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Administrative Measures On Import And Export Of Protein Assimilation Preparations And Peptide Hormones (Interim)

Original Language Title: 蛋白同化制剂、肽类激素进出口管理办法(暂行)

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(July 28, 2006 the State food and drug administration and the General Administration of customs, State Sports General Administration announced 25th come into force on September 1, 2006) the first to standardize the import and export administration of protein assimilation preparations and peptide hormones, according to the People's Republic of China medicine management law, the People's Republic of China Customs law, the anti-doping regulations and other laws and administrative regulations, these measures are formulated.
    Article States for anabolic agents and peptide hormone management of import and export permit.
    Article importing anabolic agents and peptide hormones, the import entity shall apply to the State food and drug administration. Fourth article imports for medical using of protein assimilation preparations, and peptide class hormone, imports units should submitted following information: (a) drug imports application table; (ii) purchased goods contract or orders copies; (three) imports drug registered card (or medicine products registered card) (original or copy) copies; (four) imports units of drug business license, and enterprise corporate license, and import and export Enterprise qualification certificate (or foreign trade operators record registration form), and organization code certificate
    Copies; drug production enterprise imports this enterprise by needed raw materials drug and preparations intermediate (including territory points packaging with preparations), should submitted drug production license, and enterprise corporate license, and organization code certificate copies; (five) imports drug registered card (or medicine products registered card) holds who as delegate other company agent export its drug of, needed provides delegate export letter.
    Copies of these types of seals shall be affixed to imported units. Fifth article for teaching, and research need and imports protein assimilation preparations, and peptide class hormone of, imports units should submitted following information: (a) drug imports application table; (ii) purchased goods contract or orders copies; (three) domestic using units legal qualification of proved file, and drug using number of measuring according to and using units issued of legal using and management the drug guarantee letter; (four) corresponding research project of approved file or corresponding competent sector of approved file; (five) accept using units delegate agent imports of,
    Will provide the principal-agent agreement copies and the business license of the importer, the import and export Enterprise qualification certificate (or of the foreign trade operator registration form), copy of the certificate of organization code.
    Copies of these types of seals shall be affixed to imported units.
    Sixth article territory Enterprise for accept outside enterprise delegate production and need imports protein assimilation preparations, and peptide class hormone of, except needed submitted this approach fifth article first paragraph subsection (a) items, and subsection (three) items, and subsection (five) items provides of information outside, also should provides has to location province, and autonomous regions, and municipalities (food) drug supervision management sector record of proved file.
    Copies of these types of seals shall be affixed to imported units.
    Article seventh State food and drug administration after receipt of the application and related information import shall, within 15 working days to make a decision on whether to agree to import; agreed to import, issue the import permit; does not agree with the import, shall state the reasons in writing. Article eighth importer by the State food and Drug Administration issued the import permit to allow drug imports, customs declaration, customs the import permit for inspection.
    Importing anabolic agents and peptide hormones without the customs clearance of imported drugs. Nineth article imports for medical using of protein assimilation preparations, and peptide class hormone (including first in China sales of), imports units should Yu imports procedures completed Hou, timely fill in imports drug reported inspection single, holding imports drug registered card (or medicine products registered card) original (original or copy), and drug imports allowed card original, to imports port (food) drug supervision management sector submitted following information a type two copies, application handle imports drug port test notice: (a) imports drug registered card (Or medicine products registered card) (original or copy) and drug imports allowed card copies; (ii) imports units of drug production license or drug business license copies, Enterprise corporate license copies; (three) origin proved copies; (four) purchased goods contract copies; (five) boxing single, and mention AWB and freight invoice copies; (six) factory test report book copies; (seven) drug manual and the packaging, and
    Label styles (except for the drug substance and drug product intermediates).
    Copies of these types of seals shall be affixed to imported units.
    Tenth Article port (food) drug supervision management sector received imports drug reported inspection single and the related information, review correct Hou, will imports drug registered card (or medicine products registered card) (original or copy) original, and drug imports allowed card original returned imports units, and should Yu day to is responsible for test of port drug test by issued imports drug port test notice, attached this approach Nineth article provides of information a copies.
    The port drug inspection Office after receipt of the notice of the inspection of imported drugs, contact importer shall, within 2 working days, to the inventory sampling, sampling is completed, should be in the back of the original of the import permit for the first Alliance marked "sample" words, and shall affix its official seal.
    11th due to teaching and research needs of importing anabolic agents and peptide hormones accept commissioned production needs of foreign enterprises and domestic enterprises importing anabolic agents and peptide hormones, be exempt.
    12th article has following case one of of, port (food) drug supervision management sector should timely will about situation report national food drug supervision authority: (a) port (food) drug supervision management sector according to drug imports management approach (national food drug supervision authority, and Customs makes 4th,) 17th article provides, not issued imports drug port test notice of; (ii) port drug test by according to drug imports management approach 25th article provides, not sampling of.
    Port (food) drug supervision management sector on meet Qian paragraph provides and has imports of all drug, should take seized, and seized of administrative forced measures, and Yu seized, and seized of day up 7th within made granted back shipped decided, notification imports units according to this approach provides of protein assimilation preparations, and peptide class hormone export program handle drug export allowed card, will imports drug all returned original export country.
    Importer within 10th grant date of return decisions receipt does not answer or were not explicitly returned, drugs that have been sealed up, distrained by the port (food) supervised the destruction of the drug regulatory agency.
    13th article import anabolic agents and peptide hormone by the port drug inspection offices inspection does not meet the requirements of the standard, the import entity shall upon receipt of the report of the inspection of imported drugs in the 2nd, all imported drugs, using the details, reports local port (food) the pharmaceutical supervisory and administrative departments.
    Port (food) the pharmaceutical supervisory and administrative department upon receipt of the report of the inspection of imported drugs, shall take all the drugs in time to seal up or seize administrative coercive measures, and make a decision on whether to file in the 7th. Importers are not within the time stipulated in the proposed retest or retest is still not meeting the prescribed standards, the port (food) the pharmaceutical supervisory and administrative departments shall make a decision on return decisions, inform the importer in accordance with the rules of anabolic agents and peptide hormone drug export program for export permit, import drugs all returned to the original exporting country.
    Importer within 10th grant date of return decisions receipt does not reply or it is not clear that returned by the port (food) supervised the destruction of the drug regulatory agency.
    Meeting the prescribed standards upon re-inspection, the port (food) the pharmaceutical supervisory and administrative departments shall cancel the compulsory administrative measures of sealing up, distraining.
    Port (food) the pharmaceutical supervisory and administrative departments shall, in accordance with the second paragraph of this article, the third, fourth paragraph of the report to the State food and drug administration, and notify the provinces, autonomous regions and municipalities directly under the (food) and other port drug regulatory authorities (the food) the pharmaceutical supervisory and administrative departments.
    Article 14th domestic pharmaceutical producing enterprises, trading enterprises and medical institutions while procuring imported protein assimilation preparations and peptide hormones, the supplier shall provide the imported drug registration certificate (or certificate of pharmaceutical product registration) copy of the import permit for copies and copies of the report on inspection of imported drugs, and stamped copy of each of the above-mentioned supply unit seal.
    15th export protein assimilation preparations and peptide hormones, the exporter shall provide the location of provinces, autonomous regions, or municipalities directly under the (food) drug supervision and management departments to apply, submit the following information: (a) the drug export application form, (ii) the regulatory authorities of the importing country or region supply the original import permit (or notarization of copies of the text). As imports national or area on protein assimilation preparations, and peptide class hormone imports yet implemented license management system, needed provides imports national of drug management institutions provides of the class drug imports without issued imports allowed card of proved file (original) and following file one of: 1. imports national or area of drug management institutions provides of agreed imports the drug of proved file original (or copies and the notary text); 2.
    Imports units legal qualification of proved file and the drug uses legal of proved file original (or copies and the notary text); (three) purchased goods contract or orders copies (proprietary products export of production enterprise except); (four) export contract or orders copies; (five) export drug as for domestic drug production enterprise by approved production of varieties, must provides the drug production enterprise of drug production license, and enterprise corporate license and the drug of approved proved file copies; Exporting drugs, such as for domestic enterprises to accept commissioned the production of varieties of foreign enterprises, shall provide to the local provinces, autonomous regions and municipalities directly under the (food) the pharmaceutical supervisory and administrative departments for the record copies of supporting documents;

    (F) export the enterprise legal person business license of the enterprise, the import and export Enterprise qualification certificate (or of the foreign trade operator registration form), copy of the certificate of organization code.
    Copies of these types of seals shall be affixed to the exporter.
    16th according to the methods set forth in 12th, 13th return, application of drug when the export authorization, shall provide the following information: (a) apply exporter the exporter returns documents; (b) the import permit.
    17th of provinces, autonomous regions and municipalities (food) the pharmaceutical supervisory and administrative department after receiving the export application and related information shall, within 15 working days to make a decision on whether to agree to export; agreed to export, drug of the export permit; does not agree with the export, shall state the reasons in writing.
    In accordance with the measures apply medicines to the 16th article of export permit issuing authority shall indicate on the medicines of the export permit "original goods returned". 18th the exporter by provinces, autonomous regions and municipalities (food) medicines issued by the pharmaceutical supervisory and Administrative Department of the export permit to customs of customs clearance procedures.
    Customs Drug export permit for inspection. When the 19th article import and export customs clearance procedures, should submit a Joint Declaration and sign and return the application to the customs declaration form. Customs to the import permit, the export authorization, in which customs form stamped "examined" back import and export units.
    Certificate of customs in accordance with the relevant stipulations concerning collection fee.
    After the import is completed within 1 month, importers should the import permit, the export permit for the first Alliance, signed the customs declaration returned to the issuing authority.
    After obtaining the drug import and export permits is not related import and export trade, export and import unit shall, within 1 month after the expiry of the permit will be returned to the issuing authority of the permit. 20th the import permit valid for 1 year.
    Drugs of the export permit is valid for not more than 3 months (valid time limit does not span more than). The import permit, the export permit for the implementation "one card pass", can only be used within the validity period, the license content may not be changed.
    Extended import and export, you can take the original import permit apply for an extension or replacement of license. 21st the import permit, export permit certificate is lost, importers shall immediately report the loss to the original licensing authority. Primary certification authority upon receipt of the loss report, inform the customs.
    Original issuing authorities confirmed no adverse consequences, a new license.
    22nd the import permit, export permit certificate uniformly printed by the State food and drug administration. Article 23rd for processing trade imports and exports anabolic agents and peptide hormones, the Customs the import permit, let them export permit procedures and regulations.
    Unable to export due to special circumstances, transfer of goods (food) pharmaceuticals supervision and management departments in accordance with the regulations, Customs shall make relevant evidence of verification procedures.
    24th the bonded zones, export processing zones and other special customs supervision areas and bonded areas and outside access and special customs supervision areas and transported between the bonded areas of protein assimilation preparations and peptide hormones, from handling the import permit, export permit by the customs regulations.
    From the free trade zone, export processing zones and other special customs supervision areas and bonded areas into areas in the territory's anabolic agents and peptide hormones, should go through the import permit.
    From the outside in the area into the free trade zone, export processing zones and other special customs supervision areas and bonded areas of protein assimilation preparations and peptide hormones, should go through the drug of the export permit.
    25th individual medical needs to carry or mail entry and exit for personal use within a reasonable amount of protein assimilation preparations and peptide hormones, according to the health authorities, the management of the customs provisions on medical prescription, examination and release.
    Article 26th save as provided in this way, for medical use of anabolic agents, peptide hormone import and customs inspection, supervision and management, and so on, refer to the drug import regulations regarding the importation of drug regulations.
    27th article import in these measures for medical use of anabolic agents and peptide hormones, refers to importing anabolic agents and peptide hormones to be used in preparation or to be listed in China sales.
    Importer: refers to the drug in accordance with this approach the importer specified in the import permit.
    Export unit: is a drug made in accordance with these measures stated in the export permit, the exporter. 28th article of the rules take effect on September 1, 2006.
                                                                            Released on September 30, 2004, the State food and Drug Administration about anabolic agents and peptide hormones: notice of import and export management (State food and drug [2004]474) repealed simultaneously.