tories whichshall be located rationally over the country. Applications for the settingup of any enterprises to produce or sell radioactive drugs must beapproved by the Ministry of Energy before the preparations start inaccordance with related provisions.Article 12Requirements for the setting up of enterprises to produce or sellradioactive drugs are that they must have the necessary conditions asstipulated in Article 5 of the Pharmaceutical Administration Law and thatthey must meet the essential standard of radio hygiene protection set bythe State. They are also required to submit a report on environment impactto the Ministry of Energy and the Ministry of Public Health forexamination and approval and then the health administration department intheir province, autonomous region or municipality directly under theCentral Government shall issue them "License for the Production Enterpriseof Radioactive Drugs", "License for the Business Enterprise of RadioactiveDrugs". No enterprises without the license shall be permitted to engage inthe production or sale of radioactive drugs.Article 13The term of validity of "License for the Production Enterprise ofRadioactive Drugs" and "License for the Business Enterprise of RadioactiveDrugs" is five years. If needed, the enterprises engaged in the productionor sale of radioactive drugs shall make a new application six monthsbefore the expiration to the health administration department which shall,in accordance with Article 12 of these Provisions, issue them a newlicense.Article 14Before an approved pharmaceutical enterprise produces radioactive drugswith specifications already set by the State, it must forward anapplication which has to be examined and approved by the Ministry ofPublic Health in conjunction with the Ministry of Energy. If any changesin the technological process and specifications of the drugs previouslyapproved by the Ministry of Public Health are to be made, thepharmaceutical factory shall be required to go through the same proceduresfor approval.
Article 15The production and business enterprises of radioactive drugs are requiredto employ technical personnel who are qualified for the work and to havesafety and protection facilities as well as waste gas, liquid and materialdisposal facilities. They must also have a strict quality control system.Article 16The production and business enterprises of radioactive drugs are requiredto set up quality inspection offices. The entire process of productionmust be put under strict qualify control and inspection.All radioactive drugs are subject to quality testing. Only the productsthat meet the State pharmaceutical standard shall be allowed to be shippedout from the factories. Products that are not up to the standard are notallowed out of the factory. As for the drugs with short half-liferadionuclide previously approved by the Ministry of Public Health, theymay be shipped out from the factory while having sample testing. If thedrugs are found to be below the State pharmaceutical standard, the factorymust stop the production and sale of the drugs immediately and informconsuming units to stop using the drugs without delay. A report about thecase must be submitted to both the Ministry of Public Health and theMinistry of Energy.Article 17The production, supply and sale of radioactive drugs are under the unifiedadministration of the Ministry of Energy.When ordering these stuff, the pharmaceutical factory must furnish aLicense for the Production Enterprise of Radioactive Drugs while thebusiness unit must present a License for the Business Enterprise ofRadioactive Drugs issued by the health administration department at theprovincial, autonomous regional or municipal (directly under the CentralGovernment) level. As for the medical treatment unit, they must orderthese drugs with a License for the Use of Radioactive Drugs jointly issuedby the public security department, the environment protection departmentand health administration department at the provincial, autonomousregional or the municipal (directly under the Central Government) level.Article 18The import and export business of radioactive drugs shall be handled bythe units appointed by the Ministry of Foreign Economic Relations andTrade in accordance with the State provisions related to foreign trade.Prior to the import or export of radioactive drugs, an application must bemade and be examined and approved by the Ministry of Public Health.Imported radioactive drugs are required to meet the State standards forpharmaceuticals or other medical requirements.
Article 19Imported radioactive drugs are subject to sample examination by the StateAdministration for the Inspection and Testing of Pharmaceuticals andBiological Products or by an inspection and testing institution ofpharmaceuticals authorized by the Ministry of Public Health. Only thosedrugs that have met the State standards are allowed to be imported. As forthe drugs with short half-life radionuclide previously approved by theMinistry of Public Health, they may be put to use upon being shipped inwhile having import inspection. If the import inspection unit finds thequality of imported drugs not up to the standard, they must inform theconsuming units promptly to stop using the drugs. A report about thequality problem must be submitted to both the Ministry of Public Healthand the Ministry of Energy.
【章名】Chapter IV The Packaging and Shipment of Radioactive Drugs
Article 20The packaging of radioactive drugs must be safe and reliable, and up tothe standards for the quality requirements of radioactive drug. There mustbe protection devices that will match different radio dosages. Thepackaging is required to consist of packing and inner packaging. Theremust be trade mark, label, specifications and marker of radioactive drugson the packing and a label on the inner packaging. On the label there mustbe name of the drug, radiospecific activity and packings.The specifications must indicate the name of the producer, license number,batch number, main composition, date of manufacture, half-life ofradionuclide, indications, administration, dosage, contraindication,expiry date and precautions in addition to name of the drug, radioapecificactivity and packings.Article 21The shipment of radioactive drugs shall be handled in accordance with therules formulated by the State transportation and postal departments. Nounit or person shall be allowed to carry along radioactive drugs on anymeans of public transportation.
【章名】Chapter V The Use of Radioactive Drugs
Article 22If a medical treatment unit desires to set up a radiologic department or aradioisotope department, it is required to employ technical personnel whoare qualified for radiotherapeutic work after special technical training.Without prior technical training no personnel shall be allowed to use thedrugs in radiotherapy.Article 23When a medical treatment unit uses radioactive drugs, it must observe therules formulated by the State concerning radioisotope hygiene andprotection. The health administration department, the public securitydepartment and the environment protection department at provincial,autonomous regional or municipal (directly under the Central Government)level shall issue a certain grade of License for the Use of RadioactiveDrugs according to technical skill and professional level of theradiological personnel and equipment of the medical treatment unit. Nomedical treatment unit without a license is allowed to use radioactivedrugs clinically.The term of validity of a License for the Use of Radioactive Drugs is 5years. If needed, the medical treatment unit must make a new application 6months before the expiration of its license to the health administrationdepartment which, after examination and verification shall issue it a newlicense.
Article 24Before a medical treatment unit holding a License for the Use ofRadioactive Drugs starts the preparation of any forms of radioactive drug