quarantine of entry/exit special articles within their respective jurisdictions. Article 4 The supervision and administration of the health and quarantine of entry/exit special articles shall follow the principle of risk management and the quarantine approval, quarantine inspection, and supervision and administration shall be implemented on the basis of risk assessment and according to risk levels. The General Administration of Customs may assess the bio-safety control system of the export country or region. Article 5 The consigner of the entry/exit special articles or its agent shall, in accordance with the laws and regulations and the relevant standards, import, export, produce, operate, and use the special articles, be accountable to the society and the general public, guarantee the safety of the special articles, accept social supervision, and assume social responsibilities. Chapter II Quarantine Approval Article 6 The customs offices directly under the General Administration of Customs shall be responsible for the approval of health and quarantine of entry/exit special articles within their respective jurisdictions (hereinafter referred to as the “approval of special articles”). Article 7 To apply for the approval of special articles, the applicant shall meet the following conditions: (1) Where it is provided in laws and regulations that the applicant must obtain the approval documents of the relevant authorities, the applicant shall obtain corresponding approval documents. (2) The applicant shall have bio-safety control capabilities that are consistent with such entry/exit special articles. Article 8 The consigner of the entry special articles or its agent shall file an application for the approval of special articles with the customs offices directly under the General Administration of Customs at the destination before delivering the special articles for shipment. The consigner of the exit special articles or its agent shall file an application for the approval of special articles with the local customs offices directly under the General Administration of Customs before delivering the special articles for shipment. Article 9 To apply for the approval of special articles, the consigner of such special articles or its agent shall submit the following materials in accordance with the relevant provisions: (1) The Application Form for the Approval of Health and Quarantine of Entry/Exit Special Articles shall be provided. (2) The descriptive documents of entry/exit special articles, including the Chinese and English names, categories, components, sources, purposes, main sale channels, export/import countries or regions, and manufacturers of such special articles, shall be provided. (3) For entry biological products and human blood products that are used for preventing, diagnosing, and treating human diseases, the registration certificates for imported drugs issued by the drug supervision and administration department of the State Council shall be provided. (4) For entry/exit special articles that contain or are likely to contain pathogenic microorganisms, the names (both in Chinese and in Latin) of such pathogenic microorganisms, the descriptive documents on the biological characters (with both Chinese and English versions), and the certificates proving that the manufacturer and operator or the user has the corresponding bio-safety prevention and control level shall be provided. (5) For exit biological products and human blood products that are used for preventing, diagnosing, and treating human diseases, the sale certificates issued by the drug supervision and administration departments shall be provided. (6) For exit special articles that are involved in the scope of administration of human genetic resources, the approval documents issued by the administrative departments of human genetic resources shall be obtained, and the Customs will conduct automatic comparative verification of the electronic data on the relevant approval documents.. (7) For entry/exit special articles that contain or are likely to contain pathogenic microorganisms, the entity using them shall provide the qualification certificate for its bio-safety laboratory that is consistent with the bio-safety risk level, and the laboratory at or above the BSL-Grade 3 shall be certified by the state certification organ. (10) For entry/exit highly pathogenic microorganisms (viruses) or their samples, the approval documents of the competent health departments of the people's governments at or above the provincial level shall be provided. Article 10 Where the applicant is an entity, when making application for the approval of special articles for the first time, besides materials as prescribed in Article 9 of these Provisions, the applicant shall provide the following materials: (1) the basic information of the entity, including the management system certification of the entity, the address of the entity, the manufacturing site, the laboratory equipment, the warehousing facilities, the product processing, the manufacturing process or technical process, and the floor plan; or (2) laboratory biosafety qualification certification documents. Where the a......