【正文】 抽查檢驗。 Drug manufacturers, drug distributors and medical institutions areprohibited from secret offering or accepting rakeoffs or other benefits(not shown in the account book) in the course of purchasing and sellingdrugs.、經(jīng)營企業(yè)或者其代理人以任何名義給予使用其藥品的醫(yī)療機構(gòu)的負(fù)責(zé)人、藥品采購人員、醫(yī)師等有關(guān)人員以財物或者其他利益。 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。 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(biāo)明有效期或者更改有效期的； The date of expiry is not indicated or is altered。 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(wù)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。The State exercises special control over narcotic drugs, psychotropicsubstances, toxic drugs for medical use and radioactive pharmaceuticals.。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。 No medical institution is permitted to dispense pharmaceutical preparationswithout the Pharmaceutical Preparation Certificate for Medical Institution.62.《醫(yī)療機構(gòu)制劑許可證》應(yīng)當(dāng)標(biāo)明有效期，到期重新審查發(fā)證。Drug distributors shall keep a real and perfect records of purchasing andselling drugs.、劑型、規(guī)格、批號、有效期、生產(chǎn)廠商、購（銷）貨單位、購（銷）貨數(shù)量、購銷價格、購（銷）貨日期及國務(wù)院藥品監(jiān)督管理部門規(guī)定的其他內(nèi)容。 A drug distributor to be established shall meet the followingrequirements:(1) staffed with legally qualified pharmaceuticalprofessionals。 Active pharmaceutical ingredients (API) and recipients for the manufactureof pharmaceutical products shall meet the requirements for medicinal use.。 Any drug manufacturer to be established shall meet the followingrequirements: (1) stuffed with legally qualified pharmaceutical andengineering professionals and the necessary technical workers。s Republic of China shall abide by drug control law of the people39。 The drug regulatory agencies of the governments of provinces, autonomousregions, and municipalities directly under the Central Government shall beresponsible for drug regulation in their administrative areas. ，承擔(dān)依法實施藥品審批和藥品質(zhì)量監(jiān)督檢查所需的藥品檢驗工作。 and (4) establishing rules andregulations to govern the quality of drugs.《藥品生產(chǎn)質(zhì)量管理規(guī)范》組織生產(chǎn)。 A drug manufacturer may not accept any contract production of drugs unlessit is approved by the drug regulatory agency of the State Council, or by thedrug regulatory agency of the government of a province, autonomous region,or municipality directly under the Central Government authorized by the drugregulatory agency of the State Council.，須經(jīng)企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)并發(fā)給《藥品經(jīng)營許可證》.Any newly established drug wholesaler shall be subject to approval of thelocal drug agency of the government of the province, autonomous region ormunicipality directly under the Central Government and be granted the DrugSupply Certificate.，須經(jīng)企業(yè)所在地縣級以上地方藥品監(jiān)督管理部門批準(zhǔn)并發(fā)給《藥品經(jīng)營許可證》。 and(4) establishing rules and regulations to govern the qualityof the drugs to be distributed.《藥品經(jīng)營質(zhì)量管理規(guī)范》經(jīng)營藥品。 A drug distributor shall pass the established system for drug storage, andtake necessary measures to ensure drug quality, such as cold storing,protecting from being frozen and moisture and guarding against insects androdents.。 No pharmaceutical preparations dispensed by medical institutions arepermitted to be marketed.，必須按照國務(wù)院藥品監(jiān)督管理部門的規(guī)定如實報送研制方法、質(zhì)量指標(biāo)、藥理及毒理試驗結(jié)果等有關(guān)資料和樣品，經(jīng)國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)后，方可進行臨床試驗。The Pharmacopoeia of the People39。 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.。（四）被污染的； It is contaminated。（四）直接接觸藥品的包裝材料和容器未經(jīng)批準(zhǔn)的； No approval certificate is obtained for the immediate packaging material orcontainer。 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(biāo)簽并附有說明書。 Prescription drugs may be introduced in the medical or pharmaceuticalprofessional journals jointly designated by the administrative agency ofhealth and the drug regulatory agency of the State Council, but theiradvertisements are not permitted to be released by mass media ordisseminated to the general public by other means.、合法，以國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)的說明書為準(zhǔn)，不得含有虛假的內(nèi)容。The drug regulatory agency shall take administrative enforcement to seal orseize the drugs and related materials proved to be potentially harmful tohuman health and shall. ，依據(jù)《藥品生產(chǎn)質(zhì)量管理規(guī)范》、《藥品經(jīng)營質(zhì)量管理規(guī)范》，對經(jīng)其認(rèn)證合格的藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)進行認(rèn)證后的跟蹤檢查。Drug manufacturers refer to enterprises exclusively or partly engaged indrug production.，是指經(jīng)營藥品的專營企業(yè)或者兼營企業(yè)。Class Ⅲ medical devices shall be inspected, approved and issuedregistration certificates by the drug regulatory agency directly under theState Council.。Medical institutions shall not use medical devices without registration, orwithout certificate for qualified products, or they shall not use medicaldevices which are beyond their expiry dates, of promised effectiveness,or obsolete.、無合格證明、過期、失效或者淘汰的醫(yī)療器