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
China Banking Regulatory Commission
Measures for the Administration on Consolidated Financial Statements in Conducting Supervision Over Foreign-funded Banks
YinJianFa [2004] No.10
March 8th, 2004
Chapter I General Provisions
Article 1
The present Measures are hereby formulated for the purpose of implementing the Banking Supervision Law of the People’s Republic of
China and the Regulations of the People’s Republic of China on the Administration of Foreign-funded Financial Institutions and other
laws and regulations, for the purpose of regulating the supervision over the consolidation of financial statements and implementing
effective risk supervision.
Article 2
China Banking Regulatory Commission (hereinafter referred to as CBRC) shall be responsible for the guidance over the administration
of the consolidation of financial statements in foreign-funded banks.
Article 3
CBRC shall conduct supervision over the solely foreign-owned banks or joint-stock banks that have established operative branch institutions
or affiliated institutions, and foreign banks that have established two or more operative branches in China through the consolidation
of financial statements.
Through the consolidation of financial statements, CBRC can fully supervise over the worldwide operation and risk status of foreign-funded
corporate institutions registered in China, the overall business and risk status of the foreign banks in China, and pay attention
to the business risk and market behaviors thereof worldwide.
Article 4
The leading reporting bank as mentioned hereinafter refers to the parent bank of the solely foreign-funded or joint-stock banks, and
institutions for reporting consolidated financial statements and comprehensive information, which are designated by the parent bank
of a foreign bank or the regional management departments it authorizes and are put on records at the agencies of CBRC. The “supervision
bureau of consolidated financial statements ” refers to the agency of CBRC at the place where the leading reporting bank of a foreign-funded
bank is located. And “the territorial supervision bureau” refers to the agency of CBRC at the place where other business branches
of a foreign-funded bank are located.
Article 5
The “year” as mentioned in the present Measures refers to the year of the Gregorian calendar from January 1 to December 31. The fiscal
year refers to the legal fiscal year of each country.
Chapter II The Determination of the Leading Reporting Banks and their Functions
Article 6
The foreign-funded banks that the conditions of consolidated financial statement in conducting supervision as prescribed in Article
3 of the present Measures shall determine a leading reporting bank.
Article 7
Those foreign-funded corporate institutions that meet the conditions for the supervision over the consolidation of financial statements
as a result of the establishment of additional branch institutions or mergers shall file for a record at an agency of the CBRC at
the place where the parent bank is located within one month after the conditions are met.
Where a foreign bank meets the conditions for the supervision over the consolidation of financial statements due to the establishment
of additional institutions, its parent bank or authorized regional management department shall assign a leading reporting bank within
one month after they have been approved officially by the CBRC. And the leading reporting bank shall then file for a record at the
agency of CBRC at the place where it is located, and send a copy to the relevant territorial supervision bureau.
Article 8
Where a foreign bank needs to change the leading reporting bank, its parent bank or authorized regional management department shall
change the leading reporting bank one month before the end of the fiscal year. The former leading reporting bank and newly appointed
one shall put this on records at the respective local agencies of the CBRC, and send a copy to the relevant territorial supervision
bureau.
The newly appointed leading reporting bank shall undertake the functions of the leading reporting bank from the next fiscal year.
Article 9
The leading reporting bank shall employ full-time or part-time eligible managers in the China Region in light of circumstances. The
examination on the qualifications for holding such a post shall apply the filing system for the senior management personnel of foreign-funded
financial institutions as prescribed in the Detailed Rules for the Implementation of the Regulations of the People’s Republic of
China on the Administration of the Foreign-funded Financial Institutions.
Article 10
The leading reporting bank is an institution for the collection of consolidated financial statements and the comprehensive information
of a foreign-funded bank. It performs the following functions:
1.
The leading reporting bank shall submit or put on record the supervision statements, statement and report of major matters concerned,
and other supervision materials to the supervisory bureaus of consolidated financial statements according to the requirements of
supervision, and shall be responsible for the truthfulness, accuracy and timeliness of the contents submitted and filed on record.
The leading reporting bank shall also be responsible for submitting the business applications concerning several branch banks within
China to the supervisory bureaus of consolidated financial statements uniformly, and send a copy thereof to the territorial supervisory
bureaus.
2.
The leading reporting bank may attend the work meeting or proseminar convened by the CBRC on behalf of the foreign-funded bank it
is subordinated to, and propose opinions and suggestions in the name of the foreign-funded bank. The leading reporting bank, which
attends the meeting shall report in time the information of the meeting to the parent bank (general bank) or the regional management
departments and circulate a timely notice to other business branches within the territory.
The opinions and suggestions of foreign-funded banks on relevant Chinese supervision laws and regulations shall be submitted to the
supervisory bureaus of consolidated financial statements uniformly by the leading reporting bank after being collected by it, After
obtaining the feedback opinions, the leading reporting bank convey them to other business branches within China in time.
3.
The leading reporting bank shall report the relevant information in respect of economy and finance of the parent bank and home country
or region as supervision requires;
4.
The leading reporting bank shall be responsible for the information disclosure of the domestic business branches of a foreign-funded
bank.;
5.
Implementing other requirements of the supervision bureau;
The leading reporting bank shall attach electronic documents at the time of submitting written material.
Article 11
The person in charge of the leading reporting bank shall be responsible for the consolidation of financial statements undertaken by
the leading reporting bank.
Chapter III Non-On-The-Spot Supervision
Article 12
The CBRC shall be responsible for guiding and supervising over the work of its agencies in the non-on-the-spot supervision over the
consolidation of financial statements at foreign-funded banks.
Article 13
The supervisory bureaus of consolidated financial statements shall supervise over the quarterly reports on consolidated financial
statements from the institutions operating at home submitted by the leading reporting bank, of which, the financial statements from
the overseas branches and subordinate institutions of a solely foreign-funded bank or joint-stock bank and the consolidated financial
statements of a group company shall be reported with written documents by year.
Article 14
The supervisory bureaus of consolidated financial statements shall see to it that the leading reporting banks file for a timely record
of the following matters:
1.
The annual report already publicized and the information disclosure of the business branches operating at home for the fiscal year.
2.
The rating by external rating institutions.
3.
The major news released by the parent bank.
4.
The documents specifying the events under investigation.
5.
Appraisal of the supervision bureau of the home country or region and major supervision measures.
6.
The statement on major adjustment of policies in respect of finance and economy of the home country or region. And
7.
Other relevant documents as prescribed in the Detailed Rules for the Implementation of the Regulations of the People’s Republic of
China on the Administration of Foreign-funded Financial Institutions
Article 15
The consolidated financial statement supervision bureaus shall require the leading reporting bank to submit one copy of the Summary
Report of the Business Conditions of Foreign Funded Banks half a year, which shall include basic information (the number of operative
institutions, number of employees, alteration of the business scope, etc.), the specification on centralization of loan granting,
analysis on reserves for losses of loans, the transfer of large amount of assets, analysis on flowing in or out of capitals, connected
transaction, listing of overseas loans or investment, and the trends in operation of the business branches, and other contents. There
are also statements on alteration of the structure, business strategies, level of capital adequacy, financial status and market credit
standing of the parent banks.
Article 16
The consolidated financial statement supervision bureaus shall be responsible for monitoring the indicators for eligible supervision
over the examination through consolidated financial statement on a quarterly basis, and make analysis on the trend of risk supervision
indicators and overall business behaviors.
Article 17
The consolidated financial statement supervision bureaus shall collect the business management systems of foreign-funded banks, and
communicate with the leading reporting bank or senior management personnel of regional management departments on contents of risk
management of foreign-funded banks such as the pattern of management, management information system, risk and authorization management,
compliance management, credit management and financial management, etc..
Article 18
The consolidated financial statement supervision bureaus shall submit the following matters concerned to the CBRC according to relevant
provisions:
1.
The major events concerned and various management systems that have been put on records by foreign-funded banks.
2.
The errors in the reports of the data about consolidated financial statements.
3.
The regulation violation and abnormal alteration of the indexes for examination through consolidated financial statement. And
4.
Attitude toward supervision over consolidated financial statements.
Article 19
The consolidated financial statement supervision bureaus shall, on the basis of comprehensive analysis of various supervision information
and on-the-spot examination, complete the half-year and annual supervision reports on consolidated financial statements
Article 20
The CBRC shall be responsible for communicating with the supervision authorities of the home country or region of the foreign-funded
corporate institutions and the supervision authorities of the home country or region of a foreign bank on issues of supervision they
commonly concern, and carry out cooperation on supervision information exchange.
Article 21
The CBRC shall be responsible for promoting the exchange and share of the comprehensive supervision information within their organs,
and provide or disclose the business conditions of the foreign-funded banks within China.
Article 22
The CBRC shall be responsible for unifying the procedures and requirements for the supervision over the consolidation of financial
statements.
Chapter IV On-the-spot Examination
Article 23
The CBRC shall be responsible for organizing, guiding and coordinating the on-the-spot examination of consolidated financial statements
at foreign-funded banks.
Article 24
There shall be two ways for organizing on-the-spot examination through consolidated financial statements:
1.
Entrusting the consolidated financial statement supervision bureaus and the territorial supervision bureaus to assign examination
groups, and carrying out on-the-spot examination through consolidated financial statements respectively according to examination
plans. And
2.
The CBRC shall organize the supervisors of foreign-funded banks to form an examination group to carry out on-the-spot examination
through consolidated financial statement on the consolidated financial statement institutions.
Article 25
The CBRC shall, according to the conditions of risk supervision and periods of on-the-spot examination, determine plans of on-the-spot
examination of consolidated financial statement at foreign-funded banks, and put forward guiding requirements for the form, contents
and emphasis of the examination.
Article 26
The CBRC shall adjust the contents of consolidated financial statement for on-the-spot examination in light of realities, and coordinate
the time and progress of the examination items. In case the examination group finds any major problem in the examination, it shall
report to the CBRC in time.
Article 27
The CBRC shall uniformly formulate plans of consolidated financial statement for on-the-spot examination organized by it. The examination
group shall carry out on-the-spot examination in light of the procedures and requirements as prescribed in the examination handbook
and plan, and complete the examination task within the prescribed time limit.
After ending the on-the-spot task, the examination group shall finish the “Examination Facts and Appraisal” and relevant ratings of
CAMELs/ROCA, and make a final confirmation on the facts concerned with the senior management of the examined institution. After the
end of the examination, the examination team shall transfer the “Examination Facts and Appraisal” and the result of the grading of
CAMELs/ROCA and the examination files to the agency of the CBRC at their locality.
Upon completion of all the examination plans, the examination group shall collect the report of consolidated financial statement for
on-the-spot examination, and report it to the CBRC together with the “Examination Facts and Appraisal” and the ratings of a single
institution.
Article 28
The supervision opinions on consolidated financial statement for on-the-spot examination shall be coordinated uniformly by the CSRC,
who shall then propose suggestions according to the “Examination Facts and Appraisal” and reflect to the corresponding agencies of
the CBRC.
Article 29
The agencies of the CBRC shall be responsible for following up and handling the consolidated financial statement for on-the-spot examination.
The agencies of the CBRC shall, according to the “Examination Facts and Appraisal” and the suggestions of the CBRC, issue opinions
on the consolidated financial statement for on-the-spot examination to the institutions at their locality, require them to rectify
and correct, and impose punishment on acts in violation of regulations according to relevant provisions.
The agencies of the CBRC shall, within 3 months after the on-the-spot examination through consolidated financial statement, follow
up the implementation of the measures for rectification, or make follow-up on-the-spot examination on the consolidated financial
statement institutions at their locality, and report the rectification and correction to CBRC in time.
Article 30
The CBRC shall be responsible for accepting the application of the supervision bureau of the home country or region of a foreign bank
for the transnational on-the-spot examination, and entrust the local agencies of the CBRC and the examination team to exchange opinions
on the supervision over the examined institution.
After the end of the contact, the agencies of the CBRC shall report the information they have acquired to the CBRC in time, and follow
up the issues referred to by the examination team.
Chapter V External Audit and Three Party Talks
Article 31
Where a foreign-funded bank conforms to the conditions for consolidated financial statement supervision, it shall engage the same
accountant office in principle to be responsible for auditing and consolidated financial statement auditing on domestic business
branches and affiliated institutions.
Article 32
The leading reporting bank shall, one month before the end of the fiscal year, put on records the external auditors and auditing group
they engage in the current fiscal year at the consolidated financial statement supervision bureau, and send a copy to the corresponding
territorial supervision bureau at the same time. In case of changing accountant office, the leading reporting bank shall also submit
statement in writing.
In case the agencies of the CBRC have negative opinions on auditing quality made by the external auditors, who are engaged by the
foreign-funded banks, they may make a suggestion to the foreign-funded banks and ask it to change the auditing team or accountant
office within 14 working days after receiving the letter of recording.
Article 33
The external auditors shall communicate with the consolidated financial statement supervision bureau on the auditing requirements
before conducting the consolidated financial statement auditing.
Article 34
The leading reporting banks shall, within 5 months after the end of the fiscal year, report the “Auditing Report for Consolidated
Financial Statement” and the “Letter of Suggestion on Management through Consolidated Financial Statement” to the consolidated financial
statement supervision bureaus.
Article 35
The territorial supervision bureaus shall, within 30 days after receiving the External Auditing Report and the Letter of Suggestion
on Management, reflect the opinions of appraisal on quality of external auditing to the consolidated financial statement supervision
bureau.
The consolidated financial statement supervision bureaus shall be responsible for making comprehensive appraisal on quality of external
auditing through combination of the feedback opinions of each territorial supervision bureau, and issues reflected in the Auditing
Report for Consolidated Financial Statement and the Letter of Suggestion on Management through Consolidated Financial Statement.
Article 36
The consolidated financial statement supervision bureaus shall, on the basis of comprehensive supervision of foreign-funded banks,
be responsible for proposing plans for three -party talks.
The three-party talks on consolidated financial statement shall be organized by the CBRC, and the participating parties shall include
the CBRC, the consolidated financial statement supervision bureau, the territorial supervision bureau, external auditors and the
leading reporting banks. After the end of the talks, the consolidated financial statement supervision bureaus shall complete the
summary of three parties meeting for the consolidated financial statement, and supervise over the leading reporting bank for its
timely feedback of the implementation of the opinions for rectification and correction.
Chapter VI Supplementary Provisions
Article 37
The present Measures shall be interpreted by the CBRC.
Article 38
The relevant opinions on consolidated financial statement in conducting supervision shall be considered as the basis for examination
of such applications as the establishment of additional institutions of a foreign-funded bank and business access, etc..
Article 39
The present Measures shall come into force as of April 1, 2004. Where other relevant provisions concerning the supervision over consolidated
financial statement at foreign-funded banks conflict with the present Measures, the former will be invalidated simultaneously.
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