国家安全监管总局关于冶金有色建材机械轻工纺织烟草商贸等行业企业贯彻落实国务院《通知》的指导意见
国家安全生产监督管理总局
国家安全监管总局关于冶金有色建材机械轻工纺织烟草商贸等行业企业贯彻落实国务院《通知》的指导意见
安监总管四〔2010〕169号
各省、自治区、直辖市及新疆生产建设兵团安全生产监督管理局，有关中央企业：
为认真贯彻落实《国务院关于进一步加强企业安全生产工作的通知》（国发〔2010〕23号）精神，切实加强冶金、有色、建材、机械、轻工、纺织、烟草、商贸等行业（以下简称冶金、机械等行业）企业的安全生产工作，推动冶金、机械等行业企业（以下简称企业）安全生产主体责任的落实，促进安全生产形势实现根本好转，提出以下指导意见：
一、完善安全生产体制机制，切实落实企业主体责任
1．落实安全生产责任体系。企业是安全生产的责任主体。企业要牢固树立安全发展的理念，把生产经营和企业发展建立在安全生产有可靠保障的基础上，坚持依法依规生产经营，切实落实企业安全生产主体责任。企业要建立主要负责人是本企业安全生产第一责任人、分管安全生产负责人和其他负责人在各自职责内对本企业安全生产工作负责的责任体系。集团公司对其所属分公司、子公司、控股公司的安全生产工作负领导和管理责任。
2．落实各项安全生产规章制度。企业要建立健全安全生产责任制、规章制度和操作规程。建立至少包括以下内容的安全生产制度：危险因素辨识、危险源管理、安全检查及隐患排查治理、危险作业审批及确认、各工种工序操作规程、防护用品、安全资金提取投入和使用、安全培训、特种作业人员培训考核、应急救援与演练、事故报告及处理等，并建立台账，切实加强安全生产基础工作，把各项制度落实到实际作业中。要依据国家有关标准和规范及时对规章制度和操作规程进行修订完善和评审。
3．健全安全生产管理机构和配备人员。企业要设置配备与企业发展相适应的安全管理机构和人员。从业人员超过300人的企业，要设置安全生产管理机构，并按照冶金、有色、建材企业不少于从业人员3‰、其他企业不少于2‰的比例配备专职安全生产管理人员；从业人员在300人以下的企业，要配备专职或者兼职安全生产管理人员。安全生产管理人员要具备胜任本企业安全生产工作的能力，取得安全培训资格证书，同时享受相当类别管理岗位的待遇。
4．落实安全生产资金、设备、装备投入。企业要加大安全生产投入，足额提取安全资金，并保证下列事项所需资金的提取和使用：完善、改造和维护安全防护设备设施；安全生产教育培训和配备劳动防护用品；安全评价、重大危险源监控、重大事故隐患评估和整改；职业危害防治，职业危害因素检测、监测和职业健康体检；设备设施安全性能检测检验；应急救援器材、装备的配备及应急救援演练；其他与安全生产直接相关的物品或者活动等。危险性大的企业（分厂、车间、班组）要积极探索实行安全生产责任保险和全员安全风险抵押金制度。
5．加强安全技术管理和技术研发。企业要明确技术管理机构的安全职能，按规定配备安全技术人员，切实落实企业负责人安全生产技术管理负责制，强化企业主要技术负责人的技术决策和指挥权。企业要加强安全生产技术研发，积极引进先进适用安全技术，加快安全生产关键技术装备的换代升级，提高本质安全水平。
6．落实建设项目安全管理。企业要对建设项目安全设施“三同时”工作负责，确保安全设施与主体工程同时设计、同时施工、同时投入生产和使用，建设项目的安全预评价报告、安全专篇、安全验收评价报告要按有关规定报安全监管部门审批或备案。
7．全面实施安全达标。企业要把安全生产标准化创建工作作为提高企业本质安全水平、保证安全生产的重要抓手，健全企业安全标准体系和工作考核激励机制，要按照《企业安全生产标准化基本规范》（AQ/T9006—2010）和企业安全生产标准化建设的具体要求，深入开展“零事故”活动，全面深入开展岗位达标、专业达标和企业达标，做到管理台账化、装备现代化、指令书面化、操作程序化、行为规范化。
8．建立完善安全生产预警机制。企业要积极开展安全生产预警机制建设，建立完善安全生产动态监控及预警预报体系，每月进行一次安全生产风险分析。重大隐患要及时报当地安全监管部门及有关部门备案。出现事故征兆后要立即发布预警信息，落实预防和应急处置措施，事故可能波及周边居民时，必须第一时间将预警信息告知地方政府有关部门。
9．注重开展安全文化建设。企业要搞好安全生产宣传教育，把安全文化建设融入到企业管理工作之中，充分发挥工会、共青团、妇联等组织的作用，依法维护和落实企业职工的权益，形成全体职工关爱生命、关注安全的良好氛围。认真履行社会责任，努力建设安全诚信企业。
10．严格目标绩效考核。企业要将安全生产工作作为发展规划和年度生产经营计划的重要内容，设置目标绩效考核指标，把安全生产工作的各项要求落实在企业发展和日常管理工作之中，实施严格的目标绩效考核，奖优罚劣，确保各项安全措施执行到位。
二、强化生产过程管理，切实保障职工生命财产安全
11．加强危险源监控。企业要对本单位存在的各类危险源进行辨识，实行分级管理，确保处于受控状态。对于重大危险源，要按规定登记建档，进行定期检测、评估和监控，并报安全监管部门备案；对于未构成重大危险源的，也要登记建档，并自行安排定期检测、评估和监控，确保处于受控状态。
12．落实隐患排查治理整改。企业要把隐患排查治理作为日常性工作进行开展，并使之制度化、规范化。要实行台账管理和闭环管理，切实做到整改措施、责任、资金、时限和预案“五到位”，对重大隐患整改效果要进行安全评价，确保整改到位。坚决纠正和查处违章指挥、违章作业、违反劳动纪律行为；坚决禁止超能力、超强度、超定员组织生产，确保在有安全保障的条件下组织生产。
13．强化危险作业安全管理。对危险性较大的作业，企业必须实行工作票（作业票）和操作票管理，并实施作业前确认。涉及动火等作业，必须执行相关审批制度。
交叉作业安全管理。企业在正常生产与建设施工或检修之间出现交叉作业的情况下，要全面负责建设施工和检修的安全生产工作，对建设施工或检修承担统一、协调、管理的职责，必须签订安全管理协议，将涉及本企业和施工企业、检修单位安全生产管理的事项纳入本企业的安全管理体系；必须制定施工或检修方案，其安全技术措施和应急预案须经相关机构负责人审查同意。对涉及的各项工作内容、各个单位的任务、安全技术交底、职责等作出明确规定，未经重新确认不得更改。
受限空间作业安全管理。企业要建立健全封闭、半封闭设备、地下受限空间和地上受限空间等受限空间的安全管理制度及安全操作规程，落实责任制。落实作业现场通风、照明、警戒、应急等措施；作业前要对现场有毒有害气体进行检测；要确保机械设备安全可靠，配足安全设备设施，安排专人监护等。
冶金企业要认真落实有关煤气安全管理的要求；水泥企业要进一步加强各类料仓清库的安全管理，坚决遏制事故多发势头。
14．加强外委外包工程安全管理。企业不得将施工、检修等工程项目发包给不具备相应资质的单位。签订的承包协议应明确规定双方的安全生产责任和义务。承包单位要服从企业统一管理，并对工程或检修项目的现场安全管理负责。工程项目不得违法转包、分包。
15．实施领导干部和管理人员现场带班制度。企业要针对本企业实际，制定领导干部和管理人员值班、带班制度。加强现场安全管理，及时发现和解决问题。值班、带班制度要在企业公告，接受职工监督。
16．加强安全教育培训。企业主要负责人、安全生产管理人员要按有关规定定期接受安全生产教育和培训，具备与本单位所从事的生产经营活动相适应的安全生产知识和管理能力。企业应当定期对职工进行安全生产教育和培训，保证职工具备作业需要的安全生产知识，了解有关的安全生产法律法规，熟悉规章制度和安全技术操作规程，掌握本岗位的安全操作技能、应急措施、作业场所危险危害因素等。未经安全生产教育和培训合格的从业人员，不得上岗作业。企业所有特种作业人员必须持证上岗。冶金、有色企业从事煤气生产、储存、输送、使用、维护检修的作业人员，应当按照有关规定进行专门的煤气安全基本知识、煤气安全技术、煤气监测方法、煤气中毒紧急救护技术等内容的培训，并经考核合格后，取得特种作业操作证。
17．强化应急预案和应急演练。企业要建立健全事故应急救援体系，按照相关法规标准规范应急预案的编制、评审、发布、备案、培训、演练和修订等管理。要确保应急预案程序简明具体、可操作性强，并配备必要的应急救援装备与器材，定期开展应急宣传、教育、培训、演练。要赋予生产现场带班人员、班组长和调度人员在遇到险情时第一时间下达停产撤人命令的直接决策权和指挥权。应急预案要与周边相关企业（单位）和当地政府的应急预案相衔接，形成应急联动机制，使应急预案真正发挥在应急状态下挽救生命、减少财产损失的作用。坚决防止因盲目施救扩大伤亡和财产损失。
18．切实落实事故防范措施。企业要加强事故事前防范，关口前移。要制定本企业的事故调查程序，在配合政府做好事故调查的同时，深入分析事故原因，查找问题，完善制度。要认真吸取事故教训，严格落实事故调查报告中提出的各项防范措施，防止同类事故再次发生。同时要认真吸取其他企业的事故教训，举一反三，堵塞漏洞，防止类似事故在本企业发生。
三、注重经济发展方式转变，切实淘汰落后技术和产能
19．采用先进的技术标准和操作规程。企业要按照国家现行的法律法规和标准规范的要求，结合本单位实际，修改、补充、完善各项操作规程和技术规程，采用先进的技术标准和操作规程组织生产。安全监管部门要在对现有标准规范进行梳理和清理的基础上，会同有关部门加快相关行业安全技术标准规范的制修订工作，力争到“十二五”末形成比较健全的行业安全生产标准体系。
20．推行先进适用的技术装备。企业要积极采用安全性能可靠适用的技术装备和生产工艺。冶金企业要按照《国家安全监管总局关于印发进一步加强冶金企业煤气安全技术管理有关规定的通知》（安监总管四〔2010〕125号）的要求，落实各项措施。在煤气危险区域，安装固定式一氧化碳监测报警装置；为在煤气区域工作的作业人员配备一氧化碳检测报警仪，并于2011年底前完成。各有关企业要安装使用桥式起重机准确定位装置、起重机吊钩上下限位安全保护装置和压力机滑块防坠落装置，并于2013年底前完成。对于凡未按要求完成的企业，相关安全监管部门要责令限期整改，直至停产整顿。
21．强制淘汰落后技术。企业要按照国家产业结构调整指导目录和所在地省级人民政府制订的目录，淘汰不符合有关安全标准、安全性能低下、职业危害严重、危及安全生产的落后技术、工艺和装备。各级安全监管部门要加强监督检查，对目前仍使用目录中确定的落后技术装备、构成重大安全隐患的企业，要予以公布，责令限期整改，逾期未整改的，要提请政府依法予以关闭。
22．支持配合有关部门，加快淘汰落后产能工作。各相关企业要按照国家淘汰落后产能的要求，加快淘汰炼铁、炼钢、焦炭、铁合金、电解铝、铜冶炼、铅冶炼、锌冶炼、水泥、玻璃、造纸、酒精、味精、柠檬酸、制革、印染和化纤等方面规定的落后产能；各级安全监管部门要在同级政府的统一领导下，支持配合有关部门做好淘汰落后产能的相关工作。
四、严格安全生产监管执法，切实落实责任追究
23．强化企业安全生产属地管理。各级安全监管部门要按照分级属地原则，对当地企业（包括中央企业）实行严格的安全生产监督管理，确保安全监管无盲区。要组织对企业安全生产状况进行安全标准化分级考核评价，评价结果向社会公开，并向金融、保险等主管部门通报，作为企业信用评级的重要参考依据。
24．强化安全生产监管执法。各级安全监管部门要根据企业点多面广的实际情况，有计划、有针对性地开展监管执法工作。要针对监管范围内的企业制订检查计划、检查表，组织对企业开展落实安全生产主体责任等方面内容的监督检查。要对重大安全隐患治理实行逐级挂牌督办、公告制度。要充分发挥工伤保险和安全生产保险费率的奖惩作用，建立健全考核、事故处罚额度、安全生产执法处罚等方面的激励约束机制，大力推进安全生产标准化企业创建工作。对拒不执行监管指令、在规定时间内未实现达标的企业，要依法依规从重处罚。
25．加强建设项目安全监管。各级安全监管部门要加强与建设项目审批部门的联系，建立工作机制，强化企业建设项目安全设施“三同时”的核准审批。安全设施与建设项目主体工程未做到同时设计的一律不予审批，未做到同时施工的责令立即停止施工，未做到同时使用的不得投入生产，并视情况追究有关单位负责人的责任。严格落实建设、设计、施工、监理、监管等各方安全责任。
26．加强安全监管能力建设。负责冶金、机械等行业的安全监管人员要了解相关行业国家的方针政策和产业政策，了解相关行业发展规划、发展状况，熟悉相关行业安全生产基本状况、特点和事故预防的重点，以及相关行业安全生产法律法规和标准，具备对相关企业现场进行安全监管执法和技术指导的基本能力，具备分析相关行业安全生产形势，提出工作措施和建议的基本能力。要了解辖区内相关企业的性质、主要负责人、设备装备、各级管理人员、技术人员和从业人员，以及安全管理机构设置、人员配备、教育培训、安全生产规章制度、事故风险等基本情况，进行综合分析，加强分类监管。各级安全监管部门配备的冶金、机械等行业的监管力量要与所承担的工作任务相适应。
27．依法维护职工的参与权和监督权。各级安全监管部门要大力宣传和依法维护企业职工了解作业场所和岗位的危险因素、防范措施，拒绝违章指挥和强令冒险作业，在危及人身安全情况下停止作业等权利；公布举报电话，鼓励职工监督举报各类安全隐患，并积极协调有关部门落实对举报者予以奖励。
28．严肃事故查处，落实防范措施和责任追究。要认真查明事故原因，提出有针对性的防范措施，防止类似事故再次发生，按规定严肃追究事故责任人的责任，并及时将事故调查处理结果向社会公布，接受社会监督。要对事故防范措施的落实情况进行跟踪检查，把事故经济处罚、责任追究落实到位。
各地区要根据本指导意见，结合实际制定具体实施办法，强化安全监管执法，促进企业认真落实安全生产主体责任，切实做好冶金、机械等行业的安全生产工作。
国家安全生产监督管理总局
二○一○年十月十一日
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.