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以进养出试行办法(附英文)(已失效)

作者:法律资料网 时间:2024-06-28 17:46:02  浏览:9470   来源:法律资料网
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以进养出试行办法(附英文)(已失效)

国务院


以进养出试行办法(附英文)

1979年3月26日,国务院

为了实现新时期的总任务,把工作的着重点转移到社会主义现代化建设上来,对外贸易要有一个大的发展。要引进新技术,进口成套设备,必须大量地增加出口。各有关部门和各地区,要千方百计地发展出口商品生产,在充分挖掘国内出口货源潜力的同时,积极利用国外原材料和技术,发挥国内生产能力,大力发展以进养出业务,把出口贸易做大做活,增加外汇收入,增强国家的外汇支付能力。
一、以进养出的范围:
(一)进料加工,包括进口全部原材料或主要原材料,加工成品出口;
(二)进口主件或配件,加工装配产品出口,如进口船用主机或船用仪器装配船舶出口;
(三)以国产原材料为主,进口辅助材料,加工成品出口;
(四)进口饲料、肥料、种子、种畜等,养殖、种植农副土特畜产品出口,以及用进口商品,调换国内农副土特产品出口。
二、现在由国内供应出口商品用的原料、材料和辅料,要按现行物资供应渠道继续保证供应,不得减少或中断,凡国内能增加供应的,应减少进口或不进口。实行以进养出后,各部门、各地区现在供应出口的商品,应随着生产的发展,保持出口的正常增长。
三、以进养出的商品,应当是国际市场适销,创汇率合算,产品质量符合出口要求,国内有生产能力,燃料、电力供应有保证。
四、以进养出需要的外汇,纳入国家进口用汇计划,由外贸部统一掌握使用。具体业务主要由各进出口总公司负责组织进行。各省、自治区、直辖市外贸局对以进养出外汇的使用和业务执行情况要进行监督检查。以进养出的商品需要使用银行外汇贷款时,按短期外汇贷款办法办理。对国外商人来料加工的原材料、辅料和其它物资,不论是否互开信用证,只要实际不用外汇支付的,均不应算作以进养出。
五、以进养出的商品,经外贸部门同有关地区或部门协商,纳入国家生产计划和外贸计划,并逐步实行计划单列,材料直拨,定点生产,以销定产。在保证完成国家计划的前提下,如生产尚有潜力,国外有销路,能及时出口的产品,可在计划外增加安排以进养出,由省、自治区、直辖市外贸局负责组织进行,所需外汇由外贸部专门拨给。
六、以进养出的进口物资和出口产品,不参加国内的平衡分配,逐步做到进口物资由外贸公司直拨生产单位,产品由生产单位直供外贸公司收购出口。
七、以进养出的产品,要择优安排生产。工业品要选择条件比较好的工厂定点生产。农副土特产品要因地制宜划片生产。定点和划片都要相对稳定。
八、根据军民结合、平战结合的原则,要积极发挥军工企业的生产潜力,发展以进养出商品的生产。军工企业生产供应出口产品的价格,要与民用企业的出口产品实行同质同价。
九、以进养出的工业品,外贸公司同生产或供货单位,应签订经济合同或协议,规定各自承担的义务。任何一方不按合同或协议执行而造成的损失,要承担经济赔偿的责任。
十、以进养出的农副土特畜产品,在安排进口饲料、肥料、种子、种畜等的同时,外贸公司同生产或供货单位,应商定增加供应出口商品的品种、数量、规格质量和交货时间。
十一、以进养出的工业品,外贸公司同生产或供货单位,要商定供应出口产品的合格率,原材料、辅料的消耗定额和交货时间。对于产品合格率低,质量没有保证,原材料消耗多,生产成本高的生产企业,不要安排以进养出。
十二、以进养出商品的创汇,要逐项进行核算,出口成品创汇率一般应掌握在百分之三十至五十以上。生产技术工艺比较复杂的产品,创汇率要高一些;生产技术工艺比较简单的产品,创汇率可低一些,但最低不得少于百分之三十。
十三、承担以进养出的生产企业(包括国营农场),要努力做到按时、按质、按量完成生产和供货任务。由于生产某些批量小、花色品种复杂、交货期短的出口产品,如果影响企业的正常利润,经外贸部门和有关部门商定,可由外贸公司给予必要的价外补贴。
十四、以进养出所需进口物资的国内人民币作价,原则上按照现行进口作价办法办理。对以进养出中由于进口原辅料国内调拨价格或利润、税率偏高而使出口成品外贸亏损大的少数品种,只要国际市场好销,创汇率合算,经过批准,可采用外贸部门代理进口只收手续费,或免征关税、工商税的办法处理。生产、供货单位供应出口的产品,应按外贸进口原辅料实际拨交的价格计算成本。
十五、以进养出商品的外汇留成按国家统一规定的留成办法办理。
各地区、各有关部门及外贸公司、生产企业单位对以进养出的业务活动,要建立专项登记和统计,加强经济核算,保证有关业务凭证、原始记录的完整。
十六、进行以进养出的生产或供货单位,经营好、创汇多,工资、奖金和福利可以多给一些。粗制滥造、克扣进口物资和私分产品的,要追究责任,严肃处理。
十七、对以进养出的生产或供货单位,外货公司应随时提供国外先进产品的样本、样品和技术资料,吸收生产或供货单位的人员参加对外谈判,有计划地组织出国考察和邀请外商进行技术交流。
十八、对以进养出的工作,各地区、各有关部门要加强领导,积极组织进行,并解决生产、供货中存在的问题。生产、供货部门和外贸部门要及时总结经验,推动这项工作不断发展。

TRIAL MEASURES CONCERNING THE PROMOTION OF EXPORTS BY IMPORTATION

Important Notice: (注意事项)
英文本源自中华人民共和国务院法制局编译, 中国法制出版社出版的《中华人民共和国涉外法规汇编》(1991年7月版).
当发生歧意时, 应以法律法规颁布单位发布的中文原文为准.
This English document is coming from "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 (法规全文)
TRIAL MEASURES CONCERNING THE PROMOTION OF EXPORTS BY IMPORTATION
(Approved and promulgated by the State Council on March 26, 1979)
In order to carry out the general task of the new period and to shift the
focus of the work on to the track of socialist modernization, foreign
trade should be greatly expanded and developed. Exports must be greatly
increased for the purpose of introducing new technology and importing
equipment in complete sets. All departments concerned and all regions
should try their best and use every possible means to develop the
production of export commodities; while tapping fully the domestic
potentials for increasing the sources of export commodities, raw materials
and technology from abroad should be utilized fully so as to bring into
full play the domestic production capacity, to devote major efforts to the
promotion of exports by importation and to expand export trade extensively
and in a flexible way, thus increasing foreign exchange earnings, and
strengthening the country's paying capability in foreign exchange.
1. The scope of promoting exports through importation:
(1) to import materials for processing, including the importation of all
raw and semifinished materials or key raw and semifinished materials, and
to process them into finished products for export;
(2) to import main component parts or fittings, and to process and
assemble them into finished products for export; for example, to import
ships' main engines or instruments for assembling vessels for export;
(3) to mainly use home-produced raw and semifinished materials, and import
auxiliary materials, then to process them into finished products for
export; and (4) to import animal feeds, fertilizers, seeds, and breeding
stocks, and to use them in growing and breeding occupations, then to use
the animal, farm, and side-line products and local specialties for export;
or to exchange imported commodities for home-produced farm and side-line
products and local specialties, and to use them for export.
2. With respect to the raw, semifinished and auxiliary materials now
supplied domestically for the production of export commodities, such
supplies shall be guaranteed through the current supplying channel of
materials and shall not be reduced or cut; the materials which can be
supplied domestically shall not be imported or their importation shall be
reduced. After the implementation of the policy of promoting exports by
imports, various departments and areas, which are at present supplying
commodities for export, shall maintain a normal increase in export with
the development of production.
3. The commodities manufactured under the policy of promoting exports by
importation, shall be marketable on the international market;
profitable in earning foreign exchange; up to the quality standards for
export; and can be manufactured domestically with a guarantee for the
supply of fuels and power.
4. The amount of foreign exchange needed for carrying out the policy of
promoting exports by importation shall be included in the state plan for
the allocation of foreign exchange for imports, which shall be executed
solely by the Ministry of Foreign Trade. The specific business operations
shall be organized by the head offices of various national import and
export corporations. The bureaus of foreign trade of various provinces,
autonomous regions and municipalities directly under the Central
Government shall be responsible for supervising and examining the use of
foreign exchange for promoting exports by importation and the situation of
business operations. Where bank loans in foreign exchange are needed for
commodities for promoting exports by importation, the case shall be
handled in accordance with the measures for granting short-term foreign
exchange loans. With respect to the raw and semifinished materials,
auxiliary materials and other materials supplied by businessmen abroad for
processing on the basis of materials supplied, no matter letters of credit
are mutually opened or not, so long as the payment is not actually
effected in foreign exchange, the aforesaid materials shall not be counted
as the materials used for promoting exports by importation.
5. The commodities for promoting exports by importation shall, after
consultation made by the foreign trade departments with the relevant
regions or departments, be included in the state plans for production and
for foreign trade, and the following principles shall be implemented step
by step; separate plans; direct allocation of materials; production at
designated units and production quota fixed according to sales conditions.
On the condition that the fulfillment of the state plan is guaranteed, if
there still exist production potentials and products marketable on the
international market can be timely exported, then arrangements may be made
for extra exports for promoting exports by importation beyond the plans,
and the foreign trade bureaus of provinces, autonomous regions, or
municipalities directly under the Central Government shall be responsible
for organizing this matter; the foreign exchange needed for the production
shall be allotted specially by the Ministry of Foreign Trade.
6. The materials imported, and the products exported for promoting exports
by importation, shall not be included in the domestic scheme for balanced
distribution; imported materials shall, step by step, be allocated
directly by foreign trade companies to production units, and the products
shall be supplied directly by the production units to foreign trade
companies which shall purchase the products for export.
7. The production of products for promoting exports by importation shall
be arranged on the basis of good quality. For the manufacture of
industrial commodities, only factories with better production conditions
shall be designated specially for the said purpose. With respect to farm
and side-line products and local specialities, the production shall be
developed in the light of local conditions with tracts of land assigned
for the purpose. The aforesaid designation of factories and division of
arable land shall remain relatively stable.
8. In accordance with the principle of "integration of military production
and civil production" and "integration of production in peacetime and that
in wartime", it is imperative to tap the productive potentials of the
military industrial enterprises, and to made full use of these military
industrial enterprises in promoting the production of export commodities
for promoting exports by importation. The prices of export commodities
manufactured by the military industrial enterprises shall be fixed
according to the principle of "same quality, same price" as the export
commodities manufactured by civil enterprises.
9. With respect to industrial commodities for promoting exports by
importation, the foreign trade company and the production or supplying
unit shall conclude and sign an economic contract or agreement, in which
are stipulated their respective obligations. In the event that either of
the two parties fails to execute the said contract or agreement, which
consequently has given rise to economic losses, the violator shall be
liable for compensating for the economic losses.
10. With respect to the farm and side-line products, livestock products
and local specialties for promoting exports by importation, while
arrangements are being made for the importation of animal feeds,
fertilizers, seeds and breeding stocks, the foreign trade company and the
production or supplying unit shall reach an agreement through consultation
concerning the increase of varieties and quantity, the specifications and
quality of the commodities they supply for export, as well as the time for
delivery.
11. With respect to the industrial products for promoting exports by
importation, the foreign trade company and the production or supplying
unit shall reach an agreement through consultation concerning the rate of
quality products for export, the rating for the consumption of raw,
semifinished, and auxiliary materials, and the time for delivery.
Those production enterprises, whose rate of quality products for export is
low, thus unable to guarantee the quality of their products, and whose
consumption of raw and semifinished materials and production costs are
high, are not eligible to be engaged in "promoting exports by
importation".
12. With respect to the earnings of foreign exchange from commodities for
promoting exports by importation, business accounting shall be carried out
item by item, and the rate of foreign exchange earnings from exporting
finished goods should generally be controlled at the rate from 30% to 50%
or higher. The rate of foreign exchange earnings from products that call
for more sophisticated production technology shall be higher, while the
rate of foreign exchange earnings from products that are turned out with
simpler production technology shall be lower, but it shall not be lower
than 30%.
13. Production enterprises (including state-run farms) that engage in
promoting exports by importation shall try their best to fulfil their
production tasks on time with the required quality and quantity and
deliver their goods on schedule. In the event that a production enterprise
undertakes the task of manufacturing a particular item of export product
in small quantity, with complicated designs and varieties and a very short
time limit for delivery, and consequently suffers a loss in its normal
profit earnings, the foreign trade company shall make compensation for
this by giving the production enterprise a necessary subsidy not included
in the calculated purchasing prices after the foreign trade department and
the relevant departments have reached an agreement through consultation.
14. The making of prices in Renminbi within the country for the imported
goods and materials needed for promoting exports by importation shall, in
principle, be handled in accordance with the current measures for making
prices for imported goods. With respect to a few varieties of export goods
included in promoting exports by importation, which, as a consequence of
the high domestic appropriation prices of imported raw and auxiliary
materials or the high profit and tax rates, give rise to great losses in
exporting such finished goods, so long as the aforesaid varieties of goods
sell well on the international market and the rate of earnings in foreign
exchange is acceptable, they may, with approval, be imported through
agency by the foreign trade department and only service fees shall be
charged or Customs duty/consolidated industrial and commercial tax be
exempted from. The products supplied by production or supplying units for
export shall calculate the production costs in accordance with the actual
appropriation price of the said raw and auxiliary materials imported
through the foreign trade channel.
15. With respect to the retention quota of foreign exchange earnings from
the commodities for promoting exports by importation, the case shall be
handled in accordance with the retention measures prescribed uniformly by
the State. With respect to the business activities carried out for
promoting exports by importation, all regions and areas, all departments
concerned, as well as foreign trade companies and production enterprises,
shall set up special register and compile statistics for the said business
activities, strengthen the cost check-up and accounting, and guarantee the
completeness of all business vouchers and original records.
16. With respect to those production or supplying units engaged in
promoting exports by importation, which maintain better business
performance and higher foreign exchange earnings, higher pay, more bonuses
and welfare allowances may be allowed. As to those production or supplying
units which turn out poor quality products, embezzle imported goods and
materials, and plot to share among themselves the products, an
investigation shall be made into their illegal acts, and their cases shall
be dealt with seriously.
17. To the production or supplying units engaged in promoting exports by
importation, the foreign trade companies should, at any time, provide the
aforesaid production or supplying units with specimens and samples of
foreign advanced products as well as relevant technical data, invite the
personnel from the production or supplying units to participate in
business talks with foreign companies or businessmen, organize, according
to plan, study groups to carry out investigations abroad, and invite
foreign businessmen for technical exchange.
18. All regions and areas, and all departments concerned, should
strengthen the leadership of the work concerning the production of export
commodities for promoting exports by importation, enthusiastically
organize the implementation, and solve the problems arising in production
and supply of goods. The production and supplying units and foreign trade
departments should sum up, in good time, their experience so as to push
forward the steady development of this work.


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关于开展爱国卫生运动做好防控甲型流感等的通知

卫生部


关于开展爱国卫生运动做好防控甲型流感等的通知


各省、自治区、直辖市及新疆生产建设兵团爱卫会:

  近期,一些国家发生的甲型H1N1流感疫情,已经成为全世界高度关注的公共卫生事件。党中央、国务院高度重视疫情发展情况,胡锦涛总书记作出重要批示,对防范工作提出明确要求。温家宝总理主持召开国务院常务会议,对防控工作做出全面部署。为认真贯彻落实党中央国务院防控甲型H1N1流感的决策部署,当前要充分发挥爱国卫生运动的优势,各成员单位形成合力,同时,发动群众、依靠群众、群策群力、群防群控,共同做好甲型H1N1流感等传染病防控工作。

  一、认真贯彻落实党中央指示精神和国务院的统一部署

  今年4月14日,全国爱卫会召开了全体委员会议,中共中央政治局常委、国务院副总理、全国爱国卫生运动委员会主任李克强同志主持会议并作重要讲话。会议分析了当前爱国卫生工作和手足口病等传染病防治工作的形势,部署了2009年爱国卫生重点工作。按照国务院领导的指示精神,全国爱卫办于4月24日召开了开展爱国卫生运动推进卫生防病工作电视电话会议,贯彻落实全委会会议精神,并对手足口病等传染病防控工作做了进一步部署。针对目前防控甲型H1N1流感的严峻形势,各级爱卫会要在已经部署的手足口病等传染病防控的基础上,大力强化已经采取的措施,积极防控甲型H1N1流感等传染病的发生与传播。各成员部门要各司其职,各尽其责,团结协作,形成合力,共同保护好人民群众身体健康和生命安全。

  农业部门要加强牲畜监测和流行病学调查,全面加强生猪防疫管理,做好应急准备。全力抓好人畜共患病、推进农村清洁能源建设和开展污染源治理,积极配合卫生部门做好工作。住房和城乡建设部门要结合城市棚户区改造,加强城市整体环境的建设;结合农村危房改造,配合卫生部门对农户厕所进行改造;与环境保护部门一起,加大对城市污水、垃圾处理设施的监督力度,确保其正常运行。环境保护部门要对影响可持续发展和群众健康的突出环境问题,开展专项整治行动,并纳入到今年农村环境保护重点工作。宣传部门要加强对传染病防治工作的宣传,不仅要让群众了解卫生知识,还要正确把握舆论导向,避免群众产生恐慌心理。铁道部门要针对流动人群聚集的站、车开展健康教育活动,加强铁路建设工地的卫生管理,搞好铁路部门单位环境治理。采取有力措施,防止传染病通过铁路传播。人力资源社会保障部门要加强对农民工的健康教育,改善农民工工作和居住环境。教育部门要配合卫生部门,指导和督促各地学校改善卫生条件,开展学校健康教育,落实学校卫生防疫和食品卫生的措施,预防和控制学校传染病等突发公共卫生事件的发生和蔓延。财政部门要积极配合卫生部门,在传染病防治方面提供经费支持和保障。公安部门要密切关注疫情和社会动态,切实维护好社会稳定;认真做好疫情高发地区的治安管理,加强值班备勤,做好处置突发事件的准备;加强协调配合,形成工作合力。民政部门要在组织开展城乡社区建设工作当中,继续把开展爱国卫生运动,防控疾病作为社区建设的一个重要内容,在社区开展健康、环保和文明生活方式的宣传教育。卫生部门要进一步加强对传染病防控的组织领导;要继续加强疫情监测,特别是加强农村、学校、托幼机构、建设工地、流动人口聚集地等重点地区和场所的疫情监测。密切关注疫情动态,做到早发现、早诊断、早治疗。在重点地区,对于重点人群,要提供特殊的经费支持和保障措施;要继续加强对新闻舆论的正确引导,建立舆情跟踪分析机制,不断提高风险沟通能力,通过媒体,主动、及时、准确发布疫情信息,确保群众的知情权和参与权,维护社会和谐稳定。

  二、广泛宣传防控甲型H1N1流感等传染病的卫生知识

  要充分发挥报纸、电视、互联网等媒体的作用,通过各种通俗易懂的形式,在全国城乡广泛宣传开展群众性爱国卫生运动,对于防控甲型H1N1流感、手足口病等传染病、对于发展公共卫生事业、提高全民族健康水平的重要性的认识。要传递健康信息,扩大健康文化的影响力,使人民群众了解环境与健康的关系。当前尤其是要大力宣传以防控甲型H1N1流感、手足口病为重点的基本卫生知识,使群众真正了解到只要我们科学理性地应对,传染病可防、可控、可治,并不可怕。使群众充分理解搞好环境卫生和个人卫生与防控传染病的关系,引导广大群众尽量不接触、不食用病死禽畜和野生动物,不随地吐痰、大小便,不乱扔垃圾,勤洗手、勤通风、勤晒衣被、吃熟食、喝开水,让群众自觉养成良好的文明、卫生习惯,建立科学健康的生活方式。从我做起,从现在做起,从身边做起,使群众自觉地投入到“改陋习、讲文明、讲卫生、爱环境和树新风”活动中,在全社会形成人人讲卫生、处处讲卫生的良好风尚,不断提高人民群众的整体素质。

  三、进一步加大城乡环境卫生整治力度

  要按照国务院常务会议和全国爱卫会全委会的精神,大力开展爱国卫生运动,加大环境卫生整治力度。各级爱卫会要组织成员单位和基层单位,积极发动群众、依靠群众,在贯彻落实《关于开展第21个爱国卫生月活动暨迎接新中国成立60周年爱国卫生运动实施方案》的基础上,结合当地实际,大力开展以“清洁城乡,保护健康”为主题的爱国卫生活动,在全国范围内对城乡环境卫生进行一次集中清理。重点清除城乡结合部、城中村、铁路公路沿线、车站、港口、农贸市场和居民生活区的垃圾,消除污水坑塘。在农村,结合社会主义新农村建设,切实抓好生活垃圾和污水的处置,生活垃圾要做到集中收集、定点掩埋。有条件的地区力求做到“村收集、乡镇运输、县处理”。要进一步加快改水改厕步伐,加强人畜粪便的无害化处理。重点要发动群众、依靠群众搞好家庭卫生、个人卫生、托幼机构、学校和农民工居住地的卫生。在此基础上,进一步推动卫生城市和文明村镇的建设,树立典型,鼓励先进,积极引导各地加快城乡基础卫生设施建设步伐,争取在短期内使全国城乡环境卫生面貌有较大改观,使群众的文明卫生素质有较大提高,为防控各类传染病奠定坚实基础。

  四、各级政府要切实加强对爱国卫生工作的领导

  各级政府要进一步提高对爱国卫生工作重要性的认识,按照“政府组织,地方负责,部门协调,群众动手,科学治理,社会监督”的工作方针,各地区各有关部门切实加强对爱国卫生运动的组织领导和工作指导,完善工作机制。爱国卫生工作是公共卫生体系建设的重要内容,是卫生防病的基础,要列入当地国民经济和社会发展总体规划。甲型H1N1流感和手足口病等传染病防治直接涉及人民群众利益,是重要民生问题,要列入政府的重要工作日程。各级政府要及时研究解决本地区爱国卫生和传染病防治工作中的重大问题,为保护人民群众健康多办实事。要积极支持爱卫会工作,加强爱卫会的组织建设,健全爱卫会及其办事机构,为爱卫会开展工作创造条件。要充分发挥城乡爱国卫生基层组织的作用,动员群众、发动群众、依靠群众,采取有力措施,防控甲型H1N1流感等传染病的发生与传播,使传染病防控和城乡环境卫生工作更好地落到基层、落到实处,取得实效。

                     二〇〇九年五月三日


Provisions for Drug Insert Sheets and Labels

Commissioner of SFDA


Provisions for Drug Insert Sheets and Labels



(SFDA Decree No.24)

The Provisions for Drug Insert Sheets and Labels, adopted at the executive meeting of the State Food and Drug Administration on March 10, 2006, is hereby promulgated and shall go into effect as of June 1, 2006.


Shao Mingli
Commissioner of SFDA

March 15, 2006





Provisions for Drug Insert Sheets and Labels


Chapter I General Provisions

Article 1 The Provisions are enacted with a view to regulating drug insert sheets and labels in accordance with the Drug Administration Law of the People’s Republic of China and the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China.

Article 2 The insert sheets and labels of drugs marketed within the territory of the People’s Republic of China shall meet the requirements of the Provisions.

Article 3 Drug insert sheets and labels shall be reviewed and approved by the State Food and Drug Administration.

A drug shall be labeled on the basis of its insert sheet. The content of the label shall be within the scope of the insert sheet. Any words and marks with implied therapeutic effects, misleading information on usage, or inappropriate promotion of the product shall not be printed.

Article 4 A drug label shall be printed on or affixed to the drug package, and no other written words, audio and/or visual materials or other information are attached to introduce or publicize the product or the enterprise.

An insert sheet shall be attached to the smallest package provided by the drug manufacturer for marketing.

Article 5 The wording in drug insert sheets and labels shall be scientific, standardized and accurate. The insert sheet of a non-prescription drug shall be written intelligibly and convenient for patients to judge, choose and use the drug on their own.

Article 6 In the label or insert sheet, the letters or characters shall be clear and easy to be recognized and the marks shall be clear and distinctive. The label and insert sheet shall have no print faded and shall not be affixed unsteadily. Any addition or modification shall not be made by means of pasting, cutting or altering.

Article 7 Drug insert sheets and labels shall be written in standardized Chinese characters published by the National Language Commission. The versions in other languages shall comply with the Chinese version.

Article 8 With the aim to protect public health and direct the rational use of drugs, drug manufacturers may voluntarily apply to add warnings to drug insert sheets or labels. The State Food and Drug Administration may also request drug manufacturers to add warnings to drug insert sheets or labels.


Chapter II Drug Insert Sheet

Article 9 A drug insert sheet shall include the significant scientific data, conclusions and information concerning drug safety and efficacy in order to direct the safe and rational use of drugs. The specific format, content and writing requirements of drug insert sheet shall be prescribed and issued by the State Food and Drug Administration.

Article 10 Disease names, pharmaceutical terms, drug names, the names and results of clinical testing in drug insert sheets shall be expressed in professional terms published or standardized by the State. The units of measurement shall conform to the national standards.

Article 11 All the active ingredients or medicinal ingredients of traditional Chinese medicines in a prescription shall be listed in the insert sheet. For injections and non-prescription drugs, all excipients shall be listed as well.

The ingredients or excipients included in a prescription, which may cause severe adverse reaction, shall be specified.

Article 12 A drug manufacturer shall trace the safety and efficacy of its marketed drugs. For any modification to the insert sheet, an application shall be submitted timely.

The State Food and Drug Administration may also require a drug manufacturer to make modification to the insert sheet on the basis of the results of adverse drug reaction monitoring and drug re-evaluation.

Article 13 After the modification to the insert sheet is approved, the drug manufacturer shall inform relevant drug distributors, drug users and other departments of the modified content immediately, and use the modified insert sheet and label timely as required.

Article 14 The insert sheet shall provide full information on adverse drug reaction and indicate the adverse reactions in detail. A drug manufacturer, who fails to timely modify the insert sheet on the basis of the safety and efficacy data of the marketed drug or to fully explain the adverse reaction in the insert sheet, shall be liable for all the consequences arising therefrom.

Article 15 The approval date and the modification date shall be distinctively shown in the insert sheet.


Chapter III Drug Labels

Article 16 Drug labels refer to the information printed or pasted on drug packaging, including inner labels and outer labels. Inner labels refer to those that appear on immediate packaging; outer labels are those on the other packaging outside of inner labels.

Article 17 The inner label shall bear such drug information as the adopted name in China, indications or functions, strength, dose and usage, production date, batch number, expiry date and manufacturer. If there is no enough space in the package to include all the information mentioned above, the adopted name in China, strength, batch number and expiry date shall be indicated at least.

Article 18 The outer label of a drug shall indicate such information as the adopted name in China, ingredients, description, indications or functions, strength, dose and usage, adverse reactions, contraindications, precautions, storage, production date, batch number, expiry date, approval number and manufacturer. Where indications or functions, dose and usage, adverse reactions, contraindications and precautions cannot be fully noted, main information plus a “See drug insert sheet for details.” notice shall be indicated.

Article 19 The label on the package for transportation and storage shall bear at least the adopted name in China, strength, storage, production date, batch number, expiry date, approval number and manufacturer. Other information such as packaging quantity, precautions for transportation or other marks may be included when necessary.

Article 20 The label for drug substance shall include the adopted name in China, storage, production date, batch number, expiry date, applied specifications, approval number and manufacturer. Other necessary information such as packaging quantity and precautions for transportation shall also be indicated.

Article 21 Where one drug produced by a manufacturer has the same drug strength and packaging specification, the content, format and color of its labels must be the same. Where one drug produced by a manufacturer has different drug strengths or packaging specifications, its labels shall be clearly distinguished from one another, or its specifications shall be notably marked in the corresponding specification items.

Where a drug produced by a manufacturer is administrated as prescription drug and non-prescription drug respectively, their packaging colors shall be distinctly different.

Article 22 For drugs with special requirements on storage, its requirements shall be marked in the notable place of the label.

Article 23 The expiry date in the drug label shall appear in the order of year, month and day, with year shown in four digits, month and day in two digits. Its specific format shall be “Valid till XXXX year XX month” or “Valid till XXXX year XX month XX day”. It may be presented with numbers and other symbols as “Valid till XXXX.XX.” or “Valid till XXXX/XX/XX”.

For the preventive biological product, the expiry date shall be labeled according to the registration specifications approved by the State Food and Drug Administration. The expiry date of the biological product for therapeutic use shall be counted from the filling date. For other drugs, the expiry date shall be counted from the production date.

Where the expiry date is labeled to the day, it shall be marked as one day earlier than the actual expiry date; where the expiry date is labeled to the month, it shall be marked as one month earlier than the actual expiry month.


Chapter IV Use of Drug Name and Registered Trademark

Article 24 The drug name in insert sheets and labels shall conform to the nomenclature principles on the adopted name in China and trade name of drug announced by the State Food and Drug Administration, and shall be consistent with those appeared in the approval documents of the drug.

Article 25 The adopted name in China shall be conspicuous and prominent, and its typeface, size and color shall be consistent, and meet the following requirements:
(1) For horizontal labels, the adopted name in China shall appear in a prominent position within the area of the upper one-third of the label; for vertical labels, it shall appear in a prominent position within the area of the right one-third of the label;
(2) No such illegible typefaces as cursive characters and seal characters shall be used, and no such format as italics, margining and shading shall be used to modify the typefaces.
(3) The font color of the adopted name in China shall be black or white, in sharp contrast to the light-colored or dark-colored background respectively.
(4) Writing in separate lines shall be avoided unless limited by the packaging size.

Article 26 The trade name of a drug shall not be placed in the same line with the adopted name in China; its typeface and color shall be no more conspicuous than that of the adopted name in China, and its font area per character shall be no bigger than half of that of the adopted name in China.

Article 27 Unregistered trademarks and other drug names unapproved by the State Food and Drug Administration shall not be used in the drug insert sheets and labels.

Where a registered trademark is used in a drug label, it shall be printed in a corner of the label. Where a registered trademark contains characters, the font area per character shall be no bigger than a quarter of that of the adopted name in China.


Chapter V Other Provisions

Article 28 For narcotic drugs, psychotropic substances, medicinal toxic drugs, radioactive pharmaceuticals, drugs for topical use, non-prescription drugs and other drugs having special marks specified by the State, their special marks shall be printed in the drug insert sheets and labels.
Where there are special provisions issued by the State for drug insert sheets and labels, they shall prevail.

Article 29 The labeling provisions for Chinese crude drugs and prepared slices of Chinese crude drugs shall be formulated separately by the State Food and Drug Administration.

Article 30 Where drug insert sheets and labels are not in compliance with the Provisions, a punishment shall be imposed in accordance with the relevant provisions of the Drug Administration Law of the People’s Republic of China.


Chapter VI Supplementary Provisions

Article 31 These Provisions shall come into force as of June 1, 2006. the Provisions for Drug Packaging, Labels and Insert Sheets (Provisional) issued by State Food and Drug Administration on October 15, 2005 shall be annulled therefrom.



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