【文章內(nèi)容簡介】 藥品批準文號；但是，生產(chǎn)沒有實施批準文號管理的中藥材和中藥飲片除外。Production of a new drug or production of a drug plying with NationalDrug Standards shall be subject to the approval by the drug regulatoryagency of the State Council, and a drug approval number shall be issued forit, with the exception of the Chinese crude drugs and the prepared slices ofChinese crude drugs in which no control by approval number is exercised. 、中藥飲片品種目錄由國務院藥品監(jiān)督管理部門會同國務院中醫(yī)藥管理部門制定。The list of the Chinese crude drugs and the prepared slices of the Chinesecrude drugs to be controlled by the approval number shall be piled by thedrug regulatory agency of the State Council, jointly with the administrativeagency for traditional Chinese medicines of the State Council.，方可生產(chǎn)該藥品。 A drug manufacturer is permitted to produce the drug only after an approvalnumber has been granted to it.71. 藥品必須符合國家藥品標準。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 Pharmacopoeia of the People39。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 drug regulatory agency of the State Council shall organize apharmacopoeia mission, which shall be responsible for formulating andrevising the National Drug Standards.、對照品。 The drug control institution affiliated to the drug regulatory agency of theState Council is responsible for standardizing the National Drug StandardSubstance and Reference Substance.、藥品經(jīng)營企業(yè)、醫(yī)療機構(gòu)必須從具有藥品生產(chǎn)、經(jīng)營資格的企業(yè)購進藥品；但是，購進沒有實施批準文號管理的中藥材除外。 Drug manufacturers, drug distributors and medical institutions shallpurchase drugs from pharmaceutical enterprises, which are qualified forproduction and distribution, with the exception of the Chinese crude drugsin which no control by approval number is exercised.、精神藥品、醫(yī)療用毒性藥品、放射性藥品，實行特殊管理。The State exercises special control over narcotic drugs, psychotropicsubstances, toxic drugs for medical use and radioactive pharmaceuticals.。The State adopts a protection system for certain traditional Chinesemedicines.。 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。 Reviewing the drugs to be imported shall e of the jurisdiction of thedrug regulatory agency of the State Council. A drug is permitted to beimported only upon approval granted after confirming that it conforms to thequality, safely and efficiency through examination, and a drug importationlicense shall be issued.。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。 When major disasters, epidemic situations or other emergencies occur in thecountry, the department designated by the State Council may allocate drugsfrom the enterprises to meet the urgent need.82. 禁止生產(chǎn)（包括配制）、銷售假藥。 Production (including dispensing) and distribution of counterfeit drugs areprohibited.，為假藥： A drug falling into the following categories is deemed as a counterfeitdrug:（一）藥品所含成份與國家藥品標準規(guī)定的成份不符的； The ingredients in the drug are different from those specified by theNational Drug Standards。 （二）以非藥品冒充藥品或者以他種藥品冒充此種藥品的。 It is not the same drug which is claimed by its name or in reality it is nota drug at all.，按假藥論處： A drug falling into the following categories shall be deemed as acounterfeit drug:（一）國務院藥品監(jiān)督管理部門規(guī)定禁止使用的； It’s use is prohibited by the provisions of the drug regulatory agency ofthe State Council。（二）依照本法必須批準而未經(jīng)批準生產(chǎn)、進口，或者依照本法必須檢驗而未經(jīng)檢驗即銷售的； It is produced or imported without approval, or marketed without beingtested, as required by the Law。（三）變質(zhì)的； It is deteriorated。（四）被污染的； It is contaminated。 （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。 （六）所標明的適應癥或者功能主治超出規(guī)定范圍的。 The indications or functions indicated are beyond the specified scope.85. 禁止生產(chǎn)、銷售劣藥。 Production and distribution of drugs of inferior quality are prohibited.，為劣藥。 A drug with content not up to the National Drug Standards is a drug ofinferior quality.，按劣藥論處： A drug falling into the following categories shall be deemed as a drug ofinferior quality:（一）未標明有效期或者更改有效期的； The date of expiry is not indicated or is altered。（二）不注明或者更改生產(chǎn)批號的； The batch number is not indicated or is altered。（三）超過有效期的； It is beyond the date of expiry。（四）直接接觸藥品的包裝材料和容器未經(jīng)批準的； No approval certificate is obtained for the immediate packaging material orcontainer。（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。 or（六）其他不符合藥品標準規(guī)定的。 Other cases where the drug standards are not plied with.。已經(jīng)作為藥品通用名稱的，該名稱不得作為藥品商標使用。 A drug name listed in the National Drug Standards is an adopted name inChina. Such an adopted name is not permitted to be used as a trademark.、藥品經(jīng)營企業(yè)和醫(yī)療機構(gòu)直接接觸藥品的工作人員，必須每年進行健康檢查。Staff members of drug manufacturers, drug distributors and medicalinstitutions who make a direct contact with drugs shall receive physicalexamination annually.，不得從事直接接觸藥品的工作。 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。 Immediate packaging materials and containers shall meet the requirements formedicinal use and ply with the standards for ensuring human health andsafety. They along with the drugs shall be subject to reviewing and approvalby the drug regulatory agency.92. 藥品包裝必須按照規(guī)定印有或者貼有標簽并附有說明書。 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