Chapter I General Provisions

   Article 1 These Implementation Rules are formulated in accordance with the Frontier

Health and Quarantine Law of the People’s Republic of China (hereinafter referred to as “the Frontier Health and Quarantine Law).

   Article 2 For the purpose of the Frontier Health and Quarantine Law and these Implementation Rules, the definitions of the following terms
are:”Inspection” means that the Frontier Health and Quarantine Organ (hereinafter referred to as the “Health and Quarantine Organ”)
carries out medical inspection and sanitary inspection. “Quarantinable Epidemic Victim” means a person who suffers from quarantinable
infectious disease or a person who has been proved through primary diagnosis by the Health and Quarantine organ to have caught the
quarantinable infectious disease or have become an incubation carrier. “Quarantinable Epidemic Suspect” means a person who has been
exposed to the quarantinable epidemic environment and may transmit quarantinable infectious diseases. “Isolation” means that a person
affected by a quarantinable epidemic disease is being detained in a designated place for medical treatment until there is no longer
any risk of spreading the disease. “Check-up detention” means that a suspect carrier of a quarantinable epidemic disease is being
detained in a designated place for diagnosis and check-up. “On-site clinical check-up” means that a person is required to go to the
nearest health and quarantine organ or medical treatment unit for diagnosis and check-up within a specific period of time set by
the health and quarantine organ or that the person is visited by people either from the health and quarantine organ or from the medical
treatment unit for diagnosis and check-up. “Transportation facility” means cargo containers. “Sanitization” means both medical measures,
including isolation, check-up detention and on-site clinical check-up; and “sanitary measures” including disinfection, deratization,
and deinsectization. “To monitor epidemic diseases” means to carry out survey in a specific environment and among specific groups
of people on matters relating to epidemiology, serology, etiology, and clinical symptoms; and to make prognostication of the incidence,
development and spread of an epidemic disease. “Health supervision” means the sanitary inspection, identification, evaluation and
sampling conducted in the implementation of the health law and hygienic standard. “Conveyance” means vessels, aircraft, trains and
other motor vehicles. “Frontier ports” means international seaports, airports, railway or bus terminals on the border, and ports
of entry at land frontiers and boundary rivers.

   Article 3 Duty range for health and quarantine organs on the frontier shall cover those hotels, restaurants and clubs on the frontier and those
units that provide food or services for the incoming or outgoing conveyance and those places where quarantine inspection, sanitary
monitoring and health supervision on the incoming or outgoing persons, conveyance, containers and goods are carried out.

   Article 4 All persons, conveyance and containers, as well as articles such as baggage, goods, postal parcels that may transmit quarantinable
diseases are subject to quarantine inspection upon entering or exiting the country in accordance with these Rules, and entry and
exit shall be allowed to them only after an approval is issued by the health and quarantine office.

   Article 5 When a quarantinable epidemic victim is discovered by the health and quarantine organ, measures must be taken promptly in accordance
with the rules stipulated in Chapter VIII of these Rules to place him in isolation and prevent other persons from being infected.
When a quarantinable epidemic suspect is found by the health and quarantine organ, he shall be dealt with in accordance with the
rules stipulated in Chapter VIII. As for those suspects suffering from contagious diseases other than plague, cholera and yellow
fever as defined in Chapter VIII of these Rules, they shall be subject to on-site clinical check-up or check-up detention as well
as other measures of sanitization for a period of time not exceeding the longest incubation period of that contagious counting from
the day they left the infected environment.

   Article 6 Health and quarantine organs are required to bar any quarantinable epidemic victims or suspects from exit, with the exception of
those who come from abroad and have undergone on-site clinical check up on arrival. These persons can leave the port if they wish
to; if they leave in conveyance, quarantine physicians are required to annotate and comment on their Exit Quarantine Certificates
and to inform the person in charge of the conveyance to take the necessary precautionary measures.

   Article 7 When a death due to an unidentified cause other than accidental harm is discovered at a frontier port, the corpse shall be subject
to quarantine inspection and only after an entry or exit permit is granted can the corpse be removed.

   Article 8 When a quarantine infectious disease or a disease suspected to be quarantinable or a death due to an unidentified cause other than
accidental harm is discovered on conveyance from a domestic pestilence area or in the course of a domestic voyage, the persons in
charge of the conveyance are required to make a report to the health and quarantine organ on arrival at the frontier port and undergo
preliminary quarantine inspection.

   Article 9 In times when quarantinable infectious diseases are prevailing at home or abroad, the administrative department of health under the
State Council shall report the situation to the State Council for decisions on taking the following precautionary measures, partially
or totally, in quarantine inspection:

(1) giving orders to blockade relevant sections of the border and frontier water course;

(2) giving orders that certain articles must be disinfected or treated with insecticides before they are allowed in or out of the
country;

(3) giving orders to prohibit shipment, in or out, of certain articles;

(4) giving orders to designate the primary sea-ports and airports. Those vessels or aircraft from foreign pestilence areas, without
going through quarantine inspection at the primary sea-port or airport, shall not be permitted to get into any other sea-port or
airport, with the exception of cases of accidents or other special reasons.

   Article 10 Upon the arrival of containers, goods, or discarded used materials at the port ready for shipping in or out, the shipper, the carrier’s
agent or the consignor is required to report to the health and quarantine organ for inspection. Containers, goods, or used materials
that come from pestilence area or have been contaminated by an epidemic disease or are likely to spread quarantinable epidemic diseases
or are found to have carried rodents which affect human health and vectors are required to undergo disinfection, deratization, deinsectization
and other necessary sanitization process. If the owner of the containers, goods or discarded used materials asks to go through quarantine
inspection or sanitization in other places, the health and quarantine organ shall provide convenience and carry out the task in accordance
with regulations. The Customs office shall let them pass after checking the sanitization certificate issued by the health and quarantine
organ.

   Article 11 Special articles which enter or leave the country such as microzoaria, human tissue, biological, blood and hemoproducts shall be
subject to health and quarantine inspection. The carrier, the shipper or the parcel sender of the above mentioned articles is required
to declare at the health and quarantine organ for inspection. Without permission by the health and quarantine organ, there shall
be no entry or exit of such articles. The Customs office shall let them pass after checking the Certificate of Approval for Special
Articles issued by the health and quarantine organ.

   Article 12 Luggage and other articles carried along by incoming or outgoing passengers or staff members or by means of registered shipment that
may spread quarantinable epidemic diseases, are required to undergo hygienic examination. The health and quarantine organ shall exercise
sanitization or destruction of the foods, drinks and aquatic products that come from the pestilence area or have been contaminated
with epidemic diseases and issue a sanitization certificate. The customs office shall let them pass after checking the sanitization
certificate issued by the health and quarantine organ.

   Article 13 When the health and quarantine organ conducts health examination and sanitization of the registered parcels, the postal unit is required
to offer cooperation. Without permission by the health and quarantine organ, the postal unit may not ship the parcels.

   Article 14 The health administrative department under the State Council is the organ of authority for making the various kinds of health and
quarantine forms, certificates as well as for their issuance.

Chapter II Report of Epidemic Situation

   Article 15 On discovering at, or on a conveyance at a frontier port a quarantinable infectious disease, a disease suspected to be quarantinable
or a death due to an unidentified cause other than accidental harm, the relevant departmentat the frontier port and the person in
charge of the conveyance must report immediately to the health and quarantine office.

   Article 16 When the health and quarantine organ has discovered any quarantinable epidemic cases or monitored epidemic diseases or any disease
suspected to be quarantinable, it must inform the local health administrative unit and the epidemic prevention unit. When a quarantinable
disease is discovered, it must be promptly reported to the health administrative department under the State Council. On the other
hand, if the local epidemic prevention unit has discovered any quarantinable epidemic cases or monitored epidemic diseases, it must
keep the health and quarantine organ informed about the matter.

   Article 17 At the time when any quarantinable epidemic disease is prevalent in certain regions at home or abroad, the health administrative
department under the State Council may declare the regions as pestilence areas.

Chapter III Health and Quarantine Organs

   Article 18 The health and quarantine organ may set up its agent organ if necessary. The setting up, amalgamation or dissolution of any health
and quarantine organ shall be decided by the health administrative department under the State Council.

   Article 19 The studies of the health and quarantine organ are as follows: (1) enforce “The Frontier Health and Quarantine Law” and the rules
for implementation of this law as well as other state regulations concerning public health;

(2) collect, analyze information and report about the occurrence, prevalence and the cessation of quarantinable epidemic diseases
at the frontier port or abroad;

(3) exercise sanitary supervision at the frontier port and conduct quarantine inspection, epidemic disease monitoring, sanitary control
and sanitization to the conveyances, passengers, containers, corpses, human bones as well as luggage, goods, postal parcels that
may spread quarantinable epidemic diseases;

(4) carry out health and quarantine inspection of any special articles such as exported or imported microzoaria, biological, human
tissue, blood and hemoproducts as well as some animals that may spread human epidemic diseases;

(5) offer services in preventive inoculation, physical check-up, medical treatment, consultancy on hygiene and health for international
travellers;

(6) issue health and quarantine certificates;

(7) make epidemiological survey and carry out scientific experiments;

(8) fulfil other tasks assigned to it by the health administrative department under the State Council.

   Article 20 Duties of the frontier health supervisor:

(1) exercise sanitary control and carry out publicity on hygiene and health to the conveyances at the frontier port or parked on the
border waiting for exit or entry;

(2) give technical guidance in sanitization, such as disinfection, deratization and deinsectization;

(3) make investigation into the cases that has caused the spread of epidemic diseases and the proliferation of rodent, vector insects,
food-poisoning and food-borne contamination, and suggest control measures.

   Article 21 When performing its duties, the health and quarantine inspector and border health supervisor are required to wear their quarantine
uniform and their quarantine budges. Their conveyances at work are required to bear quarantine flags. The design of quarantine uniform,
sign and flag and their uses shall be determined jointly by the health administrative department under the State Council and other
departments concerned, subject to ratification by the State Council.

Chapter IV Seaport Quarantine

   Article 22 Quarantine inspection for incoming vessels must be carried out at

quarantine anchorage or at the designated place approved by the health and quarantine organ. Quarantine anchorage shall be decided
jointly by the harbour superintendency administration and the health and quarantine organ. A report about the decision shall be presented
to the transportation department and the health administration department under the State Council for the record.

   Article 23 Prior to the arrival of the vessel subject to entry quarantine inspection, the shipping agent is required to inform the health and
quarantine organ at the earliest possible time of the following matters:

(1) name and nationality of the vessel, scheduled date and time of arrival at the quarantine anchorage;

(2) port of departure and port of last call;

(3) number of crew and passengers;

(4) type of cargo.

The harbour superintendency administration must inform the health and quarantine organ at the earliest possible time of the scheduled
arrival date and time of the vessel at the quarantine anchorage.

   Article 24 In the course of navigation, if a quarantinable epidemic disease, a disease suspected to be quarantinable, or a death due to an unidentified
cause other than accidental harm is discovered, the captain must make a prompt report to the health and quarantine organ about the
following matters:

(1) name and nationality of the vessel, scheduled date and time of arrival at the quarantine anchorage;

(2) port of departure and port of final call;

(3) number of crew and passengers;

(4) type of cargo;

(5) name of disease or principal symptoms, number of cases and deaths;

(6) whether there are any vessel doctors on board the vessel.

   Article 25 All vessels subject to entry quarantine inspection are required to hoist quarantine signals ready for inspection. Without getting
an Entry Quarantine Permit issued by the health and quarantine organ, the quarantine signals shall not be lowered. In the day time,
an international signal flag shall be put up at a conspicuous place on the vessel:

(1) The “Q” sign flag means that the vessel is free from quarantinable epidemic diseases, and is applying for an Entry Quarantine
Permit;

(2) The “QQ” sign flag means that the vessel has on board a quarantinable epidemic disease or a disease suspected to be quarantinable
and asks for instant quarantine sanitization. During the night, a light-signal shall be put up vertically at a conspicuous place
on the vessel:

(1) Three red lights indicate that the vessel is free from quarantinable epidemic disease and is applying for an Entry Quarantine
Permit;

(2) Four lights in the order of Red-Red-White-Red indicate that the vessel has been contaminated by a quarantinable epidemic disease
or a disease suspected to be quarantinable and asks for instant quarantine sanitization.

   Article 26 No persons other than navigation pilot and those approved by the health and quarantine organ shall be allowed to get on board the
vessel(s) with quarantine flag or light signal(s); no unloading of luggage, cargo, postal parcels shall be allowed; no other vessel
shall be allowed to get close; no crew member shall be allowed to leave the vessel without the approval by the health and quarantine
organ, unless the vessel is in distress. The navigation pilot shall not guide the vessel(s) away from the quarantine anchorage.

   Article 27 Vessel(s) applying for quarantine inspection by telecommunication must first submit an application to the health and quarantine organ.
A sanitary certificate shall be issued to the qualified vessel(s) which may apply for telecommunicated quarantine inspection within
12 months as of the issuance of the certificate.

   Article 28 The vessel with valid sanitary certificate must make a report, twenty-four hours prior to its arrival, to the health and quarantine
organ about the following matters:

(1) name and nationality of the vessel, scheduled date and time of arrival at the quarantine anchorage;

(2) port of departure and port of last call;

(3) number of crew and passengers and their state of health;

(4) type of cargo;

(5) date of issuance and number of the vessel’s sanitary certificate; date and port of issuance of the deratization certificate or
a deratization laissez-passer, as well as other sanitary documents.

Upon approval of the above report, the vessel(s) may enter the port.

   Article 29 Entry quarantine inspection of vessel(s) shall be conducted between sunrise and sunset. Round-the-clock quarantine inspection shall
be conducted on vessel(s) at the port which have night navigation conditions for docking and unloading of cargo. No night-time quarantine
inspection shall be conducted on vessel(s) from pestilence areas.

   Article 30 The captain of the entry vessel is required to show the quarantine physician on board the vessel health declaration, crew member
list, passenger manifest and cargo declaration, signed by the captain or the vessel physician, and a deratization certificate or
a deratization laissez-passer. During the inspection, the quarantine physician has the right to read the deck logbook and other related
documents; he may ask for detailed information about the sanitary situation of the vessel during its navigation course, if he considers
it necessary and the captain or the vessel physician must give the true facts. The answers in written form must bear the signature
of the captain and that of the vessel physician.

   Article 31 After completion of entry quarantine inspection of the vessel, the quarantine physician is required to sign and issue an Entry Quarantine
Permit without delay; if the vessel needs to go through sanitization or is subject to certain restrictions, a footnote and signature
must be made on

the Permit and measures shall be taken accordingly; if the vessel is contaminated or is suspected to be contaminated with a quarantine
disease, the harbour superintendency administration shall be informed and a sanitization notice shall be given to the vessel. The
navigation pilot and those persons approved by the health and quarantine organ are required to undergo sanitization together with
crew members and passengers. The Entry Quarantine Permit shall be issued to the vessel only after the necessary sanitization is completed.
Having received the Entry Quarantine Permit issued by the health and quarantine organ, the quarantine flag and light signal(s) may
be lowered.

   Article 32 Before departure of an exit vessel, the shipping agent is required to inform the health and quarantine organ at the earliest possible
time of the following matters:

(1) name and nationality of vessel and scheduled date and time of departure;

(2) destination port and primary departure port;

(3) crew member list and passenger manifest;

(4) type of cargo.

The harbour superintendency administration is required to notify the health and quarantine organ at the earliest possible time of
the fixed date and time of departure of the exit vessel(s). If there is no change in crew members and passengers, the vessel receiving
entry and exit quarantine inspections at the same port may get a P.W.E. If there is a change in crew members or passengers, revised
manifest shall be required.

   Article 33 The captain of the vessel receiving exit quarantine inspection is required to show the deratization certificate or the deratization
laissez-passer and other related quarantine documents to the health and quarantine organ. The quarantine physician may ask the captain
or the vessel physician for

further details about the state of health of the crew members and the passengers as well as the sanitary situation on the vessel;
the captain and the vessel physician are required to give true-to-fact answers.

   Article 34 Upon completion of quarantine inspection on an exit vessel, the quarantine physician must sign and issue an Exit Quarantine Permit
without delay. If the vessel cannot yet sail at the scheduled time due to sanitization, the health and quarantine organ is required
to notify the harbour superintendency administration immediately.

   Article 35 After quarantine inspection on an exit vessel is completed, no persons other than the navigation pilot and those approved by the
health and quarantine organ shall be allowed to go on board the vessel, no loading and unloading of luggage, cargo or postal parcels
shall be allowed. Any violation of the rules may cause the vessel to undergo quarantine reinspection.

Chapter V Airport Quarantine

   Article 36 Aircraft shall be prohibited from dumping or be allowed to drop any articles that may spread epidemic diseases while flying.

   Article 37 The aviation station that conducts health and quarantine inspection is required to inform the health and quarantine organ at the
earliest possible time of the following matters:

(1) nationality, make, number and markings of the aircraft and its scheduled arrival time;

(2) departure airport, stop-over airport and destination airport;

(3) number of crew members and passengers.

   Article 38 In the course of flight, if any quarantinable epidemic disease, a disease suspected to be quarantinable, or a death due to an unidentified
cause other than accidental harm is discovered, the captain of the aircraft subject to entry quarantine inspection is required to
inform the airport of the matter and report to the health and quarantine organ about the following matters:

(1) nationality, make, number and markings of the aircraft and its scheduled arrival time;

(2) departure airport, stop-over airport and destination airport;

(3) number of crew members and passengers;

(4) name of disease or principal symptoms, number of cases and deaths.

   Article 39 After an aircraft subject to entry quarantine inspection lands at the airport, the quarantine physician shall get on board first.
The aircraft captain or his authorized agent is required to submit to the health and quarantine organ the general declaration, passenger
manifest, deck cargo declaration and the valid deinsectization certificate and other related quarantine documents; the aircraft captain
or his authorized agent is required to give true-to-fact answers to the inquiries from the quarantine physician about the sanitary
situation on the aircraft. Before completion of quarantine inspection, no persons other than those approved by the health and quarantine
organ are allowed to get on or off the aircraft; no loading and unloading of luggage, cargo and postal parcels shall be permitted.

   Article 40 Entry passengers are required to undergo entry quarantine inspection at the appointed place and answer the quarantine physician’s
inquiries orally or in written form. During the inspection time entry passengers shall not be allowed to leave the inspection place.

   Article 41 Upon completion of entry quarantine inspection of the aircraft, the quarantine physician must sign and issue an Entry Quarantine
Permit to the aircraft which is free from contamination. If the aircraft needs to undergo sanitization or is subject to certain restrictions,
a footnote and signature must be made on the Permit and the aircraft captain or his authorized agent shall be responsible for taking
necessary measures accordingly; if the aircraft is proved to be contaminated, a sanitization notice shall be given to the aircraft
and the aircraft shall be notified. After the required sanitization is done, an Entry Quarantine Permit shall be issued to the aircraft.

   Article 42 Prior to the departure of the aircraft subject to exit quarantine inspection, the airport is required to submit to the health and
quarantine organ the general declaration, deck cargo declaration and other documents related to quarantine and to inform it of the
following matters:

(1) nationality, make, number and markings of the aircraft and its scheduled time of departure;

(2) stop-over airport(s) and destination airport;

(3) number of crew members and passengers.

   Article 43 Upon completion of exit quarantine inspection of the aircraft, the quarantine physician must sign and issue an Exit Quarantine Permit
to the aircraft which is free from contamination, or, such Permit shall be issued upon completion of the necessary sanitization;
if the aircraft cannot take off at the scheduled time due to sanitization; the health and quarantine organ must notify the airport
without delay.

Chapter VI Border Quarantine

   Article 44 Prior to the arrival of the trains subject to entry quarantine inspection, the railway station is required to inform the health and
quarantine organ of the following matters:

(1) train number and scheduled arrival time;

(2) primary departure station;

(3) train marshalling.

   Article 45 After the train or other motor vehicle subject to entry quarantine inspection arrives at the railway station on the border, the quarantine
physician shall get on board the train first. The head of train crew or the person in charge of the vehicle is required to submit
a report either orally or in written form to the health and quarantine organ on the state of health of the persons on board and to
give true-to-fact answers to the inquiries by the quarantine physician concerning sanitary and health

conditions on board.

   Article 46 During quarantine inspection, without permission by the health and quarantine organ, no persons shall be allowed to get on or off
the train to other vehicle which is subjected to entry quarantine inspection; no loading or unloading of luggage, cargo or postal
parcels shall be permitted.

   Article 47 Prior to the departure of the train subject to exit quarantine inspection, the railway station is required to inform the health and
quarantine organ at the earliest possible time of the following matters:

(1) train number and scheduled departure time;

(2) destination station;

(3) train marshalling.

   Article 48 During its course of transportation, if a quarantinable infectious disease, a disease suspected to be quarantinable, or death due
to an unidentified cause other than accidental harm is discovered on the train or other vehicle subject to entry or exit quarantine
inspection, the head of the train crew or the person in charge of the vehicle is required to report to the health and quarantine
organ about the matter upon arrival at the border station.

   Article 49 In case that a quarantine infectious disease or a disease suspected to be quarantinable is discovered on the train subject to entry
or exit quarantine inspection, or in case that the train is unable to leave at scheduled time due to sanitization, the health and
quarantine organ is required to inform the station master of the case without delay. If the parking place is not suitable for sanitization,
the station master can decide on another place within the station for sanitization. Before completion of sanitization, without permission
by the health and quarantine organ, no person shall be allowed to get off or on the train, no loading or unloading of luggage, goods
or postal parcels shall be permitted. In order that the entry through train can run normally, the health and quarantine organ may
have its personnel exercise quarantine inspection on board the train in operation. The head of the train crew shall provide conveniences.

   Article 50 After completion of entry or exit quarantine inspection or necessary sanitization to the train or other vehicle, the quarantine physician
is required to sign and issue an exit and entry quarantine certificate according to quarantine inspection results.

   Article 51 Those who enter or leave the country at the border on foot are required to undergo entry or exit quarantine inspection at a designated
place. Without permission by the health and quarantine organ, no one may leave the designated place.

   Article 52 Any train or vehicle, coming from pestilence area, or having been contaminated or being suspected to have been contaminated with
an epidemic disease or being found to have carried goods with rodent or pests that may spread an epidemic disease, shall be required
to undergo health inspection and necessary sanitization.

Chapter VII Sanitization

   Article 53 While performing sanitization,the health and quarantine officers are required to see to it that:

(1) no one’s health is endangered;

(2) no damage is done to the structure of and the equipment on the vehicle;

(3) no fire is caused;

(4) no damage is done to the luggage or goods.

   Article 54 The sanitization that exit or entry containers, luggage, goods or postal parcels are required to undergo shall be conducted by the
health and quarantine organ. Any conveyance waiting for entry or exit is subject to disinfectization, deratization, deinsectization
and other necessary sanitization when found to be in any one of the following conditions:

(1) having come from a pestilence area;

(2) being contaminated by a quarantinable epidemic disease;

(3) revealing the presence of rodents which affect human health or insects which are carriers of disease and their number exceeds
the state standard.

   Article 55 Goods that are shipped from abroad and are only passing through the People’s Republic of China, shall, if there is no trans

PROVISIONS ON SEVERAL MATTERS CONCERNING CONVERSION OF FOREIGN CURRENCIES

MEASURES FOR THE IMPLEMENTATION OF THE PHARMACEUTICAL ADMINISTRATION LAW

Category	PUBLIC HEALTH AND MEDICINE	Organ of Promulgation	The State Council	Status of Effect	In Force
Date of Promulgation	1989-02-27	Effective Date	1989-02-27

Measures for the Implementation of the Pharmaceutical Administration Law of the People’s Republic of China

Chapter I  General Provisions
Chapter II  Responsibility for the Supervision and Administration of
Chapter III  Procedure for the Verification and Approval of Licenses
Chapter IV  Examination and Approval of New Medicines
Chapter V  Registered Document of Approval for Medicines
Chapter VI  Administration of Pharmaceutical Production Enterprises
Chapter VII  Administration of Pharmaceutical Trading Enterprises
Chapter VIII  Administration of Medicaments Prepared by Medical Treatment
Chapter IX  Penalty Provisions
Chapter X  Supplementary Provisions
Note:

(Approved by the State Council on January 7, 1989 and promulgated by the

Ministry of Public Health by Decree No. 1 on February 27, 1989)
Chapter I  General Provisions

    Article 1  These Measures are formulated in accordance with the
Pharmaceutical Administration Law of the People’s Republic of China
(hereinafter referred to as Pharmaceutical Administration Law).

    Article 2  These Measures are applicable to any units or individuals who
are related to the production, selling, using, testing and examination or
scientific research of medicines.

    These Measures are also applicable to the pharmaceutical enterprises in
the People’s Liberation Army that are engaged in the production of medicines
for civilian use.

    Article 3  In the production and selling of pharmaceuticals, social
benefit shall be taken as the prime concern. The production, selling or use of
fake or inferior medicines is strictly prohibited.

    Without authorization no production or sales of pharmaceuticals or
preparation of medicaments shall be allowed.
Chapter II  Responsibility for the Supervision and Administration of
Pharmaceuticals

    Article 4  The administrative department of health under the State Council
is in charge of the nationwide supervision over and administration of
pharmaceuticals. Its principal responsibilities are as follows:

    (1) to enforce the Pharmaceutical Administration Law and these Measures;

    (2) to draft laws and regulations related to the supervision and
administration of pharmaceuticals, and to formulate provisions for the
implementation of each law or regulations;

    (3) to promulgate the Pharmacopoeia of China and the national standards
for medicines;

    (4) to examine and approve new medicines and to verify and issue approval
certificates thereof;

    (5) to exercise supervision over the production, trading and use of
pharmaceuticals;

    (6) to make investigation and appraisal of the curative effect and side
effect of the medicines already put into production and to provide and publish
information related to the quality;

    (7) to make decisions on disciplinary sanctions in accordance with the
Pharmaceutical Administration Law and these Measures.

    Pharmaceutical administration organs in the administrative departments of
health at or above the county level are in charge of the supervision over and
administration of pharmaceuticals within their respective jurisdiction.

    Article 5  The medicine inspection organs set up by the administrative
departments of health at or above the county level shall, under the latter’s
leadership, conduct medicine inspection in accordance with the standards for
medicines set by the state and by the administrative department of health at
the level of province, autonomous region or municipality directly under the
Central Government.

    Article 6  Medicine supervisor(s) shall be appointed in the administrative
department of health at or above the county level. Medicine supervisors at the
state level shall be entrusted by the administrative department of health
under the State Council by credentials. Medicine supervisors at the
provincial, autonomous region or municipal government (directly under the
Central Government) level and at the autonomous prefecture, municipality or
county level shall be nominated respectively by the administrative departments
of health and entrusted with credentials by the people’s governments at the
corresponding levels.

    The duties of medicine supervisors at all levels shall be defined
separately by the administrative department of health under the State Council.

    Article 7  When carrying out their duties, the medicine supervisors are
required to present their credentials before they take sample testing and ask
for relevant technical data, with a receipt in accordance with the state
stipulations. They are required to keep confidential the technical data
provided by the production enterprise and scientific research unit.

    The medicine supervisors may temporarily seal up some medicine pending
further settlement. It is required of them to state the term of sealing up
which shall not normally exceed 15 days.
Chapter III  Procedure for the Verification and Approval of Licenses

    Article 8  The procedures for examination and approval as stipulated in
Paragraph 1 of Article 4 of the Pharmaceutical Administration Law denote that
the establishment of a pharmaceutical producing enterprise (including all
forms of inland associated enterprises, Chinese-foreign equity joint ventures
and contractual joint ventures and foreign invested enterprises) shall
involve, in addition to applying for approval for the capital construction
of the enterprise in accordance with state stipulation, the following steps:
(1) the enterprise or its leadership organ submits an application to the
competent department for the production and trading of pharmaceuticals of the
province, autonomous region or municipality directly under the Central
Government where the enterprise is located for examination and approval and
then refer it to the administrative department of health at the same level.
(2) upon approval by the administrative department of health of the province,
autonomous region or municipality directly under the Central Government, a
Pharmaceutical Producer License shall be issued. The department in charge of
the production and trading of pharmaceuticals and the administrative
department of health are required to make a decision within 30 days of receipt
of complete application materials.

    Article 9  If a pharmaceutical production enterprise desires to set up a
branch factory or any additional workshops outside the premise of the factory,
it is required to submit an application to the department in charge of the
production and trading of pharmaceuticals at the level of the province,
autonomous region or municipality directly under the Central Government for
examination and approval and then refer it to the administrative department of
health at the same level for a Pharmaceutical Producer License, on which the
status of the new set-up (a branch factory or a workshop) and its production
scope must be clearly stated.

    Article 10  The procedures for examination and approval stipulated in
Paragraph 1 of Article 10 of the Pharmaceutical Administration Law denote that
a pharmaceutical trading enterprise (including specialized and non-specialized
whole-sale or retail drug stores or companies) should apply for a
Pharmaceutical Trading Enterprise Licence in accordance with the following
provisions:

    (1) for a wholesale drug enterprise, an application must be submitted to
the department in charge of the production and trading of pharmaceuticals at
the level of the province, autonomous region or municipality directly under
the Central Government for examination and approval and then be referred to
the administrative department of health at the same government level for
verification and approval betore a Pharmaceutical Trading Enterprise License
is issued;

    (2) for a retail drug enterprise, an application must be submitted to the
department in charge of the production and trading of pharmaceuticals at the
autonomous prefecture, municipality or county government level for examination
and approval and then be referred to the administrative department of health
at the same government level for verification and approval before a
Pharmaceutical Trading Enterprise License is issued.

    The department in charge of the production and trading of pharmaceuticals
and administrative department of health are required to make a decision within
30 days of receipt of complete application materials.

    Article 11  The competent department for the production and trading of
pharmaceuticals stated in Articles 4, 10 and 22 of the Pharmaceutical
Administration Law refers to those pharmaceutical administration organs or
departments appointed by the people’s government at or above the county level.

    Article 12  If a medical treatment unit needs to prepare some medicaments,
it is required to submit an application to an administrative department of
health at the level of the province, autonomous region or municipality
directly under the Central Government for examination and approval betore a
Dispensing Permit is granted.

    The administrative department of health is required to make a decision
within 30 days of receipt of complete application materials.

    Article 13  The term of validity for a Pharmaceutical Producer Licence, a
Pharmaceutical Trading Enterprise Licence, or a Dispensing Permit is 5 years.
If the licensee wishes to continue its production or trading or making
medicament preparation upon expiration of the licence, it must reapply for
permission. The entire application procedures must be repeated.

    If an enterprise has gone bankrupt or has wound up business, the license
it is holding should be cancelled by the administrative department of health
that has issued it.

    Article 14  Pharmaceutical Producer Licence, Pharmaceutical Trading
Enterprise Licence, and Dispensing Permit shall be printed exclusively by the
administrative department of health under the State Council.
Chapter IV  Examination and Approval of New Medicines

    Article 15  The state encourages research in and development of new
medicines. All pharmaceutical research units, medical colleges, pharmaceutical
production enterprises, medical treatment units or individuals with the
necessary conditions are encouraged to engage in the research in and
development of new medicines.

    Article 16  Procedures for the examination and approval of new medicines
shall be formulated by the administrative department of health under the State
Council.

    Article 17  Before a new medicine is put to clinical testing, the research
and development unit of this medicine is required to submit an application
together with the relevant data and samples in accordance with the provisions
for the examination and approval of new medicines.

    Article 18  Clinical testing or clinical verification of a newly developed
medicine must be conducted in the medical treatment unit(s) approved by the
administrative department of health at the level of the province, autonomous
region or municipality directly under the Central Government.

    Article 19  After new medicines have been clinically tested and verified
and have passed the examination by the administrative departments of health at
the level of the province, autonomous region or municipality directly under
the Central Government, the research and development unit of these new
medicines shall submit an application to the administrative department of
health under the State Council for examination and approval and New Medicine
Certificates shall be issued accordingly.

    The administrative department of health under the State Council is
required to call, at the earliest possible time, the Medicine Appraisal
Committee to make technical appraisal of the newly developed medicine after
the complete application materials are received. A decision must be made
within two months of the technical appraisal.

    Article 20  The administrative department of health under the State
Council and those in the provinces, autonomous regions or municipalities
directly under the Central Government may set up a Medicine Appraisal
Committee which is composed of experts in medical science and pharmacology
from medical treatment units, scientific research units, pharmaceutical
factories and medical colleges.

    Article 21  The clinical testing or clinical verification unit, the
department to examine and approve the newly developed medicine and individuals
so involved are required to keep confidential the relevant data, figures,
production techniques provided by a unit or individual that has developed the
new medicine.
Chapter V  Registered Document of Approval for Medicines

    Article 22  For the production of a new medicine, the production unit
shall submit an application to the administrative department of health under
the State Council for examination and approval upon which a Registered
Document of Approval shall be issued to the unit. However, this does not
apply to the production of traditional Chinese medicine in ready-to-use forms.

    To produce a certain kind of medicine for which the state, the province,
autonomous region or municipality directly under the Central Govermnent has
already set standards, the production unit is required to submit an application
to the administrative department of health at the level of the province,
autonomous region or municipality directly under the Central Government. After
consulting the department in charge of the production and trading of
pharmaceuticals at the same level, the administrative department of health
shall make a decision on whether to issue the Registered Document of Approval
to the unit. However, this does not apply to the production of traditional
Chinese medicine in ready-to-use forms.

    Article 23  When applying for a Registered Document of Approval for a
medicine, the production unit must present testing samples and relevant data
to the medicine inspection organ appointed by the administrative department of
health at the level of the province, autonomous region or municipality
directly under the Central Government. The medicine inspection organ is
required to make a test report and refer it to the administrative department
of health for examination and approval, which shall, within 30 days of
receipt of the test report, make a decision on whether to issue the Registered
Document of Approval to the unit.

    Article 24  The Registered Document of Approval for a medicine is valid
for 5 years, during which time no change of the registration number shall be
allowed. The Registered Document Approval of a medicine shall become invalid
if the medicine has not been produced for 3 years.

    Article 25  The administrative department of health under the State
Council is required to organize investigations of medicines that have been
approved for production. The Medicine Appraisal Committee shall revoke the
Registered Document of Approval if it discovers by appraisal that the
medicine’s curative effects are uncertain, that they produce serious adverse
reactions, or that for other reasons they are harmful to people’s health.
Chapter VI  Administration of Pharmaceutical Production Enterprises

    Article 26  The state shall practise The Norms For Quality Control of
Medicine Production. The administrative department of health under the State
Council shall formulate The Norms For Quality Control of Medicine Production
and supervise the implementation thereof. The departments in charge of the
production and trading of medicines may formulate specific rules to guide the
gradual implementation of the Norms.

    Article 27  All the newly built pharmaceutical factories and the extension
or rebuilt workshops of the existing pharmaceutical factories are required to
meet the requirements stipulated in the Norms For Quality Control of Medicine
Production. The existing pharmaceutical enterprises are required to establish
hygiene rules and regulations to ensure medicine quality and strive to meet
all the requirements stipulated in the Norms For Quality Control of Medicine
Production gradually, and in a planned way.

    Article 28  Pharmaceutical production enterprises shall be staffed with
professional technical personnel and skilled workers who must meet the
following qualifications:

    (1) a factory manager in charge of pharmaceutical production and quality
control must be familiar with the techniques involved in pharmaceutical
production;

    (2) the post of the director in charge of pharmaceutical production
technology and quality inspection shall be held respectively by a
pharmaceutist, an assistant engineer or a herbdruggist, depending on the kind
of medicine being produced;

    (3) the responsible workshop technician is required to have an education
of at least the technical school level and with 5 years or more production
experience;

    (4) the technical workers are required to go through technical training
before they are allowed to operate independently;

    (5) with respect to those pharmaceutical factories processing traditional
Chinese medicines into ready-to-use forms, if they are unable to meet the
requirement stated in Item (2) of Article 28 of these Measures, the relevant
posts shall be held by Chinese medicinal herb personnel who are familiar with
the properties of the herbal medicine processed, can appraise medicinal herbs
and have a mastery of the production techniques. These personnel must be
examined by and registered with the administrative department of health above
county level.

    Article 29  Pharmaceutical enterprises are required to have factory
premises, facilities and sanitory environment to ensure the quality of the
medicine. They must be kept clean and tidy. If they are engaged in the
preparation of transfusion medicament and powdered injection, they must have
ultra clean conditions and superclean environment.

    Article 30  Pharmaceutical enterprises are required to have their own
quality inspection organ and personnel, as well as necessary instrument and
equipment to ensure the quality of their products.

    Article 31  Traditional Chinese medicine factories (including those
traditional Chinese medicine workshops in Western medicine factories) must not
only meet the requirements stipulated in Articles 28, 29, 30 and 32 of these
Measures but also abide by the following stipulations:

    (1) Raw medicinal herbs must be pretreated by way of picking, sorting,
washing and baking according to the relevant requirements.

    (2) See to it that the processing of traditional Chinese medicine into
ready-to-use forms (including batching, grinding and packaging) shall be done
in an environment free from contamination.

    (3) Traditional Chinese medicine technical personnel shall be put in
charge of quality control of the Chinese medicine produced in the Western
medicine facteries.

    Article 32  Medicines must be made in accordance with the verified
standards and through the fixed technical processes. If a pharmaceutical
factory intends to make any change in the production technique which may
affect the quality of the medicine, it is required to submit an application to
the administrative department of health at the level of the province,
autonomous region or municipality directly under the Central Government for
examination and approval.

    Article 33  Pharmaceutical enterprises are required to have a complete
production record and lab testing record on file. These records shall be kept
for one year after the expiry date of the recorded batch of medicine. With
respect to medicines without expiry dates, their records shall be kept for 3
years.

    Article 34  It is required that all raw materials and additives needed in
the production of medicines, the containers and packaging material that may
directly contact the medicine must meet the requirements of the state
pharmacopoeia or other pharmaceutical standards. Pharmaceutical factories that
plan to use other kinds of materials are required to report their plans to the
administrative department of health for the record.

    Article 35  Pharmaceutical enterprises must strengthen medicine quality
control. All kinds of medicines are subject to quality inspection by their own
medicine inspection organs before leaving the production premises. A quality
tag or lab testing report shall be put in the interior package of quality
products. Those medicines that fail to pass the quality inspection shall not
be allowed to leave the production premises.
Chapter VII  Administration of Pharmaceutical Trading Enterprises

    Article 36  Pharmaceutical trading enterprises shall be staffed with full
time pharmaceutical technical personnel who must meet the following
qualifications:

    (1) A wholesale pharmaceutical trading enterprise shall set up quality
inspection organs which shall be put under the charge of professional
pharmacists of Chinese or Western medicine.

    (2) A retail pharmaceutical trading enterprise shall be staffed with a
pharmacist or a Chinese medicine pharmacist or a full time pharmaceutical
staff worker who has been examined and registered by the administrative
department of health at or above county level.

    (3) Non-pharmaceutical workers newly recruited or staffed to engage in
pharmaceutical preparation, purchasing, storage keeping or marketing of
medicines are required to go through professional training before they are
allowed to work independently.

    Article 37  The business premises, facilities, storage facility and clean
environment of a pharmaceutical trading enterprise must meet the following
requirements:

    (1) The storage facilities must meet the requirements by the physical
properties and chemical characters of medicines. The storage must be well
equipped against dust, rats and deterioration. For those medicines which need
to be kept away from light and in low temperature, there must be light lock
and thermal protective storage devices.

    (2) A pharmaceutical trading enterprise that also deals in other
merchandise is required to install separate counters for these merchandise. No
medley of medicine and other articles in the same counter shall be allowed.

    Article 38  Pharmaceutical trading enterprises may prepare or process
Chinese medicine (including slicing, roasting, baking, shimmering, etc.) or
make up prescriptions for patients. However, they may not make any
ready-for-use Chinese medicine for sale.

    Article 39  Pharmaceutical trading enterprises are required to establish a
strict quality checking system and a storage system which includes stock
checking in and out and stock protection.

    Article 40  Pharmaceutical trading enterprises must examine carefully the
stock of medicine prior to its purchase. The items for examination shall
include its name, producer’s name, batch number, quality certificate,
registered document (number) of approval, registered trade mark, packing and
exterior quality. With respect to Chinese medicinal materials, it is required
to examine the packing which must include its name, place of origin, name of
consignor and quality inspection mark.
Chapter VIII  Administration of Medicaments Prepared by Medical Treatment
Units

    Article 41  Medical treatment units that prepare their own medicaments
shall meet the following requirements:

    (1) the post in charge of medicament preparation and inspection in
hospitals at or above the county level (including these medical treatment
units with more than 100 wardbeds in factories, mines, enterprises or
institutions) shall be held by a person who bears at least the post_title of senior
pharmacist.

    Such a post in a hospital under the county level must be held by a person
who bears at least the post_title of pharmacist.

    (2) preparation of medicaments must be made in a proper building with
adequate facilities and in clean and tidy environment. Places for preparation
of sterilized medicaments must have a locker room, buffer room, wash room,
preparation room, filling and sealing room, sterilization room, packing room
and air conditioning. Places for preparation of infusion and transfusion
medicaments are required to have superclean conditions.

    Article 42  In preparing medicaments, it is required to strictly abide by
the operating rules, quality inspection rules and hygiene rules. It is
required to have detailed and complete records for the preparation of each
batch of medicament.

    Article 43  The medical treatment units that prepare their own medicaments
are required to have appropriate medicament inspection labs.

    The medicine inspection lab shall sign and issue a quality certificate for
those medicaments that have passed the inspection and may be adopted for
clinical application. Rejects shall not be allowed for clinical use.

    Article 44  Medical treatment units may prepare only those medicaments
that are to be used clinically or in research by themselves and that are not
available on the market or insufficiently supplied. These medicaments may not
go to the market or do so in a devious manner.

    Article 45  Medical treatment units are required to prepare their
medicaments for clinical use in conformity with the norms for the preparation
of clinical medicaments stipulated by the administrative department of health
at the level of the province, autonomous region or municipality directly under
the Central Government and report to the local administrative department of
health for the record.

    Article 46  In medical treatment units, no divisions shall be allowed to
prepare and supply clinical medicaments except the division of pharmacy and
the division of radiosolope.
Chapter IX  Penalty Provisions

    Article 47  Violation of Article 15 of the Pharmaceutical Administration
Law and violation of Chapter VIII of the same law related to the
administration of advertisements shall have disciplinary sanctions imposed by
the administration department for industry and commerce; violation of the
Pharmaceutical Administration Law and these Measures shall have disciplinary
sanctions imposed by the administrative department of health at or above
county level with a written penalty notice. It is required to state a quality
inspection result on a penalty notice for fake medicine and medicine of
inferior quality. All the forfeit shall be turned in to the national treasury.

    Article 48  Those who make or sell or use fake medicine shall have their
fake medicines and illegal gains confiscated. The administrative department of
health shall impose a maximum fine five times or less the price of the
standard medicine which the fake equivalent is used to pass off for according
to the seriousness of the case.

    Article 49  Those who make or sell or use medicine of inferior quality
shall have their inferior medicine and illegal gains confiscated. The
administrative department of health shall impose a maximum fine three times or
less the price of the standard medicine which the inferior equivalent is

PREVENTION AND CONTROL OF POLLUTION FROM ENVIRONMENTAL NOISE

Law of the People’s Republic of China on Prevention and Control of Pollution From Environmental Noise      (Adopted at the 22nd Meeting of the Standing Committee of the Eighth National People’s Congress on October 29, promulgated by Order No. 77 of the President of the People’s Republic of China on October 29, and effective as of March 1, 1997) CHAPTER I GENERAL PROVISIONS    Article 1 This Law is enacted for the purpose of preventing and controlling environmental noise pollution, protecting and improving the living environment, ensuring human health and promoting economic and social development.    Article 2 For purposes of this Law, “environmental noise” means the sound that is emitted in the course of industrial production, construction, transportation and social activities and that impairs the living environment of the neighbourhood. “environmental noise pollution”, as used in this Law, means that the environmental noise emitted exceeds the environmental noise emitted limits set by the State on the environmental noise emitted and impairs people’s daily life, work and study.    Article 3 This Law shall apply to prevention and control of environmental noise pollution in the territory of the People’s Republic of China. This Law shall not apply to prevention and control of noise hazards incurred in the course of production or business operation one is engaged in.    Article 4 The State Council and local people’s governments at various levels shall incorporate prevention and control of environmental noise pollution into their environmental protection plans and adopt economic and technological policies and measures to protect the acoustic environment.    Article 5 Local people’s governments at various levels shall, when drawing up urban and rural development plans, give full consideration to the impact of noise emitted by construction projects and regional development and renovation projects on the living environment of the neighbourhood, make unified plans and rationally arrange the layout of the function areas and the buildings, in order to prevent or minimize environmental noise pollution.    Article 6 The competent administrative department for environmental protection under the State Council shall exercise unified supervision and administration of the prevention and control of environmental noise pollution throughout the country. The competent administrative departments for environmental protection of the local people’s governments at or above the county level shall exercise unified supervision and administration of the prevention and control of environmental noise pollution within their respective administrative regions. The competent administrative departments for public security, communications, railways and civil aviation as well as harbour superintendency administration at various levels shall, within their respective functions and duties, exercise supervision and administration of the prevention and control of noise pollution by traffic and social activities.    Article 7 All units and individuals shall have the obligation to protect the acoustic environment and shall have the right to inform against and accuse any unit or individual that pollutes the environment with noise.    Article 8 The State encourages and supports scientific research and technological development relating to the prevention and control of environmental noise pollution, promotes wide adoption of advanced technologies in this area and disseminates scientific knowledge about prevention and control of such pollution.    Article 9 The people’s governments shall give awards to units and individuals that have achieved outstanding successes in preventing and controlling environmental noise pollution. CHAPTER II SUPERVISION AND ADMINISTRATION OF THE PREVENTION AND CONTROL OF ENVIRONMENTAL NOISE POLLUTION    Article 10 The competent administrative department for environmental protection under the State Council shall establish national standards for acoustic environmental quality for different function areas. Local people’s governments at or above the county level shall, in accordance with the national standards for acoustic environmental quality, divide their respective administrative regions into different zones for application of different standards for acoustic environmental quality and exercise control accordingly.    Article 11 The competent administrative department for environmental protection under the State Council shall, in accordance with the national standards for acoustic environmental quality and the State’s economic and technological conditions, fix national limits for environmental noise emission.    Article 12 When determining the layout of buildings, urban planning departments shall, in accordance with the national standards for acoustic environmental quality and the sound insulation design standards for civil architecture, decide on the rational distance between the structures and the traffic trunk lines in order to keep the structures away form noise as well as the requirements on planning and design accordingly.    Article 13 Every project under construction, renovation or expansion must conform to the regulations of the State governing environmental protection. Where a construction project might cause environmental noise pollution, the unit undertaking the project must prepare an environmental impact statement which includes the measures it takes to prevent and control such pollution, and submit it, following the procedures prescribed by the State, to the competent administrative department for environmental protection for approval. The environmental impact statement shall include the comments and suggestions of the units and residents in the place where the construction project is located.    Article 14 Facilities for prevention and control of environmental noise pollution must be designed, built and put into use simultaneously with the main part of a construction project. Before a construction project is put into production or use, its facilities for prevention and control of environmental noise pollution must be inspected by the competent administrative department for environmental protection that originally approved the environmental impact statement; if such facilities fail to meet the requirements of the State, the construction project may not be put into production or use.    Article 15 Enterprises and institutions that produce environmental noise pollution must maintain normal operation of the facilities for prevention and control of such pollution; whoever intends to dismantle or leave idle such facilities must report the matter in advance to the competent administrative department for environmental protection of the local people’s government at or above the county level for approval.    Article 16 Units that produce environmental noise pollution shall take measures to control it and pay fees for excessive emission of such pollution according to the regulations of the State. The fees collected from excessive emission of pollution must be used for prevention and control of pollution and may not be appropriated for any other use.    Article 17 Any enterprise or institution that produces serious environmental noise pollution in an area where noise-sensitive structures are concentrated shall be ordered to control the pollution within a time limit. The unit that is ordered to control the pollution within a time limit must accomplish the task on schedule. A decision on such control shall be made by the people’s government at or above the county level within the limits of its power granted by the State Council. In the case of a small enterprise or institution, the decision on controlling pollution within a time limit may be made by the competent administrative department for environmental protection that is authorized by a people’s government at or above the county level within the limits of its power granted by the State Council.    Article 18 The State applies an elimination system for out-dated equipment that produces serious environmental noise pollution. The competent department for comprehensive economic and trade affairs under the State Council shall, together with relevant departments of the State Council, publish catalogs of equipment that, because of the serious environmental noise pollution it produces, is forbidden to be manufactured, sold or imported within a time limit. The manufacturers, sellers and importers must stop manufacturing, selling or importing the equipment included in the catalogs mentioned in the preceding paragraph, within the time limit set by the competent department for comprehensive economic and trade affairs under the State Council together with the relevant departments of the State Council.    Article 19 In the case where sporadic strong noise is truly unavoidable in production conducted within an urban area, the matter must first be applied to the local public security organ for approval. Upon giving approval, the local public security organ shall make it known to the public.    Article 20 The competent administrative department for environmental protection under the State Council shall establish a system for monitoring environmental noise, establish monitoring standards, and set up a monitoring network with the relevant departments. The environmental noise monitoring institutions shall, as required, submit reports on the environmental noise monitoring results to the competent administrative department for environmental protection under the State Council.    Article 21 The competent administrative departments for environmental protection of the people’s governments at or above the county level and other departments or institutions in charge of supervision and administration of the prevention and control of environmental noise pollution shall, within the limits of their respective functions and duties, have the power to conduct on-the-spot inspection of the units that emit environmental noise within the areas under their jurisdiction. The units under inspection must give a true account of the actual situation and provide the necessary information. The departments or institutions conducting such inspection shall keep confidential the technological and business secrets of the inspected units. The inspectors shall produce their credentials before conducting on-the- spot inspection. CHAPTER III PREVENTION AND CONTROL OF INDUSTRIAL NOISE POLLUTION    Article 22 For purposes of this Law, “industrial noise” means the sound that is emitted by the permanent equipment used in the course of industrial production and that impairs the living environment of the neighbourhood.    Article 23 The industrial noise emitted to the living environment of the neighbourhood within an urban area shall be kept within the limits set by the State on emission of environmental noise within the boundary of an industrial enterprise.    Article 24 Any industrial enterprise that produces environmental noise pollution due to the use of permanent equipment in the course of industrial production must, in accordance with the regulations of the competent administrative department for environmental protection under the State Council, report to the competent administrative department for environmental protection of the local people’s government at or above the county level the types and quantity of its equipment that produces environmental noise pollution, the noise level produced under normal operation and the facilities installed for prevention and control of such pollution, and provide technical information relating to the prevention and control of noise pollution. Any industrial enterprise that intends to make a substantial change in the types or quantity of the equipment that produces environmental noise pollution, in the noise level or facilities for prevention and control of such pollution must submit a report without delay and take prevention and control measures as it should.    Article 25 Industrial enterprises that produce environmental noise pollution shall take effective measures to minimize the impact of noise on the living environment of the neighbourhood.    Article 26 With regard to industrial equipment that might produce environmental noise pollution, the relevant competent departments under the State Council shall, in accordance with the requirements for protection of the acoustic environment and the State’s economic and technological conditions, gradually include the noise level limits in the national standards and trade standards for products established according to law. The level of noise emitted by the industrial equipment in operation mentioned in the preceding paragraph shall be specified in relevant technical documents. CHAPTER IV PREVENTION AND CONTROL OF CONSTRUCTION NOISE POLLUTION    Article 27 “Construction noise”, as used in this Law, means the sound that is emitted in the course of construction and that impairs the living environment of the neighbourhood.    Article 28 The construction noise emitted to the living environment of the neighbourhood within an urban area shall be kept within the limits set by the State on the emission of environmental noise within the boundary of a construction site.    Article 29 The unit in charge of a construction project which may produce environmental noise pollution due to the use of machines and other equipment, must report, 15 days before commencement of construction, to the competent administrative department for environmental protection of the local people’s government at or above the county level the name of the project, the construction site, the length of time needed for completion of the project, the possible level of environmental noise and the measures taken for prevention and control of such pollution.    Article 30 In an urban area where noise-sensitive structures are concentrated, construction operation that produces environmental noise pollution is forbidden at night, with the exception of rush repairs, rescue operations or continued operations required by production techniques or by special needs. For continued operation due to special needs, there must be a permit issued by the people’s government at or above the county level or by the relevant competent department under it. Night operation mentioned in the preceding paragraph must be made known to the residents in the neighbourhood. CHAPTER V PREVENTION AND CONTROL OF TRAFFIC NOISE POLLUTION    Article 31 “Traffic noise”, as used in this Law means the sound that is emitted by such means of transport as motor vehicles, locomotives, motor vessels and aircraft in motion and that impairs the living environment of the neighbourhood.    Article 32 It is forbidden to manufacture, sell or import automobiles that emit noise beyond the limits set on noise level.    Article 33 Mufflers and horns of motor vehicles driven within urban areas must meet the requirements of the State. Motor vehicles must be regularly serviced and kept in good repair in order to maintain excellent technical performance and help prevent and control environmental noise pollution.    Article 34 When motor vehicles are driven in urban areas, motor vessels are navigated along inland rivers in urban areas, and locomotives are running through or entering urban areas or sanatorium areas, their sound-making apparatus must be used in compliance with regulations. Alarming sirens must be installed on such motor vehicles as police cars, fire engines, engineering rescue vehicles and ambulances and used in compliance with the regulations of the public security department under the State Council. It is forbidden to use the alarming sirens unless when urgent tasks are performed.    Article 35 The public security organs of municipal people’s governments may, in line with the need to protect the local acoustic environment of the urban areas, demarcate no-motor-vehicle or no-horn road sections and hours, and make them known to the public.    Article 36 To build expressways, urban overhead road and light-tract lines that traverse areas where there are concentrated noise-sensitive structures and that might produce environmental noise pollution, sound barriers shall be erected or other effective measures shall be taken to control environmental noise pollution.    Article 37 To build noise-sensitive structures on both sides of existing urban traffic trunk lines, the construction unit shall, in accordance with the regulations of the State, keep such structures a certain distance away from the lines and take measures to mitigate or avoid the impact of traffic noise.    Article 38 Where loudspeakers are used to direct operations at transport terminals, railway marshal yards, ports, docks and airports, the sound volume shall be controlled so as to minimize the noise impact on the living environment of the neighbourhood.    Article 39 Where locomotives when traversing urban residential, cultural and education districts produce environmental noise pollution, the local municipal people’s governments shall get the railway departments and other relevant departments together to work out plans for mitigating such pollution. The railway departments and other relevant departments shall act in accordance with such plans and take effective measures to mitigate environmental noise pollution.    Article 40 With the exception of take-off, landing or other situations as provided for by law, no civil aircraft may fly over the urban areas of cities. The municipal people’s governments shall demarcate areas in the vicinity of obstacle clearance zones for the take-off and landing of aircraft where construction of noise-sensitive structures is restricted. To build noise-sensitive structures within such areas, the construction units shall take measure to mitigate or avoid the impact of the noise emitted by aircraft in motion. The civil aviation department shall take effective measures to mitigate environmental noise pollution. CHAPTER VI PREVENTION AND CONTROL OF POLLUTION BY NOISE OF SOCIAL ACTIVITIES    Article 41 “Noise of social activities”, as used in this Law, means the sound that is emitted by man-conducted activities and that impairs the living environment of the neighbourhood, other than industrial, construction and traffic noise.    Article 42 A commercial enterprise that, in an urban area where noise- sensitive structures are concentrated, produce environmental noise pollution as the result of its use of permanent equipment in the course of commercial activities must, in accordance with the regulations of the competent administrative department for environmental protection under the State Council, report to the competent administrative department for environmental protection of the local people’s government at or above the county level the condition of the equipment that produces environmental noise pollution and provide information about the facilities for prevention and control of such pollution.    Article 43 Noise level at the boundary of newly-constructed profit- making cultural and entertainment centers must be kept within the limits of environmental noise emission set by the State. No competent administrative department for culture may issue cultural operation licence and no administrative department for industry and commerce may issue business licence to the centers that fail to keep such emission within the limits. Operators and managers of cultural and entertainment centers must take effective measures to keep noise at the boundary from exceeding the limits set by the State on emission of environmental noise.    Article 44 In commercial activities high-pitch loudspeakers and other loud-noise instruments are forbidden to be used for attracting customers. When using such equipment and facilities as air-conditioners and cooling towers in commercial activities which might produce environmental noise pollution, the operators and managers shall take measures to keep the noise at the boundary from exceeding the limits set by the State on emission of environmental noise.    Article 45 All units and individuals are forbidden to use high-pitch loudspeakers in urban areas where noise-sensitive structures are concentrated. Where audio apparatus that might produce such excessive sound volume as to impair the living environment of the neighbourhood are used for entertainments arranged or gatherings held at such public places as streets, squares or parks in urban areas, the regulations of the local public security organ must be observed.    Article 46 Whoever uses household appliances or musical instruments or holds other indoor entertainment activities shall keep the sound volume under control or take other effective measures to avoid producing environmental noise pollution to the neighbours.    Article 47 Whoever makes indoor decoration and refitting in a residential building that is already completed and delivered for use shall do so in restricted hours and take other effective measures to mitigate or avoid producing environmental noise pollution to the neighbours. CHAPTER VII LEGAL LIABILITY    Article 48 Anyone who, in violation of the provisions of Article 14 of this Law, puts into production or use a construction project before the necessary facilities for prevention and control of environmental noise pollution have been completed or meet the requirements laid down by the State, shall be ordered to stop production or use and may also be fined by the competent administrative department for environmental protection that originally approved the environmental impact statement regarding this construction project.    Article 49 Anyone who, in violation of the provisions of this Law, refuses to report or makes a false report on the particulars subject to report regarding the environmental noise emission, may be given a disciplinary warning or fined in light of the seriousness of the violation by the competent administrative department for environmental protection of the local people’s government at or above the county level.    Article 50 Any enterprise or institution that, in violation of the provisions of Article 15 of this Law, dismantles or leaves idle the facilities for prevention and control of environmental noise pollution without approval of the competent administrative department for environmental protection, thereby emitting environmental noise in excess of the limits prescribed, shall be ordered to set it right and also be fined by the competent administrative department for environmental protection of the local people’s government at or above the county level.    Article 51 Any unit that, in violation of the provisions of Article 16 of this Law, fails to pay, as required by the State, fees for excessive emission of noise, may be given a disciplinary warning or fined, in light of the seriousness of the violation, by the competent administrative department for environmental protection of the local people’s government at or above the county level.    Article 52 Any enterprise or institution that, in violation of the provisions of Article 17 of this Law, fails to put the pollution under control at the expiration of the time limit, may be fined or ordered to suspend production or to relocate or close down in light of the hazards so caused, in addition to paying fees for excessive emission of noise as required by the State. The decision on a fine mentioned in the preceding paragraph shall be made by the competent administrative department for environmental protection. The order for suspension of production, relocation or closedown shall be issued by the people’s government at or above the county level within the limits of its power granted by the State Council.    Article 53 Anyone who, in violation of the provisions of Article 18 of this Law, manufactures, sells or imports equipment prohibited to be manufactured, sold or imported, shall be ordered by the competent department for comprehensive economic and trade affairs of the people’s government at or above the county level to set it right; if the violation is serious, the said department shall submit a proposal to the people’s government at the corresponding level for ordering, within the limits of its power granted by the State Council, the violator to suspend operation or close down.    Article 54 Anyone who, in violation of the provisions of Article 19 of this Law and without approval of the local public security organ, conducts activities that emit sporadic strong noise shall be given a disciplinary warning or fined by the said organ in light of the seriousness of the violation.    Article 55 Any unit emitting environmental noise that, in violation of the provisions of Article 21 of this Law, refuses to undergo on-the-spot inspection by the competent administrative department for environmental protection or by any other department or institution that exercises its power of supervision and control of environmental noise in accordance with the provisions of this Law, or resorts to fraud when being inspected, may be given a disciplinary warning or be fined in light of the seriousness of the violation by the said competent administrative department or the said department or institution.    Article 56 Any construction unit that, in violation of the provisions of Paragraph 1 of Article 30 of this Law, conducts at night, in an urban area where noise-sensitive structures are concentrated, construction operation that produces environmental noise pollution and that is therefore prohibited, shall be ordered to set it right and may also be fined by the competent administrative department for environmental protection of the people’s government at or above the county level in the place where the construction project is located.    Article 57 Anyone who uses the sound apparatus on the motor vehicle in violation of the provisions of Article 34 of this Law shall be given a disciplinary warning or be fined by the local public security organ in light of the seriousness of the violation. If a motor vessel is involved in the commission of the unlawful act mentioned in the preceding paragraph, a disciplinary warning or fine shall be imposed by the harbour superintendency administration in light of the seriousness of the act. If a railway locomotive is involved in the commission of the unlawful act mentioned in the first paragraph, the competent railway department shall impose administrative penalty on the person who is responsible for the act.    Article 58 Anyone who, in violation of the provisions of this Law, commits any of the following acts, shall be given a disciplinary warning and may also be fined by the public security organ: (1) Using a high-pitch loudspeaker in an urban area where noise- sensitive structures are concentrated; (2) Using, in violation of the regulations of the local public security organ, audio apparatus which produce such excessive sound volume as to impair the living environment of the neighbourhood when offering entertainment or holding gatherings in such public places as streets, squares or parks in urban areas; or (3) Emitting from indoors environmental noise that seriously impairs life of the neighbours, without taking measures in accordance with the provisions of Article 46 or Article 47 of this Law.    Article 59 Any operators or managers who, in violation of the provisions of Paragraph 2 of Article 43 or Paragraph 2 of Article 44 of this Law, cause environmental noise pollution, shall be ordered to set it right and may also be fined by the competent administrative department for environmental protection of the local people’s government at or above the county level.    Article 60 Any operators or managers who, in violation of the provisions of Paragraph 1 of Article 44 of this Law, cause environmental noise pollution shall be ordered to set it right and may also be fined by the public security organ. Where the people’s governments at or above the provincial level have decided according to law that the competent administrative departments for environmental protection of the local people’s governments at or above the county level exercise the power of administrative penalty mentioned in the preceding paragraph, such decision shall be abided by.    Article 61 Any unit or individual suffering from the hazards of environmental noise pollution shall have the right to demand the polluter to eliminate the hazards; if a loss has been caused, it shall be compensated according to law. Any dispute over the liability for losses or over the amount of compensation may, at the request of the parties concerned, be mediated by the competent administrative department for environmental protection or any other supervisory and administrative department or institution in charge of prevention and control of environmental noise pollution; if such mediation fails, the parties may bring a lawsuit in a People’s Court. They may also directly bring a lawsuit In a People’s Court.    Article 62 If any person who is in charge of supervision or administration of prevention and control of noise pollution abuses his power, neglects his duty or conducts malpractice for personal gain, the unit to which he belongs or the competent authority at the higher level shall give him administrative penalty. If a crime is constituted, criminal liability shall be investigated according to law. CHAPTER VIII SUPPLEMENTARY PROVISIONS    Article 63 For purposes of this Law, the meanings of the following terms are: (1) “Noise emission” means emission of noise from the source to the living environment of the neighbourhood. (2) “Noise-sensitive structures” mean structures that require a quiet environment such as hospitals, schools, government offices, research institutions and residential buildings. (3) “Areas where noise-sensitive structures are concentrated” mean such areas as medical treatment areas, cultural, education and research districts and areas where government offices or residential buildings constitute the main buildings. (4) “At night” means the period from 10:00 p.m. to 6:00 a.m. (5) “Motor vehicles” mean automobiles and motorcycles.    Article 64 This Law shall enter into force as of March 1, 1997. The Regulations of the People’s Republic of China on Prevention and Cont 123...5Page 1 of 5 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... CONSTITUTION ACT, 1982 – page 21 CONSTITUTION ACT, 1982 – page 20 CONSTITUTION ACT, 1982 – page 19 CONSTITUTION ACT, 1982 – page 18 CONSTITUTION ACT, 1982 – page 17 CONSTITUTION ACT, 1982 – page 16 CONSTITUTION ACT, 1982 – page 12 CONSTITUTION ACT, 1982 – page 11 CONSTITUTION ACT, 1982 – page 10 CONSTITUTION ACT, 1982 – page 9 CONSTITUTION ACT, 1982 – page 8 CONSTITUTION ACT, 1982 – page 7 Disclaimer: There is no confidential attorney-client relationship formed by using Laws.com website and information provided on this site is not legal advice. For legal advice, please contact your attorney. Attorneys listed on this website are not referred or endorsed by this website. By using Laws.com you agree to Laws.com Terms Of Use. 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