MEASURES FOR THE IMPLEMENTATION OF THE PHARMACEUTICAL ADMINISTRA-TION LAW OF THE PEOPLE'S REPUBLIC OF CHINA
MEASURES FOR THE IMPLEMENTATION OF THE PHARMACEUTICAL ADMINISTRA-TION LAW OF THE PEOPLE'S REPUBLIC OF CHINA
Important Notice:
This English document is coming from the "LAWS AND REGULATIONS OF THE
PEOPLE'S REPUBLIC OF CHINA GOVERNING FOREIGN-RELATED MATTERS" (1991.7)
which is compiled by the Brueau of Legislative Affairs of the State
Council of the People's Republic of China, and is published by the China
Legal System Publishing House.
In case of discrepancy, the original version in Chinese shall prevail.
Whole Document
MEASURES FOR THE IMPLEMENTATION OF THE PHARMACEUTICAL ADMINISTRA-
TION LAW OF THE PEOPLE'S REPUBLIC OF CHINA
(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 Li- censes
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 Producers
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 License 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 before 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 the 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 before
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 primary 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 Government
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 of 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 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
requirements 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 a sanitary 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 stipu-lations:
(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 factories.
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 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 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 radioisotope.
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 used to
pass off for according to the seriousness of the case.
Article 50
Any one of the following acts of making, selling or using fake or inferior
medicines shall be considered as a serious case on which the
administrative department of health shall impose severe disciplinary
sanctions:
1. a counterfeit of other medicine with narcotics, psychotropic
substances, toxic drugs or radioactive drug or vice versa;
2. an act of making or selling fake medicine or inferior medicine to be
mainly administered to babies or infants;
3. an act of making, selling or using fake or inferior medicine which has
produced harmful results as to endanger people's health;
4. repetition of an act of making, selling or using fake or inferior
medicine after being penalized;
5. any act that shall be imposed with severe punishment as stipulated in
other state laws and regulations.
Article 51
Any units engaged in the production, trading or preparation of medicines
without obtaining the Pharmaceutical Producer Licence, Pharmaceutical
trading Enterprise Licence or Dispensing Permit shall be ordered to
suspend production, business operations or preparation of such medicines.
The medicines and the illegal gains therefrom shall all be confiscated and
the administrative department of health may impose a maximum fine five
times the price of the standard medicine or medicament, according to the
seriousness of the case.
Article 52
Units or individuals that have committed any of the following violations
shall be given a disciplinary warning or penalized with a maximum fine of
20,000 CNY yuan according to the seriousness of the case:
1. to import medicines from abroad for the first time without approval by
the administrative department of health under the State Council;
2. to import medicines from abroad without inspection by the medicine
inspection organ at the border port;
3. to conduct clinical testing or verification of new medicine without
authorization;
4. to change the technological process of production without approval by
the administrative department of health and, as a result, the quality of
the medicine has been degraded;
5. to prepare medicaments for sale or for sale in devious manner by
medical treatment units.
Article 53
Any unit or individual that has committed any one of the following acts
shall be given a disciplinary warning or penalized with a maximum fine of
10,000 CNY yuan according to the seriousness of the case:
1. fail to indicate the expiry date of the medicine which ought to be
indicated;
2. violate the regulations concerning inner packaging of Chinese medicinal
materials or protective packaging of pharmaceuticals for shipment;
3. fail to label the packing as required or the items printed on the label
or on the package insert are not in conformity with the requirements;
4. to purchase or sell newly discovered Chinese medicinal materials or
those introduced from abroad that have not been examined and approved.
Article 54
Any individual at the medicine inspection organs or any medicine
supervisor who abuses his power or engages in malpractices for personal
gains shall be given a disciplinary sanction by the administrative
department if the offence is not very serious; if the case is serious as
to constitute a crime, he shall be prosecuted for criminal responsibility
according to law.
Chapter X Supplementary Provisions
Article 55
Labels for narcotics, psychotropic substances, toxic drugs, radioactive
drugs and medicines for external application shall be designed as follows
(See the attached drawings ).
Article 56
The right to interpret these Measures resides in the administrative
department of health
Article 57
These Measures shall go into effect as of the date of promulgation.
Note:
The attached drawings see page 1505. -The Editor
chnical 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 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 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 radioisotope.
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 used to
pass off for according to the seriousness of the case.
Article 50
Any one of the following acts of making, selling or using fake or inferior
medicines shall be considered as a serious case on which the
administrative department of health shall impose severe disciplinary
sanctions:
1. a counterfeit of other medicine with narcotics, psychotropic
substances, toxic drugs or radioactive drug or vice versa;
2. an act of making or selling fake medicine or inferior medicine to be
mainly administered to babies or infants;
3. an act of making, selling or using fake or inferior medicine which has
produced harmful results as to endanger people's health;
4. repetition of an act of making, selling or using fake or inferior
medicine after being penalized;
5. any act that shall be imposed with severe punishment as stipulated in
other state laws and regulations.
Article 51
Any units engaged in the production, trading or preparation of medicines
without obtaining the Pharmaceutical Producer Licence, Pharmaceutical
trading Enterprise Licence or Dispensing Permit shall be ordered to
suspend production, business operations or preparation of such medicines.
The medicines and the illegal gains therefrom shall all be confiscated and
the administrative department of health may impose a maximum fine five
times the price of the standard medicine or medicament, according to the
seriousness of the case.
Article 52
Units or individuals that have committed any of the following violations
shall be given a disciplinary warning or penalized with a maximum fine of
20,000 CNY yuan according to the seriousness of the case:
1. to import medicines from abroad for the first time without approval by
the administrative department of health under the State Council;
2. to import medicines from abroad without inspection by the medicine
inspection organ at the border port;
3. to conduct clinical testing or verification of new medicine without
authorization;
4. to change the technological process of production without approval by
the administrative department of health and, as a result, the quality of
the medicine has been degraded;
5. to prepare medicaments for sale or for sale in devious manner by
medical treatment units.
Article 53
Any unit or individual that has committed any one of the following acts
shall be given a disciplinary warning or penalized with a maximum fine of
10,000 CNY yuan according to the seriousness of the case:
1. fail to indicate the expiry date of the medicine which ought to be
indicated;
2. violate the regulations concerning inner packaging of Chinese medicinal
materials or protective packaging of pharmaceuticals for shipment;
3. fail to label the packing as required or the items printed on the label
or on the package insert are not in conformity with the requirements;
4. to purchase or sell newly discovered Chinese medicinal materials or
those introduced from abroad that have not been examined and approved.
Article 54
Any individual at the medicine inspection organs or any medicine
supervisor who abuses his power or engages in malpractices for personal
gains shall be given a disciplinary sanction by the administrative
department if the offence is not very serious; if the case is serious as
to constitute a crime, he shall be prosecuted for criminal responsibility
according to law.
Chapter X Supplementary Provisions
Article 55
Labels for narcotics, psychotropic substances, toxic drugs, radioactive
drugs and medicines for external application shall be designed as follows
(See the attached drawings ).
Article 56
The right to interpret these Measures resides in the administrative
department of health
Article 57
These Measures shall go into effect as of the date of promulgation.
Note:
The attached drawings see page 1505. -The Editor
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