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EU Legislative Process--- Key Steps and Majority
Rules
The VIIth amendment to the Cosmetics Directive ---- the institutional
game: The legislative process concerning the VIIth amendment to
the cosmetics directive has been going on since the beginning of
2001. By mid May of this year, the institutions were working out
a common position (i.e. the conclusion of the first reading). The
explanatory notes and Figure t right are an attempt to represent,
I a simple manner, the entire process.
A Commission proposal for a piece of legislation submitted to the
same rules as the VIIth amendment follows basically two paths: one
is the European Parliament, and the other is Member States. The
two paths cross at the end of each of the two or three readings.
The accompanying commentary summarizes the process and indicates
the applicable majority rules, which may play an important role,
especially in the second d reading. The reader will hopefully gain
a better understanding of the complexities of the process, perhaps
concluding that the European legislative engine is a sophisticated
one.
1st reading
- The votes of the competent European Parliament Committee
(EP Cttee) require a simple majority of the Members of the
European Parliament (MEPs) present when the votes take place;
- The decisions of the European Parliament also require
a simple majority (if 400 out of 626 MEPs are present, the
simple majority is 201 votes);
- After the EP plenary vote and before the Common Position
(CP) is adopted, the Commission usually publishes an amended
proposal that includes all amendments carried by the EP
and acceptable to the Commission;
- During the process at the EP, the Council Working Group
examines the Commission proposal and prepare the decision
(=CP) to be taken by the Ministers. If the CP follows the
amended Commission proposal, its adoption requires a qualified
majority vote of the Member States Any deviation from the
amended Commission proposal requires a unanimous vote of
the Member States.
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2nd Reading
- l The competetent EP Cttee can adopt amendments to the
CP. No amendment can be proposed on matters that could have
been dealt with during the first reading. As in the first
reading, the amendments require a simple majority vote;
- The EP Cttee vote is followed by a EP plenary vote. The
EP has three options:
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Option 1
The EP can approve the CP without amendments: the act will be deemed
to have been adopted in accordance with the CP.
Option 2
The EP can, by an absolute majority of its component members (314
out of 626), reject the CP: the proposed act will be deemed not to
have been adopted.
Option 3
The EP plenary can vote amendments to the CP by an absolute majority
of its components members (314 votes out of 626):
- The Council-still advised by the Council Working Group-can
then adopt the act with all amendments of the EP by a qualified
majority if the Commission supports these amendments, by
a unanimous vote in the case of amendments opposed by the
Commission;
- If the Council does not support at least one amendment
adopted by the EP, the Conciliation procedure starts (see
below 3rd reading)
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3rd Reading Digiscents
A conciliation Committee (CC) is convened by the President of the
Council, in agreement with the President of the EP. The CC is composed
of one representative per Member State (15) and of 15 MEPs. Their
mission is to reach an agreement on a joint text. The joint text is
then submitted to the Council and to the EP: if either institution
does not approve the joint ext (by a simple majority vote at the EP,
by a qualified majority vote at the Council), the proposed act will
be deemed not to have been adopted. The same applies if the CC cannot
agree on a joint text.
SAFETY CONCERNS & TESTING FRAGRANCE MATERIALS
"A substance can be in wide spread use for more than
20 years before any testing occurs outside the company producing
the material."
By Betty Bridges, RN
bcb56@ix.netcom.com
The Research Institute for Fragrance Materials (RIFM) is responsible
for testing the safety of raw materials. The RIFM is a major facet
of the self-regulatory process of the fragrance industry.
According to Richard Ford, Ph.D. of the RIFM
"Over the approximately 30 years since its inception, RIFM
has tested virtually all important fragrance materials in common
use. (It has always been the policy of RIFM that if a material is
used by only one company, it is that company's responsibility to
see that the material is adequately tested and evaluated.)"
(Richard A. Ford, "RIFM Activities in the Safety Assessment
of the Dermal Effects" page 184 of the book Fragrances: Beneficial
and Adverse Effects)
This is quite a surprising statement since only around 1300 of the
more than 3000 materials in use have been tested. The clarifying
statement in parenthesis raises further concerns over the extent
of the RIFM's testing.
While fragrance formulas may not be patented, fragrance chemicals
may be. During the time the patent is in force, the company holding
the patent normally has control over the production of the materials.
A patent is generally in force for around 20 years; the actual time
may vary depending on the country the patent is filed in.
The company owning a fragrance patent can solely use the material
in perfumes or fragrance it produces or use in bases it sells to
other companies. So even though one company owns the patent and
controls use of the material, it may be present in a great number
of products and widely used.
Eliminating testing of proprietary materials means a substance can
be in wide spread use for more than 20 years before any testing
occurs outside the company producing the material. Once the material
is in the public domain, it is very likely to be assumed to be safe
since it has been in use for some time. In addition the testing
data from the company developing the material will often be used
for evaluating the material. There is a highly probably that there
will be no independent testing of the material by the RIFM.
Additionally, the industry is continually developing new materials.
The RIFM program also involves review and evaluation of such materials
as they come into general use. It is generally expected, however
that the company that has developed such materials will provide
the necessary test data for proper evaluation" (Richard A.
Ford, "RIFM Activities in the Safety Assessment of the Dermal
Effects" page 188 of the book Fragrances: Beneficial and Adverse
Effects)
Acetylethyltetramethyltetralin (AETT) was a proprietary chemical
that was put into use in the 1950s. In 1975 after the patent expired
and it was in general use it was found to be severely neurotoxic.
During routine testing of a product, it was repeatedly applied to
the skin of mice to determine its irritancy. It was discovered that
the skin of the mice had a bluish tint and the mice showed signs
of neurotoxicity. Though AETT was in widespread use the neurotoxic
potential of the material was discovered by accident. Even if the
material had been tested by the RIFM, it is doubtful that their
testing methods would have detected the adverse effects of the chemical.
It was only after the discovery of the skin penetration of AETT
that the RIFM and others realized that the skin was only a limited
barrier and many materials were able to penetrate it. In spite of
this realization, the RIFM still does not routinely test for systemic
effects.
Testing by the RIFM
RIFM testing revolves around the effects on the skin. Even though
the focus is on skin testing, these test results do not always coincide
with what is reported by dermatologists. Testing methods have shortcomings
and do not duplicate conditions that are experienced with actual
use of the products. The most frequent adverse skin reaction to
fragrances is allergic reactions. It is estimated that 1-2% of the
population has skin allergies to fragrances.
In order to screen for skin sensitization and the potential for
causing skin allergies the Human Repeat Insult Patch Test (HRIPT)
is used. A 24-hour patch is applied on Monday, Wednesday, and Fridays
for a three-week period of time. There is a two-week rest period
and then a single 24-hour challenge patch. Generally the concentration
of the patch testing is at ten times the level of use of the material
in finished products. 25 participants are tested.
Repeated exposures may be more of a factor in sensitization than
the level of exposure. Nine days within a three-week period does
not duplicate the exposure that comes from months and often years
of use. Amylcinnamaldehyde and hexylcinnamaldehyde have been established
as sensitizers by dermatologists. Yet testing by the RIFM has not
revealed these materials to be sensitizers.
Amylcinnamaldehyde and hexylcinnamaldehyde are widely used in laundry
products and other things with a wet application. They are often
present in shampoos, deodorants, and lotions. There is frequent
exposure to these materials at higher levels than in the past. So
even if they are relatively weak sensitizers, the amount and frequency
of exposure could make them more problematic than a material that
had higher sensitizing potential but was used much less.
Photosensitivity and phototoxic effects are also of concern. Absorption
through the skin and accumulation in body tissue raises concerns
for systemic and long-term effects. The testing by the RIFM selectively
addresses these issues, usually after they have been discovered
by dermatologists. In reality the testing of the RIFM rarely does
anything more than confirm several years later what the dermatology
community already knew.
Now concerns are being raised concerning effects and routes of exposure
other than those pertaining to skin. More and more questions are
arising related to respiratory, neurological, and systemic effects.
At present the RIFM is not addressing these concerns. If history
repeats itself they will not address these issues until the medical
community proves there is a problem.
The RIFM loudly proclaims it has tested virtually all of the important
materials in use and yet materials are in use twenty years or more
before testing is even conducted. These newer materials are used
at much higher levels. Synergistic effects are not considered. Materials
are tested individually. Only selected routes of exposure and adverse
effects are tested. In effect the human population has been the
testing grounds for fragrance materials and informed consent was
not obtained.
Source: http://www.flipside.org/vol2/oct99/99oc22a.htm
Regulations of PRC on the Administration of
the Controlled Chemicals
(Promulgated by Decree No.190 of the State Council of the
People's Republic of China, and effective as of the date of promulgation)
Article 1
These Regulations are formulated for the purpose of strengthening
the administration of the controlled chemicals, safeguarding the
personal safety of the citizens and protecting the environment.
Article 2
All those who engage in the production, marketing and use of the
controlled chemicals within the territory of the People's Republic
of China shall abide by these Regulations.
Article 3
The controlled chemicals referred to in these Regulations mean
the following schedules of chemicals:
Schedule 1:
chemicals which can be used as chemical weapons;
Schedule 2:
chemicals which can be used as the precursors of manufacturing chemical
weapons;
Schedule 3:
chemicals which can be used as main materials of manufacturing
chemical weapons;
Schedule 4:
discrete organic chemicals except for explosives and pure
hydrocarbon compounds.
The list of the controlled chemicals outlined in the preceding
paragraph shall be put forward to by the competent department of
the chemical industry of the State Council and shall be promulgated
after being submitted to and approved by the State Council.
Article 4
The competent department of the chemical industry authority of
the State Council shall be responsible for the national-wide administration
of the controlled chemicals. The competent department of the chemical
industry of the people's government of the province, autonomous
region or municipality directly under the Central Government shall
be responsible for the administration of the controlled chemicals
in its respective region.
Article 5
Anyone who engages in production, distribution or use of controlled
chemicals shall, in accordance with these Regulations and the relevant
provisions of the State, submit to the competent department of the
chemical industry of the State Council or the competent department
of the chemical industry of the people's government of province,
autonomous region and municipality directly under the Central Government
the relevant materials, data and purpose of use concerning the production,
distribution or use of the controlled chemicals and shall be subject
to the inspection and supervision of the competent department of
the chemical industry.
Article 6
The State controls shall strictly administer the production of
Schedule 1 chemicals.
The application for production of Schedule 1 chemicals for the
purposes of scientific research, medical treatment, pharmaceutical
production or protection shall be submitted to the competent department
of the chemical industry of the State Council for approval, and
such production shall be conducted in small-sized facilities which
are designated by the competent department of the chemical industry
of the State Council.
The production of Schedule 1 chemicals is strictly prohibited
in those facilities which are not designated by the competent department
of the chemical industry of the State Council.
Article 7
The State shall practice the system of special permission granted
for the production of Schedules 2 and 3 chemicals and of Schedule
4 discrete organic chemicals containing phosphorous, sulfur and
fluorine. Without special permission, no units or individuals may
produce such controlled chemicals. The measures for the special
permission shall be made by the competent department of the chemical
industry of the State Council.
Article 8
The application for the construction of a new or extended or rebuilt
facility for producing Schedule 2 or 3 chemicals and Schedule 4
discrete organic chemicals containing phosphorous, sulfur and fluorine
shall be filed with the competent department of the chemical industry
of the local people's government of the province, autonomous region
or municipality directly under the Central Government, and after
its examination and recommendation, shall be submitted to the competent
department of the chemical industry of the State Council for approval.
The construction of the facility may be commenced only after being
approved by the department. The completed facility may be delivered
for use in production only after passing the acceptance inspection
of the competent department of the chemical industry of the local
people's government of the province, autonomous region or municipality
directly under the Central Government and obtaining the approval
of the competent department of the chemical industry of the State
Council.
Before its commencement, the construction of a new or extended
or rebuilt facility for producing Schedule 4 discrete organic chemicals
containing phosphorous, sulfur or fluorine shall be reported for
the record to the competent department of the chemical industry
of the local people's government of the province, autonomous region
or municipality directly under the Central Government.
Article 9
The controlled chemicals shall be stored in the chemical warehouse
for the special purpose and managed by the designated persons. The
conditions for storing the controlled chemicals shall comply with
the relevant provisions of the State.
Article 10
Any unit which stores the controlled chemicals shall set up the
system of strict inspection of warehouse entry and exit and record
system. If finding that a controlled chemical is lost or stolen,
a report of the matter shall, without delay, be made to the local
public security organ and the competent department of the chemical
industry of the local people's government of the province, autonomous
region or municipality directly under the Central Government; which
shall render an active cooperation with the public security organ
for investigation and punishment.
Article 11
The deteriorated expired controlled chemicals shall be disposed
of in time. Such disposition shall be conducted after being approved
by the competent department of the chemical industry of the local
people's government of the province, autonomous region or municipality
directly under the Central Government.
Article 12
Anyone who intends to use Schedule 1 chemicals for scientific
research, medical treatment, pharmaceutical production or protection
purposes shall submit an application to the competent department
of the chemical industry of the State Council, and upon the approval
of the latter and by presenting the approval document, shall conclude
a contract with the production unit designated by the competent
department of the chemical industry of the State Council, and shall
submit the copy of the contract for the record to the competent
department of the chemical industry of the State Council.
Article 13
Anyone who intends to use Schedule 2 chemicals shall submit an
application to the competent department of the chemical industry
of the local people's government of the province, autonomous region
or municipality directly under the Central Government, and upon
the approval of the latter and by presenting the approval document,
shall conclude a contract with the distribution unit designated
by the competent department of the chemical industry of the State
Council, and shall submit the copy of the contract for the record
to the competent department of the chemical industry of the local
people's government of the province, autonomous region or municipality
directly under the Central Government.
Article 14
The units designated by the competent department of the chemical
industry of the State Council jointly with the competent department
of the foreign economic cooperation and trade of the State Council
(hereinafter referred as the designated units) may engaged in import
and export activities of Schedule 1 chemicals and Schedules 2 and
3 and their manufacturing technology and specialized equipment.
Anyone who intends to import or export Schedule 1 chemicals under
and Schedules 2 and 3 and their manufacturing technology and specialized
equipment should entrust a designated unit with the agency of such
import or export. No unit or individual may be engaged in such import
and export activities, with the exception of the designated units.
Article 15
The State shall strictly administer the import and export of Schedule
1chemicals. No Schedule 1 chemicals may be imported except for the
purposes of scientific research, medical treatment, pharmaceutical
production and protection.
The designated unit which is entrusted with the importation of
Schedule 1 chemicals shall submit an application and the end-use
statement and certifying documents of the products to the competent
department of the chemical industry of the State Council, and after
the examination and recommendation of the said department, shall
submit the application to the State Council for approval. The designated
unit shall, by presenting the approval documents of the State Council,
apply for the import license to the competent department of the
foreign economic cooperation and trade of the State Council.
Article 16
The designated unit which is entrusted with the importation of
Schedules 2 and 3chemicals and their manufacturing technology and
specialized equipment shall submit an application and the end-use
statement and certifying documents of the imported chemicals, manufacturing
technology and equipment to the competent department of the chemical
industry of the State Council. Upon approval of the said department,
the designated unit shall, by presenting the document of the competent
department of the chemical industry of the State Council, apply
for the import license to the competent department of the foreign
economic cooperation and trade of the State Council.
Article 17
The designated unit which is entrusted with the exportation of
Schedule 1 chemicals shall submit to the competent department of
the chemical industry of the State Council an application and the
written guarantee of the government or its authorized agency of
the importing country which confirms that the imported chemicals
shall only be used for scientific research, medical treatment, pharmaceutical
production and protection and shall not be re-exported to a third
country; and after the examination and recommendation of the said
department, shall submit the application to the State Council for
approval. The designated unit shall, by presenting the approval
document of the State Council, apply for export license to the competent
department of the foreign economic cooperation and trade of the
State Council.
Article 18
The designated unit which is entrusted with the exportation of
Schedule 2 or 3 chemicals and their manufacturing technology and
specialized equipment shall submit to the competent department of
the chemical industry of the State Council an application and the
written guarantee of the government or its authorized agency of
the importing country which confirms that the imported chemicals,
manufacturing technology and equipment shall not be used in manufacturing
chemical weapons and shall not be re-exported to a third country.
Upon approval of the said department, the designated unit shall,
by presenting the approval document of the competent department
of the chemical industry of the State Council, apply for export
license to the competent department of the foreign economic cooperation
and trade of the State Council.
Article 19
The use of the controlled chemicals shall be consistent with the
purpose applied for. Any change of the purpose of use shall, if
needed, be submitted to the original approving organ for approval.
Article 20
Those using Schedules 1 and 2 chemicals shall, in accordance with
the relevant provisions of the State, report regularly to the local
competent department of the chemical industry of the people's government
of provinces, autonomous regions and municipalities directly under
the State Council on the quantity of the controlled chemicals they
used and the quantity of end products they made from such controlled
chemicals.
Article 21
Anyone who, in violation of the provisions of these Regulations,
produces the controlled chemicals shall be ordered to make correction
within the time limit by the competent department of the chemical
industry of the people's government of the province, autonomous
region and municipality directly under the State Council, and if
failing to make correction within the specified time limit, shall
be imposed a fine of less than 200,000 yuan, and if the circumstances
are serious, may be ordered to stop the production for rectification
by the people's government of the province, autonomous region and
municipality directly under the State Council .
Article 22
Anyone who, in violation of the provisions of these Regulations,
uses the controlled chemicals, shall be ordered to make correction
within the time limit by the competent department of the chemical
industry of the people's government of the province, autonomous
region and municipality directly under the State Council, and if
failing to make correction within the specified time limit, shall
be imposed a fine of less than 50,000 yuan .
Article 23
Anyone who, in violation of the provisions of these Regulations,
markets the controlled chemicals, shall be subject to confiscation
of the controlled chemicals he distributed illegally and his illegal
income and a fine of more than one time and less than two times
the total illegal turnover.
Article 24
Anyone who, in violation of the provisions of these Regulations,
hides or refuses to report the information or data pertaining to
the controlled chemicals or impedes or obstructs the exercise of
the inspection and supervision duty by the competent department
of the chemical industry in accordance with the provisions of these
Regulations, shall be imposed a fine of less than 50,000 yuan by
the competent department of the chemical industry of the people's
government of the province, autonomous region and municipality directly
under the State Council.
Article 25
Anyone who, in violation of the provisions of these Regulations,
commits an act contravening the public security administration,
shall be punished in accordance with the provisions of the Regulations
of the People's Republic of China on Administrative Penalties for
Public Security. If a crime is constituted, his criminal responsibility
shall be investigated according to law.
Article 26
Those who, prior to the implementation of these Regulations, have
already engaged in production, marketing or use of controlled chemicals,
shall go through the relevant formalities in accordance with the
provisions of these Regulations.
Article 27
These Regulations shall enter into force as of the date
of promulgation.
PHARMACEUTICAL ADMINISTRATION 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
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:
- 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;
- It shall have factory premises, facilities and a sanitary
environment suitable for the medicines produced;
- It shall have a unit or competent personnel capable of
inspecting the quality of the medicines produced, as well
as necessary instruments and equipment.
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Aricle 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 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:
- 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 harmaceutical
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;
- It shall have business premises, equipment, storage facilities
and a sanitary environment suitable for the pharmaceuticals
in which it trades.
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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:
- 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;
- a non-medical substance is passed off as a medicine,
or one medicine is passed off as another.
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Amedicine shall be handled as fake medicine in any of the following
cases:
- where the use of the medicine has been prohibited by
the administrative department of health under the State
Council;
- where the medicine has been produced without being assigned
a registration number;
- where the medicine has deteriorated and cannot be used
as such; or
- where the medicine has been contaminated and cannot be
used as such.
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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;
(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 andmedicines 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, 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 ublished, 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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