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THE MEASURES FOR THE ADMINISTRATION OF THE QUARANTINE OF THE ARTICLES CARRIED BY PERSONS ON ENTRY OR EXIT

State Administration of Quality Supervision, Inspection and Quarantine

Order of the State Administration of Quality Supervision, Inspection and Quarantine

No. 56

The Measures for the Administration of the Quarantine of the Articles Carried by Persons on Entry or Exit were deliberated and adopted
at the executive meeting of the State Administration of Quality Supervision, Inspection and Quarantine on September 28th, 2003. They
are hereby promulgated and shall come into force as of January 1st, 2004.

Li Changjiang, Director General

November 6th, 2003

The Measures for the Administration of the Quarantine of the Articles Carried by Persons on Entry or Exit

Chapter I General Provisions

Article 1

In order to prevent contagious or parasitic diseases of animals, diseases, insect pests and weeds dangerous to plants, and other harmful
organisms from spreading into or out of the country, to protect the human health as well as the safety of agriculture, forestry,
animal husbandry and fishery, the present Measures are formulated in accordance with the Law of the People’s Republic of China on
the Quarantine of Animals and Plants on Entry or Exit, the Detailed Rules for the Implementation of the Law of the People’s Republic
of China on the Quarantine of Animals and Plants on Entry or Exit, the Frontier Health and Quarantine Law of the People’s Republic
of China, the Detailed Rules for the Implementation of the Frontier Health and Quarantine Law of the People’s Republic of China and
relevant other laws and regulations.

Article 2

“Persons on entry or exit” as mentioned in the present Measures refers to the passengers entering or exiting China (including personnel
of diplomatic institutions who enjoy diplomatic or consular privilege and immunity), other persons and the staff of vehicles.

“Carry” as mentioned in the present Measures refers to a person takes the articles with himself or has them carried by the train,
ship, plane or other vehicles that he is taking.

Article 3

When entering or exiting China, a person who carries any of the following articles shall declare to the entry-exit inspection and
quarantine institution and accept quarantine; a person who fails to do so shall be prohibited from entering or exiting China.

(1)

Animals and plants, their products and other quarantine items on entry;

(2)

Microbes, human tissues, biological products, blood and blood products and other special articles (hereinafter referred to as the
special articles) on entry or exit;

(3)

Skeletons, bone ash, corpse and coffins with corpse on entry or exit;

(4)

The baggage and articles entering or exiting China coming from an affected region or polluted by a contagious disease or probably
spreading a contagious disease; and

(5)

Other articles that shall declare and be subject to quarantine at the entry-exit inspection and quarantine institutions.

Article 4

Any of the articles listed in Article 5 , Paragraph (1) of the Law of the People’s Republic of China on the Quarantine of Animals
and Plants on Entry and Exit, the Catalogue of the People’s Republic of China of the Plants Prohibited from Entering China under
Entry Plant Quarantine, the Catalogue of the Animals, Animal Products and Other Quarantine Articles Prohibited from Being Carried
or Posted into China, the blood products and used articles as prescribed explicitly by the State and other relevant articles prohibited
from entering China shall be prohibited from entry.

Article 5

The State Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as the SAQSIQ) shall be liable
for the nationwide administration of the quarantine of the articles carried by persons on entry or exit, and the entry-exit inspection
and quarantine institutions dispatched by the SAQSIQ at all places shall be liable for the quarantine of the articles carried by
the persons on entry or exit and the supervision over the quarantine work within their respective administrative area.

Article 6

Upon the quarantine of an inspection and quarantine institution, where it is found there exists quarantine risk in the carried articles,
a pre-warning and fast response procedure shall be started in accordance with relevant provisions.

Chapter II Quarantine Examination, Approval and License

Article 7

A person who carries plant seeds, seedlings or other reproductive materials shall, according to relevant provisions, go through the
formalities for quarantine examination and approval in advance. In case he is unable to do so under any special circumstance, he
shall make up the relevant formalities for animal and plant quarantine examination and approval according to relevant provisions.
Those carrying animals and plants or their products beyond the scope as provided in the preceding paragraph on entry who are required
to go through the formalities for quarantine examination and approval according to relevant provisions shall submit an application
to the SAQSIQ for going through the formalities for animal and plant quarantine examination and approval.

Article 8

On account of scientific research or other special purposes, a person who carries any of the articles prohibited from entering China
as listed in Article 5 , paragraph 1 of the Law of the People’s Republic of China on the Quarantine Animals and Plants on Entry or
Exit shall submit an application to the SAQSIQ for going through the special formalities for animal and plant quarantine examination
and approval.

Article 9

When entering or exiting China, a person who carries special articles shall handle the formalities for health and quarantine examination
and approval in advance according to relevant provisions.

Article 10

When entering or exiting China, a person who carries a corpse or skeleton shall handle the formalities for obtaining a Health and
Quarantine License according to relevant provisions.

Chapter III Declaration and On-the-Spot Quarantine

Article 11

When entering China, a person who carries any of the articles as listed in Article 3 , paragraph (1) of the present Measures shall
faithfully fill in the Quarantine Declaration Form on Entry, shall declare quarantine items to the inspection and quarantine institution
and accept the quarantine of the inspection and quarantine institution.

Article 12

When entering or exiting China, a person who carries any of the articles as listed in Article 3 , Paragraph (2) through (5) shall
faithfully declare the quarantine items to the inspection and quarantine institution and accept the quarantine of the inspection
and quarantine institution. In the event of entry, he shall faithfully fill in the Quarantine Declaration Form on Entry as well according
to relevant regulation.

Article 13

A quarantine inspection and quarantine institution may conduct on-the-spot inspection in the passages and baggage claim area for persons
on entry or exit, and conduct on-the-spot quarantine on the declared items; with regard to any possible undeclared articles as prescribed
in the present Measures, it may inquire the persons concerned and conduct sample inspection, and may open the trunks (bags) for inspection
when necessary.

Article 14

When entering China, a person who carries special articles shall, according to relevant provisions, present a Health and Quarantine
Form of Examination and Approval for Special Articles on Entry or Exit (hereinafter referred to as the Health and Quarantine Form
of Examination and Approval). A person who carries blood products or biological products for his own use shall only present the certification
issued by a relevant hospital. The quantity of the aforesaid items shall be limited to a period of treatment as determined in the
prescription or specification.

The inspection and quarantine institutions shall conduct on-the-spot inspection and quarantine on the special articles on entry or
exit according to the requirements as provided in the Health and Quarantine Form for Examination and Approval and relevant provisions.

With regard to a person who fails to present a Health and Quarantine Form for Examination and Approval, the inspection and quarantine
inspection institution shall temporarily withhold the special articles on entry or exit and shall issue an Evidence of Quarantine
/ Treatment of Articles Carried by Persons on Entry or Exit (hereinafter referred to as Evidence for Quarantine/ Treatment. The special
articles withheld shall be sealed up and preserved at a place designated by the inspection and quarantine institution for not any
more than 30 days, and the relevant preservation fees within the period shall be paid by the person on entry or exit.

Article 15

When entering or exiting China, a person who carries a corpse or skeleton shall, according to relevant provisions, provide the death
certificate of the dead and other relevant documents.

The inspection and quarantine institute shall conduct on-the-spot quarantine over the skeleton or corpse on entry or exit according
to relevant provisions.

Article 16

The inspection and quarantine institutions shall, according to relevant provisions, conduct on-the-spot quarantine over any baggage
and articles on entry or exit that are from an affected region, are polluted by a contagious disease or possibly spread a contagious
disease.

Article 17

A person carrying plant seeds, seedlings or other reproductive materials that are allowed to enter China shall present a Quarantine
Form for Introducing Seeds and Seedlings for Examination and Approval or Quarantine Form of Examination and Approval for Introducing
Seeds, Seedlings and Other Reproductive Materials (hereinafter referred to as the Quarantine Form of Examination and Approval for
Seeds and Seedlings).

When entering China, a person, who carries any animal, plant, and products of such animal or plant that are subject to quarantine
examination and approval or those that are be subject to special quarantine examination and approval, shall present the Animals &
Plants Entry Quarantine License of the People’s Republic of China (hereinafter referred to as the Quarantine License) issued by the
SAQSIQ and other relevant documents.

The inspection and quarantine institutions conduct on-the-spot quarantines to the animals, plants, and the products of such animals
or plants as well as other things subject to quarantine as provided for in Paragraphs 1 & 2 of the present Article as required by
the Approval Form for Seeds and Seedlings or the Quarantine License or any other relevant provisions.

With regard to a person who fails to present the Quarantine Form of Examination and Approval for Seeds and Seedlings, the Quarantine
License or other relevant documents, the inspection and quarantine institution shall temporarily withhold the animals, plants, animal
or plant products and other quarantine products carried by him on entry and shall issue an Evidence of Quarantine / Treatment to
him. The aforesaid articles withheld temporarily shall be sealed up at a place designated by the inspection and quarantine institution
for not exceeding 7 days, and the relevant preservation fees within the period shall be paid by the person on entry or exit.

Article 18

When entering China, a person who carries any animal permitted to enter China shall present a valid quarantine certificate issued
by an official animal quarantine institution of the exporting country or region; with regard to a person carrying dogs or cats on
entry, the cats or dogs shall not exceed the quota, and the person shall present a valid inoculation certificate.

The inspection and quarantine institution shall conduct on-the-spot quarantine over the animals that are allowed to enter China according
to relevant provisions.

Where a person fails to present a valid quarantine certificate or an inoculation certificate, the inspection and quarantine institution
shall temporarily withhold the animals on entry and shall issue an Evidence of Quarantine / Treatment. The aforesaid animals shall
be segregated at a segregation place designated by the inspection and quarantine institution for not any more than 7 days, and the
relevant expenses shall be dealt with according to relevant provisions.

Article 19

When exiting China, a person who carries animals or plants or products of such animals or plants and other quarantine articles shall
present relevant certifications as required by relevant provisions.

Where there are quarantine requirements for the animals, plants, or products of such animals or plants, and other quarantine objects
in an exporting country (region), the persons entering or exiting this country or region shall file an application, and the inspection
and quarantine institution shall conduct quarantine and issue relevant documents according to relevant requirements.

Chapter IV Quarantine Clearance and Treatment

Article 20

With regard to the articles carried by a person on entry or exit that pass the on-the-spot quarantine of the inspection and quarantine
institution, quarantine clearance shall be done on the spot.

Article 21

With regard to the articles withheld temporarily on account of failure of presenting relevant valid documents, the person entering
or exiting China shall supplement relevant valid documents within the time limit for withholding the articles; for those who pass
the quarantine of the inspection and quarantine institution, quarantine clearance shall be done, and the person entering or exiting
China shall take away the articles within the time limit for the temporary withholding of the articles on the strength of the Evidence
of Quarantine / Treatment.

Article 22

After the quarantine of an inspection and quarantine institution, where it is necessary to make laboratory quarantine, segregated
quarantine or sanitary harm-elimination treatment to the articles carried by a person on entry or exit, the inspection and quarantine
institution shall withhold the aforesaid articles and issue an Evidence of Quarantine / Treatment.

The expenses of and time limit for the withholding, segregation and quarantine shall be carried out in accordance with relevant provisions.

Where the articles pass the laboratory quarantine, segregation quarantine or sanitary harm-elimination treatment of the inspection
and quarantine institution, a quarantine clearance shall be done. The person on entry or exit shall take away the articles within
the time limit for withholding on the strength of Evidence of Quarantine / Treatment.

Article 23

Under any of the following circumstances, the articles carried by a person on entry or exit shall be subject to sanitary harm-elimination
treatment in accordance with relevant provisions:

(1)

Finding any of the specified diseases or pests in the animals, plants, or products of such animals or plants or other quarantine articles
on entry;

(2)

The corpse or skeleton on entering or exiting China doesn’t meet the sanitary requirements;

(3)

The baggage and articles on entry or exit come from an affected region of an epidemic disease, or are polluted by a epidemic disease,
or possibly spread an epidemic disease; or

(4)

Other circumstances in which sanitary harm-elimination treatment shall be made.

Article 24

Under any of the following circumstances, the articles carried by a person on entry or exit shall, according to relevant provisions,
be returned or destroyed within a time limit:

(1)

The articles carried are inconsistent with the description of the documents submitted by the person concerned;

(2)

The articles are withheld temporarily because of the person’s failures of presenting valid documents and supplementing valid documents
within the time limit for withholding;

(3)

The articles fail to pass the quarantine (including on-the-spot quarantine) and there is no effective method for making sanitary harm-elimination
treatment;

(4)

The animals on entry exceeds the quota;

(5)

Falling within the scope of articles prohibited from entering China as provided for in the law and regulation; or

(6)

Other circumstances in which the articles shall be returned or destroyed within a time limit.

Article 25

With regard to any of the articles withheld (including those withheld temporarily) that passes the quarantine and shall be taken away
within a time limit, if not taken away within the time limit or waived voluntarily by the person entering or exiting China in written
statement, the articles shall be regarded as unclaimed and be handled by the inspection or quarantine institution in accordance with
the law.

Chapter V Legal Liabilities

Article 26

Whoever refuses to fill in a Quarantine Declaration Form on Entry shall be given a warning or imposed on a fine of 1, 000 Yuan or
less by the inspection and quarantine institution.

Article 27

A person who conducts any of the following violations shall be imposed on a fine of 5, 000 Yuan or less by the inspection and quarantine
institution:

(1)

When entering China, a person carries any of the animals or plants or products of such animals or plants or other quarantine articles
as provided for in the present Measures, but fails to declare the items to the inspection and quarantine institution, fails to go
through the quarantine formalities, or fails to act as is required by the quarantine examination and approval;

(2)

The declared animals or plants or products of such animals or plants or other quarantine articles are not the same as they really
are;

With regard to whoever acts as is required by Item (2) of the preceding paragraph, the quarantine documents he has obtained, if any,
shall be canceled.

Article 28

Whoever conducts any of the following violations shall be given a warning or imposed on a fine of 100 Yuan up to 5, 000 Yuan:

(1)

Forging or altering any sanitary quarantine documents;

(2)

Concealing the carrying of any special articles prohibited from entering China;

(3)

Concealing the carrying of any articles that possibly spread an epidemic disease; or

(4)

Loading or unloading the baggage and articles without the permission of the inspection and quarantine institution.

Article 29

Without permission of the inspection and quarantine institution, whoever moves or carries away the corpse or skeleton entering or
exiting China shall be imposed on a fine of not less than 1, 000 Yuan but not more than 10, 000 Yuan by the inspection and quarantine
institution.

Article 30

With regard to a person who carries used articles and fails to file a declaration of the items to the inspection and quarantine institution,
but enters or exits China without submitting the articles for sanitary treatment by the inspection and quarantine institution and
without being issued relevant documents, he shall be imposed on a fine of not less than 3, 000 Yuan but not more than 30, 000 Yuan.

Article 31

Whoever, without the permission of the inspection and quarantine institution, transfers or disposes of any of the articles that are
withheld or segregated in the place as designated by the inspection and quarantine institution shall be imposed a fine of not less
than 3, 000 Yuan but not more than 30, 000 Yuan.

Article 32

With regard to a person who conducts any of the following violations, if the violation doesn’t constitute a crime or the criminal
circumstance is obviously minor, thus he is subject to no criminal punishment in jure, the inspection and quarantine institution
shall impose on him a fine of not less than 20, 000 Yuan but not more than 50, 000 Yuan:

(1)

Causing serious animal or plant epidemic situation; or

(2)

Forging or altering animal or plant quarantine documents.

Article 33

Any one on entry or exit who refuses or hinders the inspection and quarantine institution and their functionaries from performing
their functions shall be dealt with by relevant departments in accordance with the law.

Article 34

When enforcing the administrative punishments provided for in the present Measures, the inspection and quarantine institutions shall
abide by the provisions on the procedures of administrative punishments as prescribed in relevant law or regulation; whoever violates
any of the relevant provisions shall be subject to relevant liabilities in accordance with the law.

Article 35

The functionaries shall enforce the law impartially, be devoted to their duties, shall not abuse their authorities, neglect their
duties, or malpractice to seek private benefits. Whoever violates the law or his duties shall be subject to relevant liabilities
in accordance with the law.

Chapter VI Supplementary Provisions

Article 36

The responsibility to interpret the present Measures shall remain with the SAQSIQ.

Article 37

The present Measures shall come into force as of January 1st, 2004.



 
State Administration of Quality Supervision, Inspection and Quarantine
2003-11-06

 







REGULATION ON THE URGENT HANDLING OF THE ENTRY-EXIT INSPECTION AND QUARANTINE OF FRONTIER AND PORT PUBLIC HEALTH EMERGENCIES

State General Administration of Quality Supervision, Inspection and Quarantine

Order of the State Administration of Quality Supervision, Inspection and Quarantine

No. 57

The Regulation on the Urgent Handling of the Entry-Exit Inspection and Quarantine of Frontier and Port Public Health Emergencies was
deliberated and adopted at the executive meeting of the State Administrative of Quality Supervision on September 28th, 2003. It is
hereby promulgated and shall come into force as of the date of promulgation.

State General Administration of Quality Supervision, Inspection and Quarantine

November 7th, 2003

Regulation on the Urgent Handling of the Entry-Exit Inspection and Quarantine of Frontier and Port Public Health Emergencies

Chapter I General Provisions

Article 1

In order to effectively prevent, lessen, control and eliminate the harm of public health emergencies in good time, to safeguard the
physical health of the persons on entry or exit and the general public of the frontiers and ports, and to maintain the normal social
order at the frontiers and ports, the present Regulation is formulated pursuant to the Frontier Health Quarantine Law of the People’s
Republic of China, its implementation rules and the Regulation on the Urgent Handling of Public Health Emergencies.

Article 2

“Public health emergencies” as mentioned in the present Regulation (hereinafter referred to as “emergencies”) refers to the outbreak
of a serious contagious disease, colonial disease of unknown causes, serious food poisoning that has caused or may cause severe effect
on the health of the persons on entry or exit and the general public at the ports and frontiers, and to other incidents that severely
affect the health of the general public, including:

(1)

Rat plague, cholera, yellow fever, inhalational anthrax, severe acute respiratory syndrome;

(2)

The outbreak or prevailing of a contagious disease in Categories B and C in rather large scale, or the situation that several persons
die of such a disease;

(3)

The occurrence of the epidemic situation of a rare disease or a disease that the state has ever declared eliminated;

(4)

Loss of a contagious disease bacteria or virus spawns;

(5)

The occurrence of a colonial disease with similar clinical features of unknown cause which is spreading or may spread;

(6)

10 persons or more are poisoned or die of poison;

(7)

Emergencies taking place at home or abroad that may endanger the frontiers and ports.

Article 3

The present Regulation shall apply to the urgent handling of the emergencies in relation to the frontiers, ports, persons on entry
or exit, means of transport, goods, containers, luggage and post parcels, etc.

Article 4

In the urgent handling of the entry-exit inspection and quarantine of a frontier and port emergency, one shall comply with the policy
of focusing on the prophylaxis and being always on the alert, and carry out the principles of unified leadership, level-to-level
responsibilities, timely responses, definite measures, depending on science and strengthening cooperation.

Article 5

Inspection and quarantine institutions at all levels shall commend and award the persons who make outstanding contributions in the
urgent handling of entry-exit inspection and quarantine of frontier and port emergencies.

Chapter II Organization and Control

Article 6

The State Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as the SAQSIQ), the entry-exit
inspection and quarantine bureaus of all places directly under it and their branches shall form a command body for urgent handling
of the entry-exit inspection and quarantine of frontier and port emergencies.

Article 7

The SAQSIQ shall coordinate and control the overall command body for urgent handling of the entry-exit inspection and quarantine of
frontier and port emergencies and shall perform the following functions:

(1)

Studying and formulating the plan on the urgent handling of the entry-exit inspection and quarantine of frontier and port emergencies;

(2)

Commanding and coordinating the inspection and quarantine institutions to earnestly perform in the urgent handling of the entry-exit
inspection and quarantine of frontier and port emergencies, as well as organizing and bringing the technical force and relevant resources
into play;

(3)

Checking and guiding the performances of the inspection and quarantine institutions in the urgent handling of the emergencies, and
supervising the implementation of all urgent handling measures;

(4)

Coordinating the relationship between it and the relevant administrative departments of the state, and establishing necessary urgent
coordination and contact mechanism;

(5)

Making collection, arrangement, analysis and reporting to the higher level the relevant information and the variations of the situation,
and offering advice and proposals for the state to make resolutions; transmitting all relevant orders of the organs of higher levels
to the inspection and quarantine institutions of all levels, and making arrangements for the implementation of such orders;

(6)

Encouraging, supporting, and coordinating to carry out international communication and cooperation of relevant technologies concerning
the monitoring, pre-warning, response and handling of entry-exit inspection and quarantine of frontier and port emergencies.

The SAQSIQ shall establish an expert consultation team for the urgent handling of entry-exit inspection and quarantine of frontier
and port emergencies, which shall offer professional consultation services, technical guides on the urgent handling, and offer proposals
and advice for making urgent resolutions.

Article 8

An inspection and quarantine bureau directly under the SAQSIQ shall be liable for the urgent handling of the entry-exit inspection
and quarantine of frontier and port emergencies within its administrative area and shall carry out the following functions:

(1)

Organizing and implementing the emergency plan on the handling of the entry-exit inspection and quarantine of frontier and port emergencies
within its administrative area;

(2)

Mobilizing the force and resources of the inspection and quarantine institutions within its administrative area, and implementing
urgent measures;

(3)

Reporting the urgent handling information to the SAQSIQ in good time and putting forward work proposals;

(4)

Coordinating the relationship with the local people’s government and its administrative department of health, the administrative department
of the port, the customs, the departments of frontier inspection and other relevant departments, etc.

An inspection and quarantine bureau directly under the SAQSIQ shall establish a professional technical institution for the urgent
handling of entry-exit inspection and quarantine of frontier and port emergencies, which shall undertake relevant work.

Article 9

A branch shall perform the following functions:

(1)

Organizing and establishing an on-the-spot command department for the urgent handling of entry-exit inspection and quarantine of emergencies,
and organizing and implementing urgent measures on the spot in good time according to the specific situation;

(2)

Implementing urgent measures on the spot in conjunction with the professional technical institution of the entry-exit inspection and
quarantine of emergencies of the inspection and quarantine bureau directly under the SAQSIQ;

(3)

Strengthening the communication and cooperation between it and the local people’s government and other relevant departments.

Chapter III Preparations for Emergencies

Article 10

The SAQSIQ shall formulate the national plan for the handling of entry-exit inspection and quarantine of frontier and port emergencies
in accordance with the requirements of the Regulation on the Urgent Handling of Public Health Emergencies.

In light of the national plan for the handling of entry-exit inspection and quarantine of frontier and port emergencies, the inspection
and quarantine institutions of all levels shall develop their own plans for the handling of entry-exit inspection and quarantine
of frontier and port emergencies by taking the actual situation of the local ports into consideration, and each shall report to the
institution of the higher level and the local government for archival purposes.

Article 11

The inspection and quarantine institutions of all levels shall implement regular trainings of relevant urgent treatment skills of
entry-exit inspection and quarantine of frontier and port emergencies, and shall organize drills of urgent handling of entry-exit
inspection and quarantine of frontier and port emergencies and popularize advanced technologies.

Article 12

The inspection and quarantine institutions of all levels shall, in accordance with the requirements of the plan on the urgent handling
of entry-exit inspection and quarantine of frontier and port emergencies, guarantee the preparation and reservation of personnel,
facilities, equipment, prophylaxis medicines, appliances and other resources for emergencies, so as to enhance the capacity of handling
emergencies.

Article 13

The inspection and quarantine institutions shall carry out the publicity education of handling emergencies, and shall strengthen the
prophylaxis awareness of emergencies and promote the treatment ability.

Chapter IV Report and Notice

Article 14

The SAQSIQ shall formulate rules on the urgent handling of entry-exit inspection and quarantine of port and frontier emergencies,
shall establish a system for the report of the information in relation to the serious and emergent situation of any contagious disease.

When either circumstance as listed in Article 2 of the present Regulation occurs, the inspection and quarantine bureau directly under
the SAQSIQ shall report to the SAQSIQ within 1 hour after receiving such report, and shall report to the local government simultaneously.

With regard to any emergency that may result in serious social consequences, the SAQSIQ shall report to the State Council in good
time.

Article 15

An inspection and quarantine branch shall, when it learns of the occurrence of either circumstance as listed in Article 2 of the
present Regulation, report to the inspection and quarantine bureau directly under the SAQSIQ and simultaneously report to the local
government.

Article 16

The SAQSIQ and the inspection and quarantine institutions shall designate special persons to take charge of the communication of information
and circulate a notice about the name list of the relevant personnel within their respective administrative area.

Article 17

Any relevant frontier and port entity and individual shall, where it / he finds either circumstance as listed in Article 2 of the
present Regulation, in time and faithfully report to the local port inspection and quarantine institution. No one may conceal or
delay the report or make false reports or hint any other to conceal or delay the report or make false reports.

Article 18

An inspection and quarantine institution that receives a report shall, according to the present Regulation, assign persons to investigate
into, verify and corroborate the reported items, take necessary measures and report relevant information of investigation in time.

Article 19

The SAQSIQ shall inform the relevant departments of the State Council and the inspection and quarantine bureaus directly under the
SAQSIQ of the developing status of an emergency by circulating notices.

After having received a notice, each inspection and quarantine institution directly under the SAQSIQ shall notify the relevant branches
within their respective administrative area.

Article 20

The SAQSIQ shall establish a fast response information network system for the pre-warning of risks of entry-exit inspection and quarantine
of emergencies.

The inspection and quarantine institutions of all levels shall be liable for reporting the emergencies found by them to the higher
levels in good time through the network system, and the SAQSIQ shall in time circulate notices through the network system.

Chapter V Urgent Handling

Article 21

When an emergency occurs, the following on-the-spot urgent control measures shall be taken by the inspection and quarantine institution
of the venue upon approval of the institution of a higher level:

(1)

Conducting temporary control on the spot, and controlling the entry and exit of persons; under the serious epidemic situation suspected
of a human and animal disease, prohibiting patients and suspected patients from contacting the fragile animals;

(2)

Conducting medical observation or temporary isolated check-up on the relevant persons on the spot;

(3)

Taking control measures on the means of transport, cargos, containers, luggage and post parcels on entry or exit, to bar any transference;

(4)

Sealing up and preserving the equipment, materials and articles that may cause an emergency or the spread of an emergency,

(5)

Taking urgent health measures.

Article 22

An inspection and quarantine institutions shall organize experts to make epidemiological investigations into the emergency, conduct
on-the-spot monitoring and examination, determine the seriousness of the harm, make preliminary judgment on the type of the emergency
and put forward proposals on the initiation of the plan on the urgent handling of entry-exit inspection and quarantine of frontier
and port emergencies.

Article 23

The implementation of the plan on the urgent handling of entry-exit inspection and quarantine of frontier and port emergencies of
the SAQSIQ shall be subject to the approval of the State Council. The initiation of the plan on the urgent handling of entry-exit
inspection and quarantine of frontier and port emergencies of any of the inspection and quarantine institutions of any level shall
be subject to the approval of the higher level and be reported to the local government at the same time.

Article 24

The professional technical institution for the urgent handling of entry-exit inspection and quarantine of the frontier and port emergencies
established by an inspection and quarantine bureau directly under the SAQSIQ shall conduct technical investigations into, corroborate,
dispose of, control and appraise the emergencies.

Article 25

According to the need of urgent handing of an emergency, the command body for urgent handling of the entry-exit inspection and quarantine
of frontier and port emergencies shall be empowered to assemble the personnel of entry-exit inspection and quarantine, reserved materials,
means of transport and pertinent facilities and equipment. If it is necessary, the SAQSIQ may, according to Article 6 of the Frontier
Health Quarantine Law of the People’s Republic of China, submit an opinion to the State Council for approval of ordering to close
the pertinent frontiers or to take other urgent measures.

Article 26

The personnel who participate in the urgent handling of the inspection and quarantine of the frontier and port emergencies shall,
according to the requirements in the plan, take health quarantine prophylaxis measures and carry out their work under the guidance
of professionals.

Article 27

In case of finding any patient or suspected patient of a contagious disease on a means of transport, the responsible person shall
report to the local port inspection and quarantine institution as soon as possible. The inspection and quarantine institution shall
organize relevant personnel to take corresponding health quarantine measures as soon as it receives such report.

As for those who have close contacts with the patients of a contagious disease on the means of transport, they shall be subject to
a medical check-up or observation, or against whom control measures shall be taken pursuant to the health quarantine law and the
administrative law and regulation.

Article 28

The inspection and quarantine institution shall conduct necessary examination and check-up on the persons under temporary medical
check-up or isolation and note down in detail pursuant to relevant provisions. As for any patient necessary to be transferred, it
shall in time transfer the patient to the relevant department or institution for treatment.

Article 29

In the case of an emergency, the patients, suspected patients and the persons who have close contacts with the contagious patients
under medical check-up, on-site diagnosis and check-up, isolation treatment or health quarantine observation shall cooperate with
the inspection and quarantine institutions when they take heath quarantine measures.

Chapter VI Legal Liabilities

Article 30

In handling the entry-exit inspection and quarantine of frontier and port emergencies, the relevant port entities or individuals under
any of the following circumstances shall, according to the relevant law and regulation, be given a warning or be imposed on a fine.
If any crime is constituted, the offenders shall be subject to criminal liabilities in accordance with the law.

(1)

Concealing or delaying the report or making false reports of emergencies to the inspection and quarantine institutions;

(2)

Refusing the inspection and quarantine institution to enter into the site of an emergency to take urgent measures;

(3)

Impeding the handling personnel of an inspection and quarantine institution to perform their duties in the form of violence or by
other means.

Article 31

As for any inspection and quarantine institution that fails to exercise its duty of report in accordance with the present Regulation,
or conceals or delays the report or makes false reports of relevant information of an emergency or hints any other person to conceal,
delay or make false reports, the primary responsible persons and other direct responsible persons shall be given an administrative
punishment. If any crime is constituted, the offenders shall be subject to criminal liabilities in accordance with the law.

Article 32

When an emergency occurs, if an inspection and quarantine institution refuses to accept the uniform command of the inspection and
quarantine institutions of higher levels, misses the good time to take urgent measures or in violation of the requirements in the
plan, refuses the command of the inspection and quarantine institutions of higher levels on the uniform assembling of personnel and
materials, the entity shall be criticized by circulating a notice. If any serious consequence is caused, the primary responsible
persons and other direct responsible persons shall be given an administrative punishment. If any crime is constituted, the offenders
shall be subject to criminal liabilities in accordance with the law.

Article 33

When an emergency occurs, if any of the inspection and quarantine institutions fails to cooperate in the investigation by the higher
inspection and quarantine institution or impedes or interferes with the investigation by any other means, it shall be ordered by
the higher inspection and quarantine institution to get right, and the primary responsible persons and other responsible persons
shall be subject to administrative sanctions. If any crime is constituted, the offenders shall be subject to criminal liabilities
in accordance with the law.

Article 34

With regard to the functionaries who abuse their authorities, neglect their duties, or mal-practice for seeking private benefits in
the urgent handling of an emergency, the primary responsible persons and other direct responsible persons shall be given an administrative
punishment; if any crime is constituted, the offenders shall be subject to the criminal responsibilities in accordance with the law.

Chapter VII Supplementary Provisions

Article 35

The responsibility to interpret the present Regulation shall remain with the SAQSIQ.

Article 36

The present Regulation shall come into force as of the promulgation.



 
State General Administration of Quality Supervision, Inspection and Quarantine
2003-11-07

 







REGULATION OF AND SUPERVISION OVER THE BANKING INDUSTRY LAW

Law of the People’s Republic of China on Regulation of and Supervision over the Banking Industry

(Adopted at the 6th Meeting of the Standing Committee of the Tenth National People’s Congress on December 27, 2003
and promulgated by Order No.11 of the President of the People’s Republic of China on December 27, 2003) 

Contents 

Chapter I    General Provisions 

Chapter II   The Regulatory Authority 

Chapter III  Regulatory and Supervisory Responsibilities  

Chapter IV   Supervisory Measures 

Chapter V    Legal Responsibility 

Chapter VI   Supplementary Provisions 

Chapter I 

General Provisions 

Article 1  This law is enacted with a view to improving regulation of and supervision over the banking industry, standardizing
such regulation and supervision, preventing and mitigating risks in the banking industry, protecting the lawful rights and interests
of depositors and other customers, and promoting the sound development of the banking industry. 

Article 2  The banking regulatory authority under the State Council shall be responsible for the regulation of and supervision
over the financial institutions of the banking industry and their business operations throughout the country. 

For purposes of this law, the “financial institutions of the banking industry” refer to the financial institutions established in
the People’s Republic of China that receive deposits from the general public, including, among others, commercial banks, urban credit
cooperatives and rural credit cooperatives, and policy banks. 

The provisions of this Law pertaining to the regulation of and supervision over the financial institutions of the banking industry
are applicable to the regulation and supervision of the financial asset management companies, trust and investment corporations,
finance companies and financial leasing companies established in the territory of the People’s Republic of China and other financial
institutions established with the approval of the banking regulatory authority under the State Council. 

The banking regulatory authority under the State Council shall, in accordance with the relevant provisions of this Law, regulate
and supervise the financial institutions that, upon its approval, are established outside the People’s Republic of China, as well
as the business operations conducted abroad by the financial institutions mentioned in the preceding two paragraphs. 

Article 3  The objectives of regulation of and supervision over the banking industry are to promote the lawful, sound and steady
operation of the banking industry and preserve public trust in the industry. 

The banking industry shall be regulated and supervised in such a way as to protect fair competition in the industry and increase
the competitiveness of the industry. 

Article 4  When exercising regulation and supervision, the banking regulatory authority shall follow the principles of law-abiding
openness, impartiality and efficiency.  

Article 5  Performance of the duties of supervision in accordance with law by banking regulatory authority and its staff members
engaged in supervision shall be protected by law. Local governments, government departments at various levels, public organizations
and individuals shall not interfere. 

Article 6  The banking regulatory authority under the State Council shall establish a mechanism with the People’s Bank of China
and other financial regulatory authorities under the State Council for sharing supervisory information.  

Article 7  The banking regulatory authority under the State Council may establish a cooperative mechanism of supervision with
the banking regulatory authorities in other countries or regions for cross-border supervision. 

Chapter II 

The Regulatory Authority 

Article 8  In light of the need to perform its duties, the banking regulatory authority under the State Council may set up local
offices. It shall exercise unified leadership and administration of such offices. 

The local offices of the banking regulatory authority under the State Council shall perform their supervisory duties within the scope
authorized by the said authority. 

Article 9  The staff members of the banking regulatory authority who are engaged in supervision shall have the professional
knowledge and work experience commensurate with the positions they are holding. 

Article 10  Staff members of the banking regulatory authority shall be devoted to their duties, act in accordance with law and
be impartial and honest; they shall not take advantage of their positions to seek illegitimate benefits, or concurrently hold positions
in enterprises such as financial institutions. 

Article 11  Staff members of the banking regulatory authority shall, in accordance with law, guard State secrets, and it is
incumbent upon them to guard the secrets of the financial institutions of the banking industry and of the parties subject to their
supervision. 

For exchanging supervisory information with the banking regulatory authorities of other countries and regions, the banking regulatory
authority under the State Council shall make arrangements for preserving the confidentiality of information. 

Article 12  The banking regulatory authority under the State Council shall make public its supervisory procedures, and establish
a supervisory responsibility system and an internal supervisory system. 

Article 13  Local governments and the relevant government departments at various levels shall cooperate with and provide assistance
to the banking regulatory authority when the latter deals with risks confronted by financial institutions of the banking industry,
investigates and handles violations of law in finance, and exercises supervision in other manners. 

Article 14  The auditing, supervisory and other departments under the State Council shall, in accordance with the provisions
of relevant laws, oversee the activities of the banking regulatory authority under the State Council. 

Chapter III 

Regulatory and Supervisory Responsibilities 

Article 15  The banking regulatory authority under the State Council shall, in accordance with laws and administrative regulations,
formulate and promulgate supervisory rules and regulations governing the financial institutions of the banking industry and their
business activities. 

Article 16  The banking regulatory authority under the State Council shall, in accordance with the requirements and procedures
provided for in laws and administrative regulations, examine, before giving approval, the establishment, change, termination and
business scope of financial institutions of the banking industry.  

Article 17  Where an application is submitted for the establishment of a financial institution of the banking industry and where
such an institution intends to replace a shareholder that holds more than the specified percentage of the total amount of capital
or shares, the banking regulatory authority under the State Council shall examine the source of capital, financial strength, ability
to replenish capital and integrity of the shareholders.  

Article 18  The types of services offered by a financial institution of the banking industry within its business scope shall,
in accordance with relevant regulations, be subject to examination and approval by the banking regulatory authority under the State
Council or be submitted to the authority for the record. With regard to the types of services that are subject to examination and
approval or to being put on record, the banking regulatory authority under the State Council shall, in accordance with relevant laws
and administrative regulations, formulate regulations and make them known to the public.  

Article 19  Without approval by the banking regulatory authority under the State Council, no institution or individual may establish
a financial institution of the banking industry or engage in business activities of such an institution. 

Article 20  The banking regulatory authority under the State Council shall exercise control of the qualifications for the positions
of the directors and senior managers of the financial institutions of the banking industry. Specific measures in this regard shall
be formulated by the banking regulatory authority under the State Council. 

Article 21  The rules of prudent operation of the financial institutions of the banking industry shall be stipulated in laws
or administrative regulations, and they may also be formulated by the banking regulatory authority under the State Council in accordance
with relevant laws and administrative regulations. 

The rules of prudent operation mentioned in the preceding paragraph shall cover, among other things, risk management, internal control,
capital adequacy, asset quality, loan loss provisioning, risk concentration, connected transactions, and liquidity management of
assets. 

The financial institutions of the banking industry shall strictly observe the rules of prudent operation. 

Article 22   The banking regulatory authority under the State Council shall, within a prescribed period of time, make a
decision of approval or disapproval in writing in response to the following applications; if it makes a decision of disapproval,
it shall explain the reasons why: 

(1) for the establishment of a financial institution of the banking industry, it is six months from the date it receives the application
documents; 

(2) for the change or termination of a financial institution of the banking industry, for the business scope or for offering more
types of services within the business scope, it is three months from the date it receives the application documents; and 

(3) for examination of the qualifications of a director or senior manager, it is 30 days from the date it receives the application
documents. 

Article 23  The banking regulatory authority shall conduct off-site supervision of the business operations and risk profile
of the financial institutions of the banking industry, for which it shall establish an information system to analyse and assess the
risk profile of such institutions. 

Article 24  The banking regulatory authority shall conduct on-site inspection of the business operations and risk profile of
the financial institutions of the banking industry.  

The banking regulatory authority under the State Council shall formulate procedures for on-site inspection to standardize such inspection. 

Article 25  The banking regulatory authority under the State Council shall supervise the financial institutions of the banking
industry on a consolidated basis. 

Article 26 With respect to the proposal made by the People’s Bank of China for inspection of a financial institution of the banking
industry, the banking regulatory authority under the State Council shall respond within 30 days from the date it receives the proposal. 

Article 27  The banking regulatory authority under the State Council shall establish a rating system and an early-warning mechanism
for supervision over the financial institutions of the banking industry, in order to determine, on the basis of the rating and risk
profile of such institutions, the frequency and scope of on-site inspection of the institutions, as well as other supervisory measures
that need to be taken. 

Article 28  The banking regulatory authority under the State Council shall establish a system of post responsibility for identifying
and reporting emergencies in the banking industry. 

When it identifies any emergency that may lead to systemic risks in the banking industry and thus seriously jeopardize social stability,
the banking regulatory authority shall immediately report the matter to the leading member of the banking regulatory authority under
the State Council; the leading member shall, when deeming it necessary, immediately report to the State Council while informing the
People’s Bank of China, the finance department and other relevant departments under the State Council of the matter. 

Article 29  The banking regulatory authority under the State Council shall, in conjunction with the People’s Bank of China,
the finance department and other relevant departments under the State Council, establish a system for coping with emergencies in
the banking industry, including formulating contingency plans, designating institutions and staff members, specifying their responsibilities
and the measures and procedures, in order to ensure that emergencies in the banking industry are handled in a timely and effective
manner. 

Article 30  The banking regulatory authority under the State Council shall be responsible for compiling, in a unified manner,
statistics and reports of the financial institutions of the banking industry throughout the country and, in accordance with the relevant
regulations of the State, publish the statistics and reports. 

Article 31  The banking regulatory authority under the State Council shall guide and oversee the activities of the self-regulated
organizations of the banking industry. 

The self-regulated organizations of the banking industry shall submit their articles of association to the banking regulatory authority
under the State Council for the record. 

Article 32  The banking regulatory authority under the State Council may engage in international exchange and cooperation related
to regulation of and supervision over the banking industry. 

Chapter IV 

Supervisory Measures 

Article 33  The banking regulatory authority shall, in light of the need for performing its duties, have the power to require
the financial institutions of the banking industry to submit, in accordance with relevant regulations, their balance sheets, profit
statements, other financial accounting statements, statistical reports and information concerning business operations and management,
as well as the audit reports prepared by certified public accountants. 

Article 34  The banking regulatory authority may take the following measures to conduct on-site inspection, as required by prudent
supervision: 

(1)to enter a financial institution of the banking industry for on-site inspection; 

(2) to interview staff members of a financial institution and require them to provide explanations on the matters under inspection; 

(3) to check and make copies of the financial institution’s documents and materials related to the matters under inspection, and
to seal up the documents and materials that are likely to be removed, concealed or destroyed; and 

(4) to examine the computer system with which the financial institution controls its business data. 

On-site inspection shall be subject to approval by the leading member of the banking regulatory authority. For on-site inspection,
there shall be no less than two inspectors, who shall produce their legal certificates and the written notification of inspection.
Where there are less than two inspectors, or no legal certificates and written notification of inspection are produced, the financial
institution shall have the right to refuse to accept inspection. 

Article 35  The banking regulatory authority may, in light of the need for performing its duties, hold supervisory consultations
with the directors and senior managers of a financial institution of the banking industry, asking them to explain the important matters
concerning business operations and risk management. 

Article 36  The banking regulatory authority shall instruct financial institutions of the banking industry to disclose, truthfully
and in accordance with relevant regulations, to the public information, including, among other things, their financial and accounting
reports, statements of risk management, changes in the directors and senior managers and other important matters. 

Article 37  Where a financial institution of the banking industry violates the rules of prudent operation, the banking regulatory
authority under the State Council or its office at the provincial level shall instruct it to rectify within a time limit; if it fails
to comply at the expiration of the time limit, or the violation seriously threatens the sound and steady operation of the institution,
jeopardizes the lawful rights and interests of the depositors and other customers, the banking regulatory authority under the State
Council or its office at the provincial level may, with the approval of the leading member, take the following measures, depending
on the seriousness of the circumstances: 

(1) instructing it to suspend part of its business or ceasing to give approval to its starting of new businesses; 

(2) restricting the distribution of dividends and other returns; 

(3) restricting asset transfers; 

(4) instructing the holding shareholders to transfer their rights or restricting the rights of the shareholders concerned; 

(5) instructing the institution to replace the directors or senior managers or restricting their rights; and 

(6) ceasing to give approval to its establishment of new branches. 

After rectification, the financial institution shall submit a report to the banking regulatory authority under the State Council
or its office at the provincial level. After the said authority or office inspects the institution and accepts it as conforming to
the rules of prudent operation, it shall, within three days after the date of acceptance, discontinue the measures prescribed in
the preceding paragraph. 

Article 38  Where a financial institution of the banking industry is experiencing or is likely to experience a credit crisis,
thereby seriously jeopardizing the lawful rights and interests of depositors and other customers, the banking regulatory authority
under the State Council may, in accordance with law, take over the institution or facilitate its restructuring. The take-over and
restructuring shall be carried out in accordance with relevant laws and the regulations of the State Council. 

Article 39  Where a financial institution of the banking industry operates in violation of laws or is not operated or managed
properly, thereby seriously threatening financial order and undermining public interests unless it is closed, the banking regulatory
authority under the State Council shall have the power to close it. 

Article 40  Where a financial institution of banking industry is taken over, restructured, or closed, the banking regulatory
authority under the State Council shall have the power to require the directors, senior managers and other staff members of the institution
to perform their duties according to the requirements of the authority. 

In the course of the take-over, restructuring or liquidation after the closure of the institution, the banking regulatory authority
under the State Council may, with the approval of the leading member of the authority, take the following measures against the directors
and senior managers who are directly in charge and the other staff members who are directly responsible:  

(1) where their departure from the People’s Republic of China will cause heavy losses to the interests of the State, notifying the
exit control authority of the need to prevent them, in accordance with law, from leaving the country; and 

(2) submitting an application to the judicial authority for prohibiting their moving to other places or their transferring of their
property, or for establishing other rights on their property. 

Article 41  A banking regulatory authority shall, with the approval of the leading member of the banking regulatory authority
under the State Council or of its office at the provincial level, have the power to inquire about the bank accounts of the financial
institution of the banking industry suspected of violating laws in financial affairs, and the bank accounts of its staff members
and connected parties; and may, with the approval of the said leading member, submit an application to the judicial authority for
freezing the illegally obtained funds that are suspected of being about to be moved to other places or concealed.  

Chapter V 

Legal Responsibility 

Article 42  Any staff member of the banking regulatory authority engaged in supervision commits any of the following acts shall
be given administrative sanctions according to law; and if a crime is constituted, he shall be investigated for criminal responsibility
in accordance with law: 

(1) in violation of relevant regulations, examining and giving approval to the establishment, change or termination of a financial
institution of the banking industry, or its business scope or the services it offers within its business scope; 

(2) in violation of relevant regulations, conducting on-site inspection of a financial institution of the banking industry; 

(3) failing to report an emergency in accordance with the provisions in Article 28 of this Law; 

(4) in violation of relevant regulations, inquiring about bank accounts or submitting an application for freezing funds; 

(5) in violation of relevant regulations, taking measures against or penalizing a financial institution of the banking industry;
and 

(6) other acts such as abuse of power and neglect of duties. 

Any staff member of the banking regulatory authority engaged in supervision who commits embezzlement, bribery or divulgence of State
secrets or the business secrets he knows, which constitutes a crime, shall be investigated for criminal responsibility according
to law; and if it is not serious enough to constitute a crime, he shall be given administrative sanctions according to law. 

Article 43  Where a financial institution of the banking industry is established without authorization, or the business activities
of financial institutions are illegally engaged in, the banking regulatory authority under the State Council shall outlaw such an
institution and such business activities. If a crime is constituted, criminal responsibility shall be investigated according to law;
if the case is not serious enough to constitute a crime, the unlawful gains shall be confiscated by the banking regulatory authority
under the State Council; if the unlawful gains exceed RMB 500,000 yuan, a fine of not less than the amount of the unlawful gains
but not more than five times that amount shall, in addition, be imposed; and if there are no unlawful gains or the amount of such
gains is less than 500,000 yuan, a fine of not less than 500,000 yuan but not more than 2,000,000 yuan shall be imposed.  

Article 44  Where a financial institution of the banking industry commits one of the following acts, it shall be instructed
by the banking regulatory authority under the State Council to rectify; if there are unlawful gains, such gains shall be confiscated;
if the unlawful gains exceed 500,000 yuan, it shall, in addition, be fined not less than the amount of such gains but not more than
five times that amount ; if there are no unlawful gains, or such gains are less than 500,000 yuan, it shall be fined not less than
500,000 yuan but not more than 2,000,000 yuan; if the circumstances are particularly serious, or if the institution fails to rectify
within the prescribed period of time, the banking regulatory authority under the State Council may instruct it to suspend business
for rectification or revoke its business license; if a crime is constituted, the institution shall be investigated for criminal responsibility
according to law: 

(1) establishing a branch without approval; 

(2) making changes or terminating business operations without approval; 

(3) in violation of relevant regulations, engaging in business activities for which no approval is obtained or which are not put
on record; and 

(4) in violation of relevant regulations, raising or lowering interest rates on deposits or loans. 

Article 45  Where a financial institution of the banking industry commits one of the following acts, the banking regulatory
authority under the State Council shall instruct it to rectify and shall, in addition, impose on it a fine of not less than 200,000
yuan but not more than 500,000 yuan; if the circumstances are particularly serious, or if the institution fails to rectify within
the prescribed period of time, the said authority may instruct it to suspend business for rectification or revoke its business license;
if a crime is constituted, the institution shall be investigated for criminal responsibility according to law: 

(1) appointing directors or senior managers without subjecting their qualifications for the positions to examination; 

(2) refusing to accept or obstructing the off-site   supervision or on-site inspection; 

(3) providing statements, reports, documents or materials that are false or conceal important facts; 

(4) failing to disclose information to the public in accordance with relevant regulations; 

(5) violating the rules of prudent operation to a serious extent; and 

(6) refusing to enforce the measures as provided for in Article 37 of this Law. 

Article 46  Where a financial institution of the banking industry fails to provide statements, reports, documents or materials
in accordance with relevant regulations, the banking regulatory authority shall instruct it to rectify. If it fails to comply within
the prescribed period of time, it shall be fined not less than 100,000 yuan but not more than 300,000 yuan. 

Article 47  Where a financial institution of the banking industry violates laws, administrative regulations or regulations of
the State governing regulation and supervision of the banking industry, the banking regulatory authority may, in addition to the
penalties specified in Articles 43, 44, 45 and 46 of this Law, take the following measures, depending on the seriousness of the circumstances: 

(1) to instruct the financial institution to impose disciplinary sanctions on the directors and senior mangers who are directly in
charge and the other persons who are directly responsible; 

(2) if the case is not serious enough to constitute a crime, to give disciplinary warnings to the directors and senior managers who
are directly in charge and the other persons who are directly responsible and impose on them each a fine of not less than 50,000
yuan but not more than 500,000 yuan; and 

(3) to disqualify the directors and senior mangers who are directly in charge for a specified period of time or for life, or to
prohibit them and the other persons who are directly responsible from working in the banking industry for a specified period of time
or for life. 

Chapter VI 

Supplementary Provisions 

Article 48  Where with regard to the regulation of and supervision over the policy banks and asset management companies established
in the territory of the People’s Republic of China, laws and administrative regulations provide otherwise, the provisions there shall
prevail. 

Article 49  Where with regard to the regulation of and supervision over the wholly foreign-funded financial institutions, Chinese-foreign
joint venture financial institutions and branches of foreign financial institutions of the banking industry that are established
in the territory of the People’s Republic of China, laws and administrative regulations provide otherwise, the provisions there shall
prevail. 

Article 50  This Law shall go into effect as of February 1, 2004.

Notice: All Rights Reserved to the Legislative Affairs Commission of the Standing Committee of the National People’s Congress.







INTERIM MEASURES FOR THE MANAGEMENT OF THE DEALINGS OF DERIVATIVE PRODUCTS OF FINANCIAL INSTITUTIONS

China Banking Regulatory Commission

Order of the China Banking Regulatory Commission

No. 1

Interim Measures for the Management of the Dealings of Derivative Products of Financial Institutions have been adopted at the chairman
meeting of China Banking Regulatory Commission and are hereby promulgated. The present Measures shall come into effect as of March
1, 2004.

Liu Mingkang, Chairman of the China Banking Regulatory Commission

February 4, 2004

Interim Measures for the Management of the Dealings of Derivative Products of Financial Institutions

Chapter I General Provisions

Article 1

With a view to regulating the dealings of derivative products of banking institutions, effectively controlling the risk of banking
institutions in the transaction of derivative products, the present Measures are formulated in accordance with Banking Supervision
Law of People’s Republic of China and Commercial Bank Law of People’s Republic of China and other relevant laws and regulations.

Article 2

The term of financial institutions as mentioned in the present Measures refers to the banks, trust and investment companies, finance
companies, financial leasing companies, legal person of auto financing companies and branches of foreign banks established within
the territory of People’s Republic of China (hereinafter referred to as branches of foreign banks).

Article 3

The term of derivative products as mentioned in the present Measures refers to a certain type of financing contract the value of which
subjects to one or more than one basic assets or index. Basic types of these contracts are futures, transaction at usance, swap transaction
and futures rights. Derivative products also including structural financial tools that have one or more characteristic of futures,
transaction at usance, swap transaction and futures rights.

Article 4

The dealings of derivation products of financial institutions referred to in the present Measures can be divided into two categories
as followed:

(1)

The derivative product transactions for the purpose of making profit or avoiding risk of their own capital and debt. The financial
institutions are regarded as the final customer of derivative product.

(2)

Financial institutions provide the derivative product transactions to clients (including financial institutions). Financial institutions
are regarded as the broker of the derivative product transactions and those brokers who provide quoting service and negotiable service
to other brokers and clients are regarded as the market manipulators of derivative products.

Article 5

China Banking Regulating Commission (hereinafter referred as to CBRC) shall be responsible for supervision over the derivative product
transactions of financial institutions. Financial institutions shall pass the examination and approval of CBRC and accept the supervising
and administration of CBRC in operating the derivative product transactions.

Any non-financial entity shall not provide the dealing services of derivative product to the clients.

Article 6

Financial institutions shall observe the provisions on foreign exchange and other relevant provisions in operating the derivative
product transactions related with the foreign exchange, stocks and commodities and derivative product transactions on exchange.

Chapter II Administration of Market Access

Article 7

Financial institutions that apply for the operation of the derivative product transactions shall meet the following requirements

(1)

Having a perfect risk control system and internal controlling system of the derivative product transactions;

(2)

Having a operating system of auto-connection of the derivative product transactions and real-time risk control system;

(3)

Operating staff of the derivative product transactions shall has an experience of directly operating the derivative product transactions
and risk control for more than 5 years, and shall not have any defective record;

(4)

Having at least 2 operating staff that has over 2 years experience of the derivative product transactions and related derivative product
transactions and over half a year experience of special training of operating skill of the derivative product transactions, 1 executive
of risk control, 1 staff for risk model research or analyses. The mentioned staff shall be sole duty person and shall not hold a
concurrent post or have any defective record;

(5)

Having appropriate trading floor and equipment;

(6)

If the branches of foreign banks plan to run the derivative product transactions, the registered country shall have a legal system
of supervising and regulating the derivative product transactions and the competent authority of the country shall have the capability
of supervising and regulating;

(7)

Other requirements of CBRC.

The branches of foreign banks plans to run the derivative product transactions that can not meet the requirements of Item 1 to Item
5 shall conforms with Item 6, Item 7 of the preceding Paragraph and following requirements:

(1)

Having formal authorization concerning type and quota of the derivative product transactions and other matters from its headquarter,

(2)

Except definite provisions of its headquarter, all the derivative product transactions of the branches shall be operated through the
real-time system of the authorized headquarter, and the inventory adjusting, risk exposure operation and risk control shall be operated
by the headquarter.

Article 8

The Policy banks, Chinese-funded commercial banks (except the city commercial banks, rural commercial banks and rural cooperative
banks), trust and investment banks, finance companies, finance leasing companies, auto-financing companies shall, if they operate
transactions of derivative products, apply for certificate from CBRC by their legal representatives and be examined and approved
by CBRC.

City commercial banks, rural commercial banks and rural cooperative banks shall, if they operate transactions of derivative products,
submit the application materials to the local Banking Regulatory Bureau by their legal representatives and shall be examined and
approved by CBRC after the approval of local departments.

Foreign-funded financial institutions shall, if they operate the transactions of derivative products, submit application materials
signed by the authorized signer to the local Banking Regulatory Bureau and shall be examined and approved by CBRC after the approval
of local departments. Foreign-funded bank institutions that plan to operate the derivative product transactions in more than two
branches in the territory of China may submit the application materials to the local Banking Regulatory Bureau by their headquarters
or the main reporting bank of the foreign bank and shall be examined and approved by CBRC after the approval of local departments.

Article 9

Where financial institutions apply for the operation of the derivative product transactions, they shall submit the following documents
and materials in triplicate to CBRC or its agencies,

(1)

Application report, feasibility report, operation program or the derivative product transactions acquisition plan;

(2)

Internal executive regulation of the derivative product transactions;

(3)

Accounting system of the derivative product transactions;

(4)

List and resume of the governor and main derivative product transactions staff;

(5)

Authorized administrative system of risk exposure qualification or limitation;

(6)

Security testing report of trading floor, equipment and system;

(7)

Other documents and materials required by CBRC.

Branches of foreign banks operating the derivative product transactions that do not satisfy criteria listed in Item 1 to Item 5 of
Article 7 shall submit following documents to the local Banking Regulatory Bureau at the time of application,

(1)

Documents of formal written authorization from the headquarter to the branches of operating the derivative product transactions,

(2)

Promising letter from the headquarter of insuring the real-time derivative product transactions of all the derivative product transactions
of its branches through the system of the headquarters and taking charge of inventory adjusting, risk exposure operation and risk
control.

Article 10

Internal executive regulations of the financial institutions that operate the derivative product transactions shall essentially involve
following contents,

(1)

Rudder, operational procedure that shall reflect the principle of separation of pre-phase, middle-phase and after-phase, emergency
solution of the derivative product transactions;

(2)

Risk model index and qualification operation index;

(3)

Type of derivative product transactions and correspondent risk control system;

(4)

Risk report and internal audit system;

(5)

Executive and evaluation system of research and development of the derivative product transactions;

(6)

Rules of brokers;

(7)

Job responsibility system of derivative product transactions governors and questioning mechanism and prompting and restricting mechanism
of the governor at all level and traders;

(8)

Training program for the persons-in-charge and workers;

(9)

Other contents required by CBRC.

Article 11

CBRC shall give response within 60 days after the reception of all application materials submitted by the financial institutions according
to the present Measures.

Article 12

Legal person in the territory of China shall strictly examine the capability of risk control of its agencies in authorizing them to
operate the derivative product transactions and make formal written documents of authorization concerning type of derivative product
transactions and limitation. The agencies shall operate the derivative product transactions unifiedly through their headquarters’
real-time system, and their headquarters shall run inventory adjusting, risk exposure operation and risk control as a whole.

The aforesaid agencies shall report to the local Banking Regulatory Bureau within 30 days after the receipt of authorization or authorization-altering
documents from headquarter with aforesaid documents.

Chapter III Risk Management

Article 13

Financial institutions shall, according to its own characteristic of operating target, assets scale, managing ability and risk of
the derivative product transactions, make sure the capability of running the derivative product transactions and confirm the type
and scale of the derivative product transactions.

Article 14

Financial institutions shall, according to the classification of Article 4 , set up the sound systems of risk control, internal control
and operation corresponding to the type, scale and complexity of the operating derivative product transactions.

Article 15

Higher executives of financial institutions shall know the risk of the derivative product transactions, comprehensive management framework
involving principles, procedure, organization and power limitation of auditing, approving and evaluating the operation and risk control
of the derivative product transactions and shall be capable of acquiring information on the derivative product transactions through
independent risk control departments and sound examining and reporting system and giving corresponding supervision and guidance.

Article 16

Higher executives of the financial institutions shall decide the calculating method and index of risk exposure of the derivative product
transactions that is adaptive to the operation of their institutions, and shall make, regularly checkup and update the system of
risk exposure limit, loss limit and emergency solution according to the comprehensive ability, owned assets, profitability, operation
policy and estimation of market. Higher executive also shall make supervision and control procedure of limitations. Higher executives
of the financial institutions in charge of operating the derivative product transactions and of risk control shall be divided separately.

Article 17

Financial institutions shall make clear criteria of working certificate of traders, analyzers and other staff and arrange training
for the salesman and other operating staff according to the complexity of the derivative product transactions so as to ensure they
have efficient skill and competency.

Article 18

Financial institutions shall make sound policy of evaluating the other party of the derivative product transactions, including whether
the other party thoroughly understand the contract and the responsibility of perform it, whether the derivative product transactions
meet the real target of the other party and the evaluation of credit risk of the other party.

Financial institutions shall make special provisions on the qualification of the other party under the circumstance of high-risk derivative
product transactions type.

Financial institutions may reasonably rely on the formal written documents provided by the other party according to the principle
of good faith in performing the present Article.

Article 19

Financial institution shall explain the risk of the derivative product transactions to the institution or individual in operating
the derivative product transactions for them and shall get the confirmation letter from them so as to confirm that they have understand
and have the ability to bear the risk.

The information exposed to the institution or individual by the banking institution shall at least involve following contents,

(1)

Content and risk summary of the contract on the derivative product transactions,

(2)

Important factors influencing potential loss of the derivative product.

Article 20

Financial institutions shall appropriately and reasonably use all kinds of risk buffer measures like guarantee to reduce the credit
risk of the other party of the derivative product transactions, evaluate the credit risk by using appropriate method and model and
apply corresponding risk control measures.

Article 21

Financial institutions shall evaluate market risk of the derivative product transactions by using appropriate evaluation method or
model, handle the market risk according to the price principles, and adjust the operation scale, type and risk exposure level.

Article 22

Financial institutions shall make sound fluidity arrangements according to the scale and type of the derivative product transactions
in order to ensure the sufficient performing ability under the unusual market circumstances.

Article 23

Financial institutions shall establish and amplify sound systems and mechanisms of operating risk control so as to strictly control
the derivative product transactions risk.

Article 24

Financial institutions shall establish and amplify sound systems and mechanisms of legal risk control so as to strictly examine the
transacting qualification and legal status. Financial institutions shall, in signing the contract of the derivative product transactions
consult, refer to the legal documents world widely adapted, thoroughly consider factors like feasibility of demanding and saving
from damage on account of breaking a contract by using legal measures and take effective means to prevent legal risk in drafting
out transactions contract, negotiating and concluding, etc.

Article 25

Financial institutions shall submit accounting statement, statistic statement and other related reports of the derivative product
transactions to CBRC according to the provisions promulgated by CBRC.

Financial institutions shall disclose risk situation, loss situation, profit change and other unusual situation of the derivative
product transactions according to the provisions on information exposing promulgated by CBRC.

Article 26

CBRC have the privilege of inspecting materials and statements of the derivative product transactions from financial institutions
at any time and of inspecting regularly whether the risk control system, internal control system and operation system of the financial
institutions adapt the type of derivative product transactions they operate.

Article 27

Financial institutions shall timely and actively report to CBRC and submit corresponding solution under the circumstance of existing
big operation risk or tremendous loss in running the derivative product transactions.

Financial institutions shall timely and actively report detailed information to CBRC under the circumstance of important change of
operation, executive system or risk control of the derivative product transactions.

Financial institutions shall simultaneously send a copy to the State Administration of Foreign Exchange in the case that the aforesaid
matters related to the foreign exchange administration and external payment.

Article 28

Financial institutions shall properly conserve all the operation documents and documents, accounting books, original evidences, telephone
record and other materials of the derivative product transactions. Telephone record shall be conserved for more than half one year,
and other materials shall be reserved for 3 years after the maturity of the contract for the purpose of examination. The special
provisions of accounting prevail.

Chapter IV Penalty Provisions

Article 29

Where the traders of the derivative product transactions in the financial institutions violate these Measures or relevant provisions
of the institution resulting in heavy economic losses to the institution or the clients, financial institutions thereof shall give
the directly responsible higher executives and other governor and directly liable persons the penalty of demerit to expel. Those
who violate the Criminal law shall be transmitted to judiciary departments to investigate and affix criminal responsibility.

Article 30

Financial institutions that operate the derivative product transactions without permission of CBRC shall be given penalty by CBRC
according to Measures on Punishing Illegal Activity in Financing.

Non-financing institutions that violate these Measures and provide service of the derivative product transactions to the clients shall
be clamped down by CBRC and the illegal profit shall be confiscated by CBRC. Those violate criminal law shall be transmitted to judiciary
departments to investigate and affix criminal responsibility.

Article 31

CBRC shall respectively give penalty to the financial institutions that do not submit relevant statements, materials or that do not
expose related information according to the character of the institutions and Banking Supervision Law of People’s Republic of China,
Commercial Bank Law of People’s Republic of China, Regulations on Administration of Foreign-funded Financial institutions of People’s
Republic of China and other relevant laws, regulations and financial regulations.

CBRC shall give penalty to the financial institutions that provide fake information of the derivative product transactions or disguise
important information of the derivative product transactions according to Measures on Punishing Illegal Activity in Financing.

Article 32

CBRC can suspend or revoke the qualification of operating the derivative product transactions of the financial institutions under
the circumstance of finding the institutions did not effectively execute essential risk management and internal management system
of the derivative product transactions.

Chapter V Supplementary Provisions

Article 33

The power to interpret the present Measures shall remain with CBRC.

Article 34

The present Measures shall enter into effect as of March 1, 2004. If any provisions governing the derivative product transactions
of financial institutions issued previously are in conflict with the present Measures, the present Measures shall prevail



 
China Banking Regulatory Commission
2004-02-04

 







MEASURES FOR THE ADMINISTRATION OF PHARMACEUTICAL TRADE LICENSE






State Food and Drug Administration

Order of the State Food and Drug Administration

No.6

The Measures for the Administration of Pharmaceutical Trade License, deliberated and adopted at the executive meeting of the State
Food and Drug Administration on January 2, 2004, are hereby promulgated, and shall be implemented as of April st, 2004.

Zheng Xiaoyu, Director General of the State Food and Drug Administration

February 4th, 2004

Measures for the Administration of Pharmaceutical Trade License

Chapter I General Provisions

Article 1

With a view to strengthening supervision over and administration of the licensing of pharmaceutical trading, the present Measures
are hereby formulated in accordance with the Pharmaceutical Administration Law of the People’s Republic of China, the Regulations
on the Implementation of the Pharmaceutical Administration Law of the People’s Republic of China (hereinafter referred to as the
Pharmaceutical Administration Law, and Regulations on the Implementation of the Pharmaceutical Administration Law),

Article 2

The present Measures shall be applicable to the license issuance, renewal, alteration and supervision over and administration of Pharmaceutical
Trade License.

Article 3

The State Food and Drug Administration shall be in charge of the supervision over and administration of the licensing of national
pharmaceutical trading.

The departments of food and drug administration of the provinces, autonomous regions, and municipalities directly under the Central
Government shall be responsible for license issuance, renewal, alteration, and routine supervision over and administration of Pharmaceutical
Trade License of pharmaceutical wholesale enterprises within their respective jurisdictions, and shall direct and supervise the lower
level organs of food and drug administration on carrying out the supervision over and the administration of Pharmaceutical Trade
License.

The organs of food and drug administration at the level of cities with districts under them or those at the county level which are
set up directly by the departments of food and drug administration at the levels of provinces, autonomous regions, and municipalities
directly under the Central Government, shall be responsible for the work of license issuance, renewal, alteration and routine supervision
over and administration of Pharmaceutical Trade License of drug retail enterprises within their respective jurisdictions.

Chapter II Conditions for Applying for the Drug Business License

Article 4

In accordance with the provisions of Article 14 of the Pharmaceutical Administration Law, where a pharmaceutical wholesale enterprise
launches, it shall conform to the requirements for the reasonable overall arrangement for pharmaceutical wholesale enterprises of
provinces, autonomous regions, and municipalities directly under the Central Government for its establishment, and shall measure
up to the following standards for establishment:

1.

Having rules and regulations that can ensure the quality of drugs it deals in.

2.

The enterprise, the legal representative, responsible person, or the person responsible for quality control of the enterprise has
no circumstances as prescribed in Articles 76 and 83 of the Pharmaceutical Administration Law;

3.

Having a certain number of practicing apothecaries in line with its business scale. The person responsible for quality control shall
have a bachelor’s degree or above, and shall be a practicing apothecary as well;

4.

Having normal temperature warehouses, cool warehouses or refrigerators, which can ensure the quality requirements for pharmaceutical
storage and can fit in with its variety and scale of business, and in which there shall be special goods shelves for pharmaceutical
storage, and the installations and equipment of modern logistic system for the pharmaceuticals’ entering a warehouse, transmission,
sorting out, putting on shelves, and leaving a warehouse..

5.

Having independent computer management information system, which can cover the whole process of the pharmaceutical purchase, storage,
sale, and management and quality control within the enterprise, and can record all the information on the management and implementation
of the Standards for Quality Control of Pharmaceutical Trading of the enterprise; meeting the requirements of Standards for Quality
Control of Pharmaceutical Trading for each process of pharmaceutical management, and having conditions for accepting supervision
of the local departments or organs for food and drug administration; and

6.

Having conditions of conforming to the requirements of the Standards for Quality Control of Pharmaceutical Trading for pharmaceutical
business office, auxiliary and office buildings, and warehouse management, quality safeguards for pharmaceuticals in the warehouse,
and the entry-exit of warehouse, in-warehouse storage and maintenance.

Unless there are otherwise state provisions on management of stupefacient, psychotropic drugs, toxic drugs for medical treatment,
and preventive biological produce, those provisions shall prevail.

Article 5

The establishment of a pharmaceutical retail enterprise shall conform to the requirement of the number of local permanent residents,
regions, traffic status and actual needs, and follow the principle of convenience for the mass people to purchase pharmaceuticals,
and accord with the following provisions on establishment:

1.

Having rules and regulations that can ensure the quality of pharmaceuticals it deals in; and

2.

Having pharmaceutical technical personnel whose qualifications have been certified in jure.

A pharmaceutical retail enterprise, which undertakes the trading of prescriptive pharmaceuticals, or Class A non-prescriptive pharmaceuticals
(OTC), shall have practicing apothecaries or other pharmaceutical technical personnel whose qualifications have been certified in
jure. The person responsible for quality control shall have work experiences of quality control for pharmaceutical trading for no
less than one year.

A pharmaceutical retail enterprise, which undertakes the trading of Class B non-prescriptive pharmaceuticals (OTC), and the pharmaceutical
retail enterprises established in areas below the rural villages and towns, shall recruit business personnel according to Article
15 of the Regulations on the Implementation of the Pharmaceutical Administration Law, and the practicing apothecaries shall also
be recruited as long as conditions permit:

The aforesaid personnel shall be on the job during the business hours of the enterprise.

3.

The enterprise, legal representative, responsible person or person responsible for quality control of the enterprise has no circumstances
as prescribed in Articles 76 and 83 of the Pharmaceutical Administration Law;

4.

Having the places of business, equipment, warehouse facilities and sanitary conditions fitting in with the pharmaceuticals it deals
in. Where a retail pharmaceutical store is established in the supermarkets or within other commercial enterprises, it must have an
independent area; and

5.

Having abilities of supplying drugs that can meet the demand of local consumers, and ensuring the 24-hour supply. The departments
of food and drug supervision and administration of all provinces, autonomous regions, and municipalities directly under the Central
Government shall, according to the specific circumstances of the local regions, determine the variety and quantity of state basic
pharmaceuticals that shall be stocked by the pharmaceutical retail enterprises.

Unless there are otherwise state provisions on management of stupefacient, psychotropic drugs, toxic drugs for medical treatment,
and preventive biological produce, those provisions shall prevail.

Article 6

The formulation of implementation standards for checking and accepting the establishment of pharmaceutical wholesale enterprises shall
remain with the State Food and Drug Administration. The implementation standards for checking and accepting the establishment of
drug retail enterprises shall be formulated by the departments of food and drug administrations of the provinces, autonomous regions
and municipalities directly under the Central Government in accordance with the relevant contents of the present Measures and the
Standards for Quality Control of Pharmaceutical Trading, and shall be reported to the State Food and Drug Administration for archival
document.

Article 7

The checking and ratifying of the business scope of the pharmaceutical trading enterprises:

The business scope of pharmaceutical trading enterprises shall cover:

stupefacient, psychotropic drugs, and toxic drugs for medical treatment;

Biological produce;

Chinese traditional medicinal materials; Chinese traditional medicine drink pills; Chinese patent medicines, chemical material medicines
and their preparations; antibiotic material medicines and their preparations, biological and chemical medicines.

Where the enterprises undertake pharmaceutical retail, their class of business shall be checked and ratified, the applicants’ qualifications
of managing the prescriptive pharmaceuticals or non-prescriptive pharmaceuticals or Class B non-prescriptive pharmaceuticals shall
be determined first, and after the aforesaid has been clarified in their business scope, the specific scope of business shall be
checked and ratified.

The checking and ratifying of toxic drugs for medical treatment, stupefacient, psychotropic drugs, radioactive drugs and preventive
biological products shall be carried out according to the relevant state provisions on the administration of special pharmaceuticals
and preventive biological products.

Chapter III The Procedures for Applying for the Pharmaceutical Trade License

Article 8

The Pharmaceutical Trade License for opening a pharmaceutical wholesale enterprise shall be handled according to the procedures as
follows:

1.

The applicant shall file an application for preparing to establish such an enterprise with the departments of food and drug administration
of the provinces, autonomous regions, and municipalities directly under the Central Government at the place where the enterprise
to be established is located, and submit the following documents:

(1)

The original and photocopy of the certificate of educational backgrounds and personal resumes of the legal representatives, persons
responsible, and persons responsible for quality control of the enterprise to be established;

(2)

The original and photocopy of the practising license of the practicing apothecary;

(3)

The scope of pharmaceuticals to be dealt in; and

(4)

The place of business, equipment, warehouse establishments to be established and the sanitary conditions around, etc.

2.

The departments of food and drug administration shall handle the applications filed by an applicant separately according to the circumstances
as follows:

(1)

Where the matters applied for do not fall within the scope of the functions and powers of the corresponding departments, they shall
make a decision of not acceptance in time, and issue the Notice of Not Acceptance, and inform the applicant to apply to the relevant
departments of food and drug administration;

(2)

Where there is any mistake in application documents, and the mistake can be corrected on the spot, the applicant shall be permitted
to correct it on the spot;

(3)

Where the application documents are incomplete or don’t measure up to legal forms, the applicant shall be issued the Notice to Supplement
the Documents on the spot or within 5 days, and be informed to supplement the whole documents needed in one time. Where they fail
to inform the applicant within the prescribed time limit, the date of their receiving the application documents shall be deemed as
the date of acceptance; and

(4)

Where the matters applied for fall within the scope of functions and powers of the corresponding departments, and the documents thereof
are complete and conforming to the legal form, or the applicant has submitted all the supplementary documents as required, the Notice
of Acceptance shall be issued to the applicant. And the date indicated in the Notice of Acceptance shall be deemed as the date of
acceptance.

3.

The departments of food and drug administration shall, within 30 working days as of the date of accepting the application, make an
examination of the documents submitted according to the provisions of Article 4 of the present Measures, and make a decision on
whether or not to agree with the preparation for establishment, and notify the applicants in writing. Where they don’t agree with
the preparation for establishment, they shall explain the reason, and notify the applicants of their rights of applying for administrative
reconsideration or institute an administrative litigation in jure.

4.

After an applicant has finished the preparation for establishment, it shall submit an application for checking to the departments
of food and drug administration that accept the application, and submit the following documents:

(1)

Application for Pharmaceutical Trade License;

(2)

Documents of approval and certification issued by the departments for industry and commerce administration for the enterprise to be
established;

(3)

Organizational structure of the enterprise to be established;

(4)

Ground disposition plan of the places of business and warehouses, and certificates of the ownership of or right to use the houses;

(5)

Qualification certificates and letter of appointment of the special technical personnel in pharmacy certified in jure; and

(6)

The quality control documents of the enterprise to be established and the indexes of the warehouse establishments and facilities thereof.

5.

The departments of food and drug administration accepting the application shall, within 30 working days from the date of receiving
the application for checking, organize the checking according to the implementation standards for checking and accepting the establishment
of pharmaceutical wholesale enterprises, make decisions on whether or not to issue the Pharmaceutical Trade License. Those enterprises
meeting the requirements shall be issued the Pharmaceutical Trade License; and as to those not meeting the requirements, the applicants
shall be notified in writing and the reason shall be explained, and they shall be informed of the rights of applying for administrative
reconsideration or instituting an administrative litigation in jure.

Article 9

The Pharmaceutical Trade License for opening a pharmaceutical retail enterprise shall be handled according to the procedures as follows:

1.

The applicant shall file an application for preparing the establishment to the food and drug administrative organs at the level of
cities with districts under them where the enterprise to be established is located or to those of the county level established directly
by the departments of food and drug administration of provinces, autonomous regions, and municipalities directly under the Central
Government, and submit the following documents:

(1)

The originals or photocopies of the educational background, qualifications to practice or certificates of post_title of a technical post
of the legal representative, person in charge, person responsible for quality control of the enterprise to be established, and their
personal resumes and qualification certificates and letter of appointment of the special technical personnel;

(2)

The scope of pharmaceuticals to be dealt in; and

(3)

The conditions of the place of business, warehouse facilities and equipment to be established.

2.

The food and drug administrative organs shall handle the application of an applicant separately according to the following conditions:

(1)

Where the matters applied for do not fall within the scope of functions and powers of the corresponding departments, they shall make
decisions of not acceptance immediately, issue the Notice of Not Acceptance, and inform the applicant to apply to the relevant departments
of food and drug administration;

(2)

Where there is any mistake in the application documents, and it can be corrected on the spot, the applicant shall be permitted to
do it on the spot;

(3)

Where the application documents are incomplete or do not measure up to the legal form, they shall issue the Notice for Supplementing
the Documents to the applicants on the spot or within 5 days, and inform them of the whole contents to be supplemented in one time.
If they fail to inform the applicants within the prescribed time limit, the date of receiving the application documents shall be
deemed as the date of acceptance; and

(4)

Where the matters applied for fall within the scope of functions and powers of the corresponding departments, and the documents thereof
are complete and conforming to the legal form, or the applicant has submitted all the supplementary documents as required, the Notice
of Acceptance shall be issued to the applicant. And the date indicated in the Notice of Acceptance shall be deemed as the date of
acceptance.

3.

The departments of food and drug administration shall, within 30 working days from the date of accepting the application, make an
examination of the documents submitted according to the provisions of Article 5 of the present Measures, and decide whether or not
to agree with the preparation for establishment, and notify the applicant in writing. If they disagree, they shall explain the reason,
and notify the applicants of their rights of applying for administrative reconsideration or instituting an administrative litigation
in jure.

4.

After the applicant has finished the preparation for establishment, it shall file an application for checking to the departments of
food and drug administration that accept the application, and submit the following documents:

(1)

Application for Pharmaceutical Trade License;

(2)

Documents of approval and certification issued by the departments for industry and commerce administration for the enterprise to be
established;

(3)

Ground disposition plan of the places of business and warehouses, and the certificates of the ownership of or right to use the houses;

(4)

Qualification certificates and letter of appointment of the special technical personnel in pharmacy certified in jure; and

(5)

The quality control documents of the enterprise to be established and the indexes of the warehouse establishments and facilities thereof.

5.

The food and drug administrative organs accepting the application shall, within 15 working days as of the date of receiving the checking
application, organize a checkup in light of the implementation standards for checking and accepting the establishment of pharmaceutical
retail enterprises, and make decisions on whether or not to issue the Pharmaceutical Trade License. Where the enterprises fail to
meet the conditions, the applicants shall be notified in writing of the reason, and meanwhile shall be informed of their rights of
applying for administrative reconsideration or instituting an administrative litigation in jure.

Article 10

Where the departments or organs of food and drug administration find out that the matters of administrative license of an applicant
concern directly the major interests of other people when making an examination of its application, they shall notify the interested
party. The acceptance departments shall hear the statement and pleadings of the applicant or the interested party. Where the matters
shall be dealt with through a hearing in jure, a hearing shall be held in light of the provisions of law.

Article 11

The departments or organs of food and drug administration shall publicize the relevant information on Pharmaceutical Trade License
they have issued, and the general public shall have the right to consult.

Where, after the publicity of the information, an enterprise is found to have acts of providing false documents, data or other deceptive
acts in the process of applying for the Pharmaceutical Trade License, it shall be punished in jure.

Article 12

The Pharmaceutical Trade License is the legal credence of an enterprise for its undertaking of pharmaceutical trade activities, no
entity or individual may forge, alter, deal, lease or lend it.

Chapter IV Alteration and Renewal of Pharmaceutical Trade License

Article 13

The alteration of the Pharmaceutical Trade License shall include the alteration of the license matters and alteration of registration
matters.

The alteration of license matters refers to the alteration of the means of operation, scope of business, place of registration and
warehouse (including increase or decrease of the warehouses), legal representatives, person in charge, and person responsible for
quality control of the enterprise.

The alteration of registration matters refers to changes on matters not mentioned in the aforesaid paragraphs.

Article 14

Where a pharmaceutical trading enterprise alters the license matters concerning the Pharmaceutical Trade License, it shall apply for
an alteration of registration on Pharmaceutical Trade License to the former organs for issuing license 30 days in advance. And no
license matters shall be altered without approval.

The former organs for issuing license shall, within 15 working days from the date of receiving the application for enterprise alteration
and alteration of the application documents, make a decision on whether or not to grant the alteration.

Where an enterprise applies for alteration of the license matters, the original license issuing departments may not handle the formalities
for alteration until they have checked and accepted the enterprise and confirmed its eligibility in light of the conditions as prescribed
in the present Measures.

After a pharmaceutical trading enterprise has made alteration on the license matters concerning the Pharmaceutical Trade License,
it shall go through the relevant alteration procedures for enterprise registration to the departments for industry and commerce administration
in jure.

Where an enterprise divides, merges, or changes its means of operation, or transfers exceeding the former jurisdictions, its Pharmaceutical
Trade License shall be handled anew in light of the provisions of the present Measures.

Article 15

Where a non-legal person branch of an enterprise legal person alters the license matters of the Pharmaceutical Trade License, it shall
show the alteration application with the opinions of the upper level legal person signed therein.

Article 16

Where an enterprise is put on records and investigated into by the departments or organs of food and drug administration for illegal
operation, and the case has not been concluded yet; or a decision of administrative punishment has been made but the punishment has
not been executed, the organs for issuing license shall suspend the acceptance of its application for alteration of the Pharmaceutical
Trade License.

Article 17

Where a pharmaceutical trading enterprise alters the registration matters of the Pharmaceutical Trade License, it shall, within 30
days after the alteration has been approved by the departments for industry and commerce administration, apply for alteration registration
on the Pharmaceutical Trade License to the former organs for issuing license, who shall then handle alteration formalities for it
within 15 working days from the date of receiving the application for enterprise alteration and alteration application documents.

Article 18

After the registration matters of the Pharmaceutical Trade License have been altered, the former organs for issuing license shall
record the contents and time for alteration in the duplicate of the Pharmaceutical Trade License, and change and issue anew the original
copy of the Pharmaceutical Trade License in light of the contents altered, and take back the original copy of the Pharmaceutical
Trade License. The period of validity of the altered Pharmaceutical Trade License shall remain unchanged.

Article 19

The period of validity of the Pharmaceutical Trade License shall be 5 years. If the license holding enterprises need to continue the
trading of pharmaceuticals at the expiration of the period of validity, they shall apply to the original license issuing enterprises
for a renewal of the Pharmaceutical Trade License within 6 months before the expiration of the period of validity. The former organs
for issuing license shall make examination in light of the conditions for application and establishment as prescribed in the present
Measures. If the requirements are met, they shall withdraw the original license and reissue a new one. If the requirements are not
met, they shall order the enterprises to rectify within a time limit of three months. And if the requirements are still not met after
the rectification, the original Pharmaceutical Trade License shall be written off.

The departments or organs of food and drug administration shall, upon the application of pharmaceutical management enterprises, make
decisions on whether or not to approve their renewal of licenses before the expiration of the period of validity of the Pharmaceutical
Trade License. If they fail to make decisions within the time limit, they shall be considered as having approved the renewal of license.

Chapter V Supervision and Inspection

Article 20

The departments or organs of food and drug administration shall strengthen the supervision and inspection over the enterprises holding
the Pharmaceutical Trade Licenses. And the enterprises holding the licenses shall accept the supervision and inspection in light
of the provisions of the present Measures.

Article 21

The contents of supervision and inspection shall mainly include:

1.

The name of the enterprise, business address, place of warehouses, legal representative or responsible person of the enterprise, person
responsible for quality control, means of operation, scope of business, the branches, and the implementation and alteration of other
important matters concerned;

2.

The alteration of the business establishments and equipment of the enterprise and the warehouses conditions;

3.

The implementation of the Standards for Quality Control of Pharmaceutical Trading by the enterprise; and

4.

Other relevant matters that the organs for issuing license need to examine.

Article 22

The supervision and inspection may be made by ways of inspection in written forms, on-the-spot inspection or the combination of the
two ways above-mentioned.

1.

The organs for issuing license may require the license holding enterprises to submit the relevant documents of the Pharmaceutical
Trade License, and perform their supervision functions through checking the relevant documents; or

2.

The organs for issuing license may make an on-the-spot inspection on the enterprises holding the license.

In case an enterprise is under any of the following circumstances, it shall be examined on the spot:

(1)

Newly established enterprises in the last year;

(2)

Enterprises having problems in the inspection of the last year;

(3)

Enterprises being imposed upon an administrative punishment for violating the relevant laws and regulations; or

(4)

Enterprises that should be examined on the spot as believed by the organs for issuing license.

The work for supervision and inspection and examination on license alteration may be carried out together in the same year as the
renewal of the Pharmaceutical Trade License.

Article 23

The standards for on-the-spot inspection on Pharmaceutical Trade License shall be formulated by the organs for issuing license according
to the implementation standards for checking and accepting the establishment of pharmaceutical wholesale enterprises and those of
pharmaceutical retail enterprises, and the certification and inspection standards of the Standards for Quality Control of Pharmaceutical
Trading, as well as the items for on-the-spot inspection, and shall be reported to the upper level departments (organs) of (food)
drug administration for archive documents.

Article 24

Where any business enterprise is found to have violated the requirements of the Standards for Quality Control of Pharmaceutical Trading
in the supervision and inspection, the organs for issuing license shall order it to rectify within a prescribed time limit. If an
enterprise violates the provisions of Article 16 of the Pharmaceutical Administration Law, and still fails to meet the requirements
for undertaking the pharmaceutical business activities after rectification, it shall be punished in light of the provisions of Article
79 of the Pharmaceutical Administration Law.

Article 25

Where an organ for issuing license makes supervision and inspection over pharmaceutical trading enterprises in jure, it shall record
the conditions of supervision and inspection and the conclusions of disposal, and put the records on archives after they have been
signed by the supervisors and inspectors. The general public shall have the right to consult the relevant records over supervision
and inspection. And the organs for issuing license shall record the conclusions for on-the-spot inspection on the duplicate of the
Pharmaceutical Trade License and publicize them.

Article 26

Under any of the following circumstances, the Pharmaceutical Trade License shall be written off by the former organs for issuing license:

1.

The Pharmaceutical Trade License fails to be renewed at the expiration of its period of validity;

2.

The pharmaceutical trading enterprise terminates the operation of drugs or is closed down;

3.

The Pharmaceutical Trade License is revoked, withdrawn, suspended, taken back, written off or invalidated;

4.

The license matters of the Pharmaceutical Trade License fail to be implemented due to force majeure; or

5.

Other circumstances that the administrative license shall be written off as prescribed by laws and regulations.

Where the departments or organs of food and drug administration write off the Pharmaceutical Trade License, they shall notify the
relevant departments for industry and commerce within 5 working days since the date of the writing-off.

Article 27

The Pharmaceutical Trade License shall include the original copies and duplicate copies, which shall have the same legal force.

Article 28

The organs for

NOTICE OF THE MINISTRY OF FINANCE AND THE STATE ADMINISTRATION OF TAXATION ON STRICTLY IMPLEMENTING THE STANDARDS FOR EXPENSES EXEMPTED FROM INDIVIDUAL INCOME TAX AND NON-TAXABLE ITEMS

the ministry of finance, the state administration of taxation

Notice of the Ministry of Finance and the State Administration of Taxation on Strictly Implementing the Standards for Expenses Exempted
from Individual Income Tax and Non-Taxable Items

CaiShui [2004] No.40

February 6, 2004

Finance offices or bureaus and administrations of local taxation of all provinces, autonomous regions, and municipalities directly
under the Central Government, and cities directly under state planning, and finance bureau of Xinjiang Production and Construction
s:

Recently, some regions have, in violation of tax laws and the national uniform provisions, increased the standard for expenses exempted
from “income from wages and salaries” of individual income tax without permission, and enlarged the application scope for non-taxable
items. These violations have breached the principle of administering taxation according to law, and are harmful for achieving uniform
tax policies, equitable tax burdens and normalized taxation systems, and have brought about very negative influence on the adjustment
of income distribution , the organization of the revenue from individual income tax, and the rectification and normalization of taxation
order. In order to implement the policy and strategy of managing state affairs according to law, and genuinely materialize the requirements
for administration by law, and maintain the seriousness, authority and unity of the tax law, we hereby give the following Notice
on issues concerning the regulation of the standard for expenses exempted from individual income tax and non-taxable items:

I.

To administer taxation according to law and unify tax policies is the embodiment of implementing the basic policy of managing state
affairs by law and administration by law, and is also an important measure for perfecting the system of socialist market economy,
and rectifying and regulating the order of market economy. As was pointed out in the Decision of the Central Committee of the Communist
Party of China on Some Issues Concerning the Improvement of the Socialist Market Economy, which was adopted by the third Plenary
Session of the 16th CPC Central Committee, efforts shall be made to enhance law enforcement and to improve the capabilities and levels
of administrative law enforcement, so as to guarantee the effective implementation of laws and regulations and to safeguard the unity
and dignity of the legal system. The Law of the People’s Republic of China on the Administration of Tax Collection and its detailed
implementation rules prescribe that “No departments, entities or individuals are permitted to make without authorization, by violating
laws or administrative regulations, decisions regarding the collection of tax or the cessation thereof, the reduction, exemption
or refund of tax, the payment of tax evaded or overdue or other decisions in conflict with tax laws or administrative regulations”.
“Any decision conflicting with the tax laws and administrative regulations, made by whatever department, entity or individual, is
void without exception, and the tax authorities shall not execute such a decision and shall report to the higher tax authorities.”
And the Individual Income Tax Law of the People’s Republic of China is the tax law formulated by the National People’s Congress,
and all the regions, departments, entities and individuals shall have the duty to maintain the seriousness, integrity and uniformity
of the Individual Income Tax Law consciously, and have no right to change the provisions of the tax law at will.

II.

For the ten years since the implementation of the existing Individual Income Tax Law. The construction of socialist market economy
of our country has seen great developments, and the conditions of national economy and individual income have changed greatly. As
a result, some provisions of the existing Individual Income Tax Law cannot fully meet the requirements for such developments and
changes, and indeed needs to be revised and further perfected according to the new changes. Therefore, the Central Committee of the
Communist Party of China and the State Council have attached high importance to it, and the requirement for “improving individual
income tax” has been put forward in the Decision of the Central Committee of the Communist Party of China on Some Issues Concerning
the Improvement of Socialist Market Economy, and on this basis the state legislative departments have listed the revision of Individual
Income Tax Law into the lawmaking plan. But, before the completion of the revision on Individual Income Tax Law, the existing provisions
must be abided by. No district, department or entity may be permitted to improve the standards for deduction of expenses for Individual
Income Tax without authorization of the National People’s Congress and the Standing Committee of the National People’s Congress,
nor shall they enlarge the application scope for non-taxable items in any disguised form or exceeding their power. According to the
state law for the administration on tax collection, all levels of taxation authorities shall not implement the provisions of documents
concerning the improvement of standard for expenses exempted from individual income tax without permission or enlarging the application
scope for non-taxable items by some regions in violation of the uniform policy, and the provisions having been implemented shall
be stopped.

III.

Since the implementation of the new taxation system in 1994, in order to meet the requirements for economic development and the continuous
deepening the reform of economic system, the Ministry of Finance and the State Administration of Taxation have, according to their
power for taxation administration, distributed documents concerning items exempt from individual tax. The policies prescribed in
these documents have clearly specified the contents, standards and application scope (object). The taxation authorities at all levels
shall strictly abide by the provisions as required in their implementation, and shall not enlarge the application scope (objects)
or improve standards without permission, nor shall they enlarge these provisions to a uniform standard applicable to all individuals.

IV.

The finance and taxation authorities at all levels shall perform their functions resolutely in accordance with the provisions of the
law on the administration of tax collection, and propose opinions of administering taxation according to law when the local governments
are making research and planning to make provisions not in conformity with the Individual Income Tax Law. And they shall elaborate
on the relevant provisions of tax law to the respective government, and report to the upper level finance and taxation authorities
according to the provisions of law on the administration of tax collection. After receiving this Notice, the finance and taxation
authorities at all levels shall report to the local Party and government leaders in time, and do a good job in publicizing and explaining
this to the Party and government leaders and all circles of the society as well as the vast taxpayers, so as to ensure the accurate
implementation of the Individual Income Tax Law and promote the overall, coordinated and healthy development of socialist economy.

 
the ministry of finance, the state administration of taxation
2004-02-06

 




CONSTITUTION ACT, 1982 – page 22

NOTES (1) The enacting clause was repealed by the Statute Law Revision Act, 1893, 56-57 Vict., c. 14 (U.K.). It read as...