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

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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.


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兰州市人民政府办公厅关于印发兰州市城镇房屋用地分割登记发证暂行办法的通知

甘肃省兰州市人民政府办公厅


兰州市人民政府办公厅关于印发兰州市城镇房屋用地分割登记发证暂行办法的通知


兰政办发【2008】46号

各县、区人民政府,市政府各部门:
《兰州市城镇房屋用地分割登记发证暂行办法》已经2008年1月4日市政府第1次常务会议讨论通过,现予印发,请认真遵照执行。


二○○八年三月二十四日



兰州市城镇房屋用地分割登记发证暂行办法


第一条 为做好兰州市城镇房屋用地分割登记发证工作,依据《物权法》、《中华人民共和国土地管理法》、《中华人民共和国城市房地产管理法》、《土地登记办法》和《城镇地籍调查规程》等有关法律、法规和规章,结合我市实际,制定本办法。
第二条 本办法适用于兰州市行政区域内各行政机关、企事业单位和个人在国有土地上建造的商品房、经济适用房、拆迁安置房、职工集资房、房改房和自建房屋用地的分割登记。
第三条 城关区、七里河区、西固区、安宁区等行政区域内房屋分割登记发证由市国土资源行政主管部门负责。
永登县、榆中县、皋兰县、红古区等行政区域内房屋分割登记在市国土资源行政主管部门指导下,由土地所在县(区)国土资源行政主管部门负责。
第四条 城镇房屋国有土地使用权分割登记是以原国有土地使用者宗地为单位,只分摊登记建筑物所占土地面积,道路、绿化和其他公用设施所占的土地只登记不发证。
第五条 分割面积由以下方式确定:
(一)单体房屋建筑物占地面积为该建筑物垂直投影底层闭合线内土地面积。
(二)当主楼和裙楼连体时,合并计算整栋楼建筑面积,以主楼和裙楼共同垂直投影为该建筑物占地面积;当主楼镶嵌在裙楼内时,以裙楼外围垂直投影占地为该建筑物占地面积。
(三)一宗地内有两类或两类以上不同土地用途组合的,能在实地区分开的,可按不同土地用途分别划宗,分别予以登记;在实地难以区分开的,可按照“混合宗”予以登记;如果出让合同有特殊约定,依合同约定予以登记。
(四)土地面积以实测为准,在实测有困难的情况下可在1∶500或更大比例尺的地形图上量算面积;若投影图形不规则时,可近似取为规则图形量算面积。
第六条 分摊面积的计算公式:
(一)权利人分摊土地面积=该权利人建筑面积÷栋总建筑面积×栋建筑占地面积;
(二)各权利人分摊总土地面积=栋建筑占地面积。
第七条 宗地编号及土地证号实行统一编制。
城镇房屋土地登记对分割宗地编号采取原宗地号+楼号+单元号+房号,如原宗地号为03017,楼号为0l,单元号为01,房号为306,则宗地号为030170101306。
土地证号按年份+县(区)拼音的第一个大写字母+F+序号编制,如年份为2006年,县(区)名称为城关,序号为0001,则土地证号为兰国用字〔2006〕第CF0001号。
第八条 单位房改房只缴部分房款的,应缴清剩余房款后再办理房屋分割登记。
第九条 新建房屋建设单位在整个项目或单体建筑竣工验收后,持下列材料到相关国土资源行政主管部门申请办理土地分割备案登记,并从土地所在县(区)国土资源行政主管部门领取《国有土地使用权分割登记凭证》:
1、土地登记申请书;
2、申请单位法人证明及法定代表人身份证明,属于委托他人办理的,需提供委托书和被委托人的身份证明;
3、设定登记时核发的原《国有土地使用证》;
4、《商品房预售许可证》、《建设用地规划许可证》、《建设工程规划许可证》原件和复印件;
5、设计施工图纸;
6、《宗地分割情况申报调查表》内容包括竣工房屋的用途、总面积及每幢、单元和每套房子的建筑面积(建筑面积以设计图纸为准);
7、标有分割房屋平面位置的地形图或宗地图及住宅小区平面布置图;
8、分期开发的,应提供分期开发资料等;
9、相关缴费凭证;
10、其他材料。
购新建房者,在领取《房屋所有权证》后,持《国有土地使用权分割登记凭证》和相关申请材料到市国土资源行政主管部门领取《国有土地使用证》,同时对分割后的剩余宗地申请变更或注销登记。
第十条 已建成的房屋,原建设单位仍然存在的,由原建设单位持有关材料到相关国土资源行政主管部门申请办理土地分割登记,为产权人统一办理《国有土地使用证》,同时对分割后的剩余宗地申请变更或注销登记。
已建成的房屋,原建设单位已撤销的,由现在的物业公司或业主委员会持有关材料到相关国土资源行政主管部门申请办理土地分割登记,为产权人统一办理《国有土地使用证》,同时对分割后的剩余宗地申请变更或注销登记。
第十一条 已办理土地分割登记的房屋,因买卖、交换、赠与、继承或者以其他方式转让的,由房屋产权人持有关材料到相关国土资源行政主管部门申请房屋用地分割变更登记,领取《国有土地使用证》。
第十二条 土地登记实行收费制,具体收费办法依照相关规定执行。
第十三条 其他性质的房屋用地分割登记参照本办法执行。
第十四条 本办法由市国土资源行政主管部门负责解释。
第十五条 本办法自公布之日起施行。


关于严禁以国家机关名义发布广告有关问题的通知

国家工商行政管理总局


国家工商行政管理总局文件

工商广字[2008]212号


关于严禁以国家机关名义发布广告有关问题的通知

各省、自治区、直辖市及计划单列市工商行政管理局:

  近期,一些地方在广告发布中出现“国家机关专供”及类似内容,违反《广告法》关于不得以国家机关及国家机关工作人员名义发布广告的规定。为严格执行《广告法》,现就有关事项通知如下:

  广告中出现“×××(国家机关)专供”、“专供×××(国家机关)”内容的,均属于违反《广告法》第七条第二款第(二)项规定,各级工商行政管理机关应依照《广告法》第三十九条规定从重处罚。对于捏造事实,发布虚假广告或者进行虚假宣传的,依照《广告法》或者《反不正当竞争法》有关规定从重处罚;涉嫌构成犯罪的,应当依法移送司法机关处理。

国家工商行政管理总局

二00八年十月八日