The General Administration of Customs can assess the biological safety control system of the exporting country or region. Article V entry and exit of special items of cargo owners or their agents, should be in accordance with the provisions of laws and regulations and the requirements of the relevant standards, import, export, as well as the production, operation and use of special items, the community and the public is responsible for ensuring the safety of special items, to accept social supervision and social responsibility. Chapter II Quarantine Approval Article 6 The Customs directly under the jurisdiction of the Customs is responsible for the entry and exit of special items of health quarantine approval (hereinafter referred to as special items approval). Article VII application for approval of special items should have the following conditions:
(a) laws and regulations shall be required to obtain the approval of the relevant departments, should obtain the appropriate approval documents;
(b) with the entry and exit of special items with the appropriate biosafety control capabilities. Article 8 The owner of the entry of special articles or his agent shall apply for approval of special articles to the Customs directly under the destination before the delivery of special articles.
The owner of the outbound special articles or his agent shall apply for approval of special articles to the Customs directly under the location of the special articles before delivery. Article 9 To apply for approval of special articles, the owner of the goods or his agent shall provide the appropriate materials in accordance with the following provisions:
(1) "Entry/Exit Application Form for Sanitary and Quarantine Approval of Special Articles";
(2) entry and exit of special articles descriptive materials, including the name of the special articles in English and Chinese, category, composition, source, use, main sales channels, export and import countries or regions, manufacturers, etc.;
(3) the Customs shall apply for approval of special articles before delivery to the Customs directly under its seat. region, manufacturer, etc.
(3) For entry and exit of human blood, plasma, tissues, organs, cells, bone marrow, etc., the approval documents of the competent health department shall be provided;
(4) For entry and exit of human tissues, cells, organs, bone marrow for transplantation, the health certificate of the donor issued by the medical institution and the relevant inspection report shall be provided;
(5) For entry of special articles used for Prevention, diagnosis, treatment of human diseases, biological products, human blood products, should provide the State Council Drug Administration issued a certificate of registration of imported drugs;
(f) entry and exit of special items contain or may contain pathogenic micro-organisms, should be provided with the scientific name of the pathogenic micro-organisms (in Chinese and Latin), the biological characteristics of the illustrative documents (in Chinese and English) and Producers or users with the appropriate level of biosafety prevention and control documents;
(vii) exit for the prevention, diagnosis, treatment of human diseases, biological products, human blood products, should be provided with drug supervision and management departments issued by the sales certificate;
(viii) exit of special items related to the management of human genetic resources in the scope of the human genetics resource management should be provided with the approval documents issued by the department of human genetics resource management;
(h) the special items involving human genetics resource management category should be provided with the approval documents. (ix) the use of special items that contain or may contain pathogenic microorganisms of the entry and exit of the unit, should provide biosafety laboratory qualification certificates appropriate to the level of biosafety risk, BSL-3 level or above, the laboratory must be recognized by the national accreditation body;
(x) the entry and exit of highly pathogenic microorganisms strains (viruses) or samples, should provide the people's government at or above the provincial level. samples, shall provide the approval documents of the competent health department of the people's government at or above the provincial level. Article 10 The applicant is a unit, the first application for approval of special items, in addition to providing the materials specified in Article IX of these provisions, but also shall provide the following materials:
(a) unit business license and other copies of documents, while the original is submitted for inspection;
(b) the unit's basic information, such as the unit's management system certification, the unit's address, production sites, laboratory setup, storage facilities and equipment, product processing, production process, and the basic conditions. Equipment, product processing, production process or process flow, floor plan, etc.;
(c) biosafety system documents, such as special items storage management system, use of the management system, waste disposal management system, management system for professionals, emergency response protocols.
If the applicant is a natural person, a copy of the ID card should be provided, while the original is submitted.
Immigration of pathogenic microorganisms or special items that may contain pathogenic microorganisms, the applicant shall not be a natural person. Article XI directly under the Customs and Excise Department on the applicant's application for approval of special items, shall be dealt with in accordance with the following:
(a) the application does not need to obtain approval of special items, the applicant shall be immediately informed of the inadmissibility of the application;
(b) the application does not fall within the purview of the unit, it shall be immediate inadmissibility of the decision, and inform the applicant To the relevant administrative organs or other Customs applications directly under the Customs;
(C) application materials can be corrected on the spot, there are errors, the applicant should be allowed to correct on the spot;
(D) application materials are incomplete or do not comply with the statutory form, it should be on the spot or from the date of receipt of the application materials within five days of the date of the application to inform the applicant needs to make corrections to the full content. Late notification, from the date of receipt of the application materials shall be accepted;
(e) the application belongs to the terms of reference of the unit, the application materials are complete, meet the statutory form, or the applicant in accordance with the unit's requirements to submit all the corrective application materials, the application for administrative licensing shall be accepted.