河南省体育经营活动管理规定
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河南省体育经营活动管理规定
河南省体育经营活动管理规定
河南省人民政府
第一条 为了加强体育经营活动管理，保护体育活动经营者和消费者的合法权益，促进体育事业发展，根据《中华人民共和国体育法》等国家有关法律、法规的规定，结合本省实际，制定本规定。
第二条 本省行政区域内以体育项目为主要内容的体育经营活动，适用本规定。
第三条 体育经营活动应当坚持为人民服务、为社会主义服务的方向，坚持社会效益和经济效益的统一。
鼓励、支持体育活动经营者参与实施全民健身计划和为培养优秀体育人才服务。
第四条 各级人民政府应当推进体育管理体制改革，发展和培育体育市场，加强对体育经营活动管理工作的领导。
第五条 县级以上人民政府体育行政部门依法负责对本行政区域内体育经营活动的管理和监督。
县级以上人民政府公安、工商、物价、税务等部门应当按照各自的职责，共同做好体育经营活动的管理工作。
第六条 在本省举办的国际性、全国性、全省性体育经营活动及跨市地举办的体育经营活动，由省体育行政部门管理，其他体育经营活动分别由所在地市地、县（市、区）体育行政部门按照职责分工管理。
第七条 体育经营活动范围包括：
（一）营业性体育场所；
（二）营业性体育健身、体育竞赛、体育表演活动；
（三）营业性体育培训、体育咨询、体育中介服务；
（四）体育商业赞助、利用体育比赛进行的经营活动；
（五）国家允许的其他体育经营活动。
第八条 体育经营活动的具体项目由省体育行政部门根据法律、法规的规定和国家公布的体育项目予以确定并公布。
第九条 从事体育经营活动应当具备下列条件：
（一）有与经营项目相适应的场所；
（二）有必要的资金和符合标准的体育设施、器材；
（三）有取得资格证书的体育专业技术人员；
（四）有相应的安全保障条件；
（五）法律、法规、规章规定的其他条件。
第十条 从事体育经营活动，应依法向工商行政管理部门申请注册登记，领取营业执照；从事滑翔、跳伞、热气球、漂流、攀岩、蹦极、武术、拳击、赛车、摩托艇、游泳、潜水、滑水、滑冰、轮滑等危险性大、技术和保障条件要求高的体育经营活动，应当经体育行政部门审批后，方
可经营。
体育经营活动的具体审批办法由省体育行政部门会同省工商行政管理部门另行制定。
第十一条 体育经营活动应当遵循诚实信用的原则，依法经营，保证服务质量。
涉外体育经营活动应当严格遵守国家及本省的外事规定。
第十二条 体育活动经营者应当遵守公共场所安全管理规定，建立健全安全管理规章制度。危险性大、技术要求高的体育经营活动项目必须符合规定的安全条件，配备取得资格证书的安全保障人员。
体育活动经营者应当使用符合国家规定的体育设施和器材。
第十三条 体育活动经营者发布信息和广告必须真实合法，不得以任何形式提供虚假信息，欺骗消费者。
第十四条 体育经营活动应当健康有益，有利于社会主义精神文明。禁止危害人民群众身心健康及渲染暴力、淫秽、封建迷信的体育经营活动。禁止体育活动经营者以违背社会公德的手段招徕顾客。
体育经营活动不得妨碍周围单位、居民的工作、学习和休息。
第十五条 任何单位和个人不得非法侵占或破坏体育活动经营者的场所、设施、设备。侵占、破坏的应当依法退还或赔偿。
第十六条 任何单位和个人不得非法向体育活动经营者索取费用和要求提供无偿服务。
第十七条 体育活动经营者对其举办活动的名称、徽记、旗帜及吉祥物等标志，享有经营权，并依法予以保护。
第十八条 消费者有权要求体育活动经营者按规定标准提供服务。消费者对经营者未按规定的项目、内容、时间提供服务或收费超过核定标准的，有权按照有关规定要求赔偿和投诉，经营者应当依法承担相应的责任。
第十九条 体育行政部门及其工作人员不得违反规定从事体育经营活动。
第二十条 违反本规定，未经体育行政部门批准，非法从事体育经营活动的，由县级以上体育行政部门责令改正，并处30000元以下罚款。
第二十一条 违反本规定，不符合体育安全条件、不按规定配备取得资格证书的安全保障人员，或者使用不符合国家规定的体育设施、器材从事体育经营活动的，由县级以上体育行政部门责令改正；拒不改正的，处500元以上、3000元以下罚款。
第二十二条 在体育经营活动中违反国家公安、工商、物价、税务等法律、法规的，由有关部门依法处理；构成犯罪的，由司法机关依法追究刑事责任。
第二十三条 体育行政部门和有关部门工作人员有下列情形之一的，给予行政处分；构成犯罪的，依法追究刑事责任：
（一）违反规定从事体育经营活动的；
（二）利用职权侵害体育活动经营者合法权益的；
（三）滥用职权、玩忽职守、徇私舞弊的。
第二十四条 当事人对行政机关作出的行政行为不服的，可以依法申请行政复议或者提起行政诉讼。当事人对行政处罚决定不服，逾期不申请复议、不起诉又不履行处罚决定的，由作出处罚决定的机关申请人民法院强制执行。
第二十五条 本规定发布前，有关部门管理的体育经营的个别项目，由省人民政府依照国家规定协调解决。
第二十六条 本规定自发布之日起施行。
1999年6月2日
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延安市市级行政执法机关部门行政执法责任制实施办法
2000年延安市人民政府4号令
延安市市级行政执法机关部门行政执法责任制实施办法
第一章 总则
第一条 为了加强行政执法工作，提高行政执法水平、保证法律、法规、规章正确实施，促进各级行政机关依法行政，根据国家有关法律、法规和《陕西省省级行政执法机关部门执法责任制暂行规定》，结合本市实际，制定本办法。
第二条 本办法所称部门执法责任制，是指依照法律规定和行政管理权限，把法律、法规、规章规定的行政执法责任落实到有关行政机关、行政执法单位和行政执法人员，并由市人民政府监督、检查、考核、评比的一种工作制度。
第三条 本办法适用于人民政府各类行政执法机关和法律、法规授权及依法委托的其他行政执法组织（以下简称行政执法部门）。
第四条 实施行政执法责任制应当坚持有法可依、有法必依、执法必严、违法必究的方针。
第五条 市政府各工作部门应建立执法责任制领导小组。市政府各部门主要领导是本部门行政执法责任制的第一责任人。
第六条 市人民政府领导各工作部门、各直属机构的执法责任制工作。市政府法制局是市政府实施依法行政的综合部门，负责市级行政机关部门执法责任制的组织协调和监察指导工作。
第二章 行政执法目标
第七条 行政执法以保证法律、法规、规章在本行政区域、本单位的正确有效实施，推进依法行政为目标。
第八条 行政执法必须做到：各种违法案件及时得到查处，各种违章行为及时得到纠正，公民、法人和其他组织依法主张的权益和申请事项及时得到答复和办理。行政执法行为必须合法、公正、廉洁、高效。
第九条 行政执法必须坚持社会主义法制统一的原则，依法接受监督，并加强同司法机关和其他国家机关的配合和协调。
第三章 行政执法部门责任
第十条 行政执法部门要定期研究行政执法工作，及时解决出现的各种问题，组织和领导好本部门的执法责任制实施工作。
第十一条 行政执法部门对本部门负责执行或配合有关部门实施的法律、法规、规章负有宣传教育、贯彻执行的责任。做好法制宣传工作，增强公民、法人和其他组织的法制观念和守法用法的自觉性。
第十二条 行政执法部门要有计划地搞好本部门工作人员的法制教育和执法业务培训工作，使行政执法人员熟悉本部门负责执行及相关的法律、法规、规章。
第十三条 行政执法部门必须全面、正确地执行法律，不得断章取义、曲解法律，不得以任何借口和方式随意执法。
第十四条 行政执法部辩证实施行政处罚和行政许可，采取行政强制措施，必须严格按照法律、法规、规章规定的权限进行，不得失职、渎职、越权和滥用职权。
第十五条 行政执法部门要实施执法公示制，公开执法依据、执法程序、执法权限、收费（罚款）标准、办事期限、办事结果。对本部门职权范围内符合法定条件的各项申请，应当及时办理，不得拒绝和推诿；对不属于本部门职权范围或不符合法定条件不能办理的事项，应当向当事人说明情况或移送有关部门办理。
第十六条 行政执法部门不得违法要求公民、法人或其他组织履行义务。
第十七条 行政执法部门要严格执行罚缴分离制度，实行收支两条线管理，不得对行政执法人员规定罚款指标，不得将罚没收入与执法部门的奖金和经费挂钩。
第十八条 行政执法部门应当严格按照法定执法权限、执法范围、执法责任、执法程序执法，制作规范的法律文书，并按法定期限送达。
第十九条 行政执法部门在查处行政违法案件时，发现已构成犯罪的，应当及时移送司法机关处理，不得以罚代刑。
第二十条 法律、法规、规章规定执法主体由几个行政部门共同组成的，各有关行政执法部门要明确分工，认真履行各自的职责，并加强协调配合，共同做好行政执法工作。
第二十一条 法律、法规、规章规定执法行为由一个行政执法部门负责组织实施，同时需由其他部门配合的，负责组织实施的部门应当主动与有关部门加强联系，搞好衔接；配合部门要积极协同主管部门共同执法。
第二十二条 行政执法部门应当建立健全下列行政执法制度，强化内部监督机制：
（一）法律、法规、规章的学习和培训制度。各行政执法部门应当把学习和培训列入年度工作计划，采取多种形式，加强学习和培训的考核检查；
（二）法律、法规、规章的宣传制度。各部门应当充分利用各种形式，广泛深入地宣传法律、法规、规章的立法意义，确立的基本法律制度等，提高全民的法制观念和法律意识；
（三）法律、法规、规章的责任分解制度。各部门应当把其负责实施的法律、法规、规章，及时、准确地分解到所属的具体执法机构和执法人员，层层落实执法责任，并奖责任分解情况报市政府法制局备案；
（四）行政执法错案责任追究制度。各行政执法部门对故意或重大过失造成错案的，应当追究行政机关直接负责人和其他责任人的行政责任；对造成行政赔偿的，按《国家赔偿法》的规定依法予以赔偿，并将行政执法错案追究情况报市政府法制局备案；
（五）严格执行市政府已建立的其他行政执法监督制度。
第四章 行政执法人员责任
第二十三条 行政执法部门应当根据法律、法规、规章的规定和执法工作的实际需要，建立执法机构和法制监督机制，配备相应的执法人员和法制监督人员。
第二十四条 行政执法人员必须具备良好的政治、业务素质和职业道德，具有胜任本职工作的文化知识和法律知识。
第二十五条 行政执法人员必须秉公执法、文明执法，坚持有法可依、有法必依、执法必严、违法必究的执法原则。
第二十六条 行政执法人员必须经过专门培训，经市政府法制局审查考核后，领取行政执法证件，方可上岗执法。
第二十七条 行政法人员执行公务时必须出示国家或省政府统一颁发的行政执法证件，佩戴证章标志。国家规定统一着装的，必须着装整齐。
第二十八条 行政执法人员应自觉接受人大、政协及市政府法制局的监督、检查。对在执法中有下列行为之一的，要予以严肃处理：
（一）散布有损于国家声誉的言论，泄露国家秘密；
（二）贪污受贿、徇私枉法；
（三）隐瞒、伪造证据；
（四）违反法定程序执法；
（五）滥用职权，打骂、刁难群众，侵犯公民、法人和其他组织的合法权益；
（六）利用职权为自己或他人谋取私利；
（七）不积极配合执法监督、检查人员；
（八）其他违法乱纪行为。
第五章 评议考核
第二十九条 各行政执法部门要按照《延安市市级部门行政执法责任制考核办法》的要求进行评议考核。
第三十条 对部门执法责任制实施情况的评议考核结果，要作为岗位目标管理责任制、国家公务员和“文明单位”、“创佳评差”、“文明窗口”评比的重要内容。
第三十一条 市政府每年对部门实施执法责任制情况进行一次评议考核。由市政府法制局，按照职责范围负责具体考核工作。各行政执法部门应于每年12月中旬前将实施执法责任制的工作总结报市政府，同时抄送市政府法制局。
第三十二条 评议考核的内容：
（一）本办法第二章、第三章、第四章各项规定的落实情况；
（二）行政处罚实施情况及准确率（包括处罚案件数量、处罚种类、罚没及上缴情况）；
（三）行政许可行为审批情况及准确率（包括审批的件数、批准率与驳回率）；
（四）行政性收费及收支两条线的落实情况；
（五）采取行政强制措施情况；
（六）对上述（二）、（三）、（四）、（五）项具体行政行为提出行政复议、行政诉讼、行政赔偿的情况。
第六章 奖惩
第三十三条 经过考核，由市政府对各执法部门实行行政执法责任制取得显著成绩的单位和行政执法人员分别予以表彰和奖励。
第三十四条 对行政执法责任制执行不力，产生不良后果的部门，由市政府给予通报批评，并责令改进。
第三十五条 对违反本办法不实行执法责任制的部门，追究部门主要负责人的行政责任。凡是没有落实行政执法责任制的行政执法部门和行政执法人员，在当年的各类先进和工作考核中实施行政执法责任制一票否决。
第三十六条 行政执法人员有本办法第二十八条所列行为之一的，依照《国家分务员暂行条例》的有关规定给予行政处分；构成犯罪的，移送司法机关依法追究刑事责任。
第七章 附则
第三十七条 各县区人民政府，省政府各部门派驻本市的行政执法部门对照本办法执行。
第三十八条 本办法由市政府法制局负责解释。
第三十九条 本办法自2000年7月10日起施行。
Provisions for Import and Export of Anabolic Agents and Peptide Hormones (Interim)
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.
