The Standing Committee of the National People's Congress


STANDARDIZATION LAW OF THE PEOPLE'S REPUBLIC OF CHINA


(Adopted at the Fifth Meeting of the Standing Committee of the
Seventh National People's Congress on December 29, 1988, promulgated by
Order No. 11 of the President of the People's Republic of China on
December 29, 1988, and effective as of April 1, 1989)
Contents
Chapter I General Provisions
Chapter II Formulation of Standards
Chapter III Implementation of Standards
Chapter IV Legal Responsibility
Chapter V Supplementary Provisions

Chapter I General Provisions
Article 1
This Law is formulated with a view to developing the socialist commodity
economy, promoting technical progress, improving product quality,
increasing social and economic benefits, safeguarding the interests of the
State and the people and suiting standardization to the needs in socialist
modernization and in the development of economic relations with foreign
countries.
Article 2
Standards shall be formulated for the following technical requirements
that need to be unified:
(1) the varieties, specifications, quality and grades of industrial
products as well as the safety and sanitary requirements for them;
(2) the design, production, inspection, packing, storage, transportation
and methods of operation of industrial products as well as the safety and
sanitary requirements for them in the process of production, storage and
transportation;
(3) technical requirements and testing methods related to environmental
protection;
(4) the designs, construction procedure and safety requirements for
construction projects; and
(5) technical terms, symbols, code names and drawing methods related to
industrial production, project construction and environmental protection.
Major agricultural products and other items that need to be standardized
shall be designated by the State Council.
Article 3
The tasks of standardization shall include the formulation of standards
and organization of and supervision over the implementation of the
standards. Standardization shall be incorporated in the plan for national
economic and social development.
Article 4
The State shall encourage the active adoption of international standards.
Article 5
The department of standardization administration under the State Council
shall be in charge of the unified administration of standardization
throughout the country. Competent administrative authorities under the
State Council shall, in line with their respective functions, be in charge
of standardization in their respective departments and trades.
The departments of standardization administration of provinces, autonomous
regions and municipalities directly under the Central Government shall be
in charge of the unified administration of standardization within their
respective administrative areas. Competent administrative authorities
under the governments of provinces, autonomous regions and municipalities
directly under the Central Government shall, in line with their respective
functions, be in charge of standardization in their respective departments
and trades within their respective administrative areas.
The standardization administration departments and the competent
administrative authorities of cities and counties shall, in line with
their respective functions as assigned by the governments of provinces,
autonomous regions and municipalities directly under the Central
Government, be in charge of standardization within their respective
administrative areas.

Chapter II Formulation of Standards
Article 6
National standards shall be formulated for the technical requirements that
need to be unified nationwide. National standards shall be formulated by
the department of standardization administration under the State Council.
Where, in the absence of national standards, technical requirements for a
certain trade need to be unified, trade standards may be formulated. Trade
standards shall be formulated by competent administrative authorities
under the State Council and reported to the department of standardization
administration under the State Council for the record, and shall be
annulled on publication of the national standards. Where, in the absence
of both national and trade standards, safety and sanitary requirements for
industrial products need to be unified within a province, an autonomous
region or a municipality directly under the Central Government, local
standards may be formulated. Local standards shall be formulated by
departments of standardization administration of provinces, autonomous
regions and municipalities directly under the Central Government and
reported to the department of standardization administration and the
competent administrative authorities under the State Council for the
record, and shall be annulled on publication of the national or trade
standards.
Where, in the absence of both national and trade standards for products
manufactured by an enterprise, standards for the enterprise shall be
formulated to serve as the criteria for the organization of production. An
enterprise's standards for its products shall be reported to the
standardization administration department and the competent administrative
authorities under the local government for the record. Where national or
trade standards have been formulated, the State shall encourage
enterprises to formulate their enterprise standards, which are more
stringent than the national or trade standards, to be used in these
enterprises.
Where the formulation of standards is otherwise provided for by law, such
legal provisions shall be complied with.
Article 7
National standards and trade standards shall be classified into compulsory
standards and voluntary standards. Those for safeguarding human health and
ensuring the safety of the person and of property and those for compulsory
execution as prescribed by the laws and administrative rules and
regulations shall be compulsory standards, the others shall be voluntary
standards.
The local standards formulated by standardization administration
departments of provinces, autonomous regions and municipalities directly
under the Central Government for the safety and sanitary requirements of
industrial products shall be compulsory standards within their respective
administrative areas.
Article 8
The formulation of standards shall be conducive to ensuring safety and the
people's health, safeguarding consumer interests and protecting the
environment.
Article 9
The standards to be formulated shall be conducive to a rational use of the
country's resources, a wider utilization of scientific and technological
gains and the enhancement of economic returns, conform to operation
instructions, increase the universality and interchangeability of
products, and be technologically advanced and economically rational.
Article 10
The standards to be formulated shall be coordinated with and supported by
related standards.
Article 11
The standards to be formulated shall help promote economic and
technological cooperation with foreign countries and foreign trade.
Article 12
The roles of trade associations, scientific research institutions and
academic organizations shall be brought into play in the formulation of
standards. A department engaged in the formulation of standards shall
organize a committee on standardization technology composed of
specialists, which shall be responsible for the drafting of the standards
and shall participate in the examination of the draft standards.
Article 13
After the standards come into force, the department that formulated them
shall, in the light of scientific and technological developments and the
needs in economic construction, make timely reviews of the current
standards to determine if they are to remain effective or are to be
revised or annulled.

Chapter III Implementation of Standards
Article 14
Compulsory standards must be complied with. It shall be prohibited to
produce, sell or import products that are not up to the compulsory
standards. With regard to voluntary standards, the State shall encourage
their adoption by enterprises on an optional basis.
Article 15
With respect to products for which national or trade standards have been
formulated, enterprises may apply to the standardization administration
department under the State Council or agencies authorized by the same
department for product quality authentication. For products which are
authenticated to conform to the standards, certificates shall be issued by
the department that made the authentication and the use of the prescribed
authentication marks shall be permitted on such products and the packing
thereof.
If products for which authentication certificates have been granted do not
conform to national or trade standards, or if products have not undergone
authentication or found not up to the standards after the authentication
proceedings, no authentication marks shall be permitted for use on such
products leaving factories for sale.
Article 16
Technical requirements for export products shall comply with contractual
provisions.
Article 17
The development of new products, improvement of products or technical
renovation by an enterprise shall conform to standardization requirements.
Article 18
Departments of standardization administration under governments at or
above the county level shall be responsible for supervision over and
inspection of the implementation of the standards.
Article 19
Departments of standardization administration under governments at or
above the county level may, in accordance with needs, establish inspection
organizations or authorize inspection organizations of other units to
examine whether products conform to the standards. Where the laws and
administrative rules and regulations provide otherwise on inspection
organizations, such provisions shall apply.
Disputes over whether a product conforms to the standards shall be handled
in accordance with the inspection data provided by the inspection
organizations as specified in the preceding paragraph.

Chapter IV Legal Responsibility
Article 20
Whoever produces, sells or imports products that do not conform to the
compulsory standards shall be dealt with according to law by the competent
administrative authorities as prescribed by the laws and administrative
rules and regulations. In the absence of such prescriptions, his products
and unlawful proceeds shall be confiscated and he shall be concurrently
fined by the administrative authorities for industry and commerce; where
serious consequences are caused and crimes are constituted, the person
directly responsible shall be investigated for criminal responsibility in
accordance with the law.
Article 21
Where authentication marks are used on products leaving a factory for
sale, for which authentication certificates have been issued but which do
not conform to national or trade standards, the enterprise concerned shall
be ordered by the department of standardization administration to stop the
sale and shall be fined concurrently; where the circumstances are serious,
the authentication certificates shall be revoked by the department that
made the authentication.
Article 22
Whoever uses authentication marks, without authorization, on products
leaving a factory for sale, which have not undergone authentication or
have been found not up to the standards after the authentication
proceedings, shall be ordered by the department of standardization
administration to stop the sale and shall concurrently be fined.
Article 23
A party which refuses to accept the punishment of confiscation of its
products and of its unlawful proceeds and a fine may, within 15 days of
receiving the penalty notice, apply for reconsideration to the office
immediately above the one that made the punishment decision; a party which
refuses to obey the reconsideration decision may, within 15 days of
receiving the reconsideration decision, bring a suit before a people's
court. The party also may, within 15 days of receiving the penalty notice,
directly bring a suit before a people's court. If a party neither applies
for reconsideration nor brings a suit before a people's court within the
prescribed time nor complies with the punishment decision, the office that
made the punishment decision shall apply to a people's court for
compulsory execution.
Article 24
Personnel responsible for the supervision, inspection and administration
of standardization who violate the law or neglect their duties, or are
engaged in malpractices for personal gains, shall be given disciplinary
sanctions; where crimes are constituted, their criminal responsibility
shall be investigated in accordance with the law.

Chapter V Supplementary Provisions
Article 25
Rules for the implementation of this Law shall be formulated by the State
Council.
Article 26
This Law shall go into effect as of April 1, 1989.


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.


卫生部


卫生部关于加强医疗机构药品集中招标采购试点管理工作的通知
卫生部




各省、自治区、直辖市卫生厅（局），计划单列市及新疆生产建设兵团卫生局：
近几年，一些地方的卫生部门在当地政府领导下，从加强管理入手，积极进行医疗机构药品集中招标采购的试点，在纠正医药购销领域中不正之风和规范医疗机构购药行为方面作出了有益的探索，取得了很好的效果。通过药品集中招标采购，有效的遏制了分散的一对一采购过程中的不
正之风；强化了市场竞争机制，减少了流通环节，降低了药品流通成本；加强了药品质量的控制，提高了临床用药的安全性和有效性；方便了政府对药品价格的监控，有利于降低虚高药品价格；推动了药品生产结构调整、流通环节的改革和加强药品质量监控；促进了企业有计划的组织药品
生产。药品集中采购工作已经引起了社会各界广泛的关注和重视。
但是，我们在工作中也发现，少数地方和单位的药品集中招标采购工作存在着一些问题，个别地方的卫生行政部门和医疗机构，甚至把药品集中招标采购作为为单位牟利的手段，这显然是与国家倡导的药品集中招标采购的宗旨不相容的，必须及时加以纠正。因此，为了推进这一工作的
顺利开展，现根据国务院办公厅转发的国务院体改办等部门《关于城镇医药卫生体制改革的指导意见》（以下简称《指导意见》），就药品集中招标采购试点工作中需注意的有关事项通知如下，请各地在试点过程中认真贯彻执行。
一、统一思想，提高认识。要认真学习《指导意见》，把药品集中招标采购工作纳入医疗体制改革，总体安排、通盘考虑、协调实施。要充分认识到，药品集中招标采购是当前纠正医药购销中不正之风、减轻社会医药费用负担、保证城镇职工基本医疗保险制度顺利实施的具体措施，而
且也会对改善医疗机构经济运行机制、规范药品流通秩序和推进药品流通体制改革产生积极的影响。各地务必要从全局出发，积极推动这一工作顺利开展。
二、药品招标采购形式，可分为医疗机构自身组织的招标和多个医疗机构集中招标两类。集中招标采购又可分为集中委托招标代理机构招标和医疗机构联合招标两种。医疗机构是药品招标的行为主体，可以委托招标代理机构开展招标采购，具有编制招标文件和组织评标能力的医疗机构
也可自行组织或几家医疗机构联合组织招标采购。
三、药品招标采购经办机构（包括医疗机构自行组织、联合组织的招标采购机构和招标代理机构）与行政机关不得存在隶属关系或其他利益关系。卫生行政部门负责药品集中招标采购工作的组织管理和监督，不直接参与药品招标活动，更不得利用职权从中牟取利益。
四、医疗机构的药品集中招标采购一般实行公开招标。不宜实行公开招标的可采用邀请招标、竞争性谈判采购、询价采购等方式进行。具体可根据《招标投标法》和财政部印发的《政府采购招标投标管理暂行办法》有关规定组织实施。
五、药品招标采购活动必须遵循公开、公正、公平和诚实信用的原则。要严格控制医疗机构购入药品的质量，依照质量价格比优化的原则确定采购品种，努力提高临床用药的安全有效性。要依法办事，自觉接受社会监督，抵制药品购销活动中的不正之风。
六、地方政府及其卫生主管部门根据管理工作的需要，可以要求医疗机构对纳入职工医疗保险报销目录的常用药品、临床使用量比较大的药品品种实行集中招标采购。
国家特殊管理的药品仍按有关规定采购供应。
七、药品招标代理机构是依法设立、专门从事药品集中招标采购代理业务并提供相关服务的社会中介组织。国家药品监督管理局和卫生部将制定药品招标代理机构资格认定的管理办法。
试点期间，招标服务有关收费的立项和收费标准，须经省级以上物价主管部门批准。未经省级以上物价主管部门批准，任何单位不得自立收费项目和自定收费标准收取费用。
八、参与药品集中招标采购活动各方，都必须严格执行国家的药品价格政策。购销双方必须按照实际成交价格如实开据发票，如实记帐。招标采购经办机构有责任如实向政府有关部门反映药品采购工作情况和实际成交价格。
九、集中招标后的药品配送，是流通领域的重要改革内容之一，关系临床药品的及时供应，关系医疗机构的业务工作和经济运行。医疗机构和药品采购经办机构要与中标企业做好招标药品的供应协调工作，要积极支持医药流通体制的改革，促进新型医药批发配送企业的建设和发展，逐
步建立起对医院药品适时配送的供应体系。
十、各地卫生行政部门应加强对药品采购工作的管理和监督，做好有关部门和相关政策的协调，积极引导医疗机构建立适合当地实际、廉洁高效的药品集中招标采购组织管理形式。要依法加强对药品购销双方和药品招标代理机构的监督检查。要教育药品采购有关人员遵纪守法，廉洁奉
公，严禁药品采购、管理及其他有关人员利用职务之便营私舞弊牟取私利。严禁药品营销人员使用不法手段到医疗机构推销药品。
十一、《中华人民共和国招标投标法》今年1月1日起已经实施。各地要依法认真作好药品集中招标采购试点工作。要通过试点，对药品招标、投标、开标、评标、中标以及中标药品配送等工作的法律责任进行探索，逐步建立起规范的管理规章，使这项工作从起步阶段就打好基础。各地
一定要在严格规范试点的基础上，稳步推进这一工作的开展。
各地的试点工作经验和发现的问题，请及时反馈给我们。



2000年4月24日