Article 1 These Provisions are formulated in accordance with the relevant provisions of the Frontier Health and Quarantine Law of People's Republic of China (PRC) and its detailed rules for implementation in order to standardize the supervision and administration of health and quarantine of entry-exit special articles.
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 Quality Supervision, Inspection and Quarantine (hereinafter referred to as AQSIQ) shall be responsible for the supervision and administration of health and quarantine of entry-exit special articles throughout the country. The entry-exit inspection and quarantine institutions established by the AQSIQ (hereinafter referred to as the inspection and quarantine institutions) shall supervise and manage the entry-exit special articles within their jurisdiction.
Article 4 The health and quarantine administration of entry-exit special articles shall implement the system of health and quarantine examination and approval, on-site inspection and follow-up supervision and management.
Article 5 Entry-exit special articles that have obtained the Examination and Approval Form for Health and Quarantine of Entry-exit Special Articles (hereinafter referred to as the Examination and Approval Form for Health and Quarantine) and passed the health and quarantine inspection shall be allowed to enter and leave the country.
Article 6 Entry-exit special articles shall enter and exit through ports designated and announced by AQSIQ.
Chapter II Examination and Approval of Health Quarantine
Article 7 The inspection and quarantine bureau directly under the jurisdiction shall be responsible for the examination and approval of health and quarantine of entry-exit special articles.
Article 8 The consignor or his agent of inbound and outbound special articles shall submit the Application Form for Health and Quarantine Examination and Approval of Inbound and Outbound Special Articles (hereinafter referred to as the Application Form for Examination and Approval) to the inspection and quarantine bureau directly under the entry and exit port before delivery.
The owner or his agent shall fill in the application form for examination and approval according to the classification of entry-exit special articles, and fill in one for each category.
Article 9 To apply for the examination and approval procedures for entry-exit microorganisms, human tissues and blood, the following materials shall be provided:
(a) the entry and exit permit issued by the relevant competent department (original and photocopy);
(two) the scientific name (Chinese and Latin) and biological characteristics (Chinese and English versions) of the pathogenic microorganisms contained in the special articles;
(3) The user shall have a BSL-3 level (P3 level) laboratory, and provide corresponding qualification certificates for entry special articles containing or possibly containing 3-4 level pathogenic microorganisms and entry special articles containing or possibly containing unclassified pathogenic microorganisms;
(4) For special articles for scientific research, the original approval document of scientific research project or the agreement between the applicant of scientific research project and domestic and foreign cooperative institutions (original and photocopy in both Chinese and English) shall be provided;
(five) the organ transplant shall provide the donor health certificate and related inspection report issued by a qualified hospital.
Article 10 To apply for the examination and approval procedures for health quarantine of biological products and blood products, the owner or his agent shall provide the following materials:
(1) For entry biological products and blood products used for treatment, prevention and diagnosis, the import registration certificate issued by the state drug supervision and administration department shall be provided;
(2) For exit biological products and blood products used for treatment, prevention and diagnosis, the Pharmaceutical Sales Certificate issued by the pharmaceutical supervisory and administrative department shall be provided;
(3) For entry-exit biological products and blood products used in other fields, the import approval documents issued by the relevant competent authorities shall be provided.
Article 11 The inspection and quarantine bureau directly under the Central Government shall accept applications with complete application materials and legal forms.
Article 12 The inspection and quarantine bureau directly under the jurisdiction of accepting the application shall make a substantive examination of the application materials and make a decision on whether or not to grant permission within 20 working days. If a decision cannot be made within 20 working days, it may be extended by 65,438+00 working days with the approval of the person in charge, and the applicant shall be informed of the reasons for the extension.
If the license is granted, a "Health and Quarantine Approval Form" shall be issued; If the license is not granted, the reasons shall be explained in writing.
For special articles whose infectivity has not been recognized, the inspection and quarantine bureau directly under it shall report to the AQSIQ for technical analysis. The time required for technical analysis is not counted in the approval period, but the owner or his agent shall be informed in writing.
Article 13 The Examination and Approval Form for Health Quarantine of Entry-Exit Special Articles can only be used once, and the validity period is 90 days.
Article 14 If the transplanted organ fails to go through the health and quarantine examination and approval procedures for special reasons, the inspection and quarantine institution may release it upon entry or exit, and the owner or his agent shall apply for completing the health and quarantine examination and approval procedures within 10 days after release.
Chapter III Health Quarantine
Article 15 After the entry-exit special articles arrive at the port or before leaving the port, the owner or his agent shall apply to the port inspection and quarantine organ for inspection according to law. In any of the following circumstances, the inspection and quarantine institution shall not accept the inspection:
(a) can not provide the "health and quarantine approval form";
(two) the "health and quarantine approval form" has expired;
(3) Forging or altering relevant documents or certificates;
(four) other do not meet the requirements of inspection and quarantine.
Article 16 The port inspection and quarantine institution that accepts the application for inspection shall conduct on-site inspection of entry-exit special articles in accordance with the following requirements, and fill in the Record of On-site Inspection of Health and Quarantine of Entry-exit Special Articles:
(1) Check whether the names, batch numbers, specifications, quantities, import and export countries and manufacturers of entry-exit special articles are consistent with the contents specified in the approval list;
(two) to check whether the packaging of entry-exit special articles is safe, and whether there is any damage, omission or omission;
(3) When special articles leave the country, the factory inspection report shall be checked, and whether the production records, sources of raw materials and production processes meet the hygiene requirements.
Article 17 With the permission of the port inspection and quarantine organ, the owner or his agent may transport the imported special articles that need sampling inspection to places with storage conditions first, and then move or use them after passing the inspection. If the port inspection and quarantine institution does not have the inspection ability, it shall entrust a laboratory designated by the AQSIQ to conduct inspection.
Article 18. In case of special circumstances, the inspection and quarantine institution shall intercept those who mail or carry special articles for entry and exit without going through the formalities of health and quarantine examination and approval, and require them to go through the formalities of health and quarantine examination and approval in accordance with the provisions of Article 16. Only after passing the quarantine inspection can they be released.
Article 19 The port inspection and quarantine organ shall release the entry-exit special articles that meet the requirements after health and quarantine inspection. If any of the following circumstances is found, a Notice of Inspection and Quarantine Treatment shall be issued and sealed up, returned or destroyed:
(a) the name, batch number, specification and quantity are inconsistent with the contents of the examination and approval;
(two) the packaging or storage conditions do not meet the requirements;
(three) beyond the effective use period;
(four) the inspection does not meet the requirements of health and quarantine;
(five) the intercepted goods are not allowed within 60 days from the date of interception.
The port inspection and quarantine institution shall file the records of the processing results and report to the AQSIQ.
Chapter IV Follow-up Supervision
Article 20 The inspection and quarantine institution shall follow up and supervise the entry special articles that contain or may contain pathogenic microorganisms within its jurisdiction.
Special articles entering the country that need follow-up supervision shall not be used without the consent of the inspection and quarantine institution.
Article 21 The port inspection and quarantine institution shall issue the Transfer List of Inbound Goods for special inbound goods that need to be supervised in different places, and transmit the list to the destination inspection and quarantine institution electronically in time. The user shall declare to the destination inspection and quarantine institution with the Inbound Goods Transshipment Form within 30 days after the entry of special goods, and accept the follow-up supervision.
Twenty-second inspection and quarantine institutions to implement follow-up supervision of special goods entering the country include:
(1) Whether the user that contains or may contain special articles imported by pathogenic microorganisms has a biosafety laboratory of corresponding grade, and laboratories above P3 grade must be approved by a national accreditation body;
(two) whether the operating personnel of the laboratory of the user unit have the corresponding qualifications;
(3) Whether the records of the use of entry special articles are used according to the approved purposes.
Users shall provide instructions for use to the inspection and quarantine institutions in a timely manner.
Article 23 If the inspection and quarantine institution finds that it does not meet the requirements in the follow-up supervision process, it shall order it to make rectification within a time limit and seal up the special articles that have entered the country until the rectification meets the requirements. If it still does not meet the requirements after rectification, it shall be ordered to return or destroy it.
Article 24 The inspection and quarantine institution shall immediately report the problems found in the follow-up supervision to the AQSIQ and notify the inspection and quarantine bureau directly under the original examination and approval.
Chapter V Supplementary Provisions
Twenty-fifth in violation of the provisions of any of the following acts, the inspection and quarantine institutions may give a warning or impose a fine of 5000 yuan:
(1) Concealing or omitting special articles such as microorganisms, human tissues, biological products, blood and its products that are prohibited from being imported;
(2) moving, selling or using special articles without the permission of the inspection and quarantine institution;
(3) Failing to report to the inspection and quarantine institution within the prescribed time limit or refusing to accept the follow-up supervision of health and quarantine of special articles;
(4) Forging or altering quarantine documents.
Twenty-sixth violation of these regulations, causing the spread of quarantine infectious diseases or causing serious danger of the spread of quarantine infectious diseases, shall be investigated for criminal responsibility in accordance with the relevant provisions of the Criminal Law of People's Republic of China (PRC).
Article 27 The meanings of the following terms in these Provisions:
(1) Microorganisms refer to medical microorganisms such as viruses, bacteria, fungi, actinomycetes, rickettsia, spirochetes, chlamydia and mycoplasma;
(2) Human tissues refer to human embryos, organs, tissues, cells, human secretions and excretions;
Biological products refer to bacterial vaccines, viral vaccines, antitoxins, various diagnostic reagents, interferons, hormones, enzymes and their preparations, and other active preparations (toxins, antigens, allergens, monoclonal antibodies, recombinant DNA products, antigen-antibody complexes, immunomodulators, microecological preparations, nucleic acid preparations, etc.). ), and related products prepared from other biological materials;
(4) Blood and its products refer to whole blood, plasma, serum and blood cells, as well as plasma protein components or blood cell components made by blood separation, purification or application of biotechnology.
Article 28 The health and quarantine administration of entry-exit special articles entering and leaving the bonded areas and export processing zones shall be implemented in accordance with these Provisions.
Article 29 The AQSIQ shall be responsible for the interpretation of these Provisions.
Thirtieth these Provisions shall come into force as of June 6, 2006+0.
Legal basis:
Provisions on the administration of health and quarantine of entry-exit special articles
Article 16 The port inspection and quarantine institution that accepts the application for inspection shall conduct on-site inspection of entry-exit special articles in accordance with the following requirements, and fill in the Record of On-site Inspection of Health and Quarantine of Entry-exit Special Articles:
(1) Check whether the names, batch numbers, specifications, quantities, import and export countries and manufacturers of entry-exit special articles are consistent with the contents specified in the approval list;
(two) to check whether the packaging of entry-exit special articles is safe, and whether there is any damage, omission or omission;
(3) When special articles leave the country, the factory inspection report shall be checked, and whether the production records, sources of raw materials and production processes meet the hygiene requirements.