The Administrative Regulations for Health Quarantine on Entry-Exit Special Articles as adopted at the ministerial meeting of the General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China on December 4, 2014, are hereby promulgated and shall enter into force as of March 1, 2015.
 
 
  Chapter I General Provisions
Article 1 For the purpose of standardizing the supervision and administration of health quarantine on entry-exit special articles, preventing the spread of communicable diseases, preventing and controlling biohazards and protecting human health, the present Regulations are formulated in accordance with laws and regulations such as the Frontier Health Quarantine Law of People's Republic of China and its implementation rules, the Regulations on AIDS Prevention and Treatment, the Regulations on Biological Safety Management of Pathogenic Microorganism Laboratory and the Interim Measures for the Administration of Human Genetic Resources.
Article 2 These Regulations apply to the supervision and administration of health quarantine on entry-exit special articles such as microorganisms, human tissues, biological products and human blood and its products.
Article 3 General Administration of Quality Supervision, Inspection and Quarantine of China (hereinafter referred to as AQSIQ) unifies the management of the supervision and administration of health quarantine on entry-exit special articles throughout the country. The entry-exit inspection and quarantine departments established by AQSIQ in all local areas (hereinafter referred to as ‵inspection and quarantine authorities′) are in charge of the supervision and administration of health quarantine on entry-exit special articles within their jurisdictions.
Article 4 The supervision and administration of health quarantine on entry-exit special articles follow the risk management principles. Quarantine approval, quarantine inspection, supervision and administration shall be implemented according to the risk levels identified by risk assessments.
AQSIQ has the right to assess the biological safety control system of special articles exporting countries or regions.
Article 5 Owners of entry-exit special articles or their agents shall import, export, produce, trade and use those special articles in accordance with the requirements of laws, regulations and relevant standards, take responsibility for the society and public, ensure the safety of special articles, accept public supervision and assume social responsibilities.
Chapter II Quarantine Approval
Article 6  Inspection and quarantine bureaus directly under AQSIQ are responsible for entry-exit health quarantine approval of special articles (hereinafter referred to as ‵special articles approval′) within their jurisdictions.
Article 7 The application for special articles approval shall fulfill the following conditions:
1. the corresponding licenses of related departments shall be obtained when required by laws and regulations;
2. the biological safety control capability commensurate with entry-exit special articles shall be possessed.
Article 8 Owners of entry special articles or their agents shall apply to the inspection and quarantine bureaus directly under AQSIQ of destinations for the special articles approval before delivery.
Owners of exit special articles or their agents shall apply to the local inspection and quarantine bureaus directly under AQSIQ for the special articles approval before delivery.
Article 9 Applying for the special articles approval, owners or their agents shall provide the appropriate materials in accordance with the following requirements:
1. Application Form for Health Quarantine Approval on Entry-exit Special Articles;
2. descriptive documents of entry-exit special articles, including names in Chinese and English, categories, ingredients, sources, purposes, main sales channels, entry-exit countries or regions, manufacturers, etc.;
3. for entry human blood, plasma, tissues, organs, cells, marrow, etc., the approval documents issued by health authorities shall be provided;
4. for entry-exit human tissues, cells, organs and marrow for transplantation, donor health certificates and related test reports issued by medical institutions shall be provided;
5. for entry biological products and human blood products used for the prevention, diagnosis and treatment of human diseases, the imported drug license issued by the pharmaceutical supervision and administration department under the State Council shall be provided;
6. for entry-exit special articles that contain or may contain pathogenic microorganisms, descriptive documents of the scientific names of pathogenic microorganisms (both in Chinese and Latin) and biological characteristics thereof (a bilingual Chinese-English version) and supporting documents for producers, traders or users possessing the corresponding capabilities of biohazard prevention and control shall be provided;
7. for exit biological products and human blood products used for the prevention, diagnosis and treatment of human diseases, the sale certificate issued by a pharmaceutical supervision and administration department shall be provided;
8. for exit special articles falling in the scope of human genetic resource management, the approval documents issued by the human genetic resource management department shall be provided;
9. for the entities using the entry-exit special articles that contain or may contain pathogenic microorganisms, the qualifications of bio-safety laboratories fitting with the biohazard levels shall be provided, and the laboratories of BSL-3 and above must be accredited by national accreditation institutions;
10. for entry-exit highly pathogenic bacteria (viruses) or samples, the approval documents issued by health authorities at or above the provincial level shall be provided.
Article 10 For entity applicants, who apply for the special articles approval for the first time, the following materials, in addition to those specified in Article 9 of these Regulations, shall also be provided:
1. copies of entity business license, organization code certificate, etc. The originals shall also be handed over for inspection in the meantime;
2. basic information of the entity such as management system certifications, addresses, production sites, laboratory settings, warehousing facilities and equipment, product processing, production process or technical process and floor plans;
3. biological safety system documentation such as storage of special articles, management of using of special articles, waste management, professional management and emergency response procedures, etc.
For a natural person applicant, the copy of ID card shall be provided. The original shall also be handed over for inspection in the meantime.
For entry-exit pathogenic microorganisms and special articles that may contain pathogenic microorganisms, the applicant shall not be a natural person.
Article 11 With Regard to the application submitted by an applicant for the special articles approval, Inspection and quarantine bureaus directly under AQSIQ shall handle it differently in light of the following circumstances:
1. where, in accordance with law, no special articles approval is necessary for the matters which such approval is applied for, it shall directly inform the applicant that such an application is not to be accepted;
2. where, in accordance with law, the matters for which the special articles approval is applied do not fall within the scope of its functions and power, it shall directly make the decision not to accept such an application and inform the applicant of the relevant administrative department or other Inspection and quarantine bureaus directly under AQSIQ to which the application should be submitted;
3. where there are errors in the application materials which can be corrected on the spot, it shall allow the applicant to make the correction on the spot;
4. where the application materials are not complete or not in conformity with the statutory forms, on the spot or within 5 days after the application materials are received, inform the applicant, all at once, of what needs to be supplemented or corrected; and if it fails to do so at the expiration of the time limit, the application shall be deemed to be accepted as of the date it receives the application materials; and
5. where the matters for which the special articles approval is applied for fall within the scope of its functions and power, the application materials are complete and in conformity with the statutory form, or the applicant submits the materials of application which are fully supplemented and corrected as it requires, it shall accept the application for the special articles approval.
Article 12 Inspection and quarantine bureaus directly under AQSIQ shall timely carry out the written review for the materials of an application. And based on actual circumstances, expert material review, site assessment and laboratory testing may be adopted to verify those application materials.
Article 13 Where the application of an applicant is in conformity with the statutory requirements and standards,   inspection and quarantine bureaus directly under AQSIQ shall issue the Approval Certificate for Entry-Exit Health Quarantine on Special Articles (hereinafter referred to as Health Quarantine Approval Certificate on Special Articles) within 20 days from the date it accept the application.
Where the application of an applicant is not in conformity with the statutory requirements and standards,  inspection and quarantine bureaus directly under AQSIQ shall make a written decision on refusing the special articles approval and state the reasons and inform the applicant that he/she has the right, in accordance with law, to apply for administrative reconsideration or to bring an administrative suit.
If inspection and quarantine bureaus directly under AQSIQ cannot issue Health Quarantine Approval Certificate on Special Articles or make a written decision on refusing the special articles approval within 20 days, 10 days may be extended upon approval by the leading member of this administrative organization, and the applicant shall be informed of the reasons for the extension.
The review time for expert material review, site assessment and laboratory testing adopted shall not be counted in the approval period; and the applicant shall be informed in writing of the time required.
Article 14 The period of validity for Health Quarantine Approval Certificate on Special Articles is as follows:
 1. for special articles that contain or may contain highly pathogenic microorganisms, the period of validity is 3 months.
 2. for special articles that contain or may contain other pathogenic microorganisms except for those specified in Article 14. 1 of these regulations, the period of validity is 6 months.
3. for other special articles except for those specified above, the period of validity is 12 months.
 The Health Quarantine Approval Certificate on Special Articles may be written off in batches after verification within the period of validity. Such certificates beyond the period of validity, however, shall be re-applied for.
Chapter III Quarantine Inspection
Article 15 After the entry special articles arriving at the port, owners or their agents shall declare to the port inspection and quarantine authorities using the Health Quarantine Approval Certificate on Special Articles and other materials.
For the exit special articles, owners or their agents shall declare to the local inspection and quarantine authorities before exit using the Health Quarantine Approval Certificate on Special Articles and other materials.
When the declaration materials are not complete or do not conform to legal forms, the inspection and quarantine authorities shall not allow the entry or exit of those special articles.
Article 16 The inspection and quarantine authorities accepting the quarantine declaration shall conduct on-site inspections of the entry-exit special articles in accordance with the following requirements, and fill in On-Site Inspection Record for Health Quarantine on Entry / Exit Special Articles:
1. examine whether the names, ingredients, lot numbers, specifications, quantities, period of validity, storage and transport conditions, entry / exit countries and production factories of the entry-exit special articles are consistent with those listed in Health Quarantine Approval Certificate on Special Articles;
2. examine whether the packages of the entry-exit special articles are safe and free from breaking, leaking and oozing, and whether the special articles considered to be bio-hazardous are using the hazard labels meeting related requirements.
If the inspection site does not have the safety protection conditions required for the inspect on the special articles, such special articles shall be transferred to a designated site that meets the requirements of corresponding bio-safety level to accept inspection.
Article 17 For entry special articles that required laboratory tests, owners or their agents shall store the special articles at the eligible storage site meeting the requirements of port inspection and quarantine authorities; and those special articles shall not be transferred or used before pass though the quarantine inspection, Port inspection and quarantine authorities which do not have testing capabilities shall entrust the laboratory with corresponding qualifications for testing.
For special articles that contain or may contain bio-hazard agents such as pathogenic microorganisms, toxins, etc., the port inspection and quarantine authorities shall transfer related electronic information of those special articles to the inspection and quarantine authorities of destination timely after the on-site inspection. And the inspection and quarantine authorities of destination shall carry out the follow-up supervision.
Article 18 Entry-exit special articles that are posted or carried without Health Quarantine Approval Certificate on Special Articles shall be detained within a 7-day period by the port inspection and quarantine authorities. In this case, the port inspection and quarantine authorities will issue a detainment voucher.
If mailers or carriers submit the Health Quarantine Approval Certificate on Special Articles within the detainment period, the inspection and quarantine authorities shall carry out the inspection on the detained specials articles in accordance with Article 16 of these Regulations. If passing the inspection, those special articles will be released.
Article 19 For the entry-exit blood products or biological products carried for personal-use and used for disease prevention or treatment, no health quarantine approval formalities are required, but related documents issued by hospital shall be shown to the inspection and quarantine authorities during the entry-exit process; and the allowable quantity shall be limited to that needed in one treatment course which determined in prescriptions or usage instructions.
Article 20 If human tissues for transplantation are not with the Health Quarantine Approval Certificate on Special Articles for special reasons during the entry-exit process, the inspection and quarantine authorities will release them after the quarantine inspection. Owners or their agents of those human tissues shall make up the special articles approval formalities within 10 days after those human tissues being released.
Article 21 The port inspection and quarantine authorities will release the entry-exit special articles that meet the requirements of health quarantine. The port inspection and quarantine authorities will issue the Notice on Inspection and Quarantine Treatment and refuse or destroy the goods under any of the following circumstances:
1. the names, lot numbers, specifications, bioactive constituents, etc. of the special articles are not consistent with those listed in the Health Quarantine Approval Certificate on Special Articles;
2. the quantity of special articles exceeds that allowed by the special articles approval;
3. the packing conditions do not meet the safety management requirements of special articles;
4. the goods fail the health quarantine inspection;
5. the posted or carried goods that are detained fail to submit the Health Quarantine Approval Certificate on Special Articles within 7 days since the date of detainment or those goods fail the quarantine inspection after the submission of Health Quarantine Approval Certificate on Special Articles.
The port inspection and quarantine authorities shall record and file the results of quarantine treatments.
Chapter IV Supervision and Administration
Article 22 The entities of entry-exit special articles shall establish the management system of safety of special articles, and produce, use or sell such special articles in strict accordance with the purposes as specified in the quarantine approval.
 The entities of entry-exit special articles shall set up the records of production, use and sales of special articles. Those records shall be true, and the storage life of which shall not be less than 2 years.
Article 23 Inspection and quarantine authorities implement risk management on entry-exit special articles, grade the special articles according to the different risk levels that those entry-exit special articles may transmit human diseases, and take different modes of health quarantine supervision and administration.
The risk levels of entry-exit special articles and the corresponding modes of health quarantine supervision and administration are to be published by AQSIQ.
Article 24 For the entry special articles subject to follow-up supervision, the entity that uses the goods shall make a declaration to the inspection and quarantine authorities at the destination within 30 days after entry and accept the follow-up supervision. Those goods shall not be used without the permission of the inspection and quarantine authorities at the destination.
Article 25 The details subject to the follow-up supervision carried out by the inspection and quarantine authorities on entry special articles shall include:
1. whether the laboratory that used to handle the entry special articles is consistent with that one listed in the Health Quarantine Approval Certificate on Special Articles;
2. whether the entry special articles are consistent with those listed in the Health Quarantine Approval Certificate on Special Articles.
Article 26 If one of the following situations arises during the follow-up supervision, the Health Quarantine Approval Certificate on Special Articles shall be withdrawn by the inspection and quarantine authorities and the goods shall be returned or destroyed:
1.  the laboratory that used to handle the entry special articles is NOT consistent with that one listed in the Health Quarantine Approval Certificate on Special Articles;
2.  the entry special articles are NOT consistent with those listed in the Health Quarantine Approval Certificate on Special Articles;
Inspection and quarantine authorities shall report to the inspection and quarantine bureaus directly under AQSIQ about the issues that discovered in the follow-up supervision. Serious cases shall be timely reported to AQSIQ.
Article 27 Staff in the inspection and quarantine authorities shall enforce laws impartially, be loyal to their duty and be obliged to keep those business secrets that they know from the courses of performing duties.
Chapter V Legal Liabilities
Article 28 In violation of these Regulations, and if one of the following  situations arises,  inspection and quarantine authorities shall give a warning or impose a fine of ￥100 -5,000 in accordance with Article 110 of Rules for the Implementation of Frontier Health and Quarantine Law of the People’s Republic of China:
1. refusing to accept or resist the supervision and administration of health quarantine;
2. counterfeiting or altering the quarantine paper or certificates;
3. concealing the carrying of microorganisms, human tissues, biological products and human blood and its products that are forbidden to import or other animals or goods that may cause the spread of infectious diseases.
Article 29 In violation of these Regulations and, if one of the following situations arises and, moreover, when there are illegal incomes, inspection and quarantine authorities shall impose a fine up to￥30,000:
1. obtaining the special articles approval by improper means such as deception, bribery, etc.;
2. transporting, selling or using special articles without the permission of inspection and quarantine authorities;
3. failing to declare to the inspection and quarantine authorities or providing false materials for defrauding for the inspection and quarantine certificates;
 4. handling the special articles in a laboratory without corresponding bio-safety level or the entity that uses the special articles lacking corresponding bio-safety control capability; failing to set up use records and sales records for special articles or the records failing to reflect the realities;
5. using the entry special articles subject to follow-up supervision without the permission of inspection and quarantine authorities;
6. human tissues for transplantation getting through customs clearance without the Health Quarantine Approval Certificate on Special Articles and, moreover, the owners of them fails to obtain the special articles approval for those human tissues within 10 days after the clearance.
Article 30 Owners or their agents of entry-exit special articles rejecting or hindering the inspection and quarantine authorities and their staff from performing their duties shall be transferred to related departments for dealing with in accordance with the law.
Article 31 Any staff of inspection and quarantine authorities who engages in malpractice for personal benefits, abuse of power and neglect of duty violating relevant laws and regulations shall be given administrative sanctions in accordance with the law; in case of any constituted crimes, the offender shall be investigated for criminal liabilities in accordance with the law.
Article 32 Any one that violates these Regulations causing the spread of any quarantinable diseases or the great risk of transmitting any quarantinable diseases shall be investigated for criminal liabilities in accordance with the Criminal Law of the People's Republic of China.
Chapter VI Supplementary Provisions
Article 33 Definitions of the following terms as used in these Regulations:
The term “microorganism” refers to viruses, bacteria, fungi, actinomyces, rickettsiae, spirochaeta, chlamydiae, mycoplasmas and other medical bacteria (viruses) and samples, parasites, as well as microbial bioremediation agents used for environmental protection;
The term “human tissue” refers to human cells, cell lines, embryos, organs, tissues, marrow, secretion, excrement, etc.;
 The term “human genetic resources” refers to genetic materials and relevant information containing human genomes, genes and their products, such as organs, tissues, cells, blood, preparation, recombinant deoxyribonucleic acid (DNA) .
 The term “biological product” refers to bioactive agents used in related fields of human medicine and life sciences, such as vaccines, antitoxins, reagents for diagnosis, cytokines, enzymes and its preparations, toxins, antigens, allergens, antibodies, antigen-antibody complexes, nucleic acids, immunomodulator and microecologics.
The term “blood” refers to whole blood, plasma components and special blood components of human.
The term “blood products” refers to human plasma protein products.
The term “entry-exit special articles entity” refers to any legal entity and other organizations engaged in the production, use, sales, scientific research, medical treatment, examination and medicine research and development outsourcing of special articles.
Article 34 The supervision and administration of health quarantine on import-export microbial bioremediation agents used for environmental protection shall be carried out in accordance with the Administrative Measures  for Environmental Safety on Import-Export Microbial Bioremediation Agents used for Environmental Protection (Decree No. 10 of Ministry of Environmental Protection and AQSIQ).
Article 35 If animal and plant quarantine required to be conducted on entry-exit special articles shall be carried out in accordance with provisions of laws and regulations of entry-exit animals and plants.
Article 36 The power to interpret these regulations shall remain with AQSIQ.
Article 37 These Regulations shall come into force as of March 1, 2015. And the Administrative Regulations for Entry and Exit Health Quarantine of Special Articles (AQSIQ Decree No. 83) issued by AQSIQ on October 17, 2005 shall be abolished as well.
 
In case of any discrepancies between the Chinese version and the English version, the Chinese version shall prevail.



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