The State Administration of Quality Supervision, Inspection and Quarantine of the exporting country or region can assess the biosafety control system. 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, and 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 VI Inspection and Quarantine Bureau directly under the jurisdiction of the entry and exit of special items of health quarantine approval (hereinafter referred to as special items for approval) work. Article VII application for approval of special items should have the following conditions:
(a) laws and regulations shall be approved by the relevant departments, should be approved by the appropriate documents;
(b) with the entry and exit of special items compatible with the biosafety control capabilities. Article VIII of the entry of special items of cargo owners or their agents should be in special items before delivery to the destination directly under the Inspection and Quarantine Bureau to apply for special items for approval.
Outbound special items of the owner or his agent shall be in special items before delivery to its location directly under the Inspection and Quarantine Bureau to apply for special items for approval. Article IX application for approval of special items, the owner or his agent shall provide the appropriate materials in accordance with the following provisions:
(a) "inbound / outbound special items of health and quarantine approval application form";
(b) entry and exit of special items of descriptive materials, including special items of the English and Chinese name, category, composition, source, use, the main channels of sale, the export of the imported countries or 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, shall also provide the following materials:
(a) unit business license, organization code certificate and other copies of the documents, while submitting the originals;
(b) the unit's basic information, such as the unit's management system certification status, the unit's address, the production site, Laboratory settings, storage facilities and equipment, product processing, production process or process flow, floor plans, 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.