第五章 藥品管理
Chapter V Pharmaceutical Administration

第二十九條 研制新藥，必須按照國務(wù)院藥品監(jiān)督管理部門的規(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)國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)后，方可進(jìn)行臨床試驗(yàn)。藥物臨床試驗(yàn)機(jī)構(gòu)資格的認(rèn)定辦法，由國務(wù)院藥品監(jiān)督管理部門、國務(wù)院衛(wèi)生行政部門共同制定。
Article 29 When producing a new medicine, it is necessary to submit information about the methods of production, quality indices, pharmacological and toxicological testing results, and other related materials and sales as required by the pharmaceutical supervisory and administrative department of the State Council, only after whose approval can clinical tests be carried out. Certifying measures for clinical test units shall be jointly formulated by the pharmaceutical supervisory and administrative department under the State Council and the administrative department of health under the State Council.

完成臨床試驗(yàn)并通過審批的新藥，由國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)，發(fā)給新藥證書。
A new medicine which has completed its clinical tests and been approved after appraisal shall be issued a certificate of new medicine by the pharmaceutical supervisory and administrative department under the State Council.

第三十條 藥物的非臨床安全性評價(jià)研究機(jī)構(gòu)和臨床試驗(yàn)機(jī)構(gòu)必須分別執(zhí)行藥物非臨床研究質(zhì)量管理規(guī)范、藥物臨床試驗(yàn)質(zhì)量管理規(guī)范。
Article 30 The pharmaceutical non-clinical safety appraisal and research units and the clinical test units must respectively carry out the quality control standard for pharmaceutical non-clinical research and the quality control standard for pharmaceutical clinical test.

藥物非臨床研究質(zhì)量管理規(guī)范、藥物臨床試驗(yàn)質(zhì)量管理規(guī)范由國務(wù)院確定的部門制定。
The quality control standard for pharmaceutical non-clinical research and the quality control standard for pharmaceutical clinical test shall be formulated by the department appointed by the State Council.

第三十一條 生產(chǎn)新藥或者已有國家標(biāo)準(zhǔn)的藥品的，須經(jīng)國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)，并發(fā)給藥品批準(zhǔn)文號；但是，生產(chǎn)沒有實(shí)施批準(zhǔn)文號管理的中藥材和中藥飲片除外。
Article 31 A new medicine or medicine standardized by the State can be put into production only after the pharmaceutical supervisory and administrative department under the State Council has approved it and issued a registered document of approval. However, this does not apply to the production of traditional Chinese medicinal herbs and traditional Chinese medicine prepared in ready-to-use forms that are not controlled under a registered document of approval.

實(shí)施批準(zhǔn)文號管理的中藥材、中藥飲片品種目錄由國務(wù)院藥品監(jiān)督管理部門會同國務(wù)院中醫(yī)藥管理部門制定。
For those traditional Chinese medicinal herbs and traditional Chinese medicines prepared in ready-to-use forms that are controlled with registered document of approval, the pharmaceutical supervisory and administrative department under the State Council and the administrative department of traditional Chinese medicines under the State Council shall jointly formulate their type catalogue.

藥品生產(chǎn)企業(yè)在取得藥品批準(zhǔn)文號后，方可生產(chǎn)該藥品。
Pharmaceutical producing enterprises can produce medicine only after obtaining the registered document of approval.

第三十二條 藥品必須符合國家藥品標(biāo)準(zhǔn)。中藥飲片依照本法第十條第二款的規(guī)定執(zhí)行。
Article 32 Pharmaceuticals must meet the pharmaceutical standards of the State. Article 10 (2) of this Law shall be applied to traditional Chinese medicines prepared in ready-to-use forms.

國務(wù)院藥品監(jiān)督管理部門頒布的《中華人民共和國藥典》和藥品標(biāo)準(zhǔn)為國家藥品標(biāo)準(zhǔn)。
The "Pharmacopoeia of the People's Republic of China" and the pharmaceutical standards promulgated by the pharmaceutical supervisory and administrative department under the State Council shall be the State pharmaceutical standards.

國務(wù)院藥品監(jiān)督管理部門組織藥典委員會，負(fù)責(zé)國家藥品標(biāo)準(zhǔn)的制定和修訂。
The Pharmacopoeia Committee organized by the pharmaceutical supervisory and administrative department under the State Council shall be responsible for the formulation and revision of the State pharmaceutical standards.

國務(wù)院藥品監(jiān)督管理部門的藥品檢驗(yàn)機(jī)構(gòu)負(fù)責(zé)標(biāo)定國家藥品標(biāo)準(zhǔn)品、對照品。
The pharmaceutical inspection institutions of the pharmaceutical supervisory and administrative department under the State Council shall be responsible for the designation of State standard and contrastive pharmaceuticals.

第三十三條 國務(wù)院藥品監(jiān)督管理部門組織藥學(xué)、醫(yī)學(xué)和其他技術(shù)人員，對新藥進(jìn)行審評，對已經(jīng)批準(zhǔn)生產(chǎn)的藥品進(jìn)行再評價(jià)。
Article 33 The pharmaceutical supervisory and administrative department under the State Council may organize pharmaceutical, medicinal and other technological personnel to carry out examination and evaluation of new medicines, and to reevaluate medicines already placed into production.

第三十四條 藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)、醫(yī)療機(jī)構(gòu)必須從具有藥品生產(chǎn)、經(jīng)營資格的企業(yè)購進(jìn)藥品；但是，購進(jìn)沒有實(shí)施批準(zhǔn)文號管理的中藥材除外。
Article 34 Pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical organizations must purchase pharmaceuticals from the qualified enterprises with the certificates for production and trade of pharmaceuticals. However, this does not apply to the purchase of the traditional Chinese medicinal herbs which are not controlled under the registered document of approval.

第三十五條 國家對麻醉藥品、精神藥品、醫(yī)療用毒性藥品、放射性藥品，實(shí)行特殊管理。管理辦法由國務(wù)院制定。
Article 35 For narcotics, psychotropic substances, toxic drugs for medicinal use, and radioactive drugs, the State Council shall formulate administrative measures to carry out special control.

第三十六條 國家實(shí)行中藥品種保護(hù)制度。具體辦法由國務(wù)院制定。
Article 36 The State Council shall formulate detailed measures to carry out a protection system for the categorization of traditional Chinese medicines.

第三十七條 國家對藥品實(shí)行處方藥與非處方藥分類管理制度。具體辦法由國務(wù)院制定。
Article 37 The State Council shall formulate detailed measures to carry out a classified control system for prescription pharmaceuticals and non-prescription pharmaceuticals.

第三十八條 禁止進(jìn)口療效不確、不良反應(yīng)大或者其他原因危害人體健康的藥品。
Article 38 Import of medicines whose curative effects are uncertain or poor, or which produce adverse reactions or have other harmful effects on people's health shall be prohibited.

第三十九條 藥品進(jìn)口，須經(jīng)國務(wù)院藥品監(jiān)督管理部門組織審查，經(jīng)審查確認(rèn)符合質(zhì)量標(biāo)準(zhǔn)、安全有效的，方可批準(zhǔn)進(jìn)口，并發(fā)給進(jìn)口藥品注冊證書。
Article 39 The import of medicines must go through examinations organized by the pharmaceutical supervisory and administrative department under the State Council. Those confirmed to conform to quality standards to be safe and effective can be approved to be imported and shall be issued a registered certificate for import.

醫(yī)療單位臨床急需或者個(gè)人自用進(jìn)口的少量藥品，按照國家有關(guān)規(guī)定辦理進(jìn)口手續(xù)。
Medicines to be imported in small quantities for urgent clinical needs by medical organizations or for personal use shall go through import formalities according to relevant regulations of the State.

第四十條 藥品必須從允許藥品進(jìn)口的口岸進(jìn)口，并由進(jìn)口藥品的企業(yè)向口岸所在地藥品監(jiān)督管理部門登記備案。海關(guān)憑藥品監(jiān)督管理部門出具的《進(jìn)口藥品通關(guān)單》放行。無《進(jìn)口藥品通關(guān)單》的，海關(guān)不得放行。
Article 40 Pharmaceuticals must be imported through the ports which allow the import of pharmaceuticals, and the pharmaceutical import enterprise shall submit a report to the pharmaceutical supervisory and administrative department of the place where the port is located. Customs shall rely on the Import Pharmaceuticals Customs Form issued by the pharmaceutical supervisory and administrative department to proceed. Those without the Import Pharmaceuticals Customs Form shall not be permitted to pass through customs.

口岸所在地藥品監(jiān)督管理部門應(yīng)當(dāng)通知藥品檢驗(yàn)機(jī)構(gòu)按照國務(wù)院藥品監(jiān)督管理部門的規(guī)定對進(jìn)口藥品進(jìn)行抽查檢驗(yàn)，并依照本法第四十一條第二款的規(guī)定收取檢驗(yàn)費(fèi)。
The pharmaceutical supervisory and administrative department of the place where the port is located shall notify the pharmaceutical inspection institution to carry out selective examinations and inspections on the imported pharmaceuticals according to the regulations stipulated by the pharmaceutical supervisory and administrative department under the State Council, and to collect inspection fees according to Article 41(2) of this Law.

允許藥品進(jìn)口的口岸由國務(wù)院藥品監(jiān)督管理部門會同海關(guān)總署提出，報(bào)國務(wù)院批準(zhǔn)。
The nomination of the ports allowable for import of pharmaceuticals shall be jointly conducted by the pharmaceutical supervisory and administrative department under the State Council and the Customs Headquarters, and be reported to the State Council for approval.

第四十一條 國務(wù)院藥品監(jiān)督管理部門對下列藥品在銷售前或者進(jìn)口時(shí)，指定藥品檢驗(yàn)機(jī)構(gòu)進(jìn)行檢驗(yàn)；檢驗(yàn)不合格的，不得銷售或者進(jìn)口：
Article 41 The pharmaceutical supervisory and administrative department under the State Council shall appoint inspection institutions to carry out inspections before the sale and import of the following pharmaceuticals. Those having not passed the inspection shall not be allowed to be sold or imported.

（一）國務(wù)院藥品監(jiān)督管理部門規(guī)定的生物制品；
(1) Bio-products prescribed by the pharmaceutical supervisory and administrative department of the State Council.

（二）首次在中國銷售的藥品；
(2) Pharmaceuticals to be sold for the first time in China.

（三）國務(wù)院規(guī)定的其他藥品。
(3) Other pharmaceuticals prescribed by the State Council.

前款所列藥品的檢驗(yàn)費(fèi)項(xiàng)目和收費(fèi)標(biāo)準(zhǔn)由國務(wù)院財(cái)政部門會同國務(wù)院價(jià)格主管部門核定并公告。
The inspection fee and charge standards for the above-mentioned pharmaceuticals shall be jointly checked, ratified and promulgated by the financial department under the State Council and the competent authority of price control under the State Council.

檢驗(yàn)費(fèi)收繳辦法由國務(wù)院財(cái)政部門會同國務(wù)院藥品監(jiān)督管理部門制定。
The measures for the collection of inspection fees shall be jointly formulated by the financial department under the State Council and the pharmaceutical supervisory and administrative department under the State Council.

第四十二條 國務(wù)院藥品監(jiān)督管理部門對已經(jīng)批準(zhǔn)生產(chǎn)或者進(jìn)口的藥品，應(yīng)當(dāng)組織調(diào)查；對療效不確、不良反應(yīng)大或者其他原因危害人體健康的藥品，應(yīng)當(dāng)撤銷批準(zhǔn)文號或者進(jìn)口藥品注冊證書。
Article 42 The pharmaceutical supervisory and administrative department under the State Council shall organize investigations on medicines which have been approved for production or import. It shall revoke the registered documents of approval or the registered certificate of import if it discovers that the curative effects of the medicines are uncertain or poor, that they produce serious adverse reactions, or that for other reasons they are harmful to people's health.

已被撤銷批準(zhǔn)文號或者進(jìn)口藥品注冊證書的藥品，不得生產(chǎn)或者進(jìn)口、銷售和使用；已經(jīng)生產(chǎn)或者進(jìn)口的，由當(dāng)?shù)厮幤繁O(jiān)督管理部門監(jiān)督銷毀或者處理。
The medicines whose registered documents of approval or registered certificate of import have been revoked shall not be allowed to be produced, imported, sold or used. Those which have already been produced or imported shall be destroyed or disposed of under the supervision of the local pharmaceutical supervisory and administrative departments.

第四十三條 國家實(shí)行藥品儲備制度。
Article 43 A pharmaceutical reserve system shall be carried out by the State.

國內(nèi)發(fā)生重大災(zāi)情、疫情及其他突發(fā)事件時(shí)，國務(wù)院規(guī)定的部門可以緊急調(diào)用企業(yè)藥品。
In case of serious disasters, plagues and other sudden emergencies, the department prescribed by the State Council can requisite the pharmaceuticals of enterprises to deal with such emergencies.

第四十四條 對國內(nèi)供應(yīng)不足的藥品，國務(wù)院有權(quán)限制或者禁止出口。
Article 44 The State Council shall have the power to restrict or prohibit the export of the pharmaceuticals which are in short supply in the domestic market.

第四十五條 進(jìn)口、出口麻醉藥品和國家規(guī)定范圍內(nèi)的精神藥品，必須持有國務(wù)院藥品監(jiān)督管理部門發(fā)給的《進(jìn)口準(zhǔn)許證》、《出口準(zhǔn)許證》。
Article 45 Import or export licenses issued by the pharmaceutical supervisory and administrative department under the State Council are required for the import or export of narcotics and psychotropic substances falling within the restricted scope prescribed by the State.

第四十六條 新發(fā)現(xiàn)和從國外引種的藥材，經(jīng)國務(wù)院藥品監(jiān)督管理部門審核批準(zhǔn)后，方可銷售。
Article 46 Newly discovered domestic medicinal plants or medicinal plants introduced from abroad may be sold only after they have been examined and approved by the pharmaceutical supervisory and administrative department under the State Council.

第四十七條 地區(qū)性民間習(xí)用藥材的管理辦法，由國務(wù)院藥品監(jiān)督管理部門會同國務(wù)院中醫(yī)藥管理部門制定。
Article 47 Measures for controlling medicinal materials traditionally used by local people in certain regions shall be jointly formulated by the pharmaceutical supervisory and administrative department under the State Council and the administrative department of traditional Chinese medicines under the State Council.

第四十八條 禁止生產(chǎn)（包括配制，下同）、銷售假藥。有下列情形之一的，為假藥：
Article 48 The production (including preparation, which also applies to the following) and sale of fake medicines are prohibited. A fake medicine has any one of the following characteristics:

（一）藥品所含成份與國家藥品標(biāo)準(zhǔn)規(guī)定的成份不符的；
(1) Its components are different from those prescribed by state pharmaceutical standards.

（二）以非藥品冒充藥品或以他種藥品冒充此種藥品的。
(2) A non-medical substance is passed off as a medicine, or one medicine is passed off as another.

有下列情形之一的藥品，按假藥論處：
A medicine shall be handled as fake medicine in any of the following cases:

（一）國務(wù)院藥品監(jiān)督管理部門規(guī)定禁止使用的；
(1) Where the use of the medicine has been prohibited by the pharmaceutical supervisory and administrative department under the State Council;

（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)即銷售的；
(2) Where the medicine is produced and imported without an approval dictated according to this Law, or the medicine is sold without being inspected as dictated according to this Law;

（三）變質(zhì)的；
(3) Where the medicine has deteriorated; or

（四）被污染的；
(4) Where the medicine has been contaminated;

（五）使用依照本法必須取得批準(zhǔn)文號而未取得批準(zhǔn)文號的原料藥生產(chǎn)的；
(5) Where the medicine has been produced with pharmaceutical materials without obtaining the dictated registration document of approval for the materials.

（六）所標(biāo)明的適應(yīng)癥或者功能主治超出規(guī)定范圍的。
(6) Where the indications or the functions marked on the labels of the pharmaceuticals do not fall within the prescribed scope.

第四十九條 禁止生產(chǎn)、銷售劣藥。藥品成份的含量不符合國家藥品標(biāo)準(zhǔn)的，為劣藥。
Article 49 It is prohibited to produce and sell medicines of inferior quality, referring to the medicines whose components do not conform in quantity to that required by State pharmaceutical standards.

有下列情形之一的藥品，按劣藥論處：
A medicine shall be handled as medicine of inferior quality in any of the following cases:

（一）未標(biāo)明有效期或者更改有效期的；
(1) An expiry date is not indicated or is altered; or

（二）不注明或者更改生產(chǎn)批號的；
(2) A registration number is not indicated or is altered; or

（三）超過有效期的；
(3) The medicine has passed its expiration date; or

（四）直接接觸藥品的包裝材料和容器未經(jīng)批準(zhǔn)的；
(4) The packages and containers which have direct contact with pharmaceuticals have not obtained approval; or

（五）擅自添加著色劑、防腐劑、香料、矯味劑及輔料的；
(5) The medicine has been added presumptuously with color or preservative additives, spice, disguising odor or supplementary materials; or

（六）其他不符合藥品標(biāo)準(zhǔn)規(guī)定的。
(6) The medicine fails to meet the prescribed standards in other respects.

第五十條 列入國家藥品標(biāo)準(zhǔn)的藥品名稱為藥品通用名稱。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。
Article 50 The names of the pharmaceuticals listed in the State pharmaceutical standards are the generic names of the pharmaceuticals. Those names that have become the generic names of pharmaceuticals shall not be used as trademarks of pharmaceuticals.

第五十一條 藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)和醫(yī)療機(jī)構(gòu)直接接觸藥品的工作人員，必須每年進(jìn)行健康檢查�；加袀魅静』蛘咂渌�可能污染藥品的疾病的，不得從事直接接觸藥品的工作。
Article 51 Personnel in pharmaceutical producing or trading enterprises and in medical organizations who have direct contact with medicines must undergo an annual medical examination. Persons who have contracted contagious diseases or any other disease which may contaminate the medicine shall not be allowed to engage in any work which has direct contact with pharmaceuticals.

第六章 藥品包裝的管理
Chapter VI Administration on Pharmaceutical Packaging

第五十二條 直接接觸藥品的包裝材料和容器，必須符合藥用要求，符合保障人體健康、安全的標(biāo)準(zhǔn)，并由藥品監(jiān)督管理部門在審批藥品時(shí)一并審批。
Article 52 The pharmaceutical packaging materials and containers which have direct contact with pharmaceuticals must meet the requirements of medicinal use, conform with the standards of protecting people's health and safety, and obtain the approval of the pharmaceutical supervisory and administrative departments at the same time as the approval of the pharmaceutical product.

藥品生產(chǎn)企業(yè)不得使用未經(jīng)批準(zhǔn)的直接接觸藥品的包裝材料和容器。
Pharmaceutical producing enterprises shall use the packaging materials and containers which have direct contact with the pharmaceuticals only after they have obtained approval for them.

對不合格的直接接觸藥品的包裝材料和容器，由藥品監(jiān)督管理部門責(zé)令停止使用。
The pharmaceutical supervisory and administrative departments shall stop the use of those unqualified packaging materials and containers which have direct contact with the pharmaceuticals.

第五十三條 藥品包裝必須適合藥品質(zhì)量的要求，方便儲存、運(yùn)輸和醫(yī)療使用。
Article 53 Packaging must meet the specific quality requirements of the pharmaceuticals and facilitate their storage, transportation and medical use.

發(fā)運(yùn)中藥材必須有包裝。在每件包裝上，必須注明品名、產(chǎn)地、日期、調(diào)出單位，并附有質(zhì)量合格的標(biāo)志。
Traditional Chinese medicinal materials must be packaged before transportation. There must appear on the package the name of the medicine, place of production, date, name of the consignor, and an indication showing that the quality of the medicine meets standards.

第五十四條 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。
Article 54 Packages of pharmaceuticals must be labeled and include directions for use in accordance with the regulations.

標(biāo)簽或者說明書上必須注明藥品的通用名稱、成份、規(guī)格、生產(chǎn)企業(yè)、批準(zhǔn)文號、產(chǎn)品批號、生產(chǎn)日期、有效期、適應(yīng)癥或者功能主治、用法、用量、禁忌、不良反應(yīng)和注意事項(xiàng)。
The label or directions must indicate the generic name of the medicine, components, specifications, the producer, registration number, batch number of the product, production date, expiry date, indications or major functions, directions for use, dosage, restrictions, adverse reactions and precautions.

麻醉藥品、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。
Special indications must be printed as required on the labels of narcotics, psychotropic substances, toxic drugs for medical use, radioactive drugs, medicines for external use and non-prescriptive pharmaceuticals.

第七章 藥品價(jià)格和廣告的管理
Chapter VII Administration of the Prices and Advertising of Pharmaceuticals

第五十五條 依法實(shí)行政府定價(jià)、政府指導(dǎo)價(jià)的藥品，政府價(jià)格主管部門應(yīng)當(dāng)依照《中華人民共和國價(jià)格法》規(guī)定的定價(jià)原則，依據(jù)社會平均成本、市場供求狀況和社會承受能力合理制定和調(diào)整價(jià)格，做到質(zhì)價(jià)相符，消除虛高價(jià)格，保護(hù)用藥者的正當(dāng)利益。
Article 55 For pharmaceuticals controlled by the fixed and directive pricing system of the government, the competent authority of pricing of the government shall fix and adjust the price with reason in conformity with the principles for fixing prices as prescribed by the Price Law of the PRC and according to the considerations of societal average costs, market supply and demand, and the level of societal tolerance to achieve accord between quality and price, to avoid excessive prices, and to safeguard the due interests of the users of the pharmaceuticals.

藥品的生產(chǎn)企業(yè)、經(jīng)營企業(yè)和醫(yī)療機(jī)構(gòu)必須執(zhí)行政府定價(jià)、政府指導(dǎo)價(jià)，不得以任何形式擅自提高價(jià)格。
Pharmaceutical producing enterprises, trading enterprises and medical organizations must carry out the fixed price and directive price system of the government, and shall not presumptuously raise prices in any form.

藥品生產(chǎn)企業(yè)應(yīng)當(dāng)依法向政府價(jià)格主管部門如實(shí)提供藥品的生產(chǎn)經(jīng)營成本，不得拒報(bào)、虛報(bào)、瞞報(bào)。
Pharmaceutical producing enterprises shall provide the competent authority of pricing of the government with the producing and trading costs of pharmaceuticals and shall not refuse to report, make a false report or withhold the truth in such a report.

第五十六條 依法實(shí)行市場調(diào)節(jié)價(jià)的藥品，藥品的生產(chǎn)企業(yè)、經(jīng)營企業(yè)和醫(yī)療機(jī)構(gòu)應(yīng)當(dāng)按照公平、合理和誠實(shí)信用、質(zhì)價(jià)相符的原則制定價(jià)格，為用藥者提供價(jià)格合理的藥品。
Article 56 For the pharmaceuticals whose prices are to be adjusted by the market, the pharmaceutical producing enterprises, trading enterprises, and medical organizations shall fix the price in conformity with the principles of fairness, rationality, honesty, good faith and accord between quality and price to provide the users of the pharmaceuticals with reasonable prices.

藥品的生產(chǎn)企業(yè)、經(jīng)營企業(yè)和醫(yī)療機(jī)構(gòu)應(yīng)當(dāng)遵守國務(wù)院價(jià)格主管部門關(guān)于藥價(jià)管理的規(guī)定，制定和標(biāo)明藥品零售價(jià)格，禁止暴利和損害用藥者利益的價(jià)格欺詐行為。
Pharmaceutical producing enterprises, trading enterprises and medical organizations shall abide by the regulations concerning the control on prices of pharmaceuticals prescribed by the competent authority of pricing under the State Council, shall fix and mark the retail prices of pharmaceuticals, and shall avoid sudden excessive profits and deceptive acts on pricing which will harm the interests of the users of the pharmaceuticals.

第五十七條 藥品的生產(chǎn)企業(yè)、經(jīng)營企業(yè)、醫(yī)療機(jī)構(gòu)應(yīng)當(dāng)依法向政府價(jià)格主管部門提供其藥品的實(shí)際購銷價(jià)格和購銷數(shù)量等資料。
Article 57 Pharmaceutical producing enterprises, trading enterprises and medical organizations shall, in accordance with this Law, provide the competent authority of pricing of the government with information such as the actual purchasing and selling prices and quantities of the pharmaceuticals.

第五十八條 醫(yī)療機(jī)構(gòu)應(yīng)當(dāng)向患者提供所用藥品的價(jià)格清單；醫(yī)療保險(xiǎn)定點(diǎn)醫(yī)療機(jī)構(gòu)還應(yīng)當(dāng)按照規(guī)定的辦法如實(shí)公布其常用藥品的價(jià)格，加強(qiáng)合理用藥的管理。具體辦法由國務(wù)院衛(wèi)生行政部門規(guī)定。
Article 58 Medical organizations shall provide the patient with the price list of the pharmaceuticals used. Medical organizations appointed by medical insurance shall faithfully promulgate the prices of frequently used pharmaceuticals according to prescribed measures to enhance the reasonable use of pharmaceuticals.

第五十九條 禁止藥品的生產(chǎn)企業(yè)、經(jīng)營企業(yè)和醫(yī)療機(jī)構(gòu)在藥品購銷中帳外暗中給予、收受回扣或者其他利益。
Article 59 Pharmaceutical producing enterprises, trading enterprises and medical organizations are prohibited to give or receive secret commissions and other benefits during the purchasing and selling of pharmaceuticals.

禁止藥品的生產(chǎn)企業(yè)、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(jī)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(cái)物或者其他利益。禁止醫(yī)療機(jī)構(gòu)的負(fù)責(zé)人、藥品采購人員、醫(yī)師等有關(guān)人員以任何名義收受藥品的生產(chǎn)企業(yè)、經(jīng)營企業(yè)或者其代理人給予的財(cái)物或者其他利益。
Pharmaceutical producing enterprises, trading enterprises or their representatives are prohibited to give any property or other benefits under any name to the principals, buyers of pharmaceuticals, physicians and other relevant persons in the medical organizations where their pharmaceuticals are used. The principals, buyers of pharmaceuticals, physicians and other relevant persons are prohibited from receiving any property or other benefits under any name from pharmaceutical producing enterprises, trading enterprises or their agents.

第六十條 藥品廣告須經(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)給藥品廣告批準(zhǔn)文號；
Article 60 Advertisements of pharmaceuticals must be approved and issued a registration number of advertisement by the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government of the place where the enterprises are located.

未取得藥品廣告批準(zhǔn)文號的，不得發(fā)布。
In the absence of such registration numbers, advertisements for any medicines may not be placed.

處方藥可以在國務(wù)院衛(wèi)生行政部門和國務(wù)院藥品監(jiān)督管理部門共同指定的醫(yī)學(xué)、藥學(xué)專業(yè)刊物上介紹，但不得在大眾傳播媒介發(fā)布廣告或者以其他方式進(jìn)行以公眾為對象的廣告宣傳。
Prescription pharmaceuticals may be introduced in medicinal and pharmaceutical magazines jointly appointed by the administrative department of health under the State Council and the pharmaceutical supervisory and administrative department under the State Council, but shall not be advertised through mass media or publicized in any other form to the public.

第六十一條 藥品廣告的內(nèi)容必須真實(shí)、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。
Article 61 The contents of pharmaceutical advertisement must be true, legitimate, and be based on the directions for use approved by the pharmaceutical supervisory and administrative department under the State Council, and be also free of falsehood.

藥品廣告不得含有不科學(xué)的表示功效的斷言或者保證；不得利用國家機(jī)關(guān)、醫(yī)藥科研單位、學(xué)術(shù)機(jī)構(gòu)或者專家、學(xué)者、醫(yī)師、患者的名義和形象作證明。
Advertisements of pharmaceuticals shall not contain any unscientific assertion or guarantee on effects, and shall not be endorsed using the names and images of government bodies, pharmaceutical scientific research units, academic organizations, experts, scholars, physicians and sufferers.

非藥品廣告不得有涉及藥品的宣傳。
The advertisements of non-pharmaceuticals shall not be involved in the publicizing of pharmaceuticals.

第六十二條 省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門應(yīng)當(dāng)對其批準(zhǔn)的藥品廣告進(jìn)行檢查，對于違反本法和《中華人民共和國廣告法》的廣告，應(yīng)當(dāng)向廣告監(jiān)督管理機(jī)關(guān)通報(bào)并提出處理建議，廣告監(jiān)督管理機(jī)關(guān)應(yīng)當(dāng)依法作出處理。
Article 62 The pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government shall inspect on the pharmaceutical advertisements they approve, and shall notify and advise the administrative departments of advertising if the advertisements is not in conformity with this Law and the Advertisement Law of the PRC. The administrative departments of advertising shall deal with such advertisements according to relevant regulations.

第六十三條 藥品價(jià)格和廣告，本法未規(guī)定的，適用《中華人民共和國價(jià)格法》、《中華人民共和國廣告法》的規(guī)定。 　
Article 63 In the absence of regulations as provided in this Law, the Price Law of the PRC and the Advertisement Law of the PRC shall be applied to the control of pharmaceutical prices and advertisements.

第八章 藥品監(jiān)督
Chapter VIII Supervision over Pharmaceuticals

第六十四條 藥品監(jiān)督管理部門有權(quán)按照法律、行政法規(guī)的規(guī)定對報(bào)經(jīng)其審批的藥品研制和藥品的生產(chǎn)、經(jīng)營以及醫(yī)療機(jī)構(gòu)使用藥品的事項(xiàng)進(jìn)行監(jiān)督檢查，有關(guān)單位和個(gè)人不得拒絕和隱瞞。
Article 64 Pharmaceutical supervisory and administrative departments are authorized to conduct, in accordance with laws and administrative regulations, supervision and inspection over the research,development, production and trade of pharmaceuticals which they have approved, as well as the medical organizations' use of pharmaceuticals. The units and individuals concerned shall not refuse to comply.

藥品監(jiān)督管理部門進(jìn)行監(jiān)督檢查時(shí)，必須出示證明文件，對監(jiān)督檢查中知悉的被檢查人的技術(shù)秘密和業(yè)務(wù)秘密應(yīng)當(dāng)保密。
Pharmaceutical supervisory and administrative departments shall present certificate documents while conducting supervision and inspection, and shall not divulge technological and business.

第六十五條 藥品監(jiān)督管理部門根據(jù)監(jiān)督檢查的需要，可以對藥品質(zhì)量進(jìn)行抽查檢驗(yàn)。抽查檢驗(yàn)應(yīng)當(dāng)按照規(guī)定抽樣，并不得收取任何費(fèi)用。所需費(fèi)用按照國務(wù)院規(guī)定列支。
Article 65 According to the needs of supervision and inspection, pharmaceutical supervisory and administrative departments may conduct sampling examinations on the quality of pharmaceuticals. The sampling examinations shall be conducted according to relevant regulations and shall not be charged a fee. The expenses incurred shall be dispensed with in conformity with the regulations prescribed by the State Council.

藥品監(jiān)督管理部門對有證據(jù)證明可能危害人體健康的藥品及其有關(guān)材料可以采取查封、扣押的行政強(qiáng)制措施，并在七日內(nèi)作出行政處理決定；藥品需要檢驗(yàn)的，必須自檢驗(yàn)報(bào)告書發(fā)出之日起十五日內(nèi)作出行政處理決定。
Pharmaceutical supervisory and administrative departments may take administrative coercive measures including sequestration and banning against pharmaceuticals and other relevant materials which have been proven to be of possible harm to people's health; administrative measures must be taken within seven days. For pharmaceuticals which need to be inspected, decisions regarding administrative handling must be made within 15 days from the date of issue of the inspection reports.

第六十六條 國務(wù)院和省、自治區(qū)、直轄市人民政府的藥品監(jiān)督管理部門應(yīng)當(dāng)定期公告藥品質(zhì)量抽查檢驗(yàn)的結(jié)果；公告不當(dāng)?shù)模�必須在原公告范圍�?nèi)予以更正。
Article 66 The pharmaceutical supervisory and administrative departments under the State Council and of the provinces, autonomous regions and municipalities directly under the central government shall regularly promulgate the results of sampling examinations and inspections on the quality of pharmaceuticals, and shall, in the case of improperly published statements, amend such statements in the original published documents.

第六十七條 當(dāng)事人對藥品檢驗(yàn)機(jī)構(gòu)的檢驗(yàn)結(jié)果有異議的，可以自收到藥品檢驗(yàn)結(jié)果之日起七日內(nèi)向原藥品檢驗(yàn)機(jī)構(gòu)或者上一級藥品監(jiān)督管理部門設(shè)置或者確定的藥品檢驗(yàn)機(jī)構(gòu)申請復(fù)驗(yàn)，也可以直接向國務(wù)院藥品監(jiān)督管理部門設(shè)置或者確定的藥品檢驗(yàn)機(jī)構(gòu)申請復(fù)驗(yàn)。受理復(fù)驗(yàn)的藥品檢驗(yàn)機(jī)構(gòu)必須在國務(wù)院藥品監(jiān)督管理部門規(guī)定的時(shí)間內(nèi)作出復(fù)驗(yàn)結(jié)論。
Article 67 If a party concerned disagrees with the inspection decision made by the inspection institutions, it may apply for re-inspection to the original inspection institutions or ones established or appointed by the pharmaceutical supervisory and administrative departments of superior levels within seven days from the date of receiving the pharmaceutical inspection decision, and may directly apply for re-inspection to the inspection institutions established or appointed by the pharmaceutical supervisory and administrative department under the State Council. The inspection institutions which have accepted the re-inspections shall conclude the re-inspections within the time limit prescribed by the pharmaceutical supervisory and administrative department under the State Council.

第六十八條 藥品監(jiān)督管理部門應(yīng)當(dāng)按照規(guī)定，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(jìn)行認(rèn)證后的跟蹤檢查。
rticle 68 Pharmaceutical supervisory and administrative departments shall follow up on the inspections of the pharmaceutical producing enterprises or pharmaceutical trading enterprises which they have certified in conformity with the "Quality Control Standard of Pharmaceutical Production" and the "Quality Control Standard of Pharmaceutical Trade."

第六十九條 地方人民政府和藥品監(jiān)督管理部門不得以要求實(shí)施藥品檢驗(yàn)、審批等手段限制或者排斥非本地區(qū)藥品生產(chǎn)企業(yè)依照本法規(guī)定生產(chǎn)的藥品進(jìn)入本地區(qū)。
Article 69 The local people's governments and pharmaceutical supervisory and administrative departments shall not restrict or exclude the entrance of pharmaceuticals produced according to this Law by pharmaceutical producing enterprises in other regions of the country through the excuse of conducting inspection , examination and approval of the pharmaceuticals.

第七十條 藥品監(jiān)督管理部門及其設(shè)置的藥品檢驗(yàn)機(jī)構(gòu)和確定的專業(yè)從事藥品檢驗(yàn)的機(jī)構(gòu)不得參與藥品生產(chǎn)經(jīng)營活動，不得以其名義推薦或者監(jiān)制、監(jiān)銷藥品。
Article 70 Pharmaceutical supervisory and administrative departments and the pharmaceutical inspection institutions they have established, as well as the institutions exclusively engaged in pharmaceutical inspection they have appointed, shall not participate in pharmaceutical production and trade, and shall not endorse or supervise the production and sale of pharmaceuticals in their own names.

藥品監(jiān)督管理部門及其設(shè)置的藥品檢驗(yàn)機(jī)構(gòu)和確定的專業(yè)從事藥品檢驗(yàn)的機(jī)構(gòu)的工作人員不得參與藥品生產(chǎn)經(jīng)營活動。
The functionaries of pharmaceutical supervisory and administrative departments, of the pharmaceutical inspection institutions they established, and of the institutions exclusively engaged in the inspection of pharmaceuticals they appointed, shall not participate in pharmaceutical production and trade.

第七十一條 國家實(shí)行藥品不良反應(yīng)報(bào)告制度。藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)和醫(yī)療機(jī)構(gòu)必須經(jīng)�？疾毂締挝凰�生產(chǎn)、經(jīng)營、使用的藥品質(zhì)量、療效和反應(yīng)。
Article 71 A reporting system over any adverse reactions of pharmaceuticals shall be practiced by Sstate. Pharmaceutical producing enterprises, pharmaceutical trading enterprises, and medical institutions shall conduct regular surveys on the quality, curative effects and adverse reactions of the pharmaceuticals they have produced, traded or used.

發(fā)現(xiàn)可能與用藥有關(guān)的嚴(yán)重不良反應(yīng)，必須及時(shí)向當(dāng)?shù)厥�、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門和衛(wèi)生行政部門報(bào)告。具體辦法由國務(wù)院藥品監(jiān)督管理部門會同國務(wù)院衛(wèi)生行政部門制定。
When serious adverse reactions possibly related to the use of the pharmaceuticals are discovered, they must be promptly reported to the pharmaceutical supervisory and administrative departments and the administrative departments of health of the provinces, autonomous regions and municipalities directly under the central government. Detailed measures shall be formulated jointly by the pharmaceutical supervisory and administrative department under the State Council and the administrative department of health under the State Council.

對已確認(rèn)發(fā)生嚴(yán)重不良反應(yīng)的藥品，國務(wù)院或者省、自治區(qū)、直轄市人民政府的藥品監(jiān)督管理部門可以采取停止生產(chǎn)、銷售、使用的緊急控制措施，并應(yīng)當(dāng)在五日內(nèi)組織鑒定，自鑒定結(jié)論作出之日起十五日內(nèi)依法作出行政處理決定。
Regarding the pharmaceuticals which have been confirmed to cause serious adverse reactions, the pharmaceutical supervisory and administrative department under the State Council and of the provinces, autonomous regions and municipalities directly under the central government, shall take urgent control measures including the cessation of the production, sale, and use of the pharmaceuticals, shall organize appraisals within five days, and shall make decisions on their administrative handling within 15 days from the conclusion date of the appraisals.

第七十二條 藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)和醫(yī)療機(jī)構(gòu)的藥品檢驗(yàn)機(jī)構(gòu)或者人員，應(yīng)當(dāng)接受當(dāng)?shù)厮幤繁O(jiān)督管理部門設(shè)置的藥品檢驗(yàn)機(jī)構(gòu)的業(yè)務(wù)指導(dǎo)。
Article 72 The organs or personnel in charge of pharmaceutical inspection in pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical organizations shall receive operational guidance from the pharmaceutical inspection institutions established by local pharmaceutical supervisory and administrative departments.

第九章 法律責(zé)任
CHAPTER IX Legal Responsibility

第七十三條 未取得《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》或者《醫(yī)療機(jī)構(gòu)制劑許可證》生產(chǎn)藥品、經(jīng)營藥品的，依法予以取締，沒收違法生產(chǎn)、銷售的藥品和違法所得，并處違法生產(chǎn)、銷售的藥品（包括已售出的和未售出的藥品，下同）貨值金額二倍以上五倍以下的罰款；構(gòu)成犯罪的，依法追究刑事責(zé)任。
Article 73 Those who produce or trade in medicines without obtaining a Pharmaceutical Production License, Pharmaceutical Trade License, or Dispensing Permit of Medical Organizations, shall be placed under ban, have the unlawfully produced and sold medicines and any unlawful income confiscated, and may concurrently be fined a sum of money more than two but less than five times the value of the medicines unlawfully made or sold (including both sold and unsold pharmaceuticals, which also applies below). Those whose acts constitute a crime shall be investigated for criminal liabilities.

第七十四條 生產(chǎn)、銷售假藥的，沒收違法生產(chǎn)、銷售的藥品和違法所得，并處違法生產(chǎn)、銷售藥品貨值金額二倍以上五倍以下的罰款；有藥品批準(zhǔn)證明文件的予以撤銷，并責(zé)令停產(chǎn)、停業(yè)整頓；情節(jié)嚴(yán)重的，吊銷《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》或者《醫(yī)療機(jī)構(gòu)制劑許可證》；構(gòu)成犯罪的，依法追究刑事責(zé)任。
Article 74 Those who produce and sell fake medicines shall have his unlawfully produced or sold medicines and any unlawful income confiscated, and concurrently be fined a sum of money more than two but less than five times the value value of the medicines unlawfully produced and sold. Those who have an approval certificate of pharmaceuticals shall have the certificate revokeded, and be ordered to suspend production or business operations pending rectification; if the circumstances are serious, the party shall have Pharmaceutical Production License, or Pharmaceutical Trade License or Dispensing Permit of Medical Organizations revoked. Those whose acts constitute a

第七十五條 生產(chǎn)、銷售劣藥的，沒收違法生產(chǎn)、銷售的藥品和違法所得，并處違法生產(chǎn)、銷售藥品貨值金額一倍以上三倍以下的罰款；情節(jié)嚴(yán)重的，責(zé)令停產(chǎn)、停業(yè)整頓或者撤銷藥品批準(zhǔn)證明文件、吊銷《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》或者《醫(yī)療機(jī)構(gòu)制劑許可證》；構(gòu)成犯罪的，依法追究刑事責(zé)任。
Article 75 Those who produce and sell medicines of inferior quality shall have his unlawfully made and sold medicines and any unlawful income confiscated, and be concurrently fined the sum of money more than two but less than three times the value of the medicines unlawfully made or sold; if the circumstances are serious, the party shall be ordered to suspend production or business pending rectification, or have thepharmaceutical approval certificate revoked and his Pharmaceutical Production License, or Pharmaceutical Trade License or Dispensing Permit of Medical Organizations revoked. Those whose acts constitute a crime will be investigated for criminal liabilities.

第七十六條 從事生產(chǎn)、銷售假藥及生產(chǎn)、銷售劣藥情節(jié)嚴(yán)重的企業(yè)或者其他單位，其直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員十年內(nèi)不得從事藥品生產(chǎn)、經(jīng)營活動。
Article 76 The person-in-charge or personnel directly liable in the enterprise or other unit which produces and sells fake medicines or produces and sells pharmaceuticals of inferior quality shall not be permitted to engage in the production and trade of pharmaceuticals for ten years, if the circumstances are serious.

對生產(chǎn)者專門用于生產(chǎn)假藥、劣藥的原輔材料、包裝材料、生產(chǎn)設(shè)備，予以沒收。
The producers' supplementary materials, packaging materials and production equipment which are used exclusively for producing fake medicines and medicines of inferior quality shall be confiscated.

第七十七條 知道或者應(yīng)當(dāng)知道屬于假劣藥品而為其提供運(yùn)輸、保管、倉儲等便利條件的，沒收全部運(yùn)輸、保管、倉儲的收入，并處違法收入百分之五十以上三倍以下的罰款；構(gòu)成犯罪的，依法追究刑事責(zé)任。
Article 77 Those who provide facilities including transportation, preservation and storage that have been or should have been aware of the fakery or inferior quality of the pharmaceuticals, shall have the entirety of his income from such transportation, preservation and storage confiscated, and concurrently be fined a sum of money more than 50% but less than three times the value of the unlawful income. Those whose acts constitute a crime shall be investigated for criminal liabilities.

第七十八條 對假藥、劣藥的處罰通知，必須載明藥品檢驗(yàn)機(jī)構(gòu)的質(zhì)量檢驗(yàn)結(jié)果；但是，本法第四十八條第三款第（一）、（二）、（五）、（六）項(xiàng)和第四十九條第三款規(guī)定的情形除外。
Article 78 The notice of penalties on fake medicines and medicines of inferior quality shall indicate the inspection results of the inspection institution. However, this does not apply to the circumstances prescribed by Article 48(3)(a)(b)(e)(f) and Article 49 (3) of this Law.

第七十九條 藥品的生產(chǎn)企業(yè)、經(jīng)營企業(yè)、藥物非臨床安全性評價(jià)研究機(jī)構(gòu)、藥物臨床試驗(yàn)機(jī)構(gòu)未按照規(guī)定實(shí)施《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》、藥物非臨床研究質(zhì)量管理規(guī)范、藥物臨床試驗(yàn)質(zhì)量管理規(guī)范的，給予警告，責(zé)令限期改正；逾期不改正的，責(zé)令停產(chǎn)、停業(yè)整頓，并處五千元以上二萬元以下的罰款；情節(jié)嚴(yán)重的，吊銷《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》和藥物臨床試驗(yàn)機(jī)構(gòu)的資格。
Article 79 Pharmaceutical producing enterprises, trading enterprises, pharmaceutical non-clinical safety appraisal research institution, and pharmaceutical clinical testing institutions, shall be served a warning and be ordered to amend themselves within a prescribed time limit if they do not carry out the stipulations of the "Quality Control Standard of Pharmaceutical Production," the "Quality Control Standard of Pharmaceutical Trade," the quality control standard of pharmaceutical non-clinical research, and the quality control standard of pharmaceutical clinical testing. Those who do not rectify their mistakes within the prescribed time limit shall be ordered to suspend production and business operations pending rectification, and be concurrently fined more than 5000 but less than 20,000 RMB. If the circumstances are serious, they shall have their Pharmaceutical Production License, Pharmaceutical Trading License or Dispensing Permit of Medical Organizations revoked.

第八十條 藥品的生產(chǎn)企業(yè)、經(jīng)營企業(yè)或者醫(yī)療機(jī)構(gòu)違反本法第三十四條的規(guī)定，從無《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》的企業(yè)購進(jìn)藥品的，責(zé)令改正，沒收違法購進(jìn)的藥品，并處違法購進(jìn)藥品貨值金額二倍以上五倍以下的罰款；有違法所得的，沒收違法所得；情節(jié)嚴(yán)重的，吊銷《藥品生產(chǎn)許可證、《藥品經(jīng)營許可證》或者醫(yī)療機(jī)構(gòu)執(zhí)業(yè)許可證書。
Article 80 If any pharmaceutical producing enterprises, pharmaceutical trading enterprises or medical organizations violate Article 34 of this Law and purchase medicines from enterprises without the Pharmaceutical Production License or Pharmaceutical Trade License, they shall be ordered to amend themselves, have their unlawfully purchased medicines confiscated, and be concurrently fined the sum of money more than two but less than five times the value of the unlawfully purchased medicines. If they have obtained any unlawful income, the unlawful income shall be confiscated; if the circumstances are serious, their Pharmaceutical Production License, Pharmaceutical Trading License or Practicing Permit of Medical Organizations shall be revoked.

第八十一條 進(jìn)口已獲得藥品進(jìn)口注冊證書的藥品，未按照本法規(guī)定向允許藥品進(jìn)口的口岸所在地的藥品監(jiān)督管理部門登記備案的，給予警告，責(zé)令限期改正；逾期不改正的，撤銷進(jìn)口藥品注冊證書。
Article 81 Those who import pharmaceuticals with a pharmaceutical import registration document and fail to register according to this Law at the pharmaceutical supervisory and administrative department at the location of the port allowed for pharmaceutical import, shall be served a warning and be ordered to correct its mistakes within a prescribed time limit. Those who have not corrected its mistakes within the prescribed time limit shall have their registration document to import pharmaceuticals revoked.

第八十二條 偽造、變造、買賣、出租、出借許可證或者藥品批準(zhǔn)證明文件的，沒收違法所得，并處違法所得一倍以上三倍以下的罰款；沒有違法所得的，處二萬元以上十萬元以下的罰款；情節(jié)嚴(yán)重的，并吊銷賣方、出租方、出借方的《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》、《醫(yī)療機(jī)構(gòu)制劑許可證》或者撤銷藥品批準(zhǔn)證明文件；構(gòu)成犯罪的，依法追究刑事責(zé)任。
Article 82 Those who forge, alter, trade, lease or lend licenses or pharmaceutical approval certificates, shall have their unlawful income confiscated and be concurrently fined the sum of money more than two but less than three times the amount of the unlawful income. If the party has not obtained unlawful income yet, it will be fined more than 20,000 but less than 100,000 RMB; if the circumstances are serious, the Pharmaceutical Production License, Pharmaceutical trading License or Dispensing Permit of Medical Organizations of the seller, lessor or lender shall be revoked, or the pharmaceutical approval certificate shall be recalled. Those whose acts constitute a crime shall be investigated for criminal liabilities.

第八十三條 違反本法規(guī)定，提供虛假的證明、文件資料樣品或者采取其他欺騙手段取得《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》、《醫(yī)療機(jī)構(gòu)制劑許可證》或者藥品批準(zhǔn)證明文件的，吊銷《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》、《醫(yī)療機(jī)構(gòu)制劑許可證》或者撤銷藥品批準(zhǔn)證明文件，五年內(nèi)不受理其申請，并處一萬元以上三萬元以下的罰款。
Article 83 Those who violate this Law by providing false certificates or samples of documents, or obtaining the Pharmaceutical Production License, the Pharmaceutical Trading License, the Dispensing Permit of Medical Organizations or pharmaceutical approval certificates through cheating, shall have their Pharmaceutical Production License, Pharmaceutical Trade License, or Dispensing Permit of Medical Organizations revoked, have their pharmaceutical approval certificates revoked, have their application rejected for five years, and have a concurrent fine of more than 10,000 but less than 30,000 RMB be imposed upon them.

第八十四條 醫(yī)療機(jī)構(gòu)將其配制的制劑在市場銷售的，責(zé)令改正，沒收違法銷售的制劑，并處違法銷售制劑貨值金額一倍以上三倍以下的罰款；有違法所得的，沒收違法所得。
Article 84 If a medical organization sells its preparations on the market, it shall be ordered to correct its mistakes, have its unlawfully sold preparations confiscated and concurrently be fined a sum of money more than two but less than three times the value of the unlawfully sold preparations. If it has obtained any unlawful income, the unlawful income shall be confiscated.

第八十五條 藥品經(jīng)營企業(yè)違反本法第十八條、第十九條規(guī)定的，責(zé)令改正，給予警告；情節(jié)嚴(yán)重的，吊銷《藥品經(jīng)營許可證》。
Article 85 If a pharmaceutical trading enterprise violates Article 18 and Article 19 of this law, it shall be ordered to amend itself and be served a warning. If the circumstances are serious, its Pharmaceutical Trading License shall be revoked.

第八十六條 藥品標(biāo)識不符合本法第五十四條規(guī)定的，除依法應(yīng)當(dāng)按照假藥、劣藥論處的外，責(zé)令改正，給予警告；情節(jié)嚴(yán)重的，撤銷該藥品的批準(zhǔn)證明文件。
Article 86 A medicine whose mark is not in conformity with Article 54 of this Law shall be handled as fake medicine or medicine of inferior quality. In addition, a correction shall be made and a warning shall be served. If the circumstances are serious, the approval certificate of this medicine shall be revoked.

第八十七條 藥品檢驗(yàn)機(jī)構(gòu)出具虛假檢驗(yàn)報(bào)告，構(gòu)成犯罪的，依法追究刑事責(zé)任；不構(gòu)成犯罪的，責(zé)令改正，給予警告，對單位并處三萬元以上五萬元以下的罰款；對直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予降級、撤職、開除的處分，并處三萬元以下的罰款；
Article 87 A pharmaceutical inspection institution which produces false inspection reports, where the circumstances are so serious as to constitute a crime, shall be investigated for criminal liabilities; if a crime is not constituted, it shall be ordered to amend and be served a warning. The institution shall be concurrently imposed a fine of more than 30,000 but less than 50,000 RMB, and the person-in-charge and other personnel directly liable shall be demoted, dismissed from their posts, or expelled according to law, and shall be concurrently be fined less than 30,000RMB.

有違法所得的，沒收違法所得；情節(jié)嚴(yán)重的，撤銷其檢驗(yàn)資格。藥品檢驗(yàn)機(jī)構(gòu)出具的檢驗(yàn)結(jié)果不實(shí)，造成損失的，應(yīng)當(dāng)承擔(dān)相應(yīng)的賠償責(zé)任。
If any unlawful income has been obtained, the unlawful income shall be confiscated. If the circumstances are serious, the inspection qualification certificate shall be revoked. If an inspection institution produces false inspection reports and causes serious consequences, it shall bear corresponding liabilities for compensation.

第八十八條 本法第七十三條至第八十七條規(guī)定的行政處罰，由縣級以上藥品監(jiān)督管理部門按照國務(wù)院藥品監(jiān)督管理部門規(guī)定的職責(zé)分工決定；吊銷《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證、《醫(yī)療機(jī)構(gòu)制劑許可證》、醫(yī)療機(jī)構(gòu)執(zhí)業(yè)許可證書或者撤銷藥品批準(zhǔn)證明文件的，由原發(fā)證、批準(zhǔn)的部門決定。
Article 88 The decision to impose administrative sanctions stipulated from Article 73 to Article 87 by this Law shall be made by the pharmaceutical supervisory and administrative departments at or above the county level in conformity with the division of functions prescribed by the pharmaceutical supervisory and administrative department under the State Council. The original issue and approval departments shall decide regarding the revocation of the Pharmaceutical Production License, the Pharmaceutical Trading License, the Dispensing Permit of Medical Organizations, the practicing permit of medical organizations, and the pharmaceutical approval certificates.

第八十九條 違反本法第五十五條、第五十六條、第五十七條關(guān)于藥品價(jià)格管理的規(guī)定的，依照《中華人民共和國價(jià)格法》的規(guī)定處罰。
Article 89 Violations of Article 55, 56, 57 of this Law concerning the price control of pharmaceuticals shall be punished according to the Price Law of the People's Republic of China.

第九十條 藥品的生產(chǎn)企業(yè)、經(jīng)營企業(yè)、醫(yī)療機(jī)構(gòu)在藥品購銷中暗中給予、收受回扣或者其他利益的，藥品的生產(chǎn)企業(yè)、經(jīng)營企業(yè)或者其代理人給予使用其藥品的醫(yī)療機(jī)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(cái)物或者其他利益的，由工商行政管理部門處一萬元以上二十萬元以下的罰款，有違法所得的，予以沒收；
Article 90 If pharmaceutical producing enterprises, trading enterprises and medical organizations give or receive commissions or other interests in secret during the purchase or sale of pharmaceuticals; and if pharmaceutical producing enterprises, trading enterprises or their agents give any property or other interests to the directors, buyers, physicians and other relevant persons in the medical organizations where their medicines are used, a fine of more than 10,000 but less than 200,000 RMB shall be imposed and the unlawful income shall be confiscated by the government body of industry and commerce administration

情節(jié)嚴(yán)重的，由工商行政管理部門吊銷藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)的營業(yè)執(zhí)照，并通知藥品監(jiān)督管理部門，由藥品監(jiān)督管理部門吊銷其《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》；構(gòu)成犯罪的，依法追究刑事責(zé)任。
who, if the circumstances are serious, shall revoke the business licenses of the pharmaceutical producing enterprises and pharmaceutical trading enterprises, and shall notify the pharmaceutical supervisory and administrative departments which shall revoke the Pharmaceutical Production License and Pharmaceutical Trading License. If a crime is constituted, an investigation shall be made for criminal liabilities.

第九十一條 藥品的生產(chǎn)企業(yè)、經(jīng)營企業(yè)的負(fù)責(zé)人、采購人員等有關(guān)人員在藥品購銷中收受其他生產(chǎn)企業(yè)、經(jīng)營企業(yè)或者其代理人給予的財(cái)物或者其他利益的，依法給予處分，沒收違法所得；構(gòu)成犯罪的，依法追究刑事責(zé)任。
Article 91 If directors or buyers of pharmaceutical producing enterprises or trading enterprises receive any property or other interests from other producing enterprises, trading enterprises or their agents during the purchase or sale of medicines, they shall be punished according to relevant regulations and shall have their unlawful income confiscated. If a crime is constituted, an investigation shall be made for criminal liabilities.

醫(yī)療機(jī)構(gòu)的負(fù)責(zé)人、藥品采購人員、醫(yī)師等有關(guān)人員收受藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)或者其代理人給予的財(cái)物或者其他利益的，由衛(wèi)生行政部門或者本單位給予處分，沒收違法所得；對違法行為情節(jié)嚴(yán)重的執(zhí)業(yè)醫(yī)師，由衛(wèi)生行政部門吊銷其執(zhí)業(yè)證書；構(gòu)成犯罪的，依法追究刑事責(zé)任。
If the directors, buyers, physicians or other relevant persons in medical organizations receive any property or other interests from pharmaceutical producing enterprises, pharmaceutical trading enterprises or their agents, they shall be punished by the administrative departments of health or the work units where they work, and have their unlawful income confiscated. If practicing physicians seriously violate the law, his practice certificate shall be revoked by the administrative departments of health. If a crime is constituted, an investigation shall be made for criminal liabilities in conformity with relevant laws and regulations.

第九十二條 違反本法有關(guān)藥品廣告的管理規(guī)定的，依照《中華人民共和國廣告法》的規(guī)定處罰，并由發(fā)給廣告批準(zhǔn)文號的藥品監(jiān)督管理部門撤銷廣告批準(zhǔn)文號，一年內(nèi)不受理該品種的廣告審批申請；構(gòu)成犯罪的，依法追究刑事責(zé)任。
Article 92 Those who act against the administrative regulations concerning pharmaceutical advertisement as provided in this Law shall be sanctioned in conformity with the Advertisement Law of the PRC, have its advertisement registration number revoked by the pharmaceutical supervisory and administrative departments from which the registration number has been issued, and its application for the approval of the advertisement regarding this variety of medicines shall not be accepted for one year. If a crime is constituted, an investigation of criminal liabilities shall be made in conformity with relevant laws and regulations.

藥品監(jiān)督管理部門對藥品廣告不依法履行審查職責(zé)，批準(zhǔn)發(fā)布的廣告有虛假或者其他違反法律、行政法規(guī)的內(nèi)容的，對直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予行政處分；構(gòu)成犯罪的，依法追究刑事責(zé)任。
If a pharmaceutical supervisory or administrative department does not perform its duty of inspection on pharmaceutical advertisements which results in the publishing of advertisements containing falsehoods or other content against laws and administrative regulations, the directly liable person in charge and other responsible personnel shall be subject to administrative sanction. If their acts constitute a crime, they shall be investigated for criminal liabilities in conformity with relevant regulations.

第九十三條 藥品的生產(chǎn)企業(yè)、經(jīng)營企業(yè)、醫(yī)療機(jī)構(gòu)違反本法規(guī)定，給藥品使用者造成損害的，依法承擔(dān)賠償責(zé)任。
Article 93 If pharmaceutical producing enterprises, trading enterprises or medical organizations act against this law which results in damages to the users of pharmaceut, icals, they shall bear liabilities of compensation in conformity with relevant regulations.

第九十四條 藥品監(jiān)督管理部門違反本法規(guī)定，有下列行為之一的，由其上級主管機(jī)關(guān)或者監(jiān)察機(jī)關(guān)責(zé)令收回違法發(fā)給的證書、撤銷藥品批準(zhǔn)證明文件，對直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予行政處分；構(gòu)成犯罪的，依法追究刑事責(zé)任：
Article 94 If a pharmaceutical supervisory and administrative department violates this law with one of the following acts, a competent authority of a higher level or a supervisory organization shall order it to withdraw the unlawfully issued certificates, revoke the pharmaceutical approval certificates, and render administrative sanctions against the directly liable person in charge and other responsible personnel. If their acts constitute a crime, they shall be investigated for criminal liabilities.

（一）對不符合《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》的企業(yè)發(fā)給符合有關(guān)規(guī)范的認(rèn)證證書的，或者對取得認(rèn)證證書的企業(yè)未按照規(guī)定履行跟蹤檢查的職責(zé)，對不符合認(rèn)證條件的企業(yè)未依法責(zé)令其改正或者撤銷其認(rèn)證證書的；
(1) issue a certificate of qualification to an enterprise which does not meet the requirements of the "Quality Control Standard of Pharmaceutical Production" and the "Quality Control Standard of Pharmaceutical Trading," fail to conduct inspections according to relevant regulations on the enterprises which have already obtained certificates, or fail to order the unqualified enterprises to amend themselves or revoke their certificates according to relevant regulations; or

（二）對不符合法定條件的單位發(fā)給《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》或者《醫(yī)療機(jī)構(gòu)制劑許可證》的；
(2) issue a Pharmaceutical Production License, a Pharmaceutical Trading License or a Dispensing Permit of Medical Organizations to a unit which does not meet legal requirements;

（三）對不符合進(jìn)口條件的藥品發(fā)給進(jìn)口藥品注冊證書的；
(3) issue a registration certificate of import to a medicine which does not meet the requirements for import; or

（四）對不具備臨床試驗(yàn)條件或者生產(chǎn)條件而批準(zhǔn)進(jìn)行臨床試驗(yàn)、發(fā)給新藥證書、發(fā)給藥品批準(zhǔn)文號的。
(4) approve a clinic test when the requirements for clinic tests are not met, or issue certificates of new medicines and pharmaceutical approval document numbers when requirements for production are not met.

第九十五條 藥品監(jiān)督管理部門或者其設(shè)置的藥品檢驗(yàn)機(jī)構(gòu)或者其確定的專業(yè)從事藥品檢驗(yàn)的機(jī)構(gòu)參與藥品生產(chǎn)經(jīng)營活動的，由其上級機(jī)關(guān)或者監(jiān)察機(jī)關(guān)責(zé)令改正，有違法收入的予以沒收；情節(jié)嚴(yán)重的，對直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予行政處分。
Article 95 If a pharmaceutical supervisory and administrative department, or an inspection institution it has established, or an organization exclusively engaged in pharmaceutical inspection it has appointed, participates in the production and trade of pharmaceuticals, the responsible authority of a higher level or a supervisory organization shall order it to amend itself and have its unlawful income confiscated. If the circumstances are serious, the directly liable person in charge and other responsible personnel shall be subject to administrative sanctions.

藥品監(jiān)督管理部門或者其設(shè)置的藥品檢驗(yàn)機(jī)構(gòu)或者其確定的專業(yè)從事藥品檢驗(yàn)的機(jī)構(gòu)的工作人員參與藥品生產(chǎn)經(jīng)營活動的，依法給予行政處分。
If a staff member in a pharmaceutical supervisory and administrative department, or in an inspection institution it has established, or in an organization exclusively engaged in pharmaceutical inspection it has appointed, participates in the production and trade of pharmaceuticals, he or she shall be subject to administrative sanction.

第九十六條 藥品監(jiān)督管理部門或者其設(shè)置、確定的藥品檢驗(yàn)機(jī)構(gòu)在藥品監(jiān)督檢驗(yàn)中違法收取檢驗(yàn)費(fèi)用的，由政府有關(guān)部門責(zé)令退還，對直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予行政處分。對違法收取檢驗(yàn)費(fèi)用情節(jié)嚴(yán)重的藥品檢驗(yàn)機(jī)構(gòu)，撤銷其檢驗(yàn)資格。
Article 96 If a pharmaceutical supervisory and administrative department or a pharmaceutical inspection institution it has established or appointed unlawfully collects inspection fees during a pharmaceutical supervision and inspection, it shall be ordered by the government bodies concerned to make reimbursements, and the directly liable person and other responsible personnel shall be subject to administrative sanctions. If the circumstances are serious, the certificate of qualification of the inspection institution which has unlawfully collected inspection fees shall be revoked.

第九十七條 藥品監(jiān)督管理部門應(yīng)當(dāng)依法履行監(jiān)督檢查職責(zé)，監(jiān)督已取得《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》的企業(yè)依照本法規(guī)定從事藥品生產(chǎn)、經(jīng)營活動。
Article 97 A pharmaceutical supervisory and administrative department shall perform its duty of supervision and inspection according to laws and regulations, and shall supervise the production and trade of the enterprises which have obtained a Pharmaceutical Production License or a Pharmaceutical Trade License according to the regulations of this Law.

已取得《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》的企業(yè)生產(chǎn)、銷售假藥、劣藥的，除依法追究該企業(yè)的法律責(zé)任外，對有失職、瀆職行為的藥品監(jiān)督管理部門直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予行政處分；構(gòu)成犯罪的，依法追究刑事責(zé)任。
If an enterprise which has obtained a Pharmaceutical Production License or a Pharmaceutical Trade License produces and sells fake medicines and medicines of inferior quality, the enterprise shall be investigated for legal liabilities according to laws and regulations. In addition, the directly liable person in charge and other responsible personnel in the pharmaceutical supervisory and administrative department who have neglected or have been derelict in their duty shall be subject to administrative sanction. If a crime is constituted, the party shall be investigated for criminal liabilities according to laws and regulations.

第九十八條 藥品監(jiān)督管理部門對下級藥品監(jiān)督管理部門違反本法的行政行為，責(zé)令限期改正；逾期不改正的，有權(quán)予以改變或者撤銷。
Article 98 A pharmaceutical supervisory and administrative department shall, within a prescribed time limit, order a pharmaceutical supervisory and administrative department of a lower level to correct an administrative act which is not in conformity with this Law. If the administrative act is not corrected within the prescribed time limit, the department shall have the power to change or repeal it.

第九十九條 藥品監(jiān)督管理人員濫用職權(quán)、徇私舞弊、玩忽職守，構(gòu)成犯罪的，依法追究刑事責(zé)任；尚不構(gòu)成犯罪的，依法給予行政處分。
Article 99 If the personnel of the pharmaceutical supervision and administration misuse their authority, engage in irregular practices due to favoritism, or neglect their duties to such an extent that a crime is constituted, they shall be investigated for criminal liabilities. If their acts have not constituted a crime, they shall be subject to administrative sanctions.

第一百條 依照本法被吊銷《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》的，由藥品監(jiān)督管理部門通知工商行政管理部門辦理變更或者注銷登記。
Article 100 If a Pharmaceutical Production License or a Pharmaceutical Trade License is revoked according to this Law, the pharmaceutical supervisory and administrative department shall notify the industry and commerce administrative department to alter or annul the registration.

第一百零一條 本章規(guī)定的貨值金額以違法生產(chǎn)、銷售藥品的標(biāo)價(jià)計(jì)算；沒有標(biāo)價(jià)的，按照同類藥品的市場價(jià)格計(jì)算。
Article 101 The value of goods as prescribed in this chapter is designated according to the marked price of the unlawfully made or sold medicines. In the absence of a marked price, the value of goods shall be designated according to the market price of pharmaceuticals of the same kind.

第十章 附則
Chapter X Supplementary Provisions

第一百零二條 本法下列用語的含義是：
Article 102 For the purpose of this Law, the following definitions are offered:

藥品，是指用于預(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)癥或者功能主治、用法和用量的物質(zhì)，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。
" Pharmaceuticals " means the articles intended for use in the prevention, treatment or diagnosis of human diseases, or intended to effect the purposive regulation of human physiological functions, for which indications or major functions, usage and dosage are prescribed. They include raw traditional Chinese medicinal materials, traditional medicines prepared in ready-to-use forms, and other prepared Chinese medicines, medicinal chemicals and their preparations, antibiotics, biochemical medicines, radioactive drugs, serums, vaccines, blood products, diagnostic aids, etc.

輔料，是指生產(chǎn)藥品和調(diào)配處方時(shí)所用的賦形劑和附加劑。
" Supplementary materials " means the excipients and additives used for the production and dispensing of pharmaceuticals.

藥品生產(chǎn)企業(yè)，是指生產(chǎn)藥品的專營企業(yè)或者兼營企業(yè)。
" Pharmaceutical producing enterprise " means an enterprise exclusively or partly engaged in the production of pharmaceuticals.

藥品經(jīng)營企業(yè)，是指經(jīng)營藥品的專營企業(yè)或者兼營企業(yè)。
" Pharmaceutical trading enterprise " means an enterprise exclusively or partly engaged in the trade of pharmaceuticals.

第一百零三條 中藥材的種植、采集和飼養(yǎng)的管理辦法，由國務(wù)院另行制定。
Article 103 Measures for the control of cultivation, collection and breeding of all categories of medicinal materials used in traditional Chinese medicine shall be seperately formulated by the State Council .

第一百零四條 國家對預(yù)防性生物制品的流通實(shí)行特殊管理。具體辦法由國務(wù)院制定。
Article 104 The State Council shall formulate detailed measures to carry out special control on the circulation of preventive bioproducts.

第一百零五條 中國人民解放軍執(zhí)行本法的具體辦法，由國務(wù)院、中央軍事委員會依據(jù)本法制定。
Article 105 Detailed measures for the implementation of this law by the Chinese People's Army shall be formulated by the State Council and the Central Military Committee of the State on the basis of this Law.

第一百零六條 本法自２００１年１２月１日起施行。
Article 106 This Law shall enter into force as of December 1, 2001.