第八章藥品商標(biāo)和廣告的管理
CHAPTER VIII ADMINISTRATION OF DRUG TRADEMARKS AND ADVERTISING

第四十一條除中藥材、中藥飲片外，藥品必須使用注冊(cè)商標(biāo)；未經(jīng)核準(zhǔn)注冊(cè)的，不得在市場(chǎng)銷售。
[Article 41] With the exception of Chinese medicinal materials and Chinese medicines sliced and prepared for decoction, drugs must use a registered trademark and may not be sold on the market until examined and approved for registration.

注冊(cè)商標(biāo)必須在藥品的包裝和標(biāo)簽上注明。
The registered trademark must be clearly shown on the package and label of the drug.

第四十二條藥品廣告必須經(jīng)省、自治區(qū)、直轄市衛(wèi)生行政部門審查批準(zhǔn)；未經(jīng)批準(zhǔn)的，不得刊登、播放、散發(fā)和張貼。
[Article 42] An advertisement for a drug must be examined and approved by the department of the province, autonomous region or municipality under the direct control of the Central Government responsible for administering health; unless it is approved, it may not be published, broadcast, distributed or displayed on a poster.

第四十三條外國(guó)企業(yè)在我國(guó)申請(qǐng)辦理藥品廣告，必須提供生產(chǎn)該藥品的國(guó)家（地區(qū)）批準(zhǔn)的證明文件、藥品說(shuō)明書和有關(guān)資料。
[Article 43] Where a foreign enterprise applies to advertise a drug in this country, it must submit documents proving approval of the drug from the country (or place) of its production, a written description of the drug and relevant material.

第四十四條藥品廣告的內(nèi)容必須以國(guó)務(wù)院衛(wèi)生行政部門或者省、自治區(qū)、直轄市衛(wèi)生行政部門批準(zhǔn)的說(shuō)明書為準(zhǔn)。
[Article 44] The contents of an advertisement for a drug must be in accordance with the explanatory booklet approved by the department of the State Council administering health or the department of the province, autonomous region or municipality under the direct control of the Central Government administering health.

第九章藥品監(jiān)督
CHAPTER IX DRUG CONTROL

第四十五條縣級(jí)以上衛(wèi)生行政部門行使藥品監(jiān)督職權(quán)。
[Article 45] Departments administering health above the county level exercise the power of supervision over drugs.

縣級(jí)以上衛(wèi)生行政部門，可以設(shè)置藥政機(jī)構(gòu)和藥品檢驗(yàn)機(jī)構(gòu)。
Departments administering health at above county level may establish drug administration bodies and drug inspection bodies.

第四十六條縣級(jí)以上衛(wèi)生行政部門設(shè)藥品監(jiān)督員。藥品監(jiān)督員由藥學(xué)技術(shù)人員擔(dān)任，由同級(jí)人民政府審核發(fā)給證書。
[Article 46] Departments administering health at above county level will appoint Drug Controllers. Drug Controllers will be appointed from those holding the position of pharmaceutical technicians; they shall be examined, and a certificate will be issued by the People's Governments at that level.

第四十七條藥品監(jiān)督員有權(quán)按照規(guī)定對(duì)轄區(qū)內(nèi)的藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)和醫(yī)療單位的藥品質(zhì)量進(jìn)行監(jiān)督、檢查、抽驗(yàn)，必要時(shí)可以按照規(guī)定抽取樣品和索取有關(guān)資料，有關(guān)單位不得拒絕和隱瞞。
[Article 47] A Drug Controller has the power, in accordance with regulations, to control, inspect and test the quality of drugs in drug-producing enterprises, drug-handling enterprises and medical treatment units within the Controller's area of jurisdiction. If necessary, the Drug Controller may, in accordance with regulations, take samples and obtain relevant data which the relevant unit may not refuse to provide and may not conceal.

藥品監(jiān)督員對(duì)藥品的生產(chǎn)企業(yè)和科研單位提供的技術(shù)資料，負(fù)責(zé)保密。
Drug Controllers are responsible for keeping the technical data provided by drug-manufacturing enterprises or scientific research units confidential.

第四十八條藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)和醫(yī)療單位，應(yīng)當(dāng)經(jīng)常考察本單位所生產(chǎn)、經(jīng)營(yíng)、使用的藥品的質(zhì)量、療效和不良反應(yīng)。
[Article 48] Drug-producing enterprises, drug-handling enterprises and medical treatment units shall regularly inspect and study the quality, efficacy and side-effects of drugs produced, handled or used by them.

醫(yī)療單位發(fā)現(xiàn)藥品中毒事故，必須及時(shí)向當(dāng)?shù)匦l(wèi)生行政部門報(bào)止。
If a medical treatment unit discovers a case of poisoning in relation to a drug, it must immediately report it to the department administering health in that area.

第四十九條藥品生產(chǎn)企業(yè)和藥品經(jīng)營(yíng)企業(yè)的藥品檢驗(yàn)機(jī)構(gòu)或者人員，受當(dāng)?shù)厮幤窓z驗(yàn)機(jī)構(gòu)的業(yè)務(wù)指導(dǎo)。
[Article 49] The drug-inspection body or personnel of a drug-producing enterprise or drug-handling enterprise will receive guidance in their professional work from the drug-inspection organ of that area.

第十章法律責(zé)任
CHAPTER X LEGAL RESPONSIBILITIES

第五十條生產(chǎn)、銷售假藥的，沒(méi)收假藥和違法所得，處以罰款，并可以責(zé)令該單位停產(chǎn)、停業(yè)整頓或者吊銷《藥品生產(chǎn)企業(yè)許可證》、《藥品經(jīng)營(yíng)企業(yè)許可證》、《制劑許可證》。
[Article 50] Where spurious drugs are produced or sold, the spurious drugs and the illegally obtained income will be confiscated and a fine will be imposed. In addition, the relevant unit may be ordered to stop production or stop operations for rectification or its "Drug-production Enterprise Licence", "Drug-handling Enterprise Licence" or "Dispensing Licence" may be revoked.

對(duì)生產(chǎn)、銷售假藥，危害人民健康的個(gè)人或者單位直接責(zé)任人員，依照刑法第一百六十四條規(guī)定追究刑事責(zé)任。
In pursuance of the regulations of Article 164 of the Penal Code, criminal liability will be investigated and determined in relation to individuals or units directly involved in the production or sale of spurious drugs endangering the people's health.

第五十一條生產(chǎn)、銷售劣藥的，沒(méi)收劣藥和違法所得，可以并處罰款；情節(jié)嚴(yán)重的，并責(zé)令該單位停產(chǎn)、停業(yè)整頓或者吊銷《藥品生產(chǎn)企業(yè)許可證》、《藥品經(jīng)營(yíng)企業(yè)許可證》、《制劑許可證》。
[Article 51] Where inferior drugs are produced or sold, the inferior drugs and the illegally obtained income will be confiscated and a fine may also be imposed; if the circumstances are serious, the relevant unit may be ordered to stop production or stop its operations and rectify itself, or its "Drug-production Enterprise Licence", "Drug-handling Enterprise Licence" or "Dispensing Licence" may be revoked.

對(duì)生產(chǎn)銷售劣藥，危害人民健康，造成嚴(yán)重后果的個(gè)人或單位直接責(zé)任人員，比照刑法第一百六十四條的規(guī)定追究刑事責(zé)任。
In pursuance of Article 164 of the Penal Code, criminal liability will be investigated and determined in relation to individuals or units directly involved in the production or sale of inferior drugs endangering the people's health.

第五十二條未取得《藥品生產(chǎn)企業(yè)許可證》、《藥品經(jīng)營(yíng)企業(yè)許可證》、《制劑許可證》生產(chǎn)藥品、經(jīng)營(yíng)藥品或者配制制劑的，責(zé)令該單位停產(chǎn)、停業(yè)或者停止配制制劑，沒(méi)收全部藥品和違法所得，可以并處罰款。
[Article 52] Where drugs are manufactured, handled or made up without a "Drug-production Enterprise Licence", Drug-handling Enterprise Licence" or "Dispensing Licence", the relevant unit will be ordered to stop production, stop operations or stop preparing medications. All of the illegally-produced drugs and the illegally-obtained income shall be confiscated and a fine may also be imposed.

第五十三條違反本法關(guān)于藥品生產(chǎn)、藥品經(jīng)營(yíng)的管理的其他規(guī)定的，處以警告或者罰款。
[Article 53] A violation of any other provision of this law in relation to the administration of drug production or handling will be punished by a caution or by a fine.

第五十四條本法規(guī)定的行政處罰，由縣級(jí)以上衛(wèi)生行政部門決定。違反本法第十五條規(guī)定、第八章有關(guān)廣告管理的規(guī)定的行政處罰，由工商行政管理部門決定。
[Article 54] Any decision relating to the imposition of an administrative penalty pursuant to this law shall be made by the department administering health at above the county level. Any decision relating to the imposition of a penalty for and offence against Article 15 of this law or the provisions of Chapter VIII of this law with respect to the advertising of drugs, shall be made by the department administering industry and commerce. In relation to the penalty of ordering a drug-producing enterprise or drug-handling enterprise which is directly under the management of the Central Government or the People's Government of a province, autonomous region or municipality directly under the control of the Central Government to stop production or stop its operations for more than seven days, or of revoking its "Drug-production Enterprise Licence", or "Drug-handling Enterprise Licence", the department of the province, autonomous region or municipality under the direct control of the Central Government administering health shall submit it to the People's Government at the same level for decision.

對(duì)中央或者省、自治區(qū)、直轄市人民政府直接管轄的藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)處以停產(chǎn)、停業(yè)整頓7天以上或者吊銷《藥品生產(chǎn)企業(yè)許可證》、 《藥品經(jīng)營(yíng)企業(yè)許可證》處罰的，由省、自治區(qū)、直轄市衛(wèi)生行政部門報(bào)同級(jí)人民政府決定。對(duì)市、縣或者市、縣以下人民政府管轄的藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)處以停產(chǎn)，停業(yè)整頓 7天以上或者吊銷《藥品生產(chǎn)企業(yè)許可證》、《藥品經(jīng)營(yíng)企業(yè)許可證》處罰的，由市、縣人民政府衛(wèi)生行政部門報(bào)同級(jí)人民政府決定。
In relation to a penalty ordering a drug-producing enterprise or drug-handling enterprise under the direct management of the People's Government at or below the city or county level to stop production or stop operations for more than seven days or of revoking its "Drug-production Enterprise Licence" or its "Drug-handling Enterprise Licence", the department of the city or county People's Government administering health shall submit the matter to the People's Government of the same level for decision.

沒(méi)收的藥品由衛(wèi)生行政部門監(jiān)督處理。
Confiscated drugs shall be disposed of under the supervision of the department responsible for health administration.

第五十五條當(dāng)事人對(duì)行政處罰決定不服的，可以在接到處罰通知之日起 15 天內(nèi)向人民法院起訴。
[Article 55] If a party objects to the decision to impose a penalty on him, he may, within 15 days from the date of receipt of notification of the penalty, bring an action in the People's Court. H

但是，對(duì)衛(wèi)生行政部門作出的藥品控制的決定，當(dāng)事人必須立即執(zhí)行。對(duì)處罰決定不履行逾期又不起訴的，由作出行政處罰決定的機(jī)關(guān)申請(qǐng)人民法院強(qiáng)制執(zhí)行。
owever, in the case of a decision relating to drug control taken by the department responsible for health administration, the party shall immediately comply. Where the decision has not been complied with within the time limit and no action has been brought, the People's Court shall compulsorily enforce compliance upon application by the organ which made the decision.

第五十六條違反本法，造成藥品中毒事故的，致害單位或者個(gè)人應(yīng)當(dāng)負(fù)損害賠償責(zé)任。受害人可以請(qǐng)求縣級(jí)以上衛(wèi)生行政部門處理；當(dāng)事人不服的，可以向人民法院起訴。受害人也可以直接向人民法院起訴。
[Article 56] In case of drug poisoning caused by a breach of this law, the unit or person who caused it shall be liable to pay compensation. The person suffering harm may request a department administering health at above county level to handle the matter; if the party who caused the harm objects, he or it may bring an action in the People's Court. The person suffering harm may also sue directly in the People's Court.

損害賠償要求，應(yīng)當(dāng)從受害人或者其代理人知道或者應(yīng)當(dāng)知道之日起 1年內(nèi)提出；超過(guò)期限的，不予受理。
A demand to be compensated for damage shall be submitted within a period of one year from the date on which the victim or his representative became aware or ought to have become aware of it. When this period has expired, the claim will not be entertained.

第五十七條本法下列用語(yǔ)的含義是：
[Article 57] The expressions used in this law are defined as follows:

藥品：指用于預(yù)防、治療、診斷人的疾病，有目的地調(diào)節(jié)人的生理機(jī)能并規(guī)定有適應(yīng)癥、用法和用量的物質(zhì)，
"Drug" refers to a substance used for the prevention, treatment and diagnosis of human diseases, and with the object of regulating human physiological functions, with stipulated indications, usage and dosage.

包括中藥材、中藥飲片、中成藥、化學(xué)原料藥及其制劑、抗生素、生化藥品、放射性藥品、血清疫苗、血液制品和診斷藥品等。
It includes Chinese medicinal materials and Chinese medicines sliced and prepared for decoction, prepared Chinese medicines, chemical raw material drugs and their components, antibiotics, biochemical drugs, radioactive drugs, blood serums and vaccines, blood products, diagnostic drugs and so on.

新藥指我國(guó)未生產(chǎn)過(guò)的藥品。
"New drugs" refers to those drugs which have never been produced in this country.

輔料指生產(chǎn)藥品和調(diào)配處方時(shí)所用的賦形劑和附加劑。
"Supplementary materials" refers to excipients and additives used in the production and making up of drugs.

藥品生產(chǎn)企業(yè)指生產(chǎn)藥品的專營(yíng)企業(yè)或者兼營(yíng)企業(yè)。
"Drug-producing enterprise" refers to those enterprises exclusively or partially engaged in the production of drugs.

藥品經(jīng)營(yíng)企業(yè)指經(jīng)營(yíng)藥品的專營(yíng)企業(yè)或者兼營(yíng)企業(yè)。
"Drug-handling enterprise" refers to those enterprises exclusively or partially engaged in the handling of drugs.

第五十八條本法所說(shuō)的藥品生產(chǎn)，不包括中藥材的種植、采集和飼養(yǎng)。
[Article 58] The production of drugs referred to in this law does not include the cultivation and collection of raw materials for Chinese medicines or the raising of animals in relation to Chinese medicines.

第五十九條國(guó)務(wù)院衛(wèi)生行政部門根據(jù)本法制定實(shí)施辦法報(bào)國(guó)務(wù)院批準(zhǔn)施行。
[Article 59] Measures for the implementation of this law will be set down by the State Council department responsible for health administration and submitted to the State Council for approval and implementation.

中國(guó)人民解放軍特需藥品的管理辦法由國(guó)家軍事主管部門制定。
Special provisions for the management of drugs in the People's Liberation Army will be laid down by the department in charge of national military affairs.

第六十條本法自一九八五年七月一日起施行。
[Article 60] This law shall come into force on July 1, 1985.

中華人民共和國(guó)藥品管理法
The Pharmaceutical Administration Law of the People's Republic of China

第一章 總 則
Chapter I General Provisions

第一條 為加強(qiáng)藥品監(jiān)督管理，保證藥品質(zhì)量，保障人體用藥安全，維護(hù)人民身體健康和用藥的合法權(quán)益，特制定本法。
Article 1 This law is formulated to enhance the supervision and control of pharmaceuticals, ensure their quality, guarantee safety in medication, and safeguard the health and legal rights and interests of the people.

第二條 在中華人民共和國(guó)境內(nèi)從事藥品的研制、生產(chǎn)、經(jīng)營(yíng)、使用和監(jiān)督管理的單位或者個(gè)人，必須遵守本法。
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 People'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 3 The State shall develop both modern and traditional medicines encourage their role in the prevention and treatment of diseases and in health care.

國(guó)家保護(hù)野生藥材資源，鼓勵(lì)培育中藥材。
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。
Article 4 The State shall encourage the research and production of new medicine and protect the legal rights and interests of its citizens, natural persons and other organizations in the research and development of new medicine.

第五條 國(guó)務(wù)院藥品監(jiān)督管理部門主管全國(guó)藥品監(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。
Article 5 The pharmaceuticals supervisory and administrative departments under the State Council shall be responsible for the supervision and control of pharmaceuticals throughout the country. Other relevant departments under the State Council shall be responsible for the supervision and control of pharmaceuticals related to the scope of their functions.

省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門負(fù)責(zé)本行政區(qū)域內(nèi)的藥品監(jiān)督管理工作。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。
The pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and control of pharmaceuticals within their administrative regions. Other relevant departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and control of pharmaceuticals related to the scope of their functions.

國(guó)務(wù)院藥品監(jiān)督管理部門應(yīng)當(dāng)配合國(guó)務(wù)院經(jīng)濟(jì)綜合主管部門，執(zhí)行國(guó)家制定的藥品行業(yè)發(fā)展規(guī)劃和產(chǎn)業(yè)政策。
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。
Article 6 The pharmaceutical inspection institutions established or approved by the pharmaceutical supervisory and administrative departments shall be charged with the work of pharmaceutical examination and approval, as well as quality inspection, in accordance with laws and regulations.

第二章 藥品生產(chǎn)企業(yè)管理
Chapter II Administration of Pharmaceutical Producing Enterprises

第七條 開辦藥品生產(chǎn)企業(yè)，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《藥品生產(chǎn)許可證》，
Article 7 The establishment of a pharmaceutical producing enterprise must be approved by and issued a Pharmaceutical Production License by the pharmaceutical supervisory and administrative department of the province, autonomous region, or municipality directly under the Central government in which the enterprise is located.

憑《藥品生產(chǎn)許可證》到工商行政管理部門辦理登記注冊(cè)。無(wú)《藥品生產(chǎn)許可證》的，不得生產(chǎn)藥品。
The establishment shall be registered at the industry and commerce administrative department based on the Pharmaceutical Production License, without which no pharmaceuticals shall be produced.

《藥品生產(chǎn)許可證》應(yīng)當(dāng)標(biāo)明有效期和生產(chǎn)范圍，到期重新審查發(fā)證。
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)。
The approval of the establishment of pharmaceutical producing enterprises by the pharmaceutical supervisory and administrative departments shall be in conformity with Article 8 of this law, as well as the pharmaceutical development plan and the industrial policies formulated by the State to avoid the instance of a repeat establishment.

第八條 開辦藥品生產(chǎn)企業(yè)，必須具備以下條件：
Article 8 To establish a pharmaceutical producing enterprise, the following requirements must be met:

（一）具有依法經(jīng)過(guò)資格認(rèn)定的藥學(xué)技術(shù)人員、工程技術(shù)人員及相應(yīng)的技術(shù)工人；
(1) It shall be staffed with legally certified pharmaceutical technical personnel, engineering technical personnel, as well as corresponding skilled workers.

（二）具有與其藥品生產(chǎn)相適應(yīng)的廠房、設(shè)施和衛(wèi)生環(huán)境；
(2) It shall have factory premises, facilities and a sanitary environment suitable for the medicines produced.

（三）具有能對(duì)所生產(chǎn)藥品進(jìn)行質(zhì)量管理和質(zhì)量檢驗(yàn)的機(jī)構(gòu)、人員以及必要的儀器設(shè)備；
(3) It shall have a unit or competent personnel capable of inspecting the quality of the medicines produced, as well as necessary instruments and equipment.

（四）具有保證藥品質(zhì)量的規(guī)章制度。
(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)。藥品監(jiān)督管理部門按照規(guī)定對(duì)藥品生產(chǎn)企業(yè)是否符合《藥品生產(chǎn)質(zhì)量管理規(guī)范》的要求進(jìn)行認(rèn)證；對(duì)認(rèn)證合格的，發(fā)給認(rèn)證證書。
Article 9 Pharmaceutical producing enterprises must organize 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。
The detailed implementation measures and implementation process of the "Standards for Quality Control of Pharmaceutical Production" shall be formulated by the pharmaceutical supervisory and administrative department under the State Council.

第十條 除中藥飲片的炮制外，藥品必須按照國(guó)家藥品標(biāo)準(zhǔn)和國(guó)務(wù)院藥品監(jiān)督管理部門批準(zhǔn)的生產(chǎn)工藝進(jìn)行生產(chǎn)，生產(chǎn)記錄必須完整準(zhǔn)確。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 10 Except in the preparation of traditional Chinese medicines into ready-to-use forms, pharmaceuticals must be produced in accordance with the national pharmaceutical standard and the technological procedures approved by the supervisory and administrative departments of pharmaceuticals under the State Council, and the record of production must be complete and accurate. The changes of technological procedure made by the pharmaceutical producing enterprises which affect the quality of the pharmaceuticals shall be examined and approved by the original approval authorities.

中藥飲片必須按照國(guó)家藥品標(biāo)準(zhǔn)炮制；國(guó)家藥品標(biāo)準(zhǔn)沒(méi)有規(guī)定的，必須按照省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門制定的炮制規(guī)范炮制。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。
The process for preparing traditional Chinese medicines into ready-to-use forms must conform to the national pharmaceutical standards, and in the absence of such standards, the process must conform to the processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central government. The processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central governments shall be placed on record at the pharmaceutical supervisory and administrative department under the State Council.

第十一條 生產(chǎn)藥品所需的原料、輔料，必須符合藥用要求。
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。
Article 12 The pharmaceutical producing enterprises must conduct quality inspections on the pharmaceuticals they produce; 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 13 Pharmaceutical producing enterprises can accept the authorization to produce pharmaceuticals after they obtain approval from the pharmaceutical supervisory and administrative department under the State Council or the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government authorized by the supervisory and administrative department of pharmaceuticals under the State Council.

第三章 藥品經(jīng)營(yíng)企業(yè)管理
Chapter III Administration of Pharmaceutical Trading Enterprises

第十四條 開辦藥品批發(fā)企業(yè)，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(yíng)許可證》；
Article 14 The establishment of pharmaceutical wholesale enterprises must be sanctioned by the competent local authorities of the production and trade of pharmaceuticals of the provinces, autonomous regions or municipalities directly under the central government, which will issue a Pharmaceutical Trade License.

開辦藥品零售企業(yè)，須經(jīng)企業(yè)所在地縣級(jí)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(yíng)許可證》，憑《藥品經(jīng)營(yíng)許可證》到工商行政管理部門辦理登記注冊(cè)。無(wú)《藥品經(jīng)營(yíng)許可證》的，不得經(jīng)營(yíng)藥品。
The establishment of pharmaceutical retail enterprises must be sanctioned by local authorities for the supervision and control of pharmaceuticals at or above the county level, which will issue a Pharmaceutical Trade License, on the basis of which registration at the industry and commerce administrative departments shall be conducted. Without the Pharmaceutical Trade License, any enterprises shall not engage in the trade of pharmaceuticals.

《藥品經(jīng)營(yíng)許可證》應(yīng)當(dāng)標(biāo)明有效期和經(jīng)營(yíng)范圍，到期重新審查發(fā)證。
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。
The approval of the establishment of pharmaceutical trading enterprises by the pharmaceutical supervisory and administrative departments shall adhere to the principle of reasonable positioning and convenience for buying of pharmaceuticals, and in addition must conform to Article 15 of this Law.

第十五條 開辦藥品經(jīng)營(yíng)企業(yè)必須具備以下條件：
Article 15 To establish a pharmaceutical trading enterprise, the following requirements must be met

（一）具有依法經(jīng)過(guò)資格認(rèn)定的藥學(xué)技術(shù)人員；
(1) 1 It shall be staffed with legally certified pharmaceutical technical personnel.

（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；
(2) It shall have business premises, equipment, storage facilities and a sanitary environment suitable for the pharmaceuticals in which it trades.

（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；
(3) It shall have a quality control organ or personnel suitable for the pharmaceuticals in which it trades.

（四）具有保證所經(jīng)營(yíng)藥品質(zhì)量的規(guī)章制度。
(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。
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.

藥品監(jiān)督管理部門按照規(guī)定對(duì)藥品經(jīng)營(yíng)企業(yè)是否符合《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》的要求進(jìn)行認(rèn)證；對(duì)認(rèn)證合格的，發(fā)給認(rèn)證證書。
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。
Detailed implementation measures and procedures for the "Standards for Quality Control of Pharmaceutical Trading" shall be stipulated by the pharmaceutical supervisory and administrative departments under the State Council.

第十七條 藥品經(jīng)營(yíng)企業(yè)購(gòu)進(jìn)藥品，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)。
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。購(gòu)銷記錄必須注明藥品的通用名稱、劑型、規(guī)格、批號(hào)、有效期、生產(chǎn)廠商、購(gòu)（銷）貨單位、購(gòu)（銷）貨數(shù)量、購(gòu)銷價(jià)格、購(gòu)（銷）貨日期及國(guó)務(wù)院藥品監(jiān)督管理部門規(guī)定的其他內(nèi)容。
Article 18 Pharmaceutical trading enterprises shall keep accurate and complete records of purchased pharmaceuticals. Purchasing records must bear information on the pharmaceutical product'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(wú)誤，并正確說(shuō)明用法、用量和注意事項(xiàng)；調(diào)配處方必須經(jīng)過(guò)核對(duì)，對(duì)處方所列藥品不得擅自更改或者代用。對(duì)有配伍禁忌或者超劑量的處方，應(yīng)當(dāng)拒絕調(diào)配；必要時(shí)，經(jīng)處方醫(yī)師更正或者重新簽字，方可調(diào)配。
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 incompatible substances or excessive dosages shall be rejected by the dispensary. If necessary, such prescriptions can be dispensed after they have been corrected or re-signed 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。
When traditional Chinese medicinal materials are offered for sale by pharmaceutical trading enterprises, their origin must be indicated.

第二十條 藥品經(jīng)營(yíng)企業(yè)必須制定和執(zhí)行藥品保管制度，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。
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(kù)和出庫(kù)必須執(zhí)行檢查制度。
An inspection system shall be carried out for pharmaceuticals entering or leaving a warehouse

第二十一條 城鄉(xiāng)集市貿(mào)易市場(chǎng)可以出售中藥材，國(guó)務(wù)院另有規(guī)定的除外。
Article 21 Unless otherwise stipulated by the State, traditional Chinese medicinal materials may be marketed at urban or rural fairs.

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。具體辦法由國(guó)務(wù)院規(guī)定。
Pharmaceuticals other than traditional Chinese medicinal materials may not be sold at urban or rural fairs, but those retail enterprises which have the Pharmaceutical Trade License may set up stalls at urban or rural fairs to sell pharmaceuticals other than traditional Chinese medicinal materials within prescribed areas. Detailed measures shall be stipulated by the State Council.

第四章 醫(yī)療機(jī)構(gòu)的藥劑管理
Chapter IV Administration of Pharmaceuticals at Medical Organizations

第二十二條 醫(yī)療機(jī)構(gòu)必須配備依法經(jīng)過(guò)資格認(rèn)定的藥學(xué)技術(shù)人員。非藥學(xué)技術(shù)人員不得直接從事藥劑技術(shù)工作。
Article 22 Medical organizations must be staffed with legally certified pharmaceutical technical personnel. Non-pharmaceutical technical personnel may not be directly engaged in the technical work of the pharmacy.

第二十三條 醫(yī)療機(jī)構(gòu)配制制劑，須經(jīng)所在地省、自治區(qū)、直轄市人民政府衛(wèi)生行政部門審核同意，由省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)，發(fā)給《醫(yī)療機(jī)構(gòu)制劑許可證》。無(wú)《醫(yī)療機(jī)構(gòu)制劑許可證》的，不得配制制劑。
Article 23 To make medicinal preparations, a medical organization must be examined and approved by the administrative departments of health of the provinces, autonomous regions, or municipalities directly under the central government where the organization is located , and approved and issued a Dispensing Permit for Medical Organizations by the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions or municipalities directly under the central government. No medicinal preparations shall be made without a Dispensing Permit for Medical Organizations.

《醫(yī)療機(jī)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。
The Dispensing Permit for Medical Organizations shall bear a period of validity, and upon expiration a new license shall be issued after examination for its renewal.

第二十四條 醫(yī)療機(jī)構(gòu)配制制劑，必須具有能夠保證制劑質(zhì)量的設(shè)施、管理制度、檢驗(yàn)儀器和衛(wèi)生條件。
Article 24 Medical organizations that make medicinal preparations must have facilities, a m

第二十五條 醫(yī)療機(jī)構(gòu)配制的制劑，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)督管理部門批準(zhǔn)后方可配制。
Article 25 The medicinal preparations made by medical organizations shall be of the kinds that supply the clinical needs of the units themselves but have not been supplied on the market, and must not be made until the approval of the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government where the units are located.

配制的制劑必須按照規(guī)定進(jìn)行質(zhì)量檢驗(yàn)；合格的，憑醫(yī)師處方在本醫(yī)療機(jī)構(gòu)使用。特殊情況下，經(jīng)國(guó)務(wù)院或者省、自治區(qū)、直轄市人民政府的藥品監(jiān)督管理部門批準(zhǔn)，醫(yī)療機(jī)構(gòu)配制的制劑可以在指定的醫(yī)療機(jī)構(gòu)之間調(diào)劑使用。
The quality of the medicinal preparations made by medical organizations must be inspected in accordance with relevant regulations. Those preparations conforming to standard can be used as the doctor prescribes. Under special circumstances, with approval from the pharmaceutical supervisory and administrative departments of the central government or of the provinces, autonomous regions and municipalities directly under the central government, the medicinal preparations made by medical organizations can be shared among appointed medical organizations.

醫(yī)療機(jī)構(gòu)配制的制劑，不得在市場(chǎng)銷售。
Medicinal preparations made by medical organizations may not be sold on the market.

第二十六條 醫(yī)療機(jī)構(gòu)購(gòu)進(jìn)藥品，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)和使用。
Article 26 When purchasing pharmaceuticals, medical organizations must formulate and implement a system of quality inspection and check the certificates and other marks of pharmaceuticals. Those pharmaceuticals that do not meet the requirements of relevant regulations shall not be purchased and used.

第二十七條 醫(yī)療機(jī)構(gòu)的藥劑人員調(diào)配處方，必須經(jīng)過(guò)核對(duì)，對(duì)處方所列藥品不得擅自更改或者代用。對(duì)有配伍禁忌或者超劑量的處方，應(yīng)當(dāng)拒絕調(diào)配；必要時(shí)，經(jīng)處方醫(yī)師更正或者重新簽字，方可調(diào)配。
Article 27 Prescriptions being dispensed by the dispensers of medical organizations must be checked. Pharmaceuticals listed in prescriptions must not be presumptuously changed or substituted. Prescriptions containing incompatible substances or excessive dosages shall be rejected by the dispensary. If necessary, such prescriptions can be dispensed after they have been corrected or re-signed by the doctors who wrote them.

第二十八條 醫(yī)療機(jī)構(gòu)必須制定和執(zhí)行藥品保管制度，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。
Article 28 Rules for storage of pharmaceuticals shall be formulated and implemented by medical organizations, which must adopt necessary measures to facilitate cold storage and protection against cold, moisture, insects and rodents to ensure the quality of pharmaceuticals.