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.
甘肃省社会团体登记管理条例实施细则
甘肃省人民政府
甘肃省社会团体登记管理条例实施细则
（１９９１年３月４日甘肃省人民政府发布）
第一章 总则
第一条 为保障公民的结社自由，保障社会团体的合法权益，加强对社会团体的管理，发挥社会团体在社会主义建设中的积极作用，根据《社会团体登记管理条例》（以下简称条例），结合本省实际，制定本实施细则。
第二条 在本省境内组织的协会、学会、联合会、研究会、基金会、联谊会、促进会、商会等社会团体，均应依照本实施细则的规定申请登记。
第三条 下列团体不属于登记范围：
（一）参加中国人民政治协商会议的各党派；
（二）机关、学校、团体、军队、企事业中经本单位领导批准成立，其活动范围限于单位内部的团体；
（三）法律、行政法规另有规定的团体。
第四条 社会团体不得从事以营利为目的的经营性活动。
第五条 社会团体的一切活动都必须遵守宪法和法律、法规，维护国家的统一和民族的团结，维护正常的社会秩序，不得损害国家、社会、集体和其他公民的合法权益。
第六条 经过登记的社会团体，其合法权益和依照登记的章程进行活动受法律保护。
第七条 社会团体的登记管理机关是省民政厅和地（市、州）、县（市、区）民政部门。
社会团体的业务活动受有关业务主管部门的指导。
第二章 管辖
第八条 成立全省的社会团体，向省民政厅申请登记。成立本行政区域内的社会团体，向同级民政部门申请登记。成立跨行政区域的社会团体，向他们共同的上一级民政部门，申请登记。
第九条 社会团体的日常管理由有关业务主管部门和登记管理机关共同负责。
登记管理机关与其核准登记的社会团体的办事机构不在同一行政区域内，可以委托该社会团体办事机构所在地的登记管理机关负责日常管理。
第三章 登记条件
第十条 申请成立社会团体，其会员不得少于１０人。
第十一条 申请登记的社会团体，应向社团登记管理机关提交由该社团负责人签署的登记申请书、业务主管部门审查文件、社会团体章程及有关材料。
第十二条 社会团体的章程应当符合宪法和法律、法规的规定，并载明下列内容：
（一）名称；
（二）宗旨；
（三）任务及活动范围；
（四）组织机构；
（五）会员资格及入会手续；
（六）会员的权利和义务；
（七）负责人产生的程序、任期和职权范围；
（八）章程的修改程序；
（九）经费来源及使用管理；
（十）社会团体的终止程序。
第十三条 社会团体具备法人条件的，经核准登记后，取得法人资格。社会团体法人应具备下列条件：
（一）依法成立；
（二）有必要的财产或者经费；
（三）有自己的名称、组织机构和场所；
（四）能够独立承担民事责任。
第十四条 非全省性社团的名称不得冠以“甘肃”、“全省”等容易误为全省性社会团体的字样。
同一行政区域内不得重复成立相同或相似的社会团体。
第十五条 社会团体可以下设办事机构，但不得设立二级学会、协会等独立性社团组织。
全省性社会团体在地、市、州一般不得设立分会、地、市、州成立的同类社团，可以以团体会员的身份加入全省性社团。
第四章 变更登记
第十六条 社会团体改变名称、法定代表人或者负责人、业务主管部门、办事机构地址或者联络地址、印章、徽记等，应当办理变更登记。
第十七条 社会团体申请变更登记时，应当在改变后的十日内向原登记管理机关提交下列文件、证件；
（一）法定代表人或者负责人签署的变更登记申请书；
（二）业务主管部门在申请书上签署变更的审查意见；
（三）其它有关文件、证件。
第十八条 社会团体变更名称经核准后，应吊钩在三十日内将原证书、公章上交登记管理机关。变更后的印章、徽记等应当在三十日内向登记管理机关备案。
第五章 注销登记
第十九条 社会团体改变宗旨、自行解散，或者由于其他变更造成与原登记管理机关管辖范围不一致的，应当办理注销登记，并向原登记管理机关提交下列文件、证件：
（一）法定代表人或者负责人签署的注销登记申请书；
（二）原业务主管部门审查同意注销的文件；
（三）业务主管部门出具的清理债权债务完结的证明。
第二十条 登记管理机关对核准注销登记的社会团体，应当同时撤销注册好，收缴社会团体登记证书和公章，并通知开户银行。
第二十一条 社会团体法人注销登记后，由原登记管理机关登报公告。
第六章 登记审批程序
第二十二条 社会团体登记管理机关登记审批的程序为受理、审查、核准、发证。
（一）申请成立的社会团体按规定交齐全部申报材料后，登记管理机关可正式受理；
（二）登记管理机关应审查社团提交的全部材料的真实性、合法性、有效性及有关登记事项；
（三）登记管理机关接到社会团体成立登记申请后，应当在三十日内，作出登记或者不予登记的决定，并书面通知社团申请人；
（四）经核准登记的社会团体，应发给《社会团体登记证》。社会团体具备法人资格的，发给《社会团体法人登记证》，并由登记管理机关公告。
第二十三条 申请人不服登记管理机关不予登记的决定，在接到书面答复后十日内可以向上一级登记管理机关申请复议，上一级登记管理机关应当在接到申请复议后三十日内作出复议决定，并报同级人民政府备案。
第二十四条 登记管理机关在颁发登记证书时，应当分别编定登记注册号，并载入登记档案。
第二十五条 社会团体在遵守国家法律的前提下，可以通过正当途径筹集资金；可以接受国内外的赞助和捐赠。
第二十六条 任何组织和个人不得侵犯社会团体依法取得的名称、荣誉、财产、知识产权等权益。
第二十七条 社会团体凭社会登记证书，可以按照国家有关规定刻制公章、徽记、开立银行帐户，并报社团登记管理机关备案。
第二十八条 登记管理机关核发的《社会团体登记证》、《社会团体法人登记证》是该社会团体的合法凭证。除登记管理机关依法统一管理外，任何单位和个人不得复制、涂改、转让，也不得收缴、扣押或毁坏，如遗失应及时登报声明作废，并申请补发。
第七章 监督管理
第二十九条 各级登记管理机关应对管辖区域内的社会团体进行监督管理，并履行下列职责：
（一）监督社会团体遵守宪法和法律；
（二）监督社会团体按照条例和本细则的规定，办理成立登记、变更登记或注销登记手续；
（三）监督社会团体按照登记的章程进行活动。
第三十条 社会团体必须在每年第一季度到登记管理机关办理年检手续，并报送上年度工作总结、本年度工作计划和会员变动、经费收支等情况。
社会团体所办的刊物，应及时寄送登记管理机关存查。
第八章 处罚
第三十一条 登记管理机关对违反条例规定的社会团体按情节轻重给予警告、停止活动、撤销登记，依法取缔的处罚。
上级登记管理机关对下级登记管理机关做出不适当的处罚应当予以纠正。
第三十二条 对有下列行为的社会团体，登记管理机关应当作出处罚：
（一）申请登记中隐瞒真实情况，弄虚作假的，除责令提供真实情况外，予以警告；
（二）擅自改变社团名称、宗旨、活动范围等不按本细则变更登记的或复制、伪造、涂改、转让社团登记证书的，予以警告并限期纠正或变更登记；
（三）对从事以营利为目的的经营性活动的社会团体，责令停止活动，予以整顿并限期纠正；
（四）对超出或违反核准登记的章程进行活动的，予以撤销登记；
（五）对不接受登记管理机关依法监督检查或违反本细则有关规定的社会团体，视其情节轻重予以停止活动或者撤销登记的处罚；
（六）对从事危害国家利益或进行其它非法活动的社会团体依法取缔。
第三十三条 未经核准登记，擅自以社会团体名义进行活动的，由社团登记管理机关命令解散。
第三十四条 对于撤销登记、依法取缔、命令解散的社会团体，由登记管理机关收缴其登记证书和公章，并登报公布。
第三十五条 社会团体对登记管理机关作出的处罚决定不服的，可在接到处罚决定书之日起十日内，向上一级登记管理机关申请复议；上一级登记管理机关应当在接到申请复议之日起三十日内作出复议决定。
第三十六条 对社会团体撤销登记、依法取缔的处罚，在复议期间不停止执行。受处罚的社会团体必须停止一切活动。
第三十七条 社会团体被撤销登记或依法取缔后，其善后事宜由业务主管部门负责处理。
第三十八条 登记管理机关处理社团违法活动，必须查明事实，依法办理，并将处理决定书面通知社会团体法定代表人（负责人）和它的业务主管部门。
第三十九条 登记管理机关的工作人员不按规定程序办理登记、监督管理和严重失职的，根据情节轻重给予相应的行政处分；构成犯罪的，由司法机关依法处理。
第九章 附则
第四十条 本实施细则施行前已成立的社会团体，应按国家有关规定到登记管理机关办理复查登记手续。
第四十一条 涉外社会团体的登记管理办法另行规定。
第四十二条 本实施细则由省民政厅负责解释。
第四十三条 本实施细则从颁布之日起施行。
