【正文】 ractice for Pharmaceutical Products (GSP) set by the drug regulatory agencyof the State Council based on this Law.《藥品經(jīng)營質(zhì)量管理規(guī)范》的要求進行認證；對認證合格的，發(fā)給認證證書。 An examination system shall be followed for storing drugs in warehouse andreleasing them from warehouse.，國務院另有規(guī)定的除外。A full description of a new drug research and development including themanufacturing process, quality specifications, results of pharmacologicaland toxicological study, and the related data as well as the samples shall,in accordance with the regulations of the drug regulatory agency of theState Council, be truthfully submitted to the above agency for reviewing andapproval.，由國務院藥品監(jiān)督管理部門批準，發(fā)給新藥證書。s Republic of China and the Drug Standardsissued by the drug regulatory agency of the State Council shall serve as theNational Drug Standards.，負責國家藥品標準的制定和修訂。The State adopts a policy for drug storage for future use.、疫情及其他突發(fā)事件時，國務院規(guī)定的部門可以緊急調(diào)用企業(yè)藥品。 （五）使用依照本法必須取得批準文號而未取得批準文號的原料藥生產(chǎn)的； It is produced by using active pharmaceutical ingredients without approvalnumber as required by this Law。（五）擅自添加著色劑、防腐劑、香料、矯味劑及輔料的； Colorants, preservatives, spices, flavorings, or other recipients have beenadded without authorization。 A label shall be printed or stuck on the drug package with an insert sheetattached as required by regulations.、成份、規(guī)格、生產(chǎn)企業(yè)、批準文號、產(chǎn)品批號、生產(chǎn)日期、有效期、適應癥或者功能主治、用法、用量、禁忌、不良反應和注意事項。 The content of drug advertisement shall be truthful and lawful, and shall bebased on the insert sheet approved by the drug regulatory agency of theState Council. The false content shall not be contained in advertisement.；不得利用國家機關、醫(yī)藥科研單位、學術機構或者專家、學者、醫(yī)師、患者的名義和形象作證明。 Drug regulatory agencies shall, in accordance with regulations and on thebasis of the GMP and GSP, make the followup inspection on the certifieddrug manufacturers and distributors.、審批等手段限制或者排斥非本地區(qū)藥品生產(chǎn)企業(yè)依照本法規(guī)定生產(chǎn)的藥品進入本地區(qū)。 Drug distributors refer to enterprises exclusively or partly engaged in drugdistribution.。The term of validity for the registration certificate of medical devices isfour years.，應當符合醫(yī)療器械國家標準；沒有國家標準的，應當符合醫(yī)療器械行業(yè)標準。Distribution enterprises shall not distribute medical devices withoutregistration certificates or certificates for qualified products, or medicaldevices which are beyond their expiry dates, of promised effectiveness,or obsolete.《醫(yī)療器械生產(chǎn)企業(yè)許可證》的生產(chǎn)企業(yè)或者取得《醫(yī)療器械經(jīng)營企業(yè)許可證》的經(jīng)營企業(yè)購進合格的醫(yī)療器械，并驗明產(chǎn)品合格證明。For products having caused or which may potentially cause quality incidents,the drug regulatory agency of the governments at county level and aboveshall have the right to check, seal up and detain them together withmaterials related.；未經(jīng)批準。The term of validity of the Medical Device Manufacturing Enterprise Licenseis 5 years. Upon expiration, reinspection and license renewal shall beconducted.、無合格證明、過期、失效或者淘汰的醫(yī)療器械。生產(chǎn)第二類、第三類醫(yī)療器械，應當通過臨床驗證。 Excipients refer to the vehicles and additives intended for manufacturingdrug dosage forms and prescription dispensing.，是指生產(chǎn)藥品的專營企業(yè)或者兼營企業(yè)。 Sampling for selective testing shall be carried out according to relevantregulations, and no fees are permitted to be charged for sampling ortesting. 封、扣押的行政強制措施。 Drug advertisement shall be subject to approval by the drug regulatoryagencies of the government of the province, autonomous region ormunicipality directly under the Central Government where the enterprise islocated and an approval number of drug advertisement shall he issued. No oneis permitted to release advertisement without the approval number.、藥學專業(yè)刊物上介紹，但不得在大眾傳播媒介發(fā)布廣告或者以其他方式進行以公眾為對象的廣告宣傳。 Those who suffer from infectious diseases or any other diseases that maycause drug contamination are not permitted to undertake any job in directcontact with drugs.91. 直接接觸藥品的包裝材料和容器，必須符合藥用要求，符合保障人體健康、安全的標準，并由藥品監(jiān)督管理部門在審批藥品時一并審批。（三）超過有效期的； It is beyond the date of expiry。（三）變質(zhì)的； It is deteriorated。 The State adopts a system of classified management for prescription andnonprescription drugs. ，須經(jīng)國務院藥品監(jiān)督管理部門組織審查，經(jīng)審查確認符合質(zhì)量標準、安全有效的，方可批準進口，并發(fā)給進口藥品注冊證書。Drugs shall ply with the National Drug Standards.《中華人民共和國藥典》和藥品標準為國家藥品標準。The pharmaceutical preparations to be dispensed by the medical institutionshall be those satisfying the clinic need of the institution but notavailable on the market. It shall be subject to approval in advance by thelocal drug regulatory agency of the government of the province, autonomousregion or municipality directly under the Central Government.，不得在市場銷售。 Drug distributors shall indicate the habitat of Chinese crude drugs to besold.，采取必要的冷藏、防凍、防潮、防蟲、防鼠等措施，保證藥品質(zhì)量。(3) havingthe quality control units or personnel adaptable the drugs to bedistributed。 No products that do not meet the National Drug Standards or that are notproduced according to the processing procedures for the prepared slices ofChinese crude drugs formulated by the drug regulatory agency of thegovernment of a province, autonomous region, or municipality directly underthe Central Government may be released.、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準，藥品生產(chǎn)企業(yè)可以接受委托生產(chǎn)藥品。 (3) having quality management and control units and personnelcapable of quality management of and testing for drugs to be produced andthe necessary instruments and equipment。The drug regulatory agency of the State Council shall be responsible fordrug administration and supervision nationwide. 、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門負責本行政區(qū)域內(nèi)的藥品監(jiān)督管理工作。srepublic of China.。(2) providedwith the premises, facilities, and clear environment required for drugmanufacturing。Drug manufacturers shall perform quality test of their products.、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門制定的中藥飲片炮制規(guī)范炮制的，不得出廠。(2) provided with the business operation premises, equipment,warehouses, and clear environment required for drug distribution。 In the record shall be indicated the adopted name of drugs, dosage form,strength or