| 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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