【正文】 marketed at urban or rural fairs. 10 城鄉(xiāng)集市貿(mào)易市場(chǎng)不得出售中藥材以外的藥品，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。 Article 20 Rules for storage of pharmaceuticals shall be formulated and implemented by pharmaceutical trading enterprises, which must adopt necessary measures to facilitate cold storage and protection against freezing, moisture, insects and rodents to ensure pharmaceutical quality. 藥品入庫和出庫必須執(zhí)行檢查制度。 Article 19 It is imperative for pharmaceutical trading enterprises, in the sale of pharmaceuticals, to be accurate and free of mistakes, and to provide correct directions for use, dosage and precautions. Prescriptions being dispensed must be checked. Pharmaceutical products listed in the prescription must not be presumptuously changed or substituted. Prescriptions containing inpatible substances or excessive dosages shall be rejected by the dispensary. If necessary, such prescriptions can be dispensed after they have been corrected or resigned by the doctors who wrote them. 藥品經(jīng)營(yíng)企業(yè)銷售中藥材，必須標(biāo)明產(chǎn)地。s generic names, types, specifications, batches, valid periods, producing enterprises, purchasing (selling) units, purchasing (selling) quantity, purchasing and selling price, purchasing (selling) date and other contents required by the pharmaceutical supervisory and administrative department under the State Council. 第十九條 藥品經(jīng)營(yíng)企業(yè)銷售藥品必須準(zhǔn)確無誤，并正確說明用法、用量和注意事項(xiàng)； 調(diào)配處方必須經(jīng)過核對(duì)，對(duì)處方所列藥品不得擅自更改或者代用。藥品管理法（ 3） Article 18 Pharmaceutical trading enterprises shall keep accurate and plete 9 records of purchased pharmaceuticals. Purchasing records must bear information on the pharmaceutical product39。 Article 17 Pharmaceutical trading enterprises must formulate and implement check and approval rules for the purchase of pharmaceuticals, and check pharmaceutical certifications and other marks while purchasing pharmaceuticals. Pharmaceuticals that do not meet the required standards must not be purchased. 第十八條 藥品經(jīng)營(yíng)企業(yè)購(gòu)銷藥品，必須有真實(shí)完整的購(gòu)銷記錄。 Article 16 Pharmaceutical producing enterprises must trade in pharmaceuticals in accordance with the Standards for Quality Control of Pharmaceutical Trading stipulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law. Pharmaceutical supervisory and administrative departments shall certify whether pharmaceutical trading enterprises meet the requirements of the Standards for Quality Control of Pharmaceutical Trading in accordance with relevant regulations, and issue certifications to qualified enterprises. 《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》的具體實(shí)施辦法、實(shí)施步驟由國(guó)務(wù)院藥品監(jiān)督 管理部門規(guī)定。 (4) It shall have rules and regulations to ensure the quality of the pharmaceuticals in which it trades. 第十六條 藥品經(jīng)營(yíng)企業(yè)必須按照國(guó)務(wù)院藥品監(jiān)督管理部門依據(jù)本法制定的《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》經(jīng)營(yíng)藥品。 A Pharmaceutical Trade License shall bear a scope of trade and a period of validity, and upon expiration a new license shall be issued after examination for its renewal. 藥品監(jiān)督管理部門批準(zhǔn)開辦藥品經(jīng)營(yíng)企業(yè)，除依據(jù)本法第十五條規(guī)定的條件外，還應(yīng)當(dāng)遵循合理布局和方便群眾購(gòu)藥的原則。無《藥品經(jīng)營(yíng)許可證》的，不得經(jīng)營(yíng)藥品。 products which do not meet national pharmaceutical standards or are not prepared in conformity with the processing standards stipulated by the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government shall not leave the factory. 第十三條 經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門或者國(guó)務(wù)院藥品監(jiān)督管理部門授權(quán)的省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)，藥品生產(chǎn)企業(yè)可以接受委托生產(chǎn)藥品。 Article 11 The raw and supplementary materials used for the production of pharmaceuticals must conform to the requirements for medicinal use. 第十二條 藥品生產(chǎn)企業(yè)必須對(duì)其生產(chǎn)的藥品進(jìn)行質(zhì)量檢驗(yàn)；不符合國(guó)家藥品標(biāo)準(zhǔn)或者不按照省、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。省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門制定的炮制規(guī)范應(yīng)當(dāng)報(bào)國(guó)務(wù)院藥品監(jiān)督管理部門備案。藥品生產(chǎn)企業(yè)改變影響藥品質(zhì)量的生產(chǎn)工藝的，必須報(bào)原批準(zhǔn)部門審核批準(zhǔn)。 Article 9 Pharmaceutical producing enterprises must anize production in accordance with the Standards for Quality Control of Pharmaceutical Production formulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law. Pharmaceutical supervisory and administrative departments shall confirm whether the pharmaceutical producing enterprises have met the requirements of the Standards, and shall issue certificates to those qualified ones. 《藥品生產(chǎn)質(zhì)量管理規(guī)范》的具體實(shí)施辦法、實(shí)施步驟由國(guó)務(wù)院藥品監(jiān)督管理部門規(guī)定。 (4) It shall have rules and regulations to ensure the quality of medicines. 第九條 藥品生產(chǎn)企業(yè)必須按照國(guó)務(wù)院藥品監(jiān)督管理 部門依據(jù)本法制定的《藥品生產(chǎn)質(zhì)量管理規(guī)范》組織生產(chǎn)。 The Pharmaceutical Production License shall bear the scope of production and a period of validity, and upon expiration a new license shall be issued after examination for its renewal. 藥品監(jiān)督管理部門批準(zhǔn)開辦藥品生產(chǎn)企業(yè)，除依據(jù)本法第八條規(guī)定的條件外，還應(yīng)當(dāng)符合國(guó)家制定的藥品行業(yè)發(fā)展規(guī)劃和產(chǎn)業(yè)政策，防止重復(fù)建設(shè)。無《藥品生產(chǎn)許可證》的，不得生產(chǎn)藥品。 The pharmaceutical supervisory and administrative departments under the State Council shall cooperate with the general administrative department of the economy under the State Council to carry out pharmaceutical development plans and industrial policies formulated by the State. 第六條 藥品監(jiān)督管理部門設(shè)置或者確定的藥品檢驗(yàn)機(jī)構(gòu)，承擔(dān)依法實(shí)施藥品審批和藥品質(zhì)量監(jiān)督檢查所需的藥品檢驗(yàn)工作。省、自治區(qū)、直轄市人民政府有關(guān)部門在各自的職責(zé)范圍內(nèi)負(fù)責(zé)與藥品有關(guān)的監(jiān)督管理工作。國(guó)務(wù)院有關(guān)部門在各自的職責(zé)范圍內(nèi)負(fù)責(zé)與藥品有關(guān)的監(jiān)督管理工作。 The State shall protect the resources of wild medicinal resources and encourage the domestic cultivation of Chinese traditional medicinal crops. 第四條 國(guó)家鼓勵(lì)研究和創(chuàng)制新藥，保護(hù)公民、法人和其他組織研究、開發(fā)新藥的合法權(quán)益。s Republic of China. 第三條 國(guó)家發(fā)展現(xiàn)代藥和傳統(tǒng)藥，充分發(fā)揮其在預(yù)防、醫(yī)療和保健中的作用。 Article 2 The law shall be applicable to any units or individuals engaged in research, production, trade, use, supervision and management of pharmaceuticals within the territory of the People39。s Republic of China 目錄 Contents 第一章 總則 Chapter I General Provisions 第二章 藥品生產(chǎn)企業(yè)管理 Chapter II Administration of Pharmaceutical Producing Enterprises 第三章 藥品經(jīng)營(yíng)企業(yè)管理 Chapter III Administration of Pharmaceutical Trading Enterprises 第四章 醫(yī)療機(jī)構(gòu)的藥劑管理 Chap