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.


新闻出版总署


关于下发音像（电子）出版业体制改革实施方案的通知

新出字〔2009〕331号


中央和国家机关各部委、各民主党派、各人民团体新闻出版主管部门，各省、自治区、直辖市新闻出版局，新疆生产建设兵团新闻出版局，解放军总政治部宣传部新闻出版局，中国出版集团公司：
　　为进一步加快音像（电子）出版业体制改革步伐，根据《关于进一步推进新闻出版体制改革的指导意见》（新出产业〔2009〕298号）和《关于促进我国音像业健康有序发展的若干意见》（新出政发〔2009〕5号）精神，结合音像（电子）出版业的发展实际，新闻出版总署制定了音像（电子）出版单位转企改制和“三个一批”的具体实施方案。
　　一、关于转企改制要求
　　1.地方和高等院校所属音像（电子）出版单位必须在2009年年底前全部完成转制；中央各部门各单位所属音像（电子）出版单位必须在2009年年底前上报体制改革方案，在2010年年底前全部完成转制（其所属图书出版单位已确定为第一批转制的，所属音像（电子）出版单位必须同期完成转制工作）。
　　2.音像（电子）出版单位须按照《中央各部门各单位出版社转制工作基本规程》（新出字〔2009〕1号）的基本要求，认真做好清产核资、财务审计、资产评估、产权登记、参加社会保险、职工签订劳动合同、建立法人治理结构、注销事业法人、企业工商注册登记等相关工作。对未能按时完成转制任务的音像（电子）出版单位，将按照有关规定一律停办注销。
　　3.音像（电子）出版单位转制方案的主要内容及上报、审批程序参照图书出版社进行。
　　4.已转企改制的音像（电子）出版单位要按照《公司法》的要求，加快产权制度改革，完善法人治理结构，建立现代企业制度，尽快成为真正的市场主体。
　　二、关于“三个一批”方案
　　1.做强做优一批音像（电子）企业
　　对实力较强、基础条件较好的音像（电子）企业进行重点培育，在上市融资、出版资源配置、重点项目安排等方面予以支持和倾斜，力争在3年内，培育5至8家大型音像（电子）集团公司。
　　（1）重点支持组建2至3家以音乐为主业，集音乐创意、出版、制作、复制、发行及歌手演艺等于一体，在3年内实现净资产和年销售收入双超10亿元的大型集团公司。
　　（2）重点支持组建1至2家以影视类、百科类为主业，集制作、出版、复制、发行等业务于一体，在3年内实现净资产和年销售收入双超10亿元的大型集团公司。
　　（3）重点支持组建1至2家教育音像集团公司，通过整合国内教育音像、电子和网络出版资源，在3年内实现净资产和年销售收入双超10亿元的大型集团公司。
　　（4）重点支持组建一家电子出版集团公司，通过开发、整合电子和网络出版数据库资源，在3年内实现净资产和年销售收入双超10亿元的大型集团公司。
　　同时，重点支持20家导向正确、主业突出、特色鲜明、实力雄厚、管理规范、运行高效、核心竞争力强的独立音像（电子）出版、制作企业。20家企业须符合以下条件：
　　（1）企业专职人员在30人以上。
　　（2）净资产和年销售收入均超过1000万元。
　　（3）具有独立企业法人资格。
　　（4）年原创国产音像、电子出版物品种不少于50种。
　　（5）近3年来没有违规记录。
　　（6）对在承担国家重大出版项目、获得国家级奖项较多、在“走出去”方面有突出贡献的音像、电子出版、制作企业予以优先考虑。
　　符合上述条件的20家企业，力争在3年内实现净资产和年销售收入均超过1亿元。
　　2.整合重组一批音像（电子）企业
　　将音像（电子）出版体制改革同出版资源整合、产业结构优化及产业布局调整、总量压缩结合起来，通过宏观调控手段，积极鼓励和支持教育、科技、卫生等领域的音像（电子）出版单位先行整合，组建专业性音像（电子）出版集团公司；积极鼓励和支持跨媒体、跨行业、跨地区、跨所有制组建综合性音像（电子）出版集团公司；积极鼓励和支持独立音像（电子）出版单位以多种方式并入大型国有报刊集团、出版集团、印刷集团、发行集团、影视集团等文化企业集团；积极鼓励和支持大型国有企业和民营企业在政策许可领域、范围参与音像（电子）出版企业的股份制改造或重组。
　　（1）对于净资产和销售收入均低于300万元的音像(电子)出版单位原则上不再保留，要与有实力的图书出版社、报刊社或出版、影视、文化演艺集团公司进行整合。
　　（2）中央各部门各单位中同时拥有多家独立法人音像（电子）出版单位的，建议在部门内进行整合，原则上只能保留一家，或整合成立专业音像（电子）出版集团公司。
　　（3）中央各部门各单位中同时拥有独立图书和音像（电子）出版社的，建议音像（电子）出版社与图书出版社进行合并，可保留音像（电子）出版社副牌。
　　（4）鼓励和支持地方新闻出版、广电、文化等部门所属的音像（电子）出版社并入当地出版集团、报刊集团、发行集团、影视集团、文化演艺集团或有实力的图书出版社。
　　3.停办退出一批音像（电子）企业
　　对不具备市场准入条件、改革中不愿转制的予以停办；对在人员、资金、设备、场所等方面已不符合年度核验条件的予以注销；对有严重违法违规行为的依法予以吊销。
　　（1）音像（电子）出版单位经营不善、资不抵债、发展难以为继的，停办退出。
　　（2）音像（电子）出版单位在经营过程中，不守诚信，盗用他人版权有不良记录且情节严重的，停办退出。
　　（3）音像（电子）出版单位主管部门或主办单位明确表示不愿意改制或不愿意继续办下去的，停办退出。
　　（4）音像（电子）出版单位在年检中不符合以下条件之一的，予以注销：①有适应业务范围需要的组织机构和取得国家出版专业技术人员资格的编辑人员。音像（电子）出版单位人数不得少于10人，其中从事音像（电子）出版业务2年以上并具有中级以上出版专业技术人员职业资格的不得少于5人；电子出版社需有2人以上具有中级以上出版专业职业资格。②有适应业务范围需要的资金、设备和工作场所。音像出版社有30万元以上的注册资本，电子出版社有200万元以上的注册资本，固定工作场所面积不得少于200平方米。③有正常的出版业务，两年内音像、电子出版物品种必须达到10种（含）以上。
　　（5）音像（电子）出版单位有下列违法行为之一且情节严重的，依法吊销其出版许可证：①音像（电子）出版单位制作、出版含有《出版管理条例》第二十六条、第二十七条禁止内容的。②音像（电子）出版单位未将其年度出版计划和涉及国家安全、社会安定等方面的重大选题报国务院出版行政部门备案。③音像（电子）出版单位变更名称、主办单位或者主管机关、地址、法定代表人或者主要负责人、业务范围等，未按规定办理审批、变更登记手续的。④音像（电子）出版单位向其他单位、个人出租、出借、出售或者以其他任何形式转让本单位的名称，出售或者以其他形式转让本单位的版号、电子出版物专用书号的。⑤音像（电子）出版单位委托未取得《音像制品制作许可证》、《电子出版物制作许可证》的单位制作音像制品、电子出版物，或者委托未取得《复制许可证》的单位复制音像制品、电子出版物的。⑥音像（电子）出版单位出版未经批准擅自进口音像制品、电子出版物的。
　　三、关于组织领导
　　1.各省（自治区、直辖市）出版行政管理部门在当地文化体制改革办的领导下，负责本地区音像（电子）出版单位体制改革的具体协调工作。
　　2.各主管和主办单位对所属音像（电子）出版单位转制工作要切实负起责任，对于未按照规定时间完成转制的音像（电子）出版单位将予以注销，遗留问题由其主管主办单位自行解决。
　　3.各地、各部门要根据本方案的精神，加紧制订音像（电子）出版单位转制方案。地方音像（电子）出版单位的转制方案须于2009年11月底前报送新闻出版总署备案，中央各部门各单位音像（电子）出版单位的转制方案须于2009年12月底前报送新闻出版总署。
　　特此通知。
　　　　　　　　　　　　　　　　　　　　　　　　　二○○九年十月二十八日