Decree of General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China No. 160
2015-09-07

In case of any discrepancies between the Chinese version and the English version, the Chinese version shall prevail.

 

Decree of General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China

No. 160

 

 

The Administrative Regulations for Entry-Exit Health Quarantine on Special Goods 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.

 

 

Minister:

January 21, 2015


 

ADMINISTRATIVE REGULATIONS FOR ENTRY-EXIT HEALTH QUARANTINE ON SPECIAL GOODS

Chapter I General Provisions

Article 1 For the purpose of standardizing the supervision and administration of entry-exit health quarantine on special goods, preventing the spreading of infectious diseases, preventing and controlling biological safety risks 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 Administrative Regulations for Biological Safety Laboratory of Pathogenic Microorganism and the Interim Measures for the Administration of Human Genetic Resources.

Article 2 These Regulations apply to the supervision and administration of entry-exit health quarantine on special goods such as microorganisms, human tissues, biological products, blood and blood products.

Article 3 General Administration of Quality Supervision, Inspection and Quarantine of China (hereinafter simply referred to as AQSIQ)  unifies the management of the supervision and administration of entry-exit health quarantine on special goods throughout the country. The entry-exit inspection and quarantine departments established by AQSIQ in all local areas (hereinafter simply referred to as inspection and quarantine authorities) are in charge of the supervision and administration of entry-exit health quarantine on special goods within their jurisdictions.

Article 4 The supervision and administration of entry-exit health quarantine on special goods follows the risk management principles. Quarantine approval, quarantine inspection, and supervision and administration shall be implemented according to the risk levels defined by the risk assessment.

AQSIQ has the right to assess the biological safety control system of exporting countries or regions.

Article 5 Owners of entry-exit special goods or their agents shall import, export, produce, trade and use those special goods in accordance with the requirements of laws, regulations and related standards, take responsibility for the society and public, ensure the safety of special goods, 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 goods (hereinafter simply referred to as approval of special goods) within their jurisdictions.

Article 7 The application for special goods approval shall fulfill the following conditions:

1. the corresponding approval documents of related departments shall be obtained when required by laws and regulations;

2. the biological safety control capability commensurate with entry-exit special goods shall be possessed.

Article 8 Owners of entry special goods or their agents shall apply to the inspection and quarantine bureaus directly under AQSIQ of destinations for the approval of special goods before delivery.

Owners of exit special goods or their agents shall apply to the local inspection and quarantine bureaus directly under AQSIQ for the approval of special goods before delivery.

Article 9 When applying for the approval of special goods, owners or their agents shall provide corresponding documents in accordance with the following requirements:

1. Application Form for Entry-exit Health Quarantine Approval of Special Goods;

2. descriptive documents of entry-exit special goods, 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 of 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 and 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 goods 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 capability of biological safety risk prevention and control shall be provided;

7. for exit biological products and 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 goods within the scope of human genetic resource management, the approval documents issued by a human genetic resource management department shall be provided;

9. for the entities using the entry-exit special goods that contain or may contain pathogenic microorganisms, the qualifications of bio-safety laboratories fitting with the biological safety risk 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 of health authorities at or above the provincial level shall be provided.

Article 10 For entity applicants, who apply for the approval of the special goods for the first time, the following documents, 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 an entity such as management system certifications, addresses, production sites, laboratory settings, warehousing facilities and equipment, product processing, production process or technical process and plane graphs;

3. biological safety system documents such as storage of special goods, management of using of special goods, management of waste disposal, management of professionals 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 goods that may contain pathogenic microorganisms, the applicant shall not be a natural person.

Article 11 Inspection and quarantine bureaus directly under AQSIQ shall separately deal with the application of special goods approval proposed by applicants based on the following conditions:

1. for application matters that do not require the approval of special goods in accordance with the law, the applicant shall be immediately notified of rejection for such matters;

2. for application matters that do not fall within the scope of competence of this bureau according to the law, the decisions of rejection shall be immediately made and applicants shall be notified to apply to other related administrative organizations or other inspection and quarantine bureaus directly under AQSIQ;

3. if there are mistakes in the application documents that can be corrected on the spot, the applicants shall be allowed to correct them on the spot;

4. when the application documents are not complete or do not conform to legal forms, the applicant shall be notified of all the contents that need to be supplemented or corrected at a time on the spot or within 5 days after the application documents are received. If the applicant is not notified within the time limit, the application shall be considered accepted since the reception date;

5. when the application falls within the scope of competence of this bureau, the application documents are complete and conform to legal forms, or the applicant has submitted all the application documents supplemented or corrected according to the requirements of this bureau, the administrative licensing application shall be accepted.

Article 12 Inspection and quarantine bureaus directly under AQSIQ shall timely carry out the written review for application documents. And based on actual circumstances, expert material review, site assessment and laboratory testing may be adopted to verify those application documents.

Article 13 When the application conforms to the legal conditions and standards, inspection and quarantine bureaus directly under AQSIQ shall issue the Approval Certificate for Entry-Exit Health Quarantine on Special Goods (hereinafter simply referred to as Health Quarantine Approval Certificate of Special Goods) within 20 days since the date of acceptance.

When the application does not conform to legal conditions and standards, inspection and quarantine bureaus directly under AQSIQ shall make the written decision for disapproval and give reasons within 20 days since the date of acceptance and notify the applicant of the rights to apply for an administrative reconsideration or bring an administrative lawsuit according to law.

If the decision cannot be made by inspection and quarantine bureaus directly under AQSIQ within 20 days, 10 days may be extended upon the approval of the person in charge of this administrative organization, and the applicant shall be notified 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 notified in writing of the time required.

Article 14 The period of validity for Health Quarantine Approval Certificate on Special Goods is as follows:

 

1. for special goods that contain or may contain highly pathogenic microorganisms, the period of validity is 3 months.

 

2. for special goods that contain or may contain other pathogenic microorganisms, the period of validity is 6 months.

 

3. for other special goods except for those specified above, the period of validity is 12 months.

 

The Health Quarantine Approval Certificate on Special Goods 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 arrival of entry special goods at the port, owners or their agents shall declare to the port inspection and quarantine authorities with the Health Quarantine Approval Certificate on Special Goods and other documents.

For the exit special goods, owners or their agents shall declare to the local inspection and quarantine authorities before exit with the Health Quarantine Approval Certificate on Special Goods and other documents.

When the declaration documents 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 goods.

Article 16 The inspection and quarantine authorities accepting the quarantine declaration shall conduct on-site inspections of the entry-exit special goods in accordance with the following requirements, and fill in On-Site Inspection Record for Entry / Exit Health Quarantine on Special Goods:

1. examine whether the names, ingredients, lot numbers, specifications, quantities, period of validity, storage and transportation conditions, entry / exit countries and production factories of the entry-exit special goods are consistent with  those listed in Health Quarantine Approval Certificate on Special Goods;

2. examine whether the packing of the entry-exit special goods is safe and free from damage, leakage and oozing, and whether the special goods with biological safety risk possess the marks of bio-hazardous goods meeting related requirements.

If the inspection site does not have the safety protection conditions required for inspecting the special goods, such special goods shall be transported to a designated site meeting the requirements of corresponding bio-safety level for inspection.

Article 17 For entry special goods that requires laboratory testing, owners or their agents shall store the special goods at the eligible storage site meeting the requirements of port inspection and quarantine authorities; and those special goods shall not be transported or used before the quarantine inspection is passed. Port inspection and quarantine authorities without testing capabilities shall entrust the laboratory with corresponding qualifications for testing.

For special goods that contain or may contain bio-hazard factors such as pathogenic microorganisms, toxins, etc., the port inspection and quarantine authorities shall transfer related electronic information of those special goods 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 goods that are posted or carried without Health Quarantine Approval Certificate on Special Goods shall be withheld by the port inspection and quarantine authorities; the withholding vouchers shall be issued and the withholding period shall not exceed 7 days.

If mailers or carriers submit the Health Quarantine Approval Certificate on Special Goods within the withholding period, the inspection and quarantine authorities shall carry out the inspection in accordance with Article 16 of these Regulations, and those special goods can get clearance only after they are qualified for the inspection and quarantine.

Article 19 For the entry-exit blood or biological products carried for self-use and only for disease prevention or treatment, no health quarantine approval formalities are required, but related documents of hospital shall be shown to the inspection and quarantine authorities during the entry-exit process; and the allowable carrying quantity shall be limited to one course determined in the prescriptions or instructions.

Article 20 If the Health Quarantine Approval Certificate on Special Goods of human tissues for transplantation cannot be provided for special reasons during the entry-exit process, the inspection and quarantine authorities may give it clearance first after the quarantine  inspection, and then the owners or their agents shall make up for applications for quarantine approval within 10 days after the clearance.

Article 21 The port inspection and quarantine authorities shall give clearance to the entry-exit special goods that meet the requirements of health quarantine. The Notice on Inspection and Quarantine Treatment shall be issued and the goods shall be returned or destroyed under any of the following circumstances:

1. any items including the names, lot numbers, specifications, bioactive constituents, etc. do not conform to those listed in the Health Quarantine Approval Certificate on Special Goods;

2. beyond the quantitative range of health quarantine approval;

3. the packing conditions do not meet the safety management requirements of special goods;

4. the goods fail the health quarantine inspection;

5. the Health Quarantine Approval Certificate on Special Goods for the posted or carried goods that are withheld cannot be submitted within 7 days since the date of withholding or those goods fail the quarantine inspection after the submission of Health Quarantine Approval Certificate on Special Goods.

The port inspection and quarantine authorities shall record and file the treatment results.

Chapter IV Supervision and Administration

Article 22 The entities of entry-exit special goods shall establish the management system of safety of special goods, and produce, use or sell such special goods in strict accordance with the purposes as specified in the quarantine approval.

 

The entities of entry-exit special goods shall set up the production, use and sales records of special goods. Those records shall be true with the storage life no less than 2 years.

Article 23 Inspection and quarantine authorities shall implement the risk management for entry-exit special goods, divide the special goods into different risk levels according to the risks that those entry-exit special goods may transmit human diseases, and adopt different health quarantine supervision and administration modes.

The risk levels of entry-exit special goods and the corresponding health quarantine supervision and administration modes shall be uniformly published by AQSIQ.

Article 24 For the entry special goods 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 by 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 goods shall include:

1. whether the laboratory of  the entity that uses the entry special goods is consistent with that listed in the Health Quarantine Approval Certificate on Special Goods;

2. whether the entry special goods are consistent with  those listed in the Health Quarantine Approval Certificate on Special Goods.

Article 26 In case of situations during the follow-up supervision listed below , the Health Quarantine Approval Certificate on Special Goods shall be withdrawn by the inspection and quarantine authorities and the goods shall be returned or destroyed:

1.  the laboratory of the entity that uses the entry special goods  is NOT consistent with that listed in the Health Quarantine Approval Certificate on Special Goods;

2.  the entry special goods are NOT consistent with those listed in the  Health Quarantine Approval Certificate on Special Goods.

Inspection and quarantine authorities shall report to the inspection and quarantine bureau directly under AQSIQ that issued the approval upon the discovery of the problems in the follow-up supervision. The serious cases shall be timely reported to AQSIQ.

Article 27 Staff in the inspection and quarantine authorities shall enforce laws impartially, be devoted to their duty and be responsible for keeping the business secrets they learn in the course of performing their duties.

Chapter V Legal Liabilities

Article 28 In violation of these Regulations, and one of the following  situations arise,  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, blood and blood products that are forbidden to be imported or other animals or goods that may cause the infectious diseases transmission;

Article 29 In violation of these Regulations, and if one of the following situations arises, and when there are illegal incomes,  inspection and quarantine authorities shall impose a fine up to30,000:

1. obtaining the approval of special goods by improper means such as deception, bribery, etc.;

2. transporting, selling or using special goods without the permission of inspection and quarantine authorities;

3. failing to declare to the inspection and quarantine authorities or providing false documents for defrauding for the inspection and quarantine certificates;

 

4. failing to handle the special goods in the laboratory with corresponding bio-safety level or the entity that uses the special goods has no corresponding bio-safety control capability; failing to set up the use and sales records for special goods or the records do not meet the actual conditions;

5. using the entry special goods subject to follow-up supervision without the permission of inspection and quarantine authorities;

6. for human tissues for transplantation that get first clearance, the applicant fails to apply for the approval within 10 days after the goods get clearance.

Article 30 Owners or their agents of entry-exit special goods rejecting or hindering the inspection and quarantine authorities and its staff from performing their duties in accordance with the law shall be transferred to related departments for treatment in accordance with the law.

Article 31 Staff of inspection and quarantine authorities playing favoritism and committing irregularities, abusing power, neglecting duties, in violation of relevant laws and regulations, shall be given administrative sanctions in accordance with the law; and if the case is as serious as to constitute crimes, they shall be given criminal sanctions in accordance with the law.

Article 32 For any violation of these Regulations that causes the spread of any quarantinable infectious diseases or the serious risks of transmitting any quarantinable infectious diseases, criminal liabilities shall be investigated forin 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 and environmental microbial agents;

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 related information of organs, tissues, cells, blood, preparation, recombinant deoxyribonucleic acid (DNA) containing human genomes, genes and their products.

 

The term “biological product” refers to vaccines, antitoxins, reagents for diagnosis, cytokines, enzymes and its preparation for related fields of human medicine and life sciences and bioactive agents such as toxins, antigens, allergens, antibodies, antigen-antibody complexes, nucleic acids, immunomodulator and microecologics.

The term “blood” refers to the whole blood, plasma components and special blood components of human.

The term “blood products” refers to the various human plasma protein products.

The term “entity of special entry-exit goods” refers to a legal person or other organizations engaged in the production, use, sales, scientific research, medical treatment, examination and medical research outsourcing.

Article 34 The supervision and administration of health quarantine on microbial agents imported and exported for environmental protection shall be implemented in accordance with the Administrative Measures for Environmental Safety on Microbial Agents Imported and Exported for Environmental Protection (Decree No. 10 of Ministry of Environmental Protection and AQSIQ).

Article 35 The animals and plants quarantine required for entry-exit special goods shall be carried out in accordance with provisions of laws of entry-exit animals and plants.

Article 36 These Regulations shall be subject to the interpretation of 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 Goods (AQSIQ Decree No. 83) issued by AQSIQ on October 17, 2005 shall be abolished as well.