【正文】 ed with the administrative agency for industry and merce.《藥品經(jīng)營(yíng)許可證》的，不得經(jīng)營(yíng)藥品。 The valid period and the scope of business shall be indicated in the Drug Supply Certificate. For renewal of the certificate upon expiration, reviewing and approval again is required.： （一）具有依法經(jīng)過(guò)資格認(rèn)定的藥學(xué)技術(shù)人員；（二）具有與所經(jīng)營(yíng)藥品相適應(yīng)的營(yíng)業(yè)場(chǎng)所、設(shè)備、倉(cāng)儲(chǔ)設(shè)施、衛(wèi)生環(huán)境；（三）具有與所經(jīng)營(yíng)藥品相適應(yīng)的質(zhì)量管理機(jī)構(gòu)或者人員；（四）具有保證所經(jīng)營(yíng)藥品質(zhì)量的規(guī)章制度。(2) provided with the business operation premises, equipment, warehouses, and clear environment required for drug distribution。 and(4) establishing rules and regulations to govern the quality of the drugs to be distributed.《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》經(jīng)營(yíng)藥品。 The drug regulatory agency inspect a drug distributor as to its pliance with the GSP requirements, and issue a certificate to the distributor passing the inspection.，必須建立并執(zhí)行進(jìn)貨檢查驗(yàn)收制度，驗(yàn)明藥品合格證明和其他標(biāo)識(shí)；不符合規(guī)定要求的，不得購(gòu)進(jìn)。 no drugs that fail to meet the requirements are permitted to be purchased.，必須有真實(shí)完整的購(gòu)銷(xiāo)記錄。 In the record shall be indicated the adopted name of drugs, dosage form, strength or size, batch number, date of expiry, manufacturer, purchaser (or seller), amount of the drug purchased (or sold), purchase or selling price, date of purchase (or sale) , and other items specified by the drug regulatory agency of the State Council.，必須標(biāo)明產(chǎn)地。 A drug distributor shall pass the established system for drug storage, and take necessary measures to ensure drug quality, such as cold storing, protecting from being frozen and moisture and guarding against insects and rodents.。 Chinese crude drugs may be sold at fairs in urban and rural areas, except those otherwise specified by the State Council.，但持有《藥品經(jīng)營(yíng)許可證》的藥品零售企業(yè)在規(guī)定的范圍內(nèi)可以在城鄉(xiāng)集市貿(mào)易市場(chǎng)設(shè)點(diǎn)出售中藥材以外的藥品。Dispensing pharmaceutical preparations by a medical institution shall be subject to reviewing and permission by the health administration agency of the government of the province, autonomous region or municipality directly under the Central Government, and upon approval by the drug regulatory agency of the government. A Pharmaceutical Preparation Certificate for Medical Institution shall be issued by the above drug regulatory agency.《醫(yī)療機(jī)構(gòu)制劑許可證》的醫(yī)療機(jī)構(gòu)，不得配制制劑。 The term of validation shall be noted in the Pharmaceutical Preparation Certificate for Medical Institution. For renewal of the certificate upon expiration, reviewing and approval again is required.，應(yīng)當(dāng)是本單位臨床需要而市場(chǎng)上沒(méi)有供應(yīng)的品種，并須經(jīng)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)批準(zhǔn)后方可配制。 No pharmaceutical preparations dispensed by medical institutions are permitted to be marketed.，必須按照國(guó)務(wù)院藥品監(jiān)督管理部門(mén)的規(guī)定如實(shí)報(bào)送研制方法、質(zhì)量指標(biāo)、藥理及毒理試驗(yàn)結(jié)果等有關(guān)資料和樣品，經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門(mén)批準(zhǔn)后，方可進(jìn)行臨床試驗(yàn)。 When a new drug has gone through clinical trials and passed the reviewing, a New Drug Certificate shall be issued upon approval by the drug regulatory agency of the State Council.、藥物臨床試驗(yàn)質(zhì)量管理規(guī)范。Production of a new drug or production of a drug plying with National Drug Standards shall be subject to the approval by the drug regulatory agency of the State Council, and a drug approval number shall be issued for it, with the exception of the Chinese crude drugs and the prepared slices of Chinese crude drugs in which no control by approval number is exercised. 、中藥飲片品種目錄由國(guó)務(wù)院藥品監(jiān)督管理部門(mén)會(huì)同國(guó)務(wù)院中醫(yī)藥管理部門(mén)制定。 A drug manufacturer is permitted to produce the drug only after an approval number has been granted to it.71. 藥品必須符合國(guó)家藥品標(biāo)準(zhǔn)。The Pharmacopoeia of the People39。 The drug regulatory agency of the State Council shall organize a pharmacopoeia mission, which shall be responsible for formulating and revising the National Drug Standards.、對(duì)照品。 Drug manufacturers, drug distributors and medical institutions shall purchase drugs from pharmaceutical enterprises, which are qualified for production and distribution, with the exception of the Chinese crude drugs in 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(shí)行特殊管理。The State adopts a protection system for certain traditional Chinese medicines.。 Reviewing the drugs to be imported shall e of the jurisdiction of the drug regulatory agency of the State Council. A drug is permitted to be imported only upon approval granted after confirming that it conforms to the quality, safely and efficiency through examination, and a drug importation license shall be issued.。 When major disasters, epidemic situations or other emergencies occur in the country, the department designated by the State Council may allocate drugs from the enterprises to meet the urgent need.82. 禁止生產(chǎn)（包括配制）、銷(xiāo)售假藥。 （二）以非藥品冒充藥品或者以他種藥品冒充此種藥品的。（二）依照本法必須批準(zhǔn)而未經(jīng)批準(zhǔn)生產(chǎn)、進(jìn)口，或者依照本法必須檢驗(yàn)而未經(jīng)檢驗(yàn)即銷(xiāo)售的； It is produced or imported without approval, or marketed without being tested, as required by the Law。（四）被污染的； It is contaminated。 （六）所標(biāo)明的適應(yīng)癥或者功能主治超出規(guī)定范圍的。 Production and distribution of drugs of inferior quality are prohibited.，為劣藥。（二）不注明或者更改生產(chǎn)批號(hào)的； The batch number is not indicated or is altered。（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 or container。 or（六）其他不符合藥品標(biāo)準(zhǔn)規(guī)定的。已經(jīng)作為藥品通用名稱的，該名稱不得作為藥品商標(biāo)使用。Staff members of drug manufacturers, drug distributors and medical institutions who make a direct contact with drugs shall receive physical examination annually.，不得從事直接接觸藥品的工作。 Immediate packaging materials and containers shall meet the requirements for medicinal use and ply with the standards for ensuring human health and safety. They along with the drugs shall be subject to reviewing and approval by 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(shuō)明書(shū)。 In the label or insert sheet shall be indicated the adopted name of the drug, its ingredients, strength, manufacturer, approval number, product batch number, production date, date of expiry, indications or functions, usage, dosage, contraindications, drug adverse reactions, and precautions.、精神藥品、醫(yī)療用毒性藥品、放射性藥品、外用藥品和非處方藥的標(biāo)簽，必須印有規(guī)定的標(biāo)志。 Drug manufacturers, drug distributors and medical institutions shall ply with the prices fixed or guided by the government. No one is permitted t