PHARMACEUTICAL ADMINISTRATION LAW OF THE PEOPLE'S REPUBLIC OFCHINA
PHARMACEUTICAL ADMINISTRATION LAW OF THE PEOPLE'S REPUBLIC OFCHINA
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
PHARMACEUTICAL ADMINISTRATION LAW OF THE PEOPLE'S REPUBLIC OF
CHINA
(Adopted at the Seventh Meeting of the Standing Committee of the
Sixth National People's Congress, promulgated by Order No. 18 of the
President of the People's Republic of China on September 20, 1984, and
effective as of July 1, 1985)
Contents
Chapter I General Provisions
Chapter II Administration of Pharmaceutical Producing Enterprises
Chapter III Administration of Pharmaceutical Trading Enterprises
Chapter IV Administration of Pharmaceuticals at Medical Units
Chapter V Pharmaceutical Administration
Chapter VI Packaging and Repackaging of Pharmaceuticals
Chapter VII Pharmaceuticals Under Special Control
Chapter VIII Administration of Trademarks and Advertisements of
Pharmaceuticals
Chapter IX Supervision over Pharmaceuticals
Chapter X Legal Responsibility
Chapter XI Supplementary Provisions
Chapter I General Provisions
Article 1
This Law is formulated with a view to enhancing the supervision and
control of pharmaceuticals, ensuring their quality, improving their
curative effects, guaranteeing safety in medication and safeguarding the
health of the people.
Article 2
The administrative department of health under the State Council shall be
responsible for the supervision and control of pharmaceuticals throughout
the country.
Article 3
The state shall develop both modern and traditional medicines and give
full play to their role in the prevention and treatment of diseases and in
health care. The state shall protect the resources of wild medicinal
materials and encourage the domestic cultivation of Chinese traditional
medicinal crops.
Chapter II Administration of Pharmaceutical Producing Enterprises
Article 4
The establishment of a pharmaceutical producing enterprise must be
sanctioned by the competent authorities for the production and trading of
pharmaceuticals of the province, autonomous region, or municipality
directly under the Central Government in which the enterprise is located,
and approved by the administrative department of health of the same
province, autonomous region or municipality, which will issue a
Pharmaceuticals Producer Licence. The administrative authorities for
industry and commerce shall not issue business licences to any enterprises
producing pharmaceuticals without the Pharmaceutical Producer Licence.
The Pharmaceutical Producer Licence shall have a period of validity, upon
expiration of which a new licence shall be issued after an examination for
its renewal. Detailed measures for the renewal of such licences shall be
stipulated by the administrative department of health under the State
Council.
Article 5
To establish a pharmaceutical producing enterprise, the following
requirements must be met:
(1) It shall be staffed with the necessary personnel required for
producing the medicines concerned, that is, pharmacists or technical
personnel with a qualification equivalent to or higher than assistant
engineer as well as skilled workers. If an enterprise processing Chinese
traditional medicines into ready-to-use mixture and powder forms does not
have pharmacists or technical personnel with a qualification equivalent to
or higher than assistant engineer, it shall be staffed instead with
skilled pharmaceutical workers who are familiar with the properties of the
medicines processed and are registered with the administrative department
of health at or above the county level.
(2) It shall have factory premises, facilities and a sanitary environment
suitable for the medicines produced.
(3) It shall have a unit or competent personnel capable of inspecting the
quality of the medicines produced, as well as necessary instruments and
equipment.
Article 6
Pharmaceuticals must be produced in accordance with the technological
procedure, and the record of production must be complete and accurate.
The process for preparing traditional Chinese medicines in ready-to-use
forms must conform to the Pharmacopoeia of the People's Republic of China
or the Processing Norms stipulated by the administrative departments of
health of the provinces, autonomous regions, or municipalities directly
under the Central Government.
Article 7
The raw and supplementary materials used for the production of
pharmaceuticals and containers and packaging materials in direct contact
with pharmaceuticals must conform to the requirements for medicinal use.
Article 8
Pharmaceuticals must go through quality inspection before they leave the
factory; products which do not meet the standards shall not leave the
factory.
Article 9
Pharmaceutical producing enterprises must draw up and carry out rules and
regulations and sanitary requirements for ensuring the quality of
pharmaceuticals in accordance with the Standards for Quality Control of
Pharmaceutical Production stipulated by the administrative department of
health under the State Council.
Chapter III Administration of Pharmaceutical Trading Enterprises
Article 10
The establishment of a pharmaceutical trading enterprise must be
sanctioned by the local competent authorities for the production and
trading of pharmaceuticals and approved by the administrative department
of health at or above the county level, which will issue a Pharmaceutical
Trading Enterprise Licence. The administrative authorities for industry
and commerce shall not issue business licences to any enterprises without
the Pharmaceutical Trading Enterprise Licence.
The Pharmaceutical Trading Enterprise Licence shall have a period of
validity, upon expiration of which a new licence shall be issued after an
examination for its renewal. Detailed measures for the renewal of such
licences shall be stipulated by the administrative department of health
under the State Council.
Article 11
To establish a pharmaceutical trading enterprise, the following
requirements must be met:
(1) It shall be staffed with pharmaceutical technicians qualified for the
handling of the pharmaceuticals.
If an enterprise trading in Chinese traditional medicines or an enterprise
concurrently trading in medicines does not have pharmaceutical
technicians, it shall be staffed instead with pharmaceutical workers who
are familiar with the properties of the medicines it trades in and are
registered with the administrative department of health at or above the
county level.
(2) It shall have business premises, equipment, storage facilities and a
sanitary environment suitable for the pharmaceuticals in which it trades.
Article 12
The quality of pharmaceuticals must be inspected on purchasing.
Pharmaceuticals that do not meet the required standards must not be
purchased.
Article 13
It is imperative, in the sale of pharmaceuticals, to be accurate and free
of mistakes, and to provide correct directions for use, dosage and
precautions. Prescriptions being dispensed must be checked.
Pharmaceuticals listed in prescriptions must not be presumptuously changed
or substituted. Prescriptions containing incompatible substances or
excessive dosages shall be rejected by the dispensary. If necessary, such
prescriptions can be dispensed after they have been corrected or resigned
by the doctors who wrote them out.
When famous traditional Chinese medicinal materials are offered for sale,
their origin must be indicated.
Article 14
Rules for storage of pharmaceuticals shall be formulated and implemented
by pharmaceutical warehouses, which must adopt necessary measures to
facilitate cold storage and protection against moisture, insects and
rodents.
An inspection system shall be carried out for pharmaceuticals entering or
leaving warehouses.
Article 15
Unless otherwise stipulated by the state, traditional Chinese medicinal
materials may be marketed at urban or rural fairs.
Pharmaceuticals other than traditional Chinese medicinal materials may not
be sold at urban or rural fairs, except by those who have Pharmaceuticals
Trading Enterprise Licences.
Chapter IV Administration of Pharmaceuticals at Medical Units
Article 16
Medical units must be staffed with pharmaceutical technical personnel
commensurate with their medical functions. Non-pharmaceutical technical
personnel may not engage directly in pharmaceutical technical work.
Article 17
To make medicinal preparations, a medical unit must be examined, approved
and issued a Dispensing Permit by the administrative department of health
of the province, autonomous region, or municipality directly under the
Central Government in which the units is located.
The Dispensing Permit shall have a period of validity, upon expiration of
which a new permit shall be issued after an examination for its renewal.
Detailed measures for the renewal of such permits shall be stipulated by
the administrative department of health under the State Council.
Article 18
Medical units making medicinal preparations must be equipped with
facilities, inspection instruments and sanitary conditions capable of
ensuring the quality of the preparations.
Article 19
The quality of the medicinal preparations made by medical units must be
inspected in accordance with relevant regulations and clinical needs.
Those up to standard can be used as the doctor prescribes.
Medicinal preparations made by medical units may not be sold on the
market.
Article 20
Medical units must implement a system of quality inspection when
purchasing pharmaceuticals.
Chapter V Pharmaceutical Administration
Article 21
The state encourages research on and development of new medicines.
When working on a new medicine, it is necessary to submit, as required,
the methods of production, quality indices, pharmacological and
toxicological testing results, and other related materials and samples to
the administrative department of health under the State Council or to the
administrative department of health of the relevant province, autonomous
region, or municipality directly under the Central Government. Clinical
tests or clinical verifications can be carried out only after approval.
A new medicine which has completed its clinical tests or clinical
verifications and been approved after appraisal shall be issued a
certificate by the administrative department of health under the State
Council.
Article 22
A new medicine can be put into production only after the administrative
department of health under the State Council has approved it and issued a
registered document of approval. However, this does not apply to the
production of traditional Chinese medicines prepared in ready-to-use
forms.
A medicine standardized by the state or by a province, an autonomous
region, or a municipality directly under the Central Government shall be
put into production only after the administrative department of health of
the relevant province, autonomous region, or municipality directly under
the Central Government has made an examination of the medicine, given it
approval and issued a registered document of approval, seeking beforehand
the opinions of the authorities at the same level in charge of the
production and trading of medicines. However, this does not apply to the
production of traditional Chinese medicines prepared in ready-to-use
forms.
Article 23
Pharmaceuticals must meet the pharmaceutical standards of the state or
those of the relevant province, autonomous region, or municipality
directly under the Central Government.
The Pharmacopoeia of the People's Republic of China and the pharmaceutical
standards promulgated by the administrative department of health under the
State Council shall be the state pharmaceutical standards.
The Pharmacopoeia Committee of the administrative department of health
under the State Council shall be responsible for organizing the
formulation and revision of the state pharmaceutical standards.
Article 24
The administrative department of health under the State Council and
administrative departments of health of provinces, autonomous regions, and
municipalities directly under the Central Government may establish
pharmaceutical examination and evaluation committees to carry out
examination and evaluation of new medicines and to reevaluate medicines
already put into production.
Article 25
The administrative department of health under the State Council shall
organize investigations of medicines which have been approved for
production. It shall revoke the registered documents of approval if it
discovers that the medicines' curative effects are uncertain or poor, or
that they produce serious adverse reactions or for other reasons are
harmful to people's health.
Production and sale of medicines whose registered documents of approval
have been revoked shall not be allowed to continue; those which have
already been produced shall be destroyed or disposed of under the
supervision of the local administrative department of health.
Article 26
Import of medicines whose curative effects are uncertain or poor, or which
produce adverse reactions or have other harmful effects on people's health
shall be prohibited.
Article 27
For any medicine which is to be imported for the first time, the importer
must submit the manuals, quality standards, methods of inspection and
other related information and samples, as well as the exporting country's
(region's) certification documents approving its production, to the
administrative department of health under the State Council, and import
contracts may be signed only with the prior approval of the said
department.
Article 28
Imported medicines must be inspected by the pharmaceutical inspection
institutions authorized by the administrative department of public health
under the State Council; those having passed the inspection shall be
allowed to be imported. Medicines to be imported in small quantities for
urgent clinical needs by medical units or for personal use shall be
handled according to customs regulations.
Article 29
The administrative department of health under the State Council shall have
the power to restrict or prohibit the export of traditional Chinese
medicinal materials and prepared Chinese medicines which are in short
supply in the domestic market.
Article 30
Import Licences or Export Licences issued by the administrative department
of health under the State Council are required for the import or export of
narcotics and psychotropic substances falling within the restricted scope
prescribed by the administrative department of health under the State
Council.
Article 31
Newly discovered domestic medicinal plants or medicinal plants introduced
from abroad may be sold only after they have been examined and approved by
the administrative department of health of the relevant province,
autonomous region, or municipality directly under the Central Government.
Article 32
Measures for controlling medicinal materials traditionally used by local
people in certain regions shall be formulated by the administrative
department of health under the State Council.
Article 33
The production and sale of fake medicines are prohibited. A fake medicine
has either of the following characteristics:
(1) the names of its components are different from those prescribed for it
by state pharmaceutical standards or pharmaceutical standards of the
relevant province, autonomous region, or municipality directly under the
Central Government;
(2) a non-medical substance is passed off as a medicine, or one medicine
is passed off as another.
A medicine shall be handled as fake medicine in any of the following
cases:
(1) where the use of the medicine has been prohibited by the
administrative department of health under the State Council;
(2) where the medicine has been produced without being assigned a
registration number;
(3) where the medicine has deteriorated and cannot be used as such; or
(4) where the medicine has been contaminated and cannot be used as such.
Article 34
The production and sale of medicines of inferior quality shall be
prohibited. A medicine of inferior quality has any of the following
characteristics:
(1) the components of the medicine do not conform in quantity to that
required by state pharmaceutical standards or pharmaceutical standards of
the relevant province, autonomous region, or municipality directly under
the Central Government;
(2) the medicine has passed its expiry date; or
(3) the medicine fails to meet the prescribed standards in other respects.
Article 35
Personnel in pharmaceutical producing or trading enterprises and in
medical units who have direct contact with medicines must undergo an
annual medical examination. Persons who have contracted contagious
diseases or any other disease which may contaminate the medicines shall
not be allowed to engage in any work which has direct contact with
pharmaceuticals.
Chapter VI Packaging and Repackaging of Pharmaceuticals
Article 36
Packaging must meet the specific quality requirements of the
pharmaceuticals and facilitate their storage, transportation and medical
use. If a medicine has a period of validity, it must be clearly indicated
on the package.
Traditional Chinese medicinal materials must be packaged before
transportation. There must appear on the package the name of the medicine,
place of production, date, name of the consignor, and an indication that
the quality of the medicine is up to standard.
Article 37
Packages of pharmaceuticals must, in accordance with the regulations, be
labeled and include directions for use.
The label or directions must indicate the name of the medicine,
specifications, the producer, registration number, batch number of the
product, principal components, indications, directions for use dosage,
contraindications, adverse reactions and precautions.
Special indications must be printed as required on the labels of
narcotics, psychotropic substances, toxic drugs, radioactive drugs and
medicines for external use.
Article 38
A pharmaceuticals trading enterprise engaged in the repackaging of
medicines must possess the necessary facilities and sanitary conditions
suitable for the purpose, and pharmaceutical technicians must be placed in
charge of this work. The repackaging records must be complete and
accurate.
The repackaged medicine must enclose directions for use, and on the
package must be indicated the name of the medicine, specifications, the
producer, the batch number of the product, the repackaging unit and the
lot number of the repackaged product. If the medicine has a period of
validity, it must also be indicated on the new package.
Chapter VII Pharmaceuticals Under Special Control
Article 39
The state adopts special measures for the control of narcotics,
psychotropic substances, toxic drugs and radioactive drugs. Regulations
for the control of these drugs shall be formulated by the State Council.
Article 40
Narcotics, including their mother plants, must be produced only by units
jointly designated by the administrative department of health under the
State Council and other departments concerned, and must be supplied by
units jointly designated by the administrative department of health of
provinces, autonomous regions, and municipalities directly under the
Central Government and other departments concerned.
Chapter VIII Administration of Trademarks and Advertisements of Pharmaceuticals
Article 41
Registered trademarks must be used for all pharmaceuticals with the
exception of traditional Chinese medicinal materials and their
preparations in ready-to-use forms. The sale of pharmaceuticals without
completing trademark registration shall be prohibited.
The registered trademark must appear on the package and the label of the
medicine.
Article 42
Advertisements of pharmaceuticals must be examined and approved by the
administrative department of health of the relevant province, autonomous
region, or municipality directly under the Central Government. In the
absence of such approval, advertisement of any medicine may not be
published, broadcast, handed out or posted on walls.
Article 43
Foreign enterprises which apply to advertise pharmaceuticals in China must
submit relevant documents of approval by the country (region) in which the
pharmaceuticals are produced, directions for use and other relevant
materials.
Article 44
Advertisements of pharmaceuticals must be based on the directions for use
approved by the administrative department of health under the State
Council or the administrative departments of health of provinces,
autonomous regions, or municipalities directly under the Central
Government.
Chapter IX Supervision over Pharmaceuticals
Article 45
The administrative departments of health at or above the county level
shall exercise supervisory power over pharmaceuticals.
The administrative departments of health at or above the county level may
set up organs for the administration of pharmaceuticals and organs for the
inspection of pharmaceuticals.
Article 46
There shall be pharmaceutical inspectors in the administrative departments
of health at or above the county level. Pharmaceutical inspectors shall be
appointed from among pharmacological technical personnel and issued
certificates by the people's governments at the same level.
Article 47
Pharmaceutical inspectors are authorized to exercise, in accordance with
the regulations, supervision, inspection and sampling as regards the
quality of pharmaceuticals in the producing enterprises, trading
enterprises and medical units within their jurisdiction, and when
necessary may pick samples at random and ask for relevant data in
accordance with regulations. The enterprises and units concerned may not
refuse such requests or withhold relevant data. Pharmaceutical inspectors
are duty-bound to keep confidential the technical information provided by
pharmaceutical producing enterprises and scientific research institutions.
Article 48
Pharmaceutical producing enterprises, pharmaceutical trading enterprises
and medical institutions shall conduct regular surveys of the quality,
curative effects and adverse reactions of the pharmaceuticals they have
produced, traded in or used. When drug poisoning is discovered, the
medical institution concerned must promptly report the matter to the local
administrative department of health.
Article 49
The organs or personnel in charge of pharmaceutical inspection in
pharmaceutical producing enterprises and pharmaceutical trading
enterprises shall receive operational guidance from the local
pharmaceutical inspection organs.
Chapter X Legal Responsibility
Article 50
Whoever produces or sells fake medicines shall have his fake medicines and
unlawful income confiscated and may concurrently be fined; in addition, he
may be ordered to suspend production or business operations pending
rectification, or have his Pharmaceutical Producer Licence, Pharmaceutical
Trading Enterprise Licence or Dispensing Permit revoked.
An individual who produces or sells fake medicines, or the person directly
responsible for a unit which commits this offence, and thereby endangers
people's health, shall be investigated for criminal liability under
Article 164 of the Criminal Law.
Article 51
Whoever produces or sells medicines of inferior quality shall have his
medicines of inferior quality and unlawful income confiscated and may be
fined as well. If the circumstances are serious, the unit concerned shall
be ordered to suspend production or business operations pending
rectification, or have its Pharmaceutical Producer Licence, Pharmaceutical
Trading Enterprise Licence or Dispensing Permit revoked. An individual
who produces or sells medicines of inferior quality or the person directly
responsible for a unit which commits this offence, and thereby endangers
people's health and causes serious consequences, shall be investigated for
criminal liability in reference to the provisions of Article 164 of the
Criminal Law.
Article 52
Any unit 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 unlawful income shall all be confiscated and a fine may
also be imposed.
Article 53
Whoever violates any other provision of this Law on the administration of
pharmaceutical production and pharmaceutical trading shall be served a
warning or be fined.
Article 54
The decision to mete out administrative sanctions stipulated in this Law
shall be made by the administrative departments of health at or above the
county level. The decision to mete out administrative sanctions for
violations of the provisions of Article 15 or of Chapter VIII on
administration of advertisements of this Law shall be made by the
administrative departments for industry and commerce.
Punishment by suspension of production or business operations pending
rectification for seven days or more, or revocation of the Pharmaceutical
Producer Licence or Pharmaceutical Trading Enterprise Licence to be meted
out to pharmaceutical producing enterprises or pharmaceutical trading
enterprises directly under the jurisdiction of the Central Government or
of the people's governments of provinces, autonomous regions, or
municipalities directly under the Central Government, shall be submitted
by the administrative department of health of the relevant province,
autonomous region, or municipality directly under the Central Government
to the people's government at the same level for final decision.
Punishment by suspension of production or business operations for seven
days or more, or revocation of the Pharmaceutical Producer Licence or
Pharmaceutical Trading Enterprise Licence, to be meted out to
pharmaceutical producing enterprises or pharmaceutical trading enterprises
under the jurisdiction of people's governments at or below the city or
county level, shall be submitted by the administrative department of
health of the people's governments at or below the city or county level to
the people's governments at the same level for final decision. The
confiscated pharmaceuticals shall be disposed of under the supervision of
the administrative departments of health.
Article 55
If the party concerned does not accept the administrative sanction decided
on, it may file suit in the people's court within 15 days after receiving
notification of the sanction. However, the said party must immediately
carry out the decision on the control of pharmaceuticals made by the
administrative department of health. If the party neither complies with
the sanction nor files suit within the time limit, the organ which made
the decision on the administrative sanction shall apply to the people's
court for compulsory execution.
Article 56
If any individual or unit, in violation of this Law, causes drug
poisoning, he or it shall be liable for the damage. The victims may
request the administrative department of health at or above the county
level to handle the matter; if a party does not accept the decision, it
may file suit in the people's court. The victims, too, may directly take
the case to the people's court.
The claim for compensation must be made within a year from the day on
which the victim or his representative was aware or should have been aware
of the damage done. No claim for compensation shall be entertained beyond
the time limit.
Chapter XI Supplementary Provisions
Article 57
For the purpose of this Law, the definitions of the following terms are:
"Pharmaceuticals" means articles intended for use in the prevention,
treatment or diagnosis of human diseases, or intended to effect the
purposive regulation of human physiological functions, for which
indications, usage and dosage are prescribed, including raw traditional
Chinese medicinal materials, traditional medicines prepared in ready-to-
use forms and other prepared Chinese medicines, medicinal chemicals and
their preparations, antibiotics, biochemical medicines, radioactive drugs,
serums, vaccines, blood products, diagnostic aids, etc.
"New medicines" means medicines which have not been produced in this
country before. "Supplementary materials" means the excipients and
additives used for the production and dispensing of pharmaceuticals.
"Pharmaceutical producing enterprise" means an enterprise exclusively or
partly engaged in the production of pharmaceuticals.
"Pharmaceutical trading enterprise" means an enterprise exclusively or
partly engaged in the trading of pharmaceuticals.
Article 58
The production of pharmaceuticals referred to in this Law does not include
the cultivation, collection and breeding of all categories of medicinal
materials used in traditional Chinese medicine.
Article 59
The administrative department of health under the State Council shall,
pursuant to this Law, draw up measures for its implementation, which shall
enter into force after being submitted to and approved by the State
Council.
Measures for the control of pharmaceuticals specially needed by the
Chinese People's Army shall be formulated by the competent military
department of the state.
Article 60
This Law shall enter into force as of July 1, 1985.
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