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中华人民共和国对外商投资企业进出口货物监管和征税办法(附英文)

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中华人民共和国对外商投资企业进出口货物监管和征税办法(附英文)

海关总署


中华人民共和国对外商投资企业进出口货物监管和征税办法(附英文)
1992年8月22日,

第一章 总 则
第一条 为了鼓励外国公司、企业和其他经济组织或个人来中国举办中外合资经营企业、中外合作经营企业和外资企业(以下简称外商投资企业),贯彻国家产业政策,发展国民经济,方便合法进出,加强海关监管,依照《中华人民共和国海关法》和有关法律、法规的规定,制定本办法。
第二条 外商投资企业应按中华人民共和国的法律、法规和本办法的规定履行各项义务,其进出口货物应如实向海关申报,接受海关监管并可享受有关优惠。
第三条 对遵守海关规定好的外商投资企业,经审核后,由海关授予“信誉良好企业”称号并在办理海关手续方面给予相应的便利。
第四条 对符合海关监管条件的外商投资企业,可以批准其建立保税仓库、保税工厂。海关认为必要时,可以在外商投资企业中派驻关员进行监管,办理海关手续。有关企业应提供必要的便利。
第五条 外商投资企业进口的货物凡属于《中华人民共和国海关法》规定的海关监管货物,未经海关许可,不得擅自出售、转让、抵押或移作他用。

第二章 备案手续与验放依据
第六条 外商投资企业应当持凭中华人民共和国对外经济贸易管理部门或其授权机构签发的批准证书和中华人民共和国工商行政管理部门或其授权机构签发的营业执照等文件的副本或复印件以及企业章程、合同,向主管地海关办理企业登记备案手续。
第七条 外商投资企业投资各方应当根据合同、章程的规定,按照国家的有关规定缴付出资额,并在验资后的一个月内向海关递交验资报告。
第八条 外商投资企业办理进出口货物报关手续时,应当填写外商投资企业专用的进口或出口货物报关单向海关申报,并交验货物发票、集装箱单等有关单据;属于国家规定须申领许可证的商品,还应当向海关递交进(出)口许可证;不属于国家规定申领许可证的商品,海关凭批准成立企业的文件或者进出口合同验放。
外资企业进口本企业自用的、合理数量的货物免予报批,免领进口许可证。
第九条 外商投资企业为解决外汇收支平衡购买非本企业产品出口的,海关应当验凭经贸主管部门的批准文件;其中属于国家实行出口许可证管理的商品,凭批准文件申领出口许可证,海关凭以验放。
第十条 外商投资企业应于货物进口前持凭经批准的合同设备清单等单证向主管海关办理征免税审批手续。经海关核准后发给《中华人民共和国海关对外商投资企业进口货物征免税证明》(以下简称《征免税证明》)。货物进口时,企业持《征免税证明》办理报关手续。
由海关签发的《征免税证明》的有效期为三个月。如遇特殊情况,经主管海关核准,可以延期。延长期限最长为三个月。
上述征免税货物,由主管海关办理验放手续,也可由进境地海关办理验放手续。《征免税证明》第三联应当于货物验放后一个月内退回主管海关备核。
第十一条 为履行产品出口合同的外商投资企业,由海关核发《中华人民共和国海关对外商投资企业履行产品出口合同所需进口料件加工复出口登记手册》(以下简称《登记手册》)。
外商投资企业为履行产品出口合同所需进口的原材料、燃料、散件、零部件、元器件、配套件、辅料和包装物料,由海关按保税货物进行监管,进口时,免领进口许可证,海关凭企业合同或进出口合同验放。
外商投资企业加工出口的产品,凡属于国家实行出口许可证管理的,出口时,海关凭出口许可证验放。

第三章 进出口货物的税收规定
第十二条 外商投资企业按规定在投资总额以及经批准追加的投资额内进口的货物,可以享受海关给予的减免税优惠,对超出投资额进口的货物,应当照章征税。
第十三条 中外合资经营企业进口下列货物,免征关税和工商统一税:
(一)按照合同规定作为外国合营者出资的机器设备、零部件和其他物料〔其他物料指建厂(场)以及安装、加固机器所需材料,下同〕;
(二)以投资总额内的资金进口的机器设备、零部件和其他物料;
(三)以增加资本进口的国内不能保证生产供应的机器设备、零部件和其他物料。
第十四条 外资企业进口第十三条规定的货物以及生产管理设备,免征进口关税和工商统一税。
第十五条 中外合作开采海洋石油进口直接用于勘探、开发作业的机器、设备、备件和材料;为制造开采作业用的机器、设备所需进口的零部件和材料以及利用外资进口属于能源开发,铁路、公路、港口的基本建设,工业、农业、林业、牧业和养殖业,深海渔业捕捞,科学研究,教育及医疗卫生方面的项目,按照合同规定进口的机器设备以及建厂(场)和安装、加固机器设备所需材料,免征进口关税和工商统一税。
第十六条 中外合作经营的商业、饮食业、照像业和其他服务业、维修中心、职工培训、客货汽车运输、近海渔业捕捞以及其他行业进口的货物,除国家另有规定者外,应当照章征收进口关税和工商统一税。
第十七条 外商投资企业在投资总额内根据国家规定进口本企业自用合理数量的交通工具、生产用车辆、办公用品(设备),免征进口关税和工商统一税。
第十八条 本办法第十三条、第十四条、第十五条、第十七条所列享受海关减免税优惠的进口货物,由海关规定监管年限。监管年限从减免税进口货物的放行之日起计算。
下列享受税收优惠的进口货物监管年限为:
(一)船舶、飞机及建筑材料(包括钢材、木材、胶合板、人造板、玻璃等) 八年
(二)机动车辆和家用电器 六年
(三)机器设备和其他设备、材料等 五年
对超过海关监管年限的减免税货物,企业可以向海关提出解除监管申请,经主管海关核准后发给《中华人民共和国海关对外商投资企业减免税进口货物解除监管证明》。
在海关监管年限内的减免税进口货物,经原审批部门批准用于在国内转卖或销售的,海关应当按照其使用时间折旧估价,补征进口税款。
未列入海关监管年限内的减免税进口货物,实际处理时,海关根据货物使用情况进行估价,补征税款。
第十九条 外商投资企业为履行产品出口合同进口直接用于加工出口产品而在生产过程中消耗掉的、数量合理的触媒剂、催化剂、磨料、燃料等,海关免征进口关税和工商统一税。
第二十条 外商投资企业为履行产品出口合同而在生产过程中产生的副次品、边角余料转为内销时,经海关核查批准后,予以酌情补税。对于确实没有使用价值的废品可免予补税。
外商投资企业进口的试机材料,应当在进口时照章征税。
第二十一条 外商投资企业经经贸主管部门批准进口供加工内销产品的料、件,应当在进口时照章征税。
第二十二条 外商投资企业出口自产产品,除限制出口商品或国家另有规定者外,免征出口关税。

第四章 保税进口料、件的管理与核销
第二十三条 外商投资企业对保税进口料、件(以下简称料、件)的进口、储存保管、提取使用和转厂加工,以及对加工制成品的储存、出口和内销等情况,应当建立符合海关要求的专门帐册,定期列表报海关核查。
第二十四条 外商投资企业进口的料、件,除因特殊原因并经海关核准外,应当从进口之日起一年内加工成成品并履行有关出口合同。
外商投资企业进口料、件及加工的产品,因故转为内销的,应当经经贸主管部门批准并向海关补缴有关进口料、件的关税和工商统一税后方准内销,其中属于许可证管理的料、件,还应当交验进口许可证。
第二十五条 外商投资企业进口的料、件不得直接转厂加工。如因特殊情况需转厂加工的,应当事先报经海关核准并在海关批准的期限内,将转厂加工的成品、半成品调回本企业。外商投资企业进口的料、件,经生产加工成成品或半成品,如不直接出口而卖断、转让给承接另一加工复出口的企业进行再加工、装配时,进口料、件的企业应当会同该生产企业持凭双方签订的购销或者生产加工合同等有关单据向海关办理结转和核销手续。
第二十六条 对进口合同项下的料、件,外商投资企业应当在最后一批成品出口之日起一个月内,持《登记手册》和出口货物报关单等有关单据向海关办理核销手续。
第二十七条 外商投资企业进口料、件后,如发生变更、转让、终止合同等情事,应当及时向海关办理有关手续。

第五章 抵押与破产、清算
第二十八条 外商投资企业以海关监管货物向国内外的金融机构作贷款抵押的,必须事先向主管海关申请,经核准后方可办理抵押手续。
上述抵押物实际处理时,企业应当按其使用年限折旧补税并办结海关手续。
第二十九条 外商投资企业终止合同或者解除合同的,应当在审批机关批准进行财产清算的十五日内或在法院裁定准予企业破产生效之日起的十五日内,持审批机关的批准文件(复印件)、进口征免税物资清单、海关核发的《征免税证明》、《登记手册》等,向主管海关申请办理减免税进口物资的销案手续。企业应当交回《报关注册登记证明书》、《报关员证》等有关证件。
海关在办结上述企业减免税进口物资的销案手续前,应当对有关进口物资予以封存。
第三十条 破产的外商投资企业,在进行财产清偿前,对其享受海关税收优惠的监管货物,应按照国家规定办理纳税手续。
第三十一条 终止或解除合同的外商投资企业,海关对其监管年限内的减免税进口货物,按以下规定办理:
(一)留给合营中方继续使用或转让、出售给国内单位的,海关应当按其使用年限折旧补税;
(二)如转让给国内其他可享受同等优惠待遇的外商投资企业使用的,经审批机关批准并办结海关结转手续后,可以继续享受减免税优惠;
(三)经海关核准,允许合营外方将原免税进口货物退运出境。
第三十二条 上述办结海关手续的外商投资企业,由海关核发《企业办结海关手续通知书》。

第六章 附 则
第三十三条 设在经济特区、经济技术开发区、保税区、高新技术产业开发区、沿海开放城市、沿海开放地区以及实行其他特殊优惠政策地区的外商投资企业,其进出口货物除按本办法规定办理外,还执行国家给予上述地区外商投资企业的有关政策。
第三十四条 台湾、香港、澳门同胞及华侨投资企业除执行《国务院关于鼓励台湾同胞投资的规定》和《国务院关于鼓励华侨港澳同胞投资规定》有关规定外,比照本办法规定执行。
第三十五条 对违反本办法的行为,海关按《中华人民共和国海关法》、《中华人民共和国海关行政法处罚实施细则》和其他有关法规处理。对触犯刑律的,依法由司法机关追究刑事责任。
第三十六条 凡与本办法相抵触的规定,均以本办法为准。
第三十七条 本办法由海关总署负责解释。
第三十八条 本办法自1992年9月1日起实行。

Measures of the People's Republic of China on Control over andTaxation for Import and Export Goods of Enterprises with Foreign Invest-ment

(Promulgated on August 22, 1992)

Whole Doc.

关于印发《山东省中等职业学校国家助学金管理实施办法》的通知

山东省教育厅


关于印发《山东省中等职业学校国家助学金管理实施办法》的通知

鲁财教〔2007〕39号


各市财政局、教育局、劳动保障局,省属各中等职业学校:

为落实《山东省人民政府关于建立健全普通高校和中等职业学校家庭经济困难学生资助工作政策体系的实施意见》(鲁政发〔2007〕41号),加强中等职业学校国家助学金管理,确保资助工作顺利实施,根据财政部、教育部、劳动保障部有关文件精神,省财政厅、省教育厅、省劳动保障厅制定了《山东省中等职业学校国家助学金管理实施办法》。现印发给你们,请遵照执行。









二○○七年八月十六日





山东省中等职业学校国家助学金

管理实施办法



第一条 为落实《山东省人民政府关于建立健全普通高校和中等职业学校家庭经济困难学生资助工作政策体系的实施意见》(鲁政发〔2007〕41号),加强对中等职业学校国家助学金(以下简称国家助学金)的管理,确保资助工作顺利实施,根据财政部、教育部、劳动保障部有关文件精神,制定本办法。

第二条 本办法所称中等职业学校是指政府有关部门根据国家有关规定批准设立并备案,实施中等学历教育的各类职业学校,包括公办和民办的普通中专、成人中专、职业高中、技工学校、普通高校和职业技术学院附属的中专部等。

第三条 国家助学金资助对象是具有中等职业学校全日制正式学籍的在校一、二年级所有农村户籍的学生和县镇非农业户口的学生以及城市家庭经济困难学生。

中等职业学校三年级在校生通过工学结合、顶岗实习获得一定报酬,用于支付学习和生活费用。

第四条 国家助学金由中央和地方政府共同出资设立,主要资助学生的生活费开支,资助标准为每生每年1500元。

第五条 国家助学金按学年申请和评定,按月发放。学校应将《中等职业学校国家助学金申请表》(详见附件1)及《中等职业学校国家助学金申请指南》(详见附件2)随同入学通知书一并寄发给录取的新生。新生和二年级学生在新学年开学一周内向就读学校提出申请,并递交相关证明材料。

第六条 根据国家下达我省的国家助学金名额和经费预算,每年6月底前,省财政厅将省属技工学校国家助学金名额和经费预算下达省劳动保障厅,将省属其他中等职业学校国家助学金名额和经费预算下达省教育厅,将各市中等职业学校国家助学金分配名额和经费预算下达市财政局。

每年7月底前,省教育厅、劳动保障厅分别将国家助学金名额和经费预算下达省属学校,各市财政、教育、劳动保障部门负责将国家助学金名额和经费预算下达到本级中等职业学校和有关县(市、区)。

每年8月底前,各县(市、区)财政、教育、劳动保障部门将经费预算和分配名额落实到所属中等职业学校。

第七条 中等职业学校要根据本办法和各市制定的国家助学金实施细则,受理学生申请,组织初审,并将初审结果在学校内进行不少于5个工作日的公示。公示无异议后,学校将《中等职业学校国家助学金受助学生汇总表》(见附件3)报同级教育部门和劳动保障部门审核、批复。

学校应于学生入学一个月内将国家助学金发放到受助学生手中。

第八条 学校应按实际受助学生名单填写《中等职业学校国家助学金受助学生汇总表》,省属技工学校报省劳动保障厅审核汇总,每年12月15日前报山东省学生资助管理中心;其他省属中等职业学校按上述时间直接报送山东省学生资助管理中心。各市级教育、劳动保障部门填写《中等职业学校国家助学金统计表》(见附件4),技工学校报省劳动保障厅审核汇总,由劳动保障厅于每年12月15日前报山东省学生资助管理中心;其他中等职业学校由市级教育部门按上述时间直接报送山东省学生资助管理中心。

国家建立全国统一的中等职业学校学生信息管理系统,实行统一电子注册,为中等职业学校国家助学金的发放和管理提供支持。

第九条 中等职业学校国家助学金实行学校法人代表负责制,校长是第一责任人,对学校助学工作负主要责任。学校要制定本校国家助学金具体实施办法,设立专门机构和配备专职人员具体负责助学工作,要为每位受助学生分别办理银行储蓄卡,直接将助学金发放到受助学生手中,一律不得以实物或服务等形式,抵顶或扣减国家助学金。为学生办理银行储蓄卡,不得向学生收取卡费或押金等费用,也不得从学生享受的国家助学金中抵扣。

中等职业学校要建立专门档案,将学生申请表、受理结果、资金发放等有关凭证和工作情况分年度建档备查。

第十条 各中等职业学校要依法办学,规范管理,要按照国家和省政府的有关规定收取学费,并从事业收入中足额提取5%的经费,用于家庭经济困难学生的学费减免、校内奖学金、助学金和特殊困难补助等方面的开支。

第十一条 中等职业教育实行以国家助学金为主,以校内奖学金、学生工学结合、顶岗实习、学校减免学费等为辅的资助政策体系。国家鼓励地方政府、行业企业和社会团体设立中等职业学校助学金、奖学金,鼓励和引导金融机构为接受中等职业教育的学生提供助学贷款。

有条件的中等职业学校要积极实行“绿色通道”制度,对携有可证明其家庭经济困难材料的新生,可先办理入学手续,根据核实后的家庭经济情况予以不同方式的资助,再办理学籍注册。

第十二条 各级财政、教育、劳动保障部门应加强对国家助学金的管理,实行专款专用、专账核算,并接受审计、监察部门的检查和社会监督。对弄虚作假、套取财政专项资金或挤占、挪用、滞留国家助学金的行为,将追究直接责任人和相关领导的责任。

第十三条 本办法由省财政厅、教育厅、劳动保障厅负责解释,各市可根据本办法制定实施细则,并报省财政厅、省教育厅和省劳动保障厅备案。

第十四条 本办法自印发之日起执行。《财政部教育部关于印发〈中等职业教育国家助学金管理暂行办法〉的通知》(财教〔2006〕73号)和《省财政厅 省教育厅关于印发〈中等职业教育助学奖学金管理办法〉的通知》(鲁财教〔2006〕42号)同时废止。


Provisions for Import and Export of Anabolic Agents and Peptide Hormones (Interim)

State Food and Drug Administration General Administration of Customs of the People’s Republic of China


Provisions for Import and Export of Anabolic Agents and Peptide Hormones (Interim)




(SFDA Decree No. 25)

The Provisions for Import and Export of Anabolic Agents and Peptide Hormones (Interim), adopted by the State Food and Drug Administration, the General Administration of Customs of the People’s Republic of China and the General Administration of Sport of China, is hereby promulgated in the decree sequence number of the State Food and Drug Administration and shall come into force as of September 1, 2006.


Shao Mingli
Commissioner
State Food and Drug Administration

Mou Xinsheng
Minister
General Administration of Customs of the People’s Republic of China

Liu Peng
Minister
General Administration of Sport of China
July 28, 2006





Provisions for Import and Export of Anabolic Agents and Peptide Hormones (Interim)


Article 1 The Provisions are formulated with a view to standardizing the administration of import and export of anabolic agents and peptide hormones in accordance with the Drug Administration Law of the People’s Republic of China, Customs Law of People's Republic of China, Anti-doping Regulations and other relevant laws and administrative regulations.

Article 2 The State adopts license control on the import and export of anabolic agents and peptide hormones.

Article 3 The importer shall apply for the importation of anabolic agents and peptide hormones to the State Food and Drug Administration.

Article 4 For the importation of anabolic agents and peptide hormones for medical purpose, the importers shall submit the following materials:
(1) Application Form for Drug Import;
(2) Copy of the purchasing contract or order form;
(3) Copy of the Import Drug License (or the Pharmaceutical Product License) (original or duplicate);
(4) Copy of the Drug Supply Certificate, Business License for Enterprises as a Legal Person, Qualification Certificate for Import and Export Enterprise (or Foreign Trade Operator Filing and Registration Form) and Organization Code Certificate of the importer; to import drug substance and intermediate preparations including preparations to be repackaged in China for their own needs, drug manufacturers shall submit copies of the Drug Manufacturing Certificate, Corporate Business License and Organization Code Certificate;
(5) Where holders of the Import Drug License (or the Pharmaceutical Product License) entrust other companies to export their drugs, they shall provide the authorization letter for export.

All copies mentioned above should be stamped with the official seal of the importer.

Article 5 For the importation of anabolic agents and peptide hormones for teaching and scientific research purposes, the importers shall submit the following materials:
(1) Application Form for Drug Import;
(2) Copy of the purchasing contract or order form;
(3) Certificates of legitimate qualifications of users in China, calculation basis for the quantity of the drug in use and letter of guarantee issued by the user for legitimate use and management of the drug;
(4) Approval documents for relevant scientific research projects or approval documents of relevant competent authority;
(5) Where entrusted by users for importation, importers shall provide copies of the authorization agreement, the Business License for Enterprises as a Legal Person, Qualification Certificate for Import and Export Enterprise (or Foreign Trade Operator Filing and Registration Form) and Organization Code Certificate of the importers.

All copies mentioned above should be stamped with the official seal of the importer.

Article 6 Where a enterprise in China entrusted by an overseas enterprise for contract manufacturing needs to import anabolic agents and peptide hormones, it shall provide materials required in Items (1), (3) and (5) of Paragraph 1 of Article 5, in addition, official documents to prove recorded by the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government.

All copies mentioned above should be stamped with the official seal of the importer.

Article 7 The State Food and Drug Administration shall decide whether or not to approve the import within 15 working days after receiving the application for import and the relevant materials. Where the application is approved, the State Food and Drug Administration shall issue the Import License for the drug; where the application is not approved, the State Food and Drug Administration shall give reasons in writing.

Article 8 The importer may declare to the customs of the ports where drug importation is permitted upon presenting the Import License for the drug issued by the State Food and Drug Administration. The customs shall clear the drug in the presence of the Import License for the drug.
The Drug Import Note is not required for import of anabolic agents and peptide hormones.

Article 9 To import anabolic agents and peptide hormones including those sold in China for the first time for medical purpose, the importer shall fill in the Import Drug Clearance Form timely after going through the import formalities and submit the following materials in duplicate to the (food and) drug regulatory department where the port of entry is located, upon presenting the original Import Drug License (or the Pharmaceutical Product License) (original or duplicate) and the original Import License for the drug, to apply for the Notice of Import Drug Port Test:
(1) Copies of the Import Drug License (or Pharmaceutical Product License) (original or duplicate) and the Import License for the drug;
(2) Copies of the Drug Manufacturing Certificate or Drug Supply Certificate, and Copy of the Business License for Enterprises as a Legal Person.
(3) Copy of the certificate of origin;
(4) Copy of the purchasing contract;
(5) Copies of packing list, bill of lading and freight invoice;
(6) Copy of the certificate of analysis;
(7) Format of drug insert sheet, package and label (except for drug substance and intermediate preparation);

All copies mentioned above should be stamped with the official seal of the importer.

Article 10 After checking the received Import Drug Clearance Form and relevant materials, the port (food and) drug regulatory department shall return the original Import Drug License (or Pharmaceutical Product License) (original or duplicate) and the original Import License for the drug to the importer, and send the Notice of Import Drug Port Test, along with a copy of the dossier as prescribed in Article 9 of the Provisions, to the port drug testing institute on the same day.

After receiving the Notice of Import Drug Port Test, the port drug testing institute shall contact the importer within two working days and conduct sampling on the storage site. Upon the completion of the sampling, the mark “sampled” shall be stamped on the back of the first page of the original Import License for the drug, with the seal of sampling institute affixed.

Article 11 Anabolic agents and peptide hormones imported for teaching and research purposes or for the domestic manufacturing contracted by overseas enterprises are exempted from testing.

Article 12 The port (food and) drug regulatory department shall report timely to the State Food and Drug Administration in any of the following circumstances:
(1) The port (food and) drug regulatory department refuses to issue the Notice of Import Drug Port Test in accordance with the provisions in Article 17 of the Provisions for Import Drug (Decree No. 4 of the State Food and Drug Administration and the General Administration of Customs);
(2) The port (food and) drug testing institute refuses the sampling in accordance with the requirements in Article 25 of the Provisions for Import Drug.

The port (food and) drug regulatory department shall take mandatory administrative measures to seal up or seize all the imported drugs within the situations prescribed in the previous paragraph. It shall make the decision of allowing shipping back within seven days from the date of the seal-up or seizure, and inform the importer of applying for the Export License for the drug according to the export procedures for anabolic agents and peptide hormones prescribed in the Provisions and return all the import drugs to the original exporting country.

Where the importer fails to respond or make clear its intention to ship back the drugs within ten days after being informed of the decision, the sealed up or seized drugs shall be destroyed under the supervision of the port (food and) drug regulatory department.

Article 13 For imported anabolic agents and peptide hormones out of specifications upon testing by the port drug testing institute, the importer shall provide a detailed report about the distribution and use of all the imported drugs to the port (food and) drug regulatory department where the importer is located within two days after receiving the Import Drug Test Report.

After receiving the Import Drug Test Report, the port (food and) drug regulatory departments shall take mandatory administrative measures to timely seal up or seize all the drugs and, within seven days, decide whether or not to place the case on file.

Where the importer fails to apply for a retesting within the specified timeline or the result of the retesting is still out of specifications, the port (food and) drug regulatory department shall make the decision of allowing shipping back and notify the importer to apply for the Export License for the drug according to export procedures for anabolic agents and peptide hormones prescribed in the Provisions to return all the imported drugs to the original exporting country. Where the importer fails to respond or make clear its intention to ship back the drugs within ten days from the date of receiving the decision, the drugs shall be destroyed under the supervision of the port (food and) drug regulatory department.

Where the result of retesting is in compliance with the specifications, the port (food and) drug regulatory department shall remove the mandatory administrative measures of seal-up and seizure.

The port (food and) drug regulatory department shall handle the case according to the provisions in Paragraph 2, Paragraph 3 and Paragraph 4 of this Article and report the result to the State Food and Drug Administration, and, at the same time, notify the (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government as well as other port (food and) drug regulatory departments.

Article 14 Where domestic drug manufacturers, distributors and medical institutions purchase imported anabolic agents and peptide hormones, the supplier shall provide copies of the Import Drug License (or Pharmaceutical Product License), the Import License for the drug and the Import Drug Test Report, and affix its official seal to the abovementioned copies.

Article 15 The exporter shall apply for exportation of anabolic agents and peptide hormones to the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government, where it is located, and submit the following materials:
(1) Application Form for Drug Export;
(2) Original import permit (or its copy with notarization) provided by the drug regulatory authority of the importing country or region.
If the importing country or region has no license system in the importation of anabolic agents and peptide hormones, the exporter shall provide the official document (original) of the drug regulatory authority of the importing country or region to prove that the import of the drugs of this type is exempted from the import permit, along with one of the following documents:
a. Original official document (or its copy with notarization) granting import provided by the drug regulatory authority of the importing country or region;
b. Certificates of legitimate qualifications of importers and original supporting document (or its copy with notarization) proving legitimate use of the drug;
(3) Copy of the purchasing contract or order form (except for manufacturers that export their own products);
(4) Copy of the export contract or order form;
(5) Where the export drug is an approved one produced by a domestic manufacturer, the Drug Manufacturing Certificate and Business License for Enterprises as a Legal Person of the manufacturer and a copy of the approval document of the drug shall be provided;
Where the export drug is produced by a domestic enterprise under contract of an overseas enterprise, the exporter shall provide a copy of the official document to prove recorded by the local (food and) drug regulatory department of the province, autonomous region and municipality directly under the Central Government.
(6) Copies of the Business License for Enterprises as a Legal Person, Qualification Certificate for Import and Export Enterprise (or Foreign Trade Operator Filing and Registration Form) and Organization Code Certificate of the exporter.

All copies mentioned above should be stamped with the official seal of the exporter.

Article 16 Where the drugs are to be shipped back in accordance with the requirements in Article 12 and Article 13 of the Provisions, the exporter shall provide the following materials to apply for the Export License for the drug:
(1) Documents proving the request for return of goods made by the original exporter of the exporting country;
(2) Import License for the drug.

Article 17 The (food and) drug regulatory department of the province, autonomous region and municipality directly under the Central Government shall decide whether or not to approve the export within 15 working days after receiving the export application and relevant materials.

Where the application is approved, the regulatory department shall issue the Export License for the drug; where the application is not approved, the regulatory department shall give reasons in writing.

Where the Export License for the drug is applied for in accordance with the requirements in Article 16 of the Provisions, the issuing authority shall mark “return of the original goods” on the Export License for the drug.

Article 18 The exporter may go through the customs formalities upon presenting the Export License for the drug issued by the (food and) drug regulatory department of the province, autonomous region and municipality directly under the Central Government. The customs shall clear the drug in the presence of the Export License for the drug.

Article 19 The importer and exporter shall provide one more sheet of customs declaration form and apply for sign-back of the sheet when going through the customs formalities. The customs shall stamp the “proof seal” on the sheet in the presence of the Import License for the drug and Export License for the drug. The customs shall charge the cost according to the relevant regulations for issuing certificates.

The importer and exporter shall return the first sheet of the Import License for the drug or Export License for the drug along with the customs declaration form with the seal of the customs, to the issuing regulatory department within one month after completing the import and export.

Where the importer or exporter conducts no relevant importation or exportation after obtaining the Import License for the drug and Export License for the drug, the importer or exporter shall return the original license to the issuing regulatory department within one month after expiration of the license.

Article 20 The validation of the Import License for the drug is one year; the validation of the Export License for the drug is no more than three months (valid within the calendar year).

“One license for one customs clearance” is implemented for the Import License for the drug and Export License for the drug. The license shall be used only once within the validation and its content shall not be altered. Where the import or export is postponed for some reasons, the importer or exporter may request for a new license once with the original one.

Article 21 Where the Import License for the drug or Export License for the drug is lost, the importer or exporter shall report the loss to the original issuing authority in writing immediately. After receiving the loss report, the original issuing authority shall notify the port customs and reissue the license if no harmful consequences are found through confirmation.

Article 22 The Import License for the drug and Export License for the drug are uniformly printed by the State Food and Drug Administration.

Article 23 Where anabolic agents and peptide hormones are imported or exported in the form of processing trade, the customs shall go through and supervise the clearance formalities upon presentation of the Import License for the drug or Export License for the drug. Those not exported for special reasons shall be transferred to and handled by the local (food and) drug regulatory department in accordance with relevant regulations, and the customs shall conduct the verification and cancellation procedures in the presence of relevant documents.

Article 24 Anabolic agents and peptide hormones entering or leaving between bonded zones, export processing zones, other special Customs controlling areas, Customs bonded and controlling areas, with overseas, or between the special Customs controlling areas and the Customs bonded and controlling areas are exempt from application for the Import License for the drug or Export License for the drug, and supervised by the Customs.

Import License for the drug shall be applied for anabolic agents and peptide hormones entering from bonded zones, export processing zones, other special Customs controlling areas and Customs bonded and controlling areas into other places in China.

Export License for the drug shall be applied for anabolic agents and peptide hormones entering bonded zones, export processing zones, other special Customs controlling areas and Customs bonded and controlling areas from other places of China.

Article 25 Where an individual carries or mails anabolic agents and peptide hormones, within a reasonable amount, into or out of China for medical needs, the customs shall clear the drugs in the presence of prescriptions of medical institutions in accordance with relevant regulations on prescriptions of the competent health department.

Article 26 Besides prescribed in the Provisions, the importation, port test, supervision and control of anabolic agents and peptide hormones for medical purpose are implemented with reference to requirements related to drug importation in the Provisions for Drug Importation.

Article 27 Anabolic agents and peptide hormones imported for medical purpose mentioned in the Provisions refer to the import anabolic agents and peptide hormones to be used for preparation production or to be marketed in China.

Importer refers to the importer specified on the Import License for the drug obtained in accordance with the Provisions.

Exporter refers to the exporter specified on the Export License for the drug obtained in accordance with the Provisions.

Article 28 These Provisions shall go into effect as of September 1, 2006. The Notice on Import and Export of Anabolic Agents and Peptide Hormones (Guo Shi Yao Jian An [2004] No. 474) issued by the State Food and Drug Administration on September 30, 2004 shall be annulled therefrom.