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

第四十一條除中藥材


、中藥飲片外，藥品必須使用注冊商標
；未經核準注冊的，不得在市場銷售。
[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.

注冊商標必須在藥品的包裝和標簽上注明。
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省、自治區、直轄市衛生行政部門審查批準
；未經批準的
，不得刊登
、播放、散發和張貼。
[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under the direct control of the Central Government responsible for administering health; unless it is approved, it may not be published, broadcast, distributed or displayed on a poster.

第四十三條外國企業在我國申請辦理藥品廣告，必須提供生產該藥品的國家（地區）批準的證明文件

、藥品說明書和有關資料。
[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容必須以國務院衛生行政部門或者省、自治區、直轄市衛生行政部門批準的說明書為準。
[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.

第九章藥品監督
CHAPTER IX DRUG CONTROL

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

縣級以上衛生行政部門
，可以設置藥政機構和藥品檢驗機構。
Departments administering health at above county level may establish drug administration bodies and drug inspection bodies.

第四十六條縣級以上衛生行政部門設藥品監督員。藥品監督員由藥學技術人員擔任，由同級人民政府審核發給證書。
[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.

第四十七條藥品監督員有權按照規定對轄區內的藥品生產企業

、藥品經營企業和醫療單位的藥品質量進行監督
、檢查、抽驗，必要時可以按照規定抽取樣品和索取有關資料，有關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.

藥品監督員對藥品的生產企業和科研單位提供的技術資料，負責保密。
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企業、藥品經營企業和醫療單位
，應當經常考察本單位所生產、經營
、使用的藥品的質量
、療效和不良反應。
[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.

醫療單位發現藥品中毒事故，必須及時向當地衛生行政部門報止。
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企業和藥品經營企業的藥品檢驗機構或者人員，受當地藥品檢驗機構的業務指導。
[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.

第十章法律責任
CHAPTER X LEGAL RESPONSIBILITIES

第五十條生產、銷售假藥的，沒收假藥和違法所得
，處以罰款，並可以責令該單位停產、停業整頓或者吊銷《藥品生產企業許可證》、《藥品經營企業許可證》
、《製劑許可證》。
[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.

對生產、銷售假藥
，危害人民健康的個人或者單位直接責任人員，依照刑法第一百六十四條規定追究刑事責任。
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、銷售劣藥的，沒收劣藥和違法所得，可以並處罰款；情節嚴重的，並責令該單位停產
、停業整頓或者吊銷《藥品生產企業許可證》、《藥品經營企業許可證》、《製劑許可證》。
[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.

對生產銷售劣藥，危害人民健康，造成嚴重後果的個人或單位直接責任人員，比照刑法第一百六十四條的規定追究刑事責任。
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《藥品生產企業許可證》
、《藥品經營企業許可證》、《製劑許可證》生產藥品、經營藥品或者配製製劑的
，責令該單位停產、停業或者停止配製製劑，沒收全部藥品和違法所得，可以並處罰款。
[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於藥品生產、藥品經營的管理的其他規定的，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.

第五十四條本法規定的行政處罰，由縣級以上衛生行政部門決定。違反本法第十五條規定
、第八章有關廣告管理的規定的行政處罰，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.

對中央或者省、自治區、直轄市人民政府直接管轄的藥品生產企業、藥品經營企業處以停產
、停業整頓7天以上或者吊銷《藥品生產企業許可證》、 《藥品經營企業許可證》處罰的，由省、自治區
、直轄市衛生行政部門報同級人民政府決定。對市、縣或者市
、縣以下人民政府管轄的藥品生產企業、藥品經營企業處以停產

，停業整頓 7天以上或者吊銷《藥品生產企業許可證》
、《藥品經營企業許可證》處罰的，由市、縣人民政府衛生行政部門報同級人民政府決定。
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.

沒收的藥品由衛生行政部門監督處理。
Confiscated drugs shall be disposed of under the supervision of the department responsible for health administration.

第五十五條當事人對行政處罰決定不服的，可以在接到處罰通知之日起 15 天內向人民法院起訴。
[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

danshi，duiweishengxingzhengbumenzuochudeyaopinkongzhidejueding


，dangshirenbixulijizhixing。duichufajuedingbulvxingyuqiyoubuqisude
，youzuochuxingzhengchufajuedingdejiguanshenqingrenminfayuanqiangzhizhixing。
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，致害單位或者個人應當負損害賠償責任。受害人可以請求縣級以上衛生行政部門處理；當事人不服的，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，應當從受害人或者其代理人知道或者應當知道之日起 1年內提出；超過期限的，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的含義是：
[Article 57] The expressions used in this law are defined as follows:

藥品：指用於預防、治療、診斷人的疾病，有目的地調節人的生理機能並規定有適應症、用法和用量的物質


，
"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、化學原料藥及其製劑、抗生素、生化藥品、放射性藥品、血清疫苗、血液製品和診斷藥品等。
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.

新藥指我國未生產過的藥品。
"New drugs" refers to those drugs which have never been produced in this country.

輔料指生產藥品和調配處方時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.

藥品生產企業指生產藥品的專營企業或者兼營企業。
"Drug-producing enterprise" refers to those enterprises exclusively or partially engaged in the production of drugs.

藥品經營企業指經營藥品的專營企業或者兼營企業。
"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的藥品生產，不包括中藥材的種植
、采集和飼養。
[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.

第五十九條國務院衛生行政部門根據本法製定實施辦法報國務院批準施行。
[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.

中國人民解放軍特需藥品的管理辦法由國家軍事主管部門製定。
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 為加強藥品監督管理，保證藥品質量，保障人體用藥安全
，維護人民身體健康和用藥的合法權益，特製定本法。
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 在中華人民共和國境內從事藥品的研製
、生產、經營、使用和監督管理的單位或者個人，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 國家發展現代藥和傳統藥
，充分發揮其在預防、醫療和保健中的作用。
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.

國家保護野生藥材資源，鼓勵培育中藥材。
The State shall protect the resources of wild medicinal resources and encourage the domestic cultivation of Chinese traditional medicinal crops.

第四條 國家鼓勵研究和創製新藥，保護公民、法人和其他組織研究、開發新藥的合法權益。
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 國務院藥品監督管理部門主管全國藥品監督管理工作。國務院有關部門在各自的職責範圍內負責與藥品有關的監督管理工作。
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、直轄市人民政府藥品監督管理部門負責本行政區域內的藥品監督管理工作。省、自治區
、直轄市人民政府有關部門在各自的職責範圍內負責與藥品有關的監督管理工作。
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.

國務院藥品監督管理部門應當配合國務院經濟綜合主管部門

，執行國家製定的藥品行業發展規劃和產業政策。
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 藥品監督管理部門設置或者確定的藥品檢驗機構，承擔依法實施藥品審批和藥品質量監督檢查所需的藥品檢驗工作。
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 藥品生產企業管理
Chapter II Administration of Pharmaceutical Producing Enterprises

第七條 開辦藥品生產企業

，須經企業所在地省、自治區、直轄市人民政府藥品監督管理部門批準並發給《藥品生產許可證》
，
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《藥品生產許可證》到工商行政管理部門辦理登記注冊。無《藥品生產許可證》的，不得生產藥品。
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.

《藥品生產許可證》應當標明有效期和生產範圍，到期重新審查發證。
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yao品pin監jian督du管guan理li部bu門men批pi準zhun開kai辦ban藥yao品pin生sheng產chan企qi業ye，除chu依yi據ju本ben法fa第di八ba條tiao規gui定ding的de條tiao件jian外wai


，還hai應ying當dang符fu合he國guo家jia製zhi定ding的de藥yao品pin行xing業ye發fa展zhan規gui劃hua和he產chan業ye政zheng策ce，防fang止zhi重zhong複fu建jian設she。
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 開辦藥品生產企業
，必須具備以下條件：
Article 8 To establish a pharmaceutical producing enterprise, the following requirements must be met:

（一）具有依法經過資格認定的藥學技術人員、工程技術人員及相應的技術工人；
(1) It shall be staffed with legally certified pharmaceutical technical personnel, engineering technical personnel, as well as corresponding skilled workers.

（二）具有與其藥品生產相適應的廠房、設施和衛生環境；
(2) It shall have factory premises, facilities and a sanitary environment suitable for the medicines produced.

（三）具有能對所生產藥品進行質量管理和質量檢驗的機構、人員以及必要的儀器設備；
(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）具有保證藥品質量的規章製度。
(4) It shall have rules and regulations to ensure the quality of medicines.

第九條 藥品生產企業必須按照國務院藥品監督管理部門依據本法製定的《藥品生產質量管理規範》組織生產。藥品監督管理部門按照規定對藥品生產企業是否符合《藥品生產質量管理規範》的要求進行認證；對認證合格的，發給認證證書。
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.

《藥品生產質量管理規範》的具體實施辦法、實施步驟由國務院藥品監督管理部門規定。
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chu中zhong藥yao飲yin片pian的de炮pao製zhi外wai

，藥yao品pin必bi須xu按an照zhao國guo家jia藥yao品pin標biao準zhun和he國guo務wu院yuan藥yao品pin監jian督du管guan理li部bu門men批pi準zhun的de生sheng產chan工gong藝yi進jin行xing生sheng產chan
，生sheng產chan記ji錄lu必bi須xu完wan整zheng準zhun確que。藥yao品pin生sheng產chan企qi業ye改gai變bian影ying響xiang藥yao品pin質zhi量liang的de生sheng產chan工gong藝yi的de，必bi須xu報bao原yuan批pi準zhun部bu門men審shen核he批pi準zhun。
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家藥品標準炮製
；國家藥品標準沒有規定的



，必須按照省
、自治區、直轄市人民政府藥品監督管理部門製定的炮製規範炮製。省

、自治區、直轄市人民政府藥品監督管理部門製定的炮製規範應當報國務院藥品監督管理部門備案。
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 藥品生產企業必須對其生產的藥品進行質量檢驗；不符合國家藥品標準或者不按照省
、自治區、直轄市人民政府藥品監督管理部門製定的中藥飲片炮製規範炮製的
，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 經國務院藥品監督管理部門或者國務院藥品監督管理部門授權的省
、自治區、直轄市人民政府藥品監督管理部門批準，藥品生產企業可以接受委托生產藥品。
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 藥品經營企業管理
Chapter III Administration of Pharmaceutical Trading Enterprises

第十四條 開辦藥品批發企業，須經企業所在地省、自治區、直轄市人民政府藥品監督管理部門批準並發給《藥品經營許可證》
；
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，須經企業所在地縣級以上地方藥品監督管理部門批準並發給《藥品經營許可證》
，憑《藥品經營許可證》到工商行政管理部門辦理登記注冊。無《藥品經營許可證》的
，不得經營藥品。
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.

《藥品經營許可證》應當標明有效期和經營範圍，到期重新審查發證。
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.

藥品監督管理部門批準開辦藥品經營企業
，除依據本法第十五條規定的條件外，還應當遵循合理布局和方便群眾購藥的原則。
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 開辦藥品經營企業必須具備以下條件：
Article 15 To establish a pharmaceutical trading enterprise, the following requirements must be met

（一）具有依法經過資格認定的藥學技術人員；
(1) 1 It shall be staffed with legally certified pharmaceutical technical personnel.

（二）具有與所經營藥品相適應的營業場所、設備、倉儲設施
、衛生環境；
(2) It shall have business premises, equipment, storage facilities and a sanitary environment suitable for the pharmaceuticals in which it trades.

（三）具有與所經營藥品相適應的質量管理機構或者人員；
(3) It shall have a quality control organ or personnel suitable for the pharmaceuticals in which it trades.

（四）具有保證所經營藥品質量的規章製度。
(4) It shall have rules and regulations to ensure the quality of the pharmaceuticals in which it trades.

第十六條 藥品經營企業必須按照國務院藥品監督管理部門依據本法製定的《藥品經營質量管理規範》經營藥品。
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.

藥品監督管理部門按照規定對藥品經營企業是否符合《藥品經營質量管理規範》的要求進行認證；對認證合格的，發給認證證書。
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.

《藥品經營質量管理規範》的具體實施辦法
、實施步驟由國務院藥品監督管理部門規定。
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 藥品經營企業購進藥品，必須建立並執行進貨檢查驗收製度，驗明藥品合格證明和其他標識；不符合規定要求的，不得購進。
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 藥品經營企業購銷藥品，必須有真實完整的購銷記錄。購銷記錄必須注明藥品的通用名稱、劑型、規格、批號、有效期、生產廠商、購（銷）貨單位
、購（銷）貨數量
、購銷價格
、購（銷）貨日期及國務院藥品監督管理部門規定的其他內容。
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 藥品經營企業銷售藥品必須準確無誤
，並正確說明用法、用量和注意事項
；調配處方必須經過核對，對處方所列藥品不得擅自更改或者代用。對有配伍禁忌或者超劑量的處方，應當拒絕調配；必要時
，經處方醫師更正或者重新簽字，方可調配。
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.

藥品經營企業銷售中藥材


，必須標明產地。
When traditional Chinese medicinal materials are offered for sale by pharmaceutical trading enterprises, their origin must be indicated.

第二十條 藥品經營企業必須製定和執行藥品保管製度，采取必要的冷藏
、防凍、防潮、防蟲、防鼠等措施，保證藥品質量。
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.

藥品入庫和出庫必須執行檢查製度。
An inspection system shall be carried out for pharmaceuticals entering or leaving a warehouse

第二十一條 城鄉集市貿易市場可以出售中藥材

，國務院另有規定的除外。
Article 21 Unless otherwise stipulated by the State, traditional Chinese medicinal materials may be marketed at urban or rural fairs.

城鄉集市貿易市場不得出售中藥材以外的藥品

，但持有《藥品經營許可證》的藥品零售企業在規定的範圍內可以在城鄉集市貿易市場設點出售中藥材以外的藥品。具體辦法由國務院規定。
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 醫療機構的藥劑管理
Chapter IV Administration of Pharmaceuticals at Medical Organizations

第二十二條 醫療機構必須配備依法經過資格認定的藥學技術人員。非藥學技術人員不得直接從事藥劑技術工作。
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 醫療機構配製製劑，須經所在地省、自治區、直轄市人民政府衛生行政部門審核同意，由省、自治區、直轄市人民政府藥品監督管理部門批準
，發給《醫療機構製劑許可證》。無《醫療機構製劑許可證》的
，不得配製製劑。
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.

《醫療機構製劑許可證》應當標明有效期，到期重新, 審查發證。
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 醫療機構配製製劑，必須具有能夠保證製劑質量的設施、管理製度、檢驗儀器和衛生條件。
Article 24 Medical organizations that make medicinal preparations must have facilities, a m

第二十五條 醫療機構配製的製劑，應當是本單位臨床需要而市場上沒有供應的品種，並須經所在地省、自治區、直轄市人民政府藥品監督管理部門批準後方可配製。
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.

配製的製劑必須按照規定進行質量檢驗；合格的，憑醫師處方在本醫療機構使用。特殊情況下，經國務院或者省、自治區
、直轄市人民政府的藥品監督管理部門批準
，醫療機構配製的製劑可以在指定的醫療機構之間調劑使用。
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.

醫療機構配製的製劑

，不得在市場銷售。
Medicinal preparations made by medical organizations may not be sold on the market.

第二十六條 醫療機構購進藥品，必須建立並執行進貨檢查驗收製度，驗明藥品合格證明和其他標識；不符合規定要求的，不得購進和使用。
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(yi)療(liao)機(ji)構(gou)的(de)藥(yao)劑(ji)人(ren)員(yuan)調(tiao)配(pei)處(chu)方(fang)，必(bi)須(xu)經(jing)過(guo)核(he)對(dui)，對(dui)處(chu)方(fang)所(suo)列(lie)藥(yao)品(pin)不(bu)得(de)擅(shan)自(zi)更(geng)改(gai)或(huo)者(zhe)代(dai)用(yong)。對(dui)有(you)配(pei)伍(wu)禁(jin)忌(ji)或(huo)者(zhe)超(chao)劑(ji)量(liang)的(de)處(chu)方(fang)，應(ying)當(dang)拒(ju)絕(jue)調(tiao)配(pei)；必要時，經處方醫師更正或者重新簽字，方可調配。
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 醫療機構必須製定和執行藥品保管製度，采取必要的冷藏

、防凍、防潮、防蟲
、防鼠等措施，保證藥品質量。
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.