1、常用藥品監(jiān)管英語與縮略語常用藥品監(jiān)管英語與縮略語浙江省藥品監(jiān)督管理局政策法規(guī)處一、監(jiān)管英語1. 中華人民共和國藥品管理法Drug Control Law of the People's Republic of China2. 藥品生產(chǎn)企業(yè)管理control over drug manufacturers3. 藥品經(jīng)營企業(yè)管理control over drug distributors4. 醫(yī)療機(jī)構(gòu)的藥劑管理control over medicines in medical institutions5. 藥品管理control over drugs6. 藥品包裝的管理control ov

2、er drug packaging7. 藥品價格和廣告的管理control over drug price and advertisement8. 藥品監(jiān)督inspection of drugs9. 法律責(zé)任legal liabilities10. 藥品標(biāo)識labels or marks of the drugs11. 假藥counterfeit drugs112. 劣藥inferior drugs13. 藥品檢驗(yàn)機(jī)構(gòu)drug quality control laboratory14. 藥品的生產(chǎn)企業(yè)drug manufacturers15. 經(jīng)營企業(yè)drug distributors16.

3、醫(yī)療機(jī)構(gòu)medical institutions17. 藥品監(jiān)督管理部門drug regulatory agency18. 藥品批準(zhǔn)證明文件drug approval documents19. 行政處分administrative sanctions20. 刑事責(zé)任criminal liabilities21. 藥品生產(chǎn)質(zhì)量管理規(guī)范Good Manufacturing Practice for Pharmaceutical Products (GMP)22. 藥品經(jīng)營質(zhì)量管理規(guī)范Good Supply Practice for Pharmaceutical Products (GSP)23.

4、藥品生產(chǎn)許可證Drug Manufacturing Certificate224. 藥品經(jīng)營許可證Drug Supply Certificate25. 醫(yī)療機(jī)構(gòu)制劑許可證Pharmaceutical Preparation Certificate for Medical Institution26. 進(jìn)口藥品注冊證書Import Drug License27. 臨床試驗(yàn)clinical trial28. 新藥證書New Drug Certificate29. 藥品批準(zhǔn)文號Drug Approval Number30. 在中華人民共和國境內(nèi)從事藥品的研制、生產(chǎn)、經(jīng)營、使用和監(jiān)督管理的單位或者個人

5、必須遵守中華人民共和國藥品管理法All institutions or individuals engaged in research, production, distribution, use, and administration and supervision of drugs in the People's Republic of China shall abide by drug control law of the people's republic of China.31. 國務(wù)院藥品監(jiān)督管理部門主管全國藥品監(jiān)督管理工作。The drug regulatory

6、agency of the State Council shall be responsible for drug administration and supervision nationwide.32. 省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門負(fù)責(zé)本行政區(qū)域內(nèi)的藥品監(jiān)督管理工作。The drug regulatory agencies of the governments of provinces, autonomous regions, and municipalities directly under the Central Government shall be responsib

7、le for drug regulation in their administrative areas.33. 藥品監(jiān)督管理部門設(shè)置或者確定的藥品檢驗(yàn)機(jī)構(gòu)承擔(dān)依法實(shí)施藥品審批和藥品質(zhì)量監(jiān)督檢查所需的藥品檢驗(yàn)工作。The drug quality control laboratories established or designated by drug regulatory agencies shall undertake the responsibility for drug testing required for conducting3drug review and approval

8、and controlling drug quality pursuant to the law.34. 開辦藥品生產(chǎn)企業(yè)須經(jīng)企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān) 督管理部門批準(zhǔn)并發(fā)給藥品生產(chǎn)許可證憑藥品生產(chǎn)許可證到工商行 政管理部門辦理登記注冊。Any newly established pharmaceutical manufacturer shall be subject to approval by the local drug regulatory agency of the government of the province, autonomous region or mu

9、nicipality directly under the Central Government and be granted the Drug Manufacturing Certificate, and, withthe certificate, the manufacturer shall be registered with the administrative agency for industry and commerce.35. 藥品生產(chǎn)許可證應(yīng)當(dāng)標(biāo)明有效期和生產(chǎn)范圍到期重新審查發(fā)證。The term of validation and the scope of manufact

10、uring shall be notedin the Drug Manufacturing Certificate. For renewal of the certificate on expiration, reviewing and approval again is required.藥品監(jiān)督管理部門批準(zhǔn)開辦藥品生產(chǎn)企業(yè)應(yīng)當(dāng)符合國家制定的藥品行業(yè)36.發(fā)展規(guī)劃和產(chǎn)業(yè)政策防止重復(fù)建設(shè)。When giving approval to the newly-established manufacturer, the drugregulatory agency shall see to it th

11、at the development programs and policies set by the State for the pharmaceutical industry shall be complied with so as to prevent duplicate construction.37. 開辦藥品生產(chǎn)企業(yè)必須具備以下條件：，一，具有依法經(jīng)過資格認(rèn)定的藥學(xué)技術(shù)人員、工程技術(shù)人員及相應(yīng)的技術(shù)工人, 二 , 具有與其藥品生產(chǎn)相適應(yīng)的廠房、設(shè)施和衛(wèi)生環(huán)境, 三 , 具有能對所生產(chǎn)藥品進(jìn)行質(zhì)量管理和質(zhì)量檢驗(yàn)的機(jī)構(gòu)、人員以及必要的儀器設(shè)備, 四 , 具有保證藥品質(zhì)量的規(guī)章制度。An

12、y drug manufacturer to be established shall meet the followingrequirements: (1) stuffed with legally qualified pharmaceutical andengineering professionals and the necessary technical workers;(2)provided with the premises, facilities, and clear environment requiredfor drug manufacturing; (3) having q

13、uality management and control units and personnel capable of quality management of and testing for drugs tobe produced and the necessary instruments and equipment; and (4) establishing rules and regulations to govern the quality of drugs.38. 藥品生產(chǎn)企業(yè)必須按照國務(wù)院藥品監(jiān)督管理部門依據(jù)本法制定的藥品生產(chǎn)質(zhì)量管理規(guī)范組織生產(chǎn)。藥品監(jiān)督管理部門按照規(guī)定對藥品

14、生產(chǎn)企業(yè)是否符合藥品生產(chǎn)質(zhì)量管理規(guī)范的要求進(jìn)行認(rèn)證，對認(rèn)證合格的發(fā)給認(rèn) 4證證書。Drug manufacturers shall conduct production according to the Good Manufacturing Practice Products (GMP) formulated by the drug regulatory agency of the State Council based on this Law. The drug regulatory agency shall inspect a drug manufacturer as to its com

15、pliance with the GMP requirements and issue a certificate to the manufacturer passing the inspection.39. 除中藥飲片的炮制外藥品必須按照國家藥品標(biāo)準(zhǔn)和國務(wù)院藥品監(jiān)督管理 部門批準(zhǔn)的生產(chǎn)工藝進(jìn)行生產(chǎn)生產(chǎn)記錄必須完整準(zhǔn)確。With the exception of the processing of prepared slices of Chinese crude drugs, a drug shall be produced in conformity with the National Dr

16、ug Standard and with the production processes approved by the drug regulatory agency of the State Council, and the production records shall be complete and accurate.40. 藥品生產(chǎn)企業(yè)改變影響藥品質(zhì)量的生產(chǎn)工藝的必須報原批準(zhǔn)部門審核批準(zhǔn)。When drug manufacturers make any change in the production process that may affect the drug quality

17、, they shall submit the change to the original authority for reviewing and approval.41. 生產(chǎn)藥品所需的原料、輔料必須符合藥用要求。Active pharmaceutical ingredients (API) and recipients for the manufacture of pharmaceutical products shall meet the requirements for medicinal use.42. 藥品生產(chǎn)企業(yè)必須對其生產(chǎn)的藥品進(jìn)行質(zhì)量檢驗(yàn)。Drug manufacturer

18、s shall perform quality test of their products.43. 不符合國家藥品標(biāo)準(zhǔn)或者不按照省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門制定的中藥飲片炮制規(guī)范炮制的不得出廠。No products that do not meet the National Drug Standards or that are not produced according to the processing procedures for the prepared slices of Chinese crude drugs formulated by the drug regu

19、latory agency of the government of a province, autonomous region, or municipality directly under the Central Government may be released.44. 經(jīng)國務(wù)院藥品監(jiān)督管理部門或者國務(wù)院藥品監(jiān)督管理部門授權(quán)的省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)藥品生產(chǎn)企業(yè)可以接受委托生 產(chǎn)藥品。A drug manufacturer may not accept any contract production of drugs unless it is5approved b

20、y the drug regulatory agency of the State Council, or bythe drug regulatory agency of the government of a province, autonomous region, or municipality directly under the Central Government authorized by the drug regulatory agency of the State Council.45. 開辦藥品批發(fā)企業(yè)須經(jīng)企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān) 督管理部門批準(zhǔn)并發(fā)給藥品經(jīng)

21、營許可證.Any newly established drug wholesaler shall be subject to approvalof the local drug agency of the government of the province, autonomous region or municipality directly under the Central Government and be granted the Drug Supply Certificate.46. 開辦藥品零售企業(yè)須經(jīng)企業(yè)所在地縣級以上地方藥品監(jiān)督管理部門批準(zhǔn) 并發(fā)給藥品經(jīng)營許可證。Any new

22、ly established drug retailer shall be subject to approval andbe granted the above certificate by the local drug regulatory agency at or above the county level.47. 藥品批發(fā)、零售企業(yè)憑藥品經(jīng)營許可證到工商行政管理部門辦理登記注冊。With the Drug Supply Certificate , the wholesaler and the retailer shall be registered with the administ

23、rative agency for industry and commerce.47 .無藥品經(jīng)營許可證的不得經(jīng)營藥品。No one is permitted to distribute drugs without the certificate.48 .藥品經(jīng)營許可證應(yīng)當(dāng)標(biāo)明有效期和經(jīng)營范圍到期重新審查發(fā)證。The valid period and the scope of business shall be indicated in theDrug Supply Certificate. For renewal of the certificate upon expiration, rev

24、iewing and approval again is required.49 . 開辦藥品經(jīng)營企業(yè)必須具備以下條件: , 一 , 具有依法經(jīng)過資格認(rèn)定的藥學(xué)技術(shù)人員, 二 , 具有與所經(jīng)營藥品相適應(yīng)的營業(yè)場所、設(shè)備、倉儲設(shè)施、衛(wèi)生環(huán)境, 三 , 具有與所經(jīng)營藥品相適應(yīng)的質(zhì)量管理機(jī)構(gòu)或者人員, 四 ,具有保證所經(jīng)營藥品質(zhì)量的規(guī)章制度。A drug distributor to be established shall meet the following requirements:(1) staffed with legally qualified pharmaceutical profes

25、sionals;(2) provided with the business operation premises, equipment, warehouses, and clear environment required for drug distribution;(3) having the quality control units or personnel adaptable the drugs to be distributed; and(4) establishing rules and regulations to govern the quality of the drugs

26、 to be distributed.650 . 藥品經(jīng)營企業(yè)必須按照國務(wù)院藥品監(jiān)督管理部門依據(jù)本法制定的藥品經(jīng) 營質(zhì)量管理規(guī)范經(jīng)營藥品。Drug distributors shall conduct business according to the Good Supply Practice for Pharmaceutical Products (GSP) set by the drug regulatory agency of the State Council based on this Law.藥品監(jiān)督管理部門按照規(guī)定對藥品經(jīng)營企業(yè)是否符合藥品經(jīng)營質(zhì)量管理51.規(guī)范的要求進(jìn)行認(rèn)證，對

27、認(rèn)證合格的發(fā)給認(rèn)證證書。The drug regulatory agency inspect a drug distributor as to its compliance with the GSP requirements, and issue a certificate to the distributor passing the inspection.52 .藥品經(jīng)營企業(yè)購進(jìn)藥品必須建立并執(zhí)行進(jìn)貨檢查驗(yàn)收制度驗(yàn)明藥品合 格證明和其他標(biāo)識，不符合規(guī)定要求的不得購進(jìn)。After receiving the drug purchased, drug distributors shall pas

28、s the established examination and acceptance system, and check the certificate of drug quality, labels and others marks; no drugs that fail to meet the requirements are permitted to be purchased.53 .藥品經(jīng)營企業(yè)購銷藥品必須有真實(shí)完整的購銷記錄。Drug distributors shall keep a real and perfect records of purchasing and sell

29、ing drugs.54 . 購銷記錄必須注明藥品的通用名稱、劑型、規(guī)格、批號、有效期、生產(chǎn)廠商、購 , 銷 , 貨單位、購, 銷 , 貨數(shù)量、購銷價格、購, 銷 , 貨日期及國務(wù)院藥品監(jiān)督管理部門規(guī)定的其他內(nèi)容。In the record shall be indicated the adopted name of drugs, dosage form, strength or size, batch number, date of expiry, manufacturer, purchaser (or seller), amount of the drug purchased (or so

30、ld), purchase or selling price, date of purchase (or sale) , and other items specified by the drug regulatory agency of the State Council.55 .藥品經(jīng)營企業(yè)銷售中藥材必須標(biāo)明產(chǎn)地。Drug distributors shall indicate the habitat of Chinese crude drugs to be sold.56 .藥品經(jīng)營企業(yè)必須制定和執(zhí)行藥品保管制度采取必要的冷藏、防凍、防 潮、防蟲、防鼠等措施保證藥品質(zhì)量。A drug d

31、istributor shall pass the established system for drug storage, and take necessary measures to ensure drug quality, such as cold storing, protecting from being frozen and moisture and guarding against insects and rodents.57 . 藥品入庫和出庫必須執(zhí)行檢查制度。An examination system shall be followed for storing drugs i

32、n warehouse and releasing them from warehouse.58 .城鄉(xiāng)集市貿(mào)易市場可以出售中藥材國務(wù)院另有規(guī)定的除外。Chinese crude drugs may be sold at fairs in urban and rural areas, except those otherwise specified by the State Council.59 .城鄉(xiāng)集市貿(mào)易市場不得出售中藥材以外的藥品但持有藥品經(jīng)營許可證的藥品零售企業(yè)在規(guī)定的范圍內(nèi)可以在城鄉(xiāng)集市貿(mào)易市場設(shè)點(diǎn)出售中藥材以外的藥品。No drugs other than the Chinese

33、 crude drugs may be sold at fairs inurban and rural areas, but drug retailers holding the Drug SupplyCertificate may, within the specified business scope, sell such drugs at the stores they set up at the fairs.60 .醫(yī)療機(jī)構(gòu)配制制劑須經(jīng)所在地省、自治區(qū)、直轄市人民政府衛(wèi)生行政部 門審核同意由省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)發(fā)給醫(yī)療機(jī)構(gòu)制劑許可證。Dispensing ph

34、armaceutical preparations by a medical institutionshall be subject to reviewing and permission by the healthadministration agency of the government of the province, autonomous region or municipality directly under the Central Government, and upon approval by the drug regulatory agency of the governm

35、ent. APharmaceutical Preparation Certificate for Medical Institution shall be issued by the above drug regulatory agency.61 .無醫(yī)療機(jī)構(gòu)制劑許可證的醫(yī)療機(jī)構(gòu)不得配制制劑。No medical institution is permitted to dispense pharmaceutical preparations without the Pharmaceutical Preparation Certificate for Medical Institution.62

36、 .醫(yī)療機(jī)構(gòu)制劑許可證應(yīng)當(dāng)標(biāo)明有效期到期重新審查發(fā)證。The term of validation shall be noted in the PharmaceuticalPreparation Certificate for Medical Institution. For renewal of the certificate upon expiration, reviewing and approval again is required.63 .醫(yī)療機(jī)構(gòu)配制的制劑應(yīng)當(dāng)是本單位臨床需要而市場上沒有供應(yīng)的品種 并須經(jīng)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)后方可配制。The ph

37、armaceutical preparations to be dispensed by the medical institution shall be8those satisfying the clinic need of the institution but not available on the market. It shall be subject to approval in advance by the local drug regulatory agency of the government of the province, autonomous region or mu

38、nicipality directly under the Central Government.64 .醫(yī)療機(jī)構(gòu)配制的制劑不得在市場銷售。No pharmaceutical preparations dispensed by medical institutions are permitted to be marketed.65.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)。A full description of a new drug research and developm

39、ent includingthe manufacturing process, quality specifications, results ofpharmacological and toxicological study, and the related data as well as the samples shall, in accordance with the regulations of the drug regulatory agency of the State Council, be truthfully submitted to the above agency for

40、 reviewing and approval.66. 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。When a new drug has gone through clinical trials and passed the reviewing, a New Drug Certificate shall be issued upon approval by the drug regulatory agency of the State Council.67. 藥物的非臨床安全性評價研究機(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)

41、范。The institutions for non-clinical safety evaluation and study andfor clinical study institutions shall respectively follow the GoodLaboratory Practice for Non-Clinical Laboratory Studies (GLP) and Good Clinical Practice (GCP).68. 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

42、。Production of a new drug or production of a drug complying withNational Drug Standards shall be subject to the approval by the drug regulatory agency of the State Council, and a drug approval number shallbe issued for it, with the exception of the Chinese crude drugs and the prepared slices of Chin

43、ese crude drugs in which no control by approval number is exercised.69. 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9門會同國務(wù)院中醫(yī)藥管理部門制定。The list of the Chinese crude drugs and the prepared slices of theChinese crude drugs to be controlled by the approval number shall be compiled by the drug regulatory agency of th

44、e State Council, jointly with the administrative agency for traditional Chinese medicines of the State Council.70. 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。A drug manufacturer is permitted to produce the drug only after an approval number has been granted to it.71. 藥品必須符合國家藥品標(biāo)準(zhǔn)。Drugs shall comply with the National D

45、rug Standards.72. 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 Drug Standards issued by the drug regulatory agency of the State Council shall serve as the National Drug Standards.73. 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 drug regulatory agency o

46、f the State Council shall organize a pharmacopoeia commission, which shall be responsible for formulating and revising the National Drug Standards.74. 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 drug control institution affiliated to the drug regulatory agency of the State Council is responsible for stand

47、ardizing the National Drug Standard Substance and Reference Substance.75. 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。Drug manufacturers, drug distributors and medical institutions shall purchase drugs from pharmaceutical enterprises, which are qualified for production and distribut

48、ion, with the exception of the Chinese crude drugs in which no control by approval number is exercised.76. 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10理。The State exercises special control over narcotic drugs, psychotropic substances, toxic drugs for medical use and radioactive pharmaceuticals.77. 國家實(shí)行中藥品種保護(hù)制度

49、。The State adopts a protection system for certain traditional Chinese medicines.78. 國家對藥品實(shí)行處方藥與非處方藥分類管理制度。The State adopts a system of classified management for prescription and non-prescription drugs.79. 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。Reviewing the drugs to be imported sha

50、ll come of the jurisdiction ofthe drug regulatory agency of the State Council. A drug is permitted to be imported only upon approval granted after confirming that it conforms to the quality, safely and efficiency through examination, and a drug importation license shall be issued.80. 國家實(shí)行藥品儲備制度。The

51、State adopts a policy for drug storage for future use.81. 國內(nèi)發(fā)生重大災(zāi)情、疫情及其他突發(fā)事件時國務(wù)院規(guī)定的部門可以緊急 調(diào)用企業(yè)藥品。When major disasters, epidemic situations or other emergencies occur in the country, the department designated by the State Council may allocate drugs from the enterprises to meet the urgent need.82. 禁止生

52、產(chǎn), 包括配制 , 、銷售假藥。Production (including dispensing) and distribution of counterfeitdrugs are prohibited.83. 有下列情形之一的為假藥：A drug falling into the following categories is deemed as a counterfeit drug: , 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,The ingredients in the drug are different from those specified by the Nation

53、al Drug Standards;, 二 , 以非藥品冒充藥品或者以他種藥品冒充此種藥品的。It is not the same drug which is claimed by its name or in reality it is not a drug at11all.84 .有下列情形之一的藥品按假藥論處：A drug falling into the following categories shall be deemed as a counterfeit drug: , 一 , 國務(wù)院藥品監(jiān)督管理部門規(guī)定禁止使用的,It s use is prohibited by the pr

54、ovisions of the drug regulatoryagency of the StateCouncil;,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,It is produced or imported without approval, or marketed withoutbeing tested, as required by the Law;, 三 , 變質(zhì)的 ,It is deteriorated;, 四 , 被污染的,It is 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It is

55、 produced by using active pharmaceutical ingredients without approval number as required by this Law;, 六 , 所標(biāo)明的適應(yīng)癥或者功能主治超出規(guī)定范圍的。The indications or functions indicated are beyond the specified scope.85 . 禁止生產(chǎn)、銷售劣藥。Production and distribution of drugs of inferior quality are prohibited.86 .藥品成份的含量不符合國

56、家藥品標(biāo)準(zhǔn)的為劣藥。A drug with content not up to the National Drug Standards is a drug of inferior quality.87.有下列情形之一的藥品按劣藥論處：A drug falling into the following categories shall be deemed as a drug of inferior quality:, 一 , 未標(biāo)明有效期或者更改有效期的,The date of expiry is not indicated or is altered;, 二 , 不注明或者更改生產(chǎn)批號的,Th

57、e batch number is not indicated or is altered;, 三 , 超過有效期的,It is beyond the date of expiry;, 四 , 直接接觸藥品的包裝材料和容器未經(jīng)批準(zhǔn)的,12No approval certificate is obtained for the immediate packaging material or container;, 五 , 擅自添加著色劑、防腐劑、香料、矯味劑及輔料的,Colorants, preservatives, spices, flavorings, or other recipients have been added without authorization; or, 六 , 其他不符合藥品標(biāo)準(zhǔn)規(guī)定的。Other cases where the drug standards are not complied with.88. 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。A drug name listed in the National Drug Standards is an adopted na