西藏自治区行政执法检查制度
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西藏自治区行政执法检查制度
西藏自治区行政执法检查制度
西藏自治区人民政府令第8号
《西藏自治区行政执法检查制度》，已经一九九八年九月月二十二日自治区人民政府第12次常务会议通过，现予发布施行。
自治区主席 列确
一九九八年九月二十九日
西藏自治区行政执法检查制度
第一条 为加强行政执法监督工作，提高行政执法水平，保障公民、法人或者其他组织的合法权益，根据《中华人民共和国行政处罚法》和《西藏自治区人民政府行政执法监督暂行规定》，制定本制度。
第二条 本制度所称行政执法检查，是指对行政执法机关（含法律、法规授权或者行政机关依照法律、法规、规章规定委托行使行政管理职能的组织，下同）及其所属行政执法人员的行政执法情况进行的检查和监督。
第三条 行政执法检查应遵循有法必依、执法必严、违法必究的原则。
第四条 自治区人民政府统一领导全区的行政执法检查工作。各地区行署、拉萨市人民政府负责本行政区域内的行政执法检查工作。
各级人民政府所属行政执法部门在本级人民政府领导下，负责本系统的行政执法检查工作。
第五条 县级以上人民政府法制工作机构，负责组织对本级人民政府所属行政执法部门和下级人民政府的行政执法情况进行检查。
各级人民政府所属行政执法部门的法制工作机构，负责对本部门或者本系统行政执法情况进行检查。
第六条 行政执法检查的任务是：
（一）法律、法规、规章和规范性文件的实施情况；
（二）向本级人民政府或本部门汇报行政执法检查情况和实施法律、法规、规章和规范性文件申存在的问题，并提出处理意见；
（三）纠正违法或不当的行政执法行为；
（四）督促有关部门及时处理行政执法检查中发现的问题。
第七条 行政执法检查人员依法行使职权时，凭《西藏自治区行政执法监督证》进入管理范围内的部门、单位实施检查；有权调阅执法案卷和其他有关文书；有权要求被检查单位负债人和有关人员介绍行政执法的基本情况，提供有关材料或参加有关会议。
第八条 行政执法检查人员应当深入实际，深入基层，采取听取汇报、召开座谈会、个别走访、抽样调查和实地考察等形式，了解行政执法的真实情况。有关部门应当配合行政执法检查人员的工作，提供真实情况和其他必要的帮助。
第九条 各级人民政府所属行政执法部门在本行政区域内进行执法检查时，应当拟定检查项目和实施方案报本级人民政府法制工作机构备案。
法制工作机构对行政执法部门的行政执法检查项目和实施方案进行审查时，认为需要介入的，可以参与进行指导、督促和协调。
第十条 各级人民政府的法制工作机构应当根据国家权力机关、本级人民政府的决定，以及司法机关的司法建议，对有关行政执法的情况，分别进行综合性检查、专题调查或重点抽查；亦可根据公民、法人和其他组织的投诉以及新闻媒介的报道等，进行上述检查、调查和抽查。
第十一条 对行政执法检查中发现的违法或不当的行政执法行为以及其他问题，行政执法检查人员可以当场纠正或者依照《西藏自治区人民政府行政执法监督暂行规定》处理。
第十二条 对行政执法检查人员的违法行为，任何单位和个人都有权检举揭发，对检举者进行打击报复的，依照有关法律、法规的规定处理。
第十三条 本制度应用中的具体问题由自治区人民政府法制局负责解释。
第十四条 本制度自发布之日起施行。
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国家税务总局关于在京外国商会征免营业税的批复
国家税务总局关于在京外国商会征免营业税的批复
国税函[2005]370号
北京市地方税务局：
你局《关于对在京外国商会是否免予征收营业税问题的请示》（京地税营〔2005〕48号）收悉，批复如下：
根据《财政部、国家税务总局关于对社会团体收取的会费收入不征收营业税的通知》（财税字〔1997〕063号）第一条的规定，对在京外国商会按财政部门或民政部门规定标准收取的会费，不征收营业税。对其会费以外各种名目的收入，凡属于营业税应税范围的，一律照章征收营业税。
国家税务总局
二○○五年四月十九日
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.
