国家食品药品监督管理局办公室


关于进一步做好中药材质量监管工作的通知

食药监办安[2011]64号


各省、自治区、直辖市食品药品监督管理局(药品监督管理局)，新疆生产建设兵团食品药品监督管理局：

　　近日新闻媒体报道了甘肃省岷县、陇西等地药农和商户用硫磺熏蒸当归等药材的现象，引发了社会较大反响。中药材的养殖、种植及加工关系到中药制剂以及中药饮片的质量安全，应引起各级食品药品监管部门的高度重视。为确保药品质量安全，现就进一步加强中药材质量监管相关工作通知如下：

　　一、进一步提高对中药材质量监管重要性的认识。各省（区、市）食品药品监管部门应通过甘肃岷县硫熏药材事件，举一反三、防微杜渐，拓宽监管思路，进一步加强中药材流通环节的监管，加强对中药材及中药饮片经营企业以及中药材专业交易市场硫熏药材的监督检查，加大市场抽样检验的力度，进一步规范中药材及中药饮片的经营销售行为。

　　二、强化中药制剂及中药饮片生产的监督检查。各省（区、市）食品药品监管部门应按照国家局《关于进一步加强中药生产监督检查的通知》（国食药监安〔2010〕457号）和国家局会同卫生部、国家中医药管理局联合下发的《关于加强中药饮片监督管理的通知》（国食药监安〔2011〕25号）的要求，加强对中药制剂及中药饮片生产企业购进中药材及中药饮片质量检验工作的监督，加大对中药制剂及中药饮片生产企业药品生产现场监督检查的力度。

　　三、加强中药材及中药饮片质量检验。国家局正在制定中药材及中药饮片二氧化硫残留量限度标准，在此之前，各省（区、市）食品药品监管部门应设定工作时限，要求辖区内中药制剂及中药饮片生产企业制定二氧化硫残留量限度指标，作为企业物料检测内控标准。凡企业未按要求制定二氧化硫残留物检测内控标准或不按照内控标准对购进中药材或中药饮片进行检验的，其中药材或中药饮片不得用于生产投料。

　　四、加强与相关部门的协调与配合。各省（区、市）食品药品监管部门应主动与农业、工商、卫生等部门加强信息沟通与交流，及时通报中药材养殖、种植及加工过程中出现的硫磺熏蒸以及其他影响药材质量的问题，并积极配合相关部门采取措施，齐抓共管，综合治理，切实履行监管职责，确保中药制剂及中药饮片质量安全。

　　各省（区、市）食品药品监管部门在中药材质量监管工作中发现的问题和情况，应及时向所在地省级人民政府和国家局报告。
　　联系人：郭清伍、翁新愚
　　电　话：010-88330852，88330812
　　传　真：010-88330854


　　　　　　　　　　　　　　　　　　　　　　　　　国家食品药品监督管理局办公室
　　　　　　　　　　　　　　　　　　　　　　　　　　　 二○一一年五月三日



国务院


中华人民共和国进口货物许可制度暂行条例(附英文)

1984年1月10日，国务院

第一条 为了加强进口贸易的计划管理，提高经济效益，更好地为社会主义现代化建设服务，特制定本条例。
第二条 中华人民共和国实行进口货物许可制度。凡属本条例规定凭证进口的货物，除国家另有规定者外，都必须事先申请领取进口货物许可证，经由国家批准经营该项进口业务的公司办理进口订货。海关凭进口货物许可证和其他有关单证查验放行。
第三条 中华人民共和国对外经济贸易部代表国家统一签发进口货物许可证。
省级对外经济贸易管理部门，在对外经济贸易部规定的范围内，可以签发本省、自治区、直辖市进口货物许可证。
对外经济贸易部也可以授权派驻主要口岸的特派员办事处，在规定的范围内签发进口货物许可证。
第四条 经国家批准，可以经营进口业务的各类公司，都必须严格按照批准的经营范围和进口商品目录办理进口业务。
前款公司中的外贸专业进出口总公司、部属进出口公司、省级人民政府所属进出口公司进口的货物，除国家限制进口者外，免领进口货物许可证，海关凭有关进口单证查验放行。其他公司进口货物，都必须申请领取进口货物许可证，海关凭进口货物许可证和有关单证查验放行。
禁止未经批准经营进口业务的部门、企业自行进口货物。
第五条 根据国家规定，经国务院有关部委或省、自治区、直辖市人民政府批准，对外签订的来料加工、来件装配、补偿贸易、承包工程的协议、合同项下的进口货物，没有超出批准项目范围的，免领进口货物许可证。但是，补偿贸易、承包工程项下进口国家限制进口的货物，以及来?
霞庸ぁ⒗醇芭湎钕陆诘牧稀⒓蚣庸さ某善罚枰谙模急匦肷昵肓烊〗诨跷镄砜芍ぁ?
第六条 进口国家限制进口的货物，不分进口方式、外汇来源、进口渠道，都必须按照国家规定的审批权限，报经主管部门和归口审查部门审核批准，由订货单位凭批准证件申请领取进口货物许可证。
国家限制进口货物的品种，由对外经济贸易部根据国家规定统一公布、调整。
第七条 下列进口，不属于前条第二款品种范围的，免领进口货物许可证：
一、经国家批准，可以经营进出口业务的各类公司，在进出口贸易中，购进的或接受外商免费提供的货样；
二、科研、教育、文化、体育、医药、卫生部门经对外经济贸易部、省级对外经济贸易管理部门或对外经济贸易部驻口岸特派员办事处批准，自行在国外购买国际市场价格在五千美元以下的急需的业务用品；
三、厂矿企业经对外经济贸易部、省级对外经济贸易管理部门或对外经济贸易部驻口岸特派员办事处批准，自行在国外购买国际市场价格在五千美元以下的生产急需的机电仪配件；
四、经国家特别批准进口的商品。
前款第二项、第三项、第四项进口物品，海关凭批准的证件查验放行。
第八条 前条第一款第二项、第三项自行购买的物品，国际市场价格超过规定限额的，必须申请领取进口货物许可证。
前条第一款第二项、第三项以外的机关、团体，自行在国外购买急需物品进口，也必须申请领取进口货物许可证。
第九条 中外合资经营企业生产所需物资，国内不能供应的，可以委托有关外贸公司向国外订购，也可以在该企业经营范围内自行进口。申请领取进口货物许可证的范围、手续，按照《中华人民共和国中外合资经营企业法实施条例》第六十三条的规定办理。
第十条 在下列情况下，对外经济贸易部不签发或撤销已经签发的进口货物许可证：
一、国家决定停止进口或暂停进口的货物；
二、不符合国家对外政策的进口货物；
三、不符合有关双边贸易协定、支付协定内容的进口货物；
四、不符合国家卫生部门、农牧渔业部门规定的药品、食品、动植物、农产品、畜产品、水产品的卫生标准、检疫标准的进口货物；
五、其他有损国家利益或违法经营的进口货物。
第十一条 申请领取进口货物许可证，必须持有厅、局级以上单位的公函，并提交经主管部门和归口审查部门批准进口的证件。申请内容包括进口货物名称、规格、数量、金额、用途、进口国别、外汇来源、对外成交单位等项目。经发证机关审核，符合规定的，予以签发进口货物许可
证。
申请单位领取进口货物许可证，必须如实申报，不得弄虚作假。违者，追究责任。
第十二条 进口货物许可证的有效期限为一年。货物在有效期限内没有进口，领证单位可以向发证机关申请展期，发证机关可以根据合同规定相应延长许可证有效期限。
第十三条 违反本条例规定，事先没有申请领取许可证而擅自进口货物的，海关可以没收货物或责令退运；经发证机关核准补证进口的，海关可以酌情处以罚款后放行。伪造、涂改、转让进口货物许可证的，海关按照海关法规的有关规定处理。
第十四条 经济特区进口供特区内使用的货物，按照经济特区的特别规定办理；经济特区运往内地的进口货物、特区产品，都应当按照本条例规定执行。
第十五条 本条例由对外经济贸易部负责解释；施行细则由对外经济贸易部会同海关总署制定。
第十六条 本条例自发布之日起施行。

INTERIM REGULATIONS OF THE PEOPLE'S REPUBLIC OF CHINA ON THELICENCING SYSTEM FOR IMPORT COMMODITIES

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)
INTERIM REGULATIONS OF THE PEOPLE'S REPUBLIC OF CHINA ON THE
LICENCING SYSTEM FOR IMPORT COMMODITIES
(Promulgated by the State Council on January 10, 1984)
Article 1
These Regulations are formulated to strengthen planning and administration
of imports, and to upgrade the economic efficiency, so as to facilitate
the construction of socialist modernization.
Article 2
The People's Republic of China implements the licencing system for import
commodities. With respect to all those commodities subject to a licence
for import as stipulated in these Regulations, except as otherwise
provided by the state, an application must be filed in advance for
obtaining an import licence, and the import order for the required
commodities shall be handled by a company approved by the state to be
engaged in the import business of the said commodities. The Customs shall
give clearance against the import licences and other relevant documents.
Article 3
The Ministry of Foreign Economic Relations and Trade of the People's
Republic of China shall, on behalf of the state, be responsible for the
unified issue of the import licences. The departments of foreign economic
relations and trade at the provincial level may, within the scope of
competence prescribed by the Ministry of Foreign Economic Relations and
Trade, issue import licences related to the importation of the respective
provinces, autonomous regions, or municipalities directly under the
Central Government. The Ministry of Foreign Economic Relations and Trade
may also authorize its accredited representatives' offices stationed at
the main ports to issue, within the prescribed scope of competence, the
import licences.
Article 4
Various categories of companies that have been approved by the state to
engage in import business must handle the import business operations
strictly in accordance with the approved scope of business and with the
catalogue of import commodities. The goods, which are imported by the
national foreign trade corporations engaged in specialized import and
export business, or by import and export companies attached to various
ministries, or by import and export companies attached to various
provincial governments referred to by the term "companies" mentioned in
the preceding paragraph, shall, with the exception of those goods under
import restrictions imposed by the state, be exempt from the import
licences, and the Customs shall give clearance against the relevant import
documents.
All departments and enterprises without the approval of the state to
engage in import business are forbidden to import goods without
authorization.
Article 5
The goods which are imported in accordance with the provisions of the
state, and with the approval of the relevant ministries or commissions
under the State Council or of the people's governments of the respective
provinces, autonomous regions, and municipalities directly under the
Central Government, for executing various agreements and contracts
concluded with parties from abroad for processing supplied materials, for
assembling supplied parts and components, for compensation trade, or for
contracting of construction projects, and which have not exceeded the
scope of the approved items, shall be exempt from import licences.
However, where the importation with respect to the compensation trade or
the contracting of construction projects goods under import restrictions
by the state; or where the materials or the parts and components or the
finished products after processing, imported for executing contracts for
processing supplied materials or for assembling supplied parts and
components are needed to diverse for domestic sale, an application must
filed for obtaining an import licence.
Article 6
In respect of the importation of goods under import restrictions imposed
by the state, irrespective of their forms of import, sources of foreign
exchange, and channels for import, the matter shall be submitted to the
competent administrative departments and the relevant examining
departments for examination and approval in accordance with the scope of
competence and limits of authority for examination and approval provided
by the state; and then, the ordering units shall apply for the import
licences by presenting the approval document.
The varieties of goods under import restrictions imposed by the state
shall be uniformly adjusted and made known to the public by the Ministry
of Foreign Economic Relations and Trade in accordance with the provisions
formulated by the state.
Article 7
The following imports, which do not fall under the scope of varieties
stipulated in the second paragraph of the preceding article, shall be
exempt from the import licences:
1. samples purchased or provided free of charge by foreign businessmen, in
the course of import and export business, by various categories of
companies which have been approved by the state to engage in import and
export business;
2. articles urgently required for professional usage which are purchased
from abroad at the international market price of 5,000 U.S. dollars or
less, by such departments as scientific research, education, culture,
physical culture, medicine, and public health, with the approval of the
Ministry of Foreign Economic Relations and Trade, or the administrative
departments of foreign economic relations and trade at the provincial
level, or the accredited representatives' offices of the Ministry of
Foreign Economic Relations and Trade stationed at various ports;
3. machinery and electrical instruments and fittings urgently required in
production which are purchased from abroad by industrial or mining
enterprises at the international market price of 5,000 U.S. dollars or
less, with the approval of the Ministry of Foreign Economic Relations and
Trade, or the administrative departments of foreign economic relations and
trade at the provincial level, or the accredited representatives' offices
of the Ministry of Foreign Economic Relations and Trade stationed at
various ports;
4. commodities imported with the special approval by the state.
The Customs shall give clearance to the imported goods mentioned in Items
2, 3 and 4 of the preceding paragraph against the approval documents.
4 of the preceding paragraph against the approval documents.
Article 8
With respect to the goods purchased as mentioned in Items 2 and 3 of the
first paragraph of the preceding article, if they are bought at an
international market price that exceeds the prescribed limit, an
application must be filed for obtaining the import licences. If
departments or public institutions other than those mentioned in Items 2
and 3 of the first paragraph of the preceding article are to purchase from
abroad the urgently required articles, they must also apply for obtaining
the import licences.
Article 9
With respect to the goods and materials required in production by Chinese-
foreign equity joint ventures, if they cannot be obtained in the domestic
market, the aforesaid equity joint ventures may order them from abroad
through the relevant foreign trade companies, or the equity joint ventures
may, within their scope of business operation, import the goods and
materials by themselves. Matters concerning the scope of and the
procedures for the import licences shall be handled in accordance with the
provisions of Article 63 of the Rules for the Implementation of the Law of
the People's Republic of China on Chinese-Foreign Equity Joint Ventures.
Article 10
Under any one of the following circumstances, the Ministry of Foreign
Economic Relations and Trade shall not issue the import licence, or revoke
the import licence already issued:
1. goods the importation of which the state has decided to stop or to stop
for the time being;
2. goods the importation of which is not in conformity with the foreign
policy of the state;
3. the imported goods that are not in conformity with the contents of
bilateral trade agreements or the agreements of payment;
4. the imported goods that are not in conformity with the sanitation
criteria or the quarantine criteria for medicine, foodstuff, animals and
plants, agricultural products, livestock products, aquatic products, as
set by the state public health departments and the departments of
agriculture, animal husbandry and fishery;
5. other imported goods that jeopardize the interests of the state, or
that are handled illegally.
Article 11
To apply for the import licence, the applicant must present an official
certifying letter issued by a unit at the provincial department or bureau
level or higher, and submit also the certifying document indicating the
approval of the importation of the said goods by the relevant competent
administrative departments and the examining departments. The application
shall contain such items as the names of the imported goods,
specifications, quantity, amount of money paid, purposes of usage, the
country from which the goods are to be imported, sources of foreign
exchange, and the domestic units that shall conclude the transaction with
external units. The licence issuing department shall issue the import
licence after it has examined the application and found it to be in
conformity with relevant provisions.
In applying for the licence for import goods, the applying unit must make
the application strictly according to the facts and must not resort to
deception or trickery. Violators shall be investigated and punished.
Article 12
The term of validity of the import licence shall be one year. In the event
that within the term of validity the goods have not been imported, the
unit that holds the licence may make an application to the licence issuing
authorities for an extension of the term of validity; the licence issuing
authorities may, in accordance with the stipulations of the relevant
contract, extend the term of validity accordingly.
Article 13
In the event of a violation of the provisions of these Regulations, with
respect to the goods imported arbitrarily without applying for the import
licence in advance, the Customs may confiscate the goods or give an order
for the goods to be shipped back; where the importation has been verified
by the licence issuing department and the import licence has been issued
afterwards, the Customs may, at its discretion, impose a fine on the
violator and then give clearance. With respect to the forgery, alteration
or illegal transfer of the import licence, the case shall be dealt with by
the Customs in accordance with the pertinent provisions of the Customs
laws and regulations.
Article 14
Matters concerning goods imported by the special economic zones for the
use within the special economic zones shall be handled in accordance with
the special provisions of the special economic zones; matters concerning
the imported goods and the goods manufactured in the special economic
zones, which are to be transported to the inland of the country, shall all
be handled in accordance with the provisions of these Regulations.
Article 15
The Ministry of Foreign Economic Relations and Trade shall be responsible
for the interpretation of these Regulations; and the rules for the
implementation of these Regulations shall be formulated jointly by the
Ministry of Foreign Economic Relations and Trade and the General
Administration of Customs.
Article 16
These Regulations shall go into effect as of the date of promulgation.