紧急！请高手帮忙汉译英 翻得好追加得分！谢谢！
国家食品药品监督管理局令24号Provisions for Drug Insert Sheets and Labels (SFDA Order No. 24)
http://www.sfda.gov.cn/cmsweb/webportal/W53384/A64007722.html
这里有国家英文网站的几篇法规，可以参考一下
http://www.sfda.gov.cn/cmsweb/webportal/W43879539/index.html?UID=DWV1_WOUID_URL_43879539
哪位大侠帮帮忙，感激不尽！！！
求好心人帮帮忙吧，翻好了，我会追加分的！
药品说明书和标签管理规定
The drugs manual and labels manage the provision
第一条 为规范药品说明书和标签的管理，根据《中华人民共和国药品管理法》和《中华人民共和国药品管理法实施条例》制定本规定。
第二条 在中华人民共和国境内上市销售的药品，其说明书和标签应当符合本规定的要求。
第三条 药品说明书和标签由国家食品药品监督管理局予以核准。
药品的标签应当以说明书为依据，其内容不得超出说明书的范围，不得印有暗示疗效、误导使用和不适当宣传产品的文字和标识。
第四条 药品包装必须按照规定印有或者贴有标签，不得夹带其他任何介绍或者宣传产品、企业的文字、音像及其他资料。
药品生产企业生产供上市销售的最小包装必须附有说明书。
第五条 药品说明书和标签的文字表述应当科学、规范、准确。非处方药说明书还应当使用容易理解的文字表述，以便患者自行判断、选择和使用。
第六条 药品说明书和标签中的文字应当清晰易辨，标识应当清楚醒目，不得有印字脱落或者粘贴不牢等现象，不得以粘贴、剪切、涂改等方式进行修改或者补充。
第七条 药品说明书和标签应当使用国家语言文字工作委员会公布的规范化汉字，增加其他文字对照的，应当以汉字表述为准。
第八条 出于保护公众健康和指导正确合理用药的目的，药品生产企业可以主动提出在药品说明书或者标签上加注警示语，国家食品药品监督管理局也可以要求药品生产企业在说明书或者标签上加注警示语。
Article 1 manages for the norm drugs manual and label, according to 《 the People's Republic of China drugs management method 》 and 《 the People's Republic of China drugs management method implement regulation 》 establishment rule originally.
Article 2 is inshore to appear on market the drugs of the sale in the People's Republic of China, its manual and labels should meet the request of this provision.
The third drugs manual and labels is given the sanction by the national food drugs direct management bureau.
The label of the drugs should take manual as the basis, its contents can not outrun the scope of the manual, can not print to have the allusion curative effect and mislead the usage and inadequacy to publicizee the writing and the marking of the product.
The fourth drugs packing must print according to the provision or stick the label, can not clip to take other any introduction or the writing, sound of the publicity product, business enterprise be like and other data.
The drugs produce the business enterprise to produce to provide minimum packing of appear on market the sale must fish-eye manual.
The writing form of the fifth drugs manual and labels say should science, norm, accurate.The non- prescription medicine manual should still use the writing form of the easy comprehension to say, for the purpose of sufferer by oneself judge, choice and usage.
The sixth drugs manual and writing in the label should clear easy , the marking should know refreshing, can not print the word to shed off or glue to stick rickety etc. phenomenon, can not stick, shear by glue to slice, alter etc. the method carry on modification or complement.
The seventh drugs manual and labels should use the norm of the national language writing work committee announcement to turn the Chinese characters, increasing other writings to check against of, should with the Chinese characters form say for precise.
Article 8 proceed from protect public health and guide right reasonable use the medicine of purpose, the drugs produce the business enterprise and can put forward actively at the drugs manual or label up add to note the caution language, the national food drugs direct management the bureau can also request the drugs production business enterprise at the manual or label up add to note the caution
language.
第二章 药品说明书
A drugs manual
第九条 药品说明书应当包含药品安全性、有效性的重要科学数据、结论和信息，用以指导安全、合理使用药品。药品说明书的具体格式、内容和书写要求由国家食品药品监督管理局制定并发布。
第十条 药品说明书对疾病名称、药学专业名词、药品名称、临床检验名称和结果的表述，应当采用国家统一颁布或规范的专用词汇，度量衡单位应当符合国家标准的规定。
第十一条 药品说明书应当列出全部活性成份或者组方中的全部中药药味。注射剂和非处方药还应当列出所用的全部辅料名称。
药品处方中含有可能引起严重不良反应的成份或者辅料的，应当予以说明。
第十二条 药品生产企业应当主动跟踪药品上市后的安全性、有效性情况，需要对药品说明书进行修改的，应当及时提出申请。
根据药品不良反应监测、药品再评价结果等信息，国家食品药品监督管理局也可以要求药品生产企业修改药品说明书。
第十三条 药品说明书获准修改后，药品生产企业应当将修改的内容立即通知相关药品经营企业、使用单位及其他部门，并按要求及时使用修改后的说明书和标签。
第十四条 药品说明书应当充分包含药品不良反应信息，详细注明药品不良反应。药品生产企业未根据药品上市后的安全性、有效性情况及时修改说明书或者未将药品不良反应在说明书中充分说明的，由此引起的不良后果由该生产企业承担。
第十五条 药品说明书核准日期和修改日期应当在说明书中醒目标示。
The ninth drugs manual should include the important science data, conclusion and informations of the drugs safety, usefulness, guiding the safety, reasonable usage drugs in order to.The concrete format, contents of the drugs manual and write to request from the national food drugs direct management bureau the establishment erupts the cloth.
The tenth drugs manual examines the form of the name and result to say to the professional word, drugs name, clinic of disease name, pharmacy, should adopt the appropriation phrase that the nation unifies the promulgation or norm to remit, the weights and measures unit should meet the provision of the nation standard.
The 11th drugs manual should list all live composition or all Chinese herbal medicine medicine flavor within a square.Inject the and the non- prescription medicines should still list use of assist to anticipate the name all.
The composition with probably cause severity badly reaction assists to anticipate perhaps in the drugs prescription of, should give the elucidation.
The 12th drugs produce the business enterprise should follow actively after drugs appear on market of safety, the usefulness circumstance, need to carry on the modification to the drugs manual of, should put forward the application in time.
According to the drugs badly respond the monitor, drugs to revalue the result etc. information, the national food drugs direct management the bureau can also request the drugs production business enterprise modification drugs manual.
After the 13th drugs manual permits the modification, the drugs produce the business enterprise and should request the contents of the modification notifies the related drugs management business enterprise and uses unit and other sectionses immediately, and press in time to use the manual and the label of modify the empress.
The 14th drugs manual should include the bad reaction information of drugs well, detailed note the drugs bad reaction.The drugs production business enterprise don't according to drugs the safety, the usefulness circumstance after appear on market modifies in time manual or did not produce the bad reaction of drugs is well explanatory in the manual, from here cause of bad result from should the business enterprise undertake.
The date of the 15th drugs manual sanction and date of modifications should be refreshing in the manual to mark.
第三章 药品的标签
The label of a drugs
第十六条 药品的标签是指药品包装上印有或者贴有的内容，分为内标签和外标签。药品内标签指直接接触药品的包装的标签，外标签指内标签以外的其他包装的标签。
第十七条 药品的内标签应当包含药品通用名称、适应症或者功能主治、规格、用法用量、生产日期、产品批号、有效期、生产企业等内容。
包装尺寸过小无法全部标明上述内容的，至少应当标注药品通用名称、规格、产品批号、有效期等内容。
第十八条 药品外标签应当注明药品通用名称、成份、性状、适应症或者功能主治、规格、用法用量、不良反应、禁忌、注意事项、贮藏、生产日期、产品批号、有效期、批准文号、生产企业等内容。适应症或者功能主治、用法用量、不良反应、禁忌、注意事项不能全部注明的，应当标出主要内容并注明“详见说明书”字样。
第十九条 用于运输、储藏的包装的标签，至少应当注明药品通用名称、规格、贮藏、生产日期、产品批号、有效期、批准文号、生产企业，也可以根据需要注明包装数量、运输注意事项或者其他标记等必要内容。
第二十条 原料药的标签应当注明药品名称、贮藏、生产日期、产品批号、有效期、执行标准、批准文号、生产企业，同时还需注明包装数量以及运输注意事项等必要内容。
第二十一条 同一药品生产企业生产的同一药品，药品规格和包装规格均相同的，其标签的内容、格式及颜色必须一致；药品规格或者包装规格不同的，其标签应当明显区别或者规格项明显标注。
同一药品生产企业生产的同一药品，分别按处方药与非处方药管理的，两者的包装颜色应当明显区别。
第二十二条 对贮藏有特殊要求的药品，应当在标签的醒目位置注明。
第二十三条 药品标签中的有效期应当按照年、月、日的顺序标注，年份用四位数字表示，月、日用两位数表示。其具体标注格式为“有效期至XXXX年XX月”或者“有效期至XXXX年XX月XX日”；也可以用数字和其他符号表示为“有效期至XXXX.XX.”或者“有效期至XXXX/XX/XX”等。
预防用生物制品有效期的标注按照国家食品药品监督管理局批准的注册标准执行，治疗用生物制品有效期的标注自分装日期计算，其他药品有效期的标注自生产日期计算。
有效期若标注到日，应当为起算日期对应年月日的前一天，若标注到月，应当为起算月份对应年月的前一月。
The 16th label of drugs mean that the drugs packing prints to have up or stick some contentses, is divided into inside the label and the outside labels.The label inside the drugs points the label of the packing of the direct contact drugs, the outside label point inside the label outside of other packing of label.
The 17th drugs of inside the label should include in general use name, adaption of drugs or the function lord cure, specification, method of using dosage, produce the date, product batch number, term of validity and produce the business enterprise etc. contents.
Pack the size lead small can't mark clearly the above-mentioned contents all of, should mark the in general use name, specification, product batch number, term of validity of drugs at least etc. contents.
The 18th label with outside drugs should note in general use name, composition, sex form, adaption of drugs or the function lord cure, specification, method of using dosage, bad respond, taboo, regulation, store, produce date, product batch number, term of validity, grant text number, produce business enterprise etc. contents.Adaption or the function lord cure, method of using dosage, bad respond, the taboo, regulation can't note all of, should mark out the main contents and note" know well to see the manual" certain context.
A the label of the packing that useds for the conveyance and stores, should note the in general use name, specification of drugs, store, produce the date, product batch number, term of validity, grant the text number and produce the business enterprise at least, can also note to pack according to the demand quantity, the conveyance regulation or necessary contents of etc. of other markings.
The 20th label of raw material medicine should note the drugs name and store, produce the date, product batch number, term of validity, performance standard, grant the text number and produce the business enterprise, still need to note to pack the quantity and transport the regulation to wait the necessary contents at the same time.
A same drugs produce same drugs of the business enterprise production, the drugs specification is in accordance with the packing specification all the homology of, the contents, format and colors of its label must;The drugs specification or the packing specification is different, its label should distinguish obviously or the specification item marks obviously.
Same drugs produce same drugs of the business enterprise production, pressing the prescription medicine and the non- prescription medicine management respectively of, both of packing color should distinguish obviously.
A drugs that has the special request to the hoarding, should note in the refreshing position of the label.
The term of validity within the 23th drugs label should mark according to the sequence of the year, month, day, the age means with four numerals, the month, day uses two number to mean.It marks the format as" the term of validity goes to the XXXX year XX month" in a specific way or" the term of validity goes to the XXXX year XX month XX day";Can also mean with the numerical and other sign for" the term of validity goes to the XXXX.XX." Or" the term of validity goes to the XXXX/ XX/ XX" etc..
The prevention marks the registration standard performance that manages the bureau approval according to the national food drugs direct with the living creature ware term of validity, the treatment marks with the living creature ware term of validity from load separately the date to compute, other drugs term of validities mark from produce the date to compute.
If the term of validity mark till day, should for start counting the date to should exergue day the first 1 day, if mark till month, should for start counting the month to should first month of exergue.
第四章 药品名称和注册商标的使用
A drugs name and register the usage of the trademark
第二十四条 药品说明书和标签中标注的药品名称必须符合国家食品药品监督管理局公布的药品通用名称和商品名称的命名原则，并与药品批准证明文件的相应内容一致。
第二十五条 药品通用名称应当显著、突出，其字体、字号和颜色必须一致，并符合以下要求：
（一）对于横版标签，必须在上三分之一范围内显著位置标出；对于竖版标签，必须在右三分之一范围内显著位置标出；
（二）不得选用草书、篆书等不易识别的字体，不得使用斜体、中空、阴影等形式对字体进行修饰；
（三）字体颜色应当使用黑色或者白色，与相应的浅色或者深色背景形成强烈反差；
（四）除因包装尺寸的限制而无法同行书写的，不得分行书写。
第二十六条 药品商品名称不得与通用名称同行书写，其字体和颜色不得比通用名称更突出和显著，其字体以单字面积计不得大于通用名称所用字体的二分之一。
第二十七条 药品说明书和标签中禁止使用未经注册的商标以及其他未经国家食品药品监督管理局批准的药品名称。
药品标签使用注册商标的，应当印刷在药品标签的边角，含文字的，其字体以单字面积计不得大于通用名称所用字体的四分之一。
The 24th drugs manual is in accordance with the label in mark of the drugs name must match the drugs of the announcement in the national food drugs direct management bureau assign name to of in general use name and merchandise name principle, and with the drugs the approval the certificate correspond the contents.
The 25th name with in general use drugs should show the , outstanding, its form of written, characters is in accordance with the color must, and meet the following request:
( A) for horizontal version label, must show the position of to mark out within the scope of up 1/3;For the version label, must show the position of to mark out within the scope of right 1/3;
( Two) can not choose to use the form of written that cursive, seal script...etc. not easily identify, can not use the italic, hollow, shadow etc. the form carries on the modifier to the form of written;
( Three) the form of written color should use black or white, with homologous shallow color or deep the color background formation mightiness anti- bad;
( Four) in addition to can't go together to write of because of the restrict of the packing size, can not the branch office write.
The 26th drugs merchandise name can not go together with in general use name to write, its form of written and colors can not be more more outstanding than in general use name and show the , its form of written accounts with the word area can not big in 1/2 of the body that in general use name choice of words.
It forbid the usage to have not yet the registered trademark in the 27th drugs manual and labels and other have not yet the drugs name of the approval in the national food drugs direct management bureau.
The drugs label usage registers the trademark of, should print the side Cape in the drugs label, quarter with literalness, its form of written with the word area account can not big in the body that in general use name choice of words.
第五章 其他规定
第二十八条 麻醉药品、精神药品、医疗用毒性药品、放射性药品、外用药品和非处方药品等国家规定有专用标识的，其说明书和标签必须印有规定的标识。
国家对药品说明书和标签有特殊规定的，从其规定。
第二十九条 中药材、中药饮片的标签管理规定由国家食品药品监督管理局另行制定。
第三十条 药品说明书和标签不符合本规定的，按照《中华人民共和国药品管理法》的相关规定进行处罚。
第六章 附 则
第三十一条 本规定自2006年6月1日起施行。国家药品监督管理局于2000年10月15日发布的《药品包装、标签和说明书管理规定（暂行）》同时废止。
Other provision of chapter 5
The 28th anaesthesia drugs, spirit drugs, medical treatment use the toxicity drugs, radio drugs and have the appropriation marking with the nations such as drugs and the non- prescription drugs etc. provision outside of, its manual and labels must print the marking of have the provision.
The nation has special provision to the drugs manual and label of, ruling from it.
The 29th Chinese herbal medicine material, Chinese herbal medicine drinks the label management provision of the slice to be managed the bureau by the national food drugs direct to go another establishment.
The 30th drugs manual out of accordance with label match this provision of, according to 《 the People's Republic of China drugs management method 》 of related the provision carries on the punishment.
Chapter 6 attach then
Article 31 rules to implement since June 1 in 2006 originally.The national drugs direct management bureau releases on October 15 in 2000 《 the drugs packing, label and manuals manage the provision( temporary) 》 abolish at the same time.
看着给吧！！~谢谢
The drugs manual and labels manage the provision
第一条 为规范药品说明书和标签的管理，根据《中华人民共和国药品管理法》和《中华人民共和国药品管理法实施条例》制定本规定。
第二条 在中华人民共和国境内上市销售的药品，其说明书和标签应当符合本规定的要求。
第三条 药品说明书和标签由国家食品药品监督管理局予以核准。
药品的标签应当以说明书为依据，其内容不得超出说明书的范围，不得印有暗示疗效、误导使用和不适当宣传产品的文字和标识。
第四条 药品包装必须按照规定印有或者贴有标签，不得夹带其他任何介绍或者宣传产品、企业的文字、音像及其他资料。
药品生产企业生产供上市销售的最小包装必须附有说明书。
第五条 药品说明书和标签的文字表述应当科学、规范、准确。非处方药说明书还应当使用容易理解的文字表述，以便患者自行判断、选择和使用。
第六条 药品说明书和标签中的文字应当清晰易辨，标识应当清楚醒目，不得有印字脱落或者粘贴不牢等现象，不得以粘贴、剪切、涂改等方式进行修改或者补充。
第七条 药品说明书和标签应当使用国家语言文字工作委员会公布的规范化汉字，增加其他文字对照的，应当以汉字表述为准。
第八条 出于保护公众健康和指导正确合理用药的目的，药品生产企业可以主动提出在药品说明书或者标签上加注警示语，国家食品药品监督管理局也可以要求药品生产企业在说明书或者标签上加注警示语。
Article 1 manages for the norm drugs manual and label, according to 《 the People's Republic of China drugs management method 》 and 《 the People's Republic of China drugs management method implement regulation 》 establishment rule originally.
Article 2 is inshore to appear on market the drugs of the sale in the People's Republic of China, its manual and labels should meet the request of this provision.
The third drugs manual and labels is given the sanction by the national food drugs direct management bureau.
The label of the drugs should take manual as the basis, its contents can not outrun the scope of the manual, can not print to have the allusion curative effect and mislead the usage and inadequacy to publicizee the writing and the marking of the product.
The fourth drugs packing must print according to the provision or stick the label, can not clip to take other any introduction or the writing, sound of the publicity product, business enterprise be like and other data.
The drugs produce the business enterprise to produce to provide minimum packing of appear on market the sale must fish-eye manual.
The writing form of the fifth drugs manual and labels say should science, norm, accurate.The non- prescription medicine manual should still use the writing form of the easy comprehension to say, for the purpose of sufferer by oneself judge, choice and usage.
The sixth drugs manual and writing in the label should clear easy , the marking should know refreshing, can not print the word to shed off or glue to stick rickety etc. phenomenon, can not stick, shear by glue to slice, alter etc. the method carry on modification or complement.
The seventh drugs manual and labels should use the norm of the national language writing work committee announcement to turn the Chinese characters, increasing other writings to check against of, should with the Chinese characters form say for precise.
Article 8 proceed from protect public health and guide right reasonable use the medicine of purpose, the drugs produce the business enterprise and can put forward actively at the drugs manual or label up add to note the caution language, the national food drugs direct management the bureau can also request the drugs production business enterprise at the manual or label up add to note the caution
language.
第二章 药品说明书
A drugs manual
第九条 药品说明书应当包含药品安全性、有效性的重要科学数据、结论和信息，用以指导安全、合理使用药品。药品说明书的具体格式、内容和书写要求由国家食品药品监督管理局制定并发布。
第十条 药品说明书对疾病名称、药学专业名词、药品名称、临床检验名称和结果的表述，应当采用国家统一颁布或规范的专用词汇，度量衡单位应当符合国家标准的规定。
第十一条 药品说明书应当列出全部活性成份或者组方中的全部中药药味。注射剂和非处方药还应当列出所用的全部辅料名称。
药品处方中含有可能引起严重不良反应的成份或者辅料的，应当予以说明。
第十二条 药品生产企业应当主动跟踪药品上市后的安全性、有效性情况，需要对药品说明书进行修改的，应当及时提出申请。
根据药品不良反应监测、药品再评价结果等信息，国家食品药品监督管理局也可以要求药品生产企业修改药品说明书。
第十三条 药品说明书获准修改后，药品生产企业应当将修改的内容立即通知相关药品经营企业、使用单位及其他部门，并按要求及时使用修改后的说明书和标签。
第十四条 药品说明书应当充分包含药品不良反应信息，详细注明药品不良反应。药品生产企业未根据药品上市后的安全性、有效性情况及时修改说明书或者未将药品不良反应在说明书中充分说明的，由此引起的不良后果由该生产企业承担。
第十五条 药品说明书核准日期和修改日期应当在说明书中醒目标示。
The ninth drugs manual should include the important science data, conclusion and informations of the drugs safety, usefulness, guiding the safety, reasonable usage drugs in order to.The concrete format, contents of the drugs manual and write to request from the national food drugs direct management bureau the establishment erupts the cloth.
The tenth drugs manual examines the form of the name and result to say to the professional word, drugs name, clinic of disease name, pharmacy, should adopt the appropriation phrase that the nation unifies the promulgation or norm to remit, the weights and measures unit should meet the provision of the nation standard.
The 11th drugs manual should list all live composition or all Chinese herbal medicine medicine flavor within a square.Inject the and the non- prescription medicines should still list use of assist to anticipate the name all.
The composition with probably cause severity badly reaction assists to anticipate perhaps in the drugs prescription of, should give the elucidation.
The 12th drugs produce the business enterprise should follow actively after drugs appear on market of safety, the usefulness circumstance, need to carry on the modification to the drugs manual of, should put forward the application in time.
According to the drugs badly respond the monitor, drugs to revalue the result etc. information, the national food drugs direct management the bureau can also request the drugs production business enterprise modification drugs manual.
After the 13th drugs manual permits the modification, the drugs produce the business enterprise and should request the contents of the modification notifies the related drugs management business enterprise and uses unit and other sectionses immediately, and press in time to use the manual and the label of modify the empress.
The 14th drugs manual should include the bad reaction information of drugs well, detailed note the drugs bad reaction.The drugs production business enterprise don't according to drugs the safety, the usefulness circumstance after appear on market modifies in time manual or did not produce the bad reaction of drugs is well explanatory in the manual, from here cause of bad result from should the business enterprise undertake.
The date of the 15th drugs manual sanction and date of modifications should be refreshing in the manual to mark.
第三章 药品的标签
The label of a drugs
第十六条 药品的标签是指药品包装上印有或者贴有的内容，分为内标签和外标签。药品内标签指直接接触药品的包装的标签，外标签指内标签以外的其他包装的标签。
第十七条 药品的内标签应当包含药品通用名称、适应症或者功能主治、规格、用法用量、生产日期、产品批号、有效期、生产企业等内容。
包装尺寸过小无法全部标明上述内容的，至少应当标注药品通用名称、规格、产品批号、有效期等内容。
第十八条 药品外标签应当注明药品通用名称、成份、性状、适应症或者功能主治、规格、用法用量、不良反应、禁忌、注意事项、贮藏、生产日期、产品批号、有效期、批准文号、生产企业等内容。适应症或者功能主治、用法用量、不良反应、禁忌、注意事项不能全部注明的，应当标出主要内容并注明“详见说明书”字样。
第十九条 用于运输、储藏的包装的标签，至少应当注明药品通用名称、规格、贮藏、生产日期、产品批号、有效期、批准文号、生产企业，也可以根据需要注明包装数量、运输注意事项或者其他标记等必要内容。
第二十条 原料药的标签应当注明药品名称、贮藏、生产日期、产品批号、有效期、执行标准、批准文号、生产企业，同时还需注明包装数量以及运输注意事项等必要内容。
第二十一条 同一药品生产企业生产的同一药品，药品规格和包装规格均相同的，其标签的内容、格式及颜色必须一致；药品规格或者包装规格不同的，其标签应当明显区别或者规格项明显标注。
同一药品生产企业生产的同一药品，分别按处方药与非处方药管理的，两者的包装颜色应当明显区别。
第二十二条 对贮藏有特殊要求的药品，应当在标签的醒目位置注明。
第二十三条 药品标签中的有效期应当按照年、月、日的顺序标注，年份用四位数字表示，月、日用两位数表示。其具体标注格式为“有效期至XXXX年XX月”或者“有效期至XXXX年XX月XX日”；也可以用数字和其他符号表示为“有效期至XXXX.XX.”或者“有效期至XXXX/XX/XX”等。
预防用生物制品有效期的标注按照国家食品药品监督管理局批准的注册标准执行，治疗用生物制品有效期的标注自分装日期计算，其他药品有效期的标注自生产日期计算。
有效期若标注到日，应当为起算日期对应年月日的前一天，若标注到月，应当为起算月份对应年月的前一月。
The 16th label of drugs mean that the drugs packing prints to have up or stick some contentses, is divided into inside the label and the outside labels.The label inside the drugs points the label of the packing of the direct contact drugs, the outside label point inside the label outside of other packing of label.
The 17th drugs of inside the label should include in general use name, adaption of drugs or the function lord cure, specification, method of using dosage, produce the date, product batch number, term of validity and produce the business enterprise etc. contents.
Pack the size lead small can't mark clearly the above-mentioned contents all of, should mark the in general use name, specification, product batch number, term of validity of drugs at least etc. contents.
The 18th label with outside drugs should note in general use name, composition, sex form, adaption of drugs or the function lord cure, specification, method of using dosage, bad respond, taboo, regulation, store, produce date, product batch number, term of validity, grant text number, produce business enterprise etc. contents.Adaption or the function lord cure, method of using dosage, bad respond, the taboo, regulation can't note all of, should mark out the main contents and note" know well to see the manual" certain context.
A the label of the packing that useds for the conveyance and stores, should note the in general use name, specification of drugs, store, produce the date, product batch number, term of validity, grant the text number and produce the business enterprise at least, can also note to pack according to the demand quantity, the conveyance regulation or necessary contents of etc. of other markings.
The 20th label of raw material medicine should note the drugs name and store, produce the date, product batch number, term of validity, performance standard, grant the text number and produce the business enterprise, still need to note to pack the quantity and transport the regulation to wait the necessary contents at the same time.
A same drugs produce same drugs of the business enterprise production, the drugs specification is in accordance with the packing specification all the homology of, the contents, format and colors of its label must;The drugs specification or the packing specification is different, its label should distinguish obviously or the specification item marks obviously.
Same drugs produce same drugs of the business enterprise production, pressing the prescription medicine and the non- prescription medicine management respectively of, both of packing color should distinguish obviously.
A drugs that has the special request to the hoarding, should note in the refreshing position of the label.
The term of validity within the 23th drugs label should mark according to the sequence of the year, month, day, the age means with four numerals, the month, day uses two number to mean.It marks the format as" the term of validity goes to the XXXX year XX month" in a specific way or" the term of validity goes to the XXXX year XX month XX day";Can also mean with the numerical and other sign for" the term of validity goes to the XXXX.XX." Or" the term of validity goes to the XXXX/ XX/ XX" etc..
The prevention marks the registration standard performance that manages the bureau approval according to the national food drugs direct with the living creature ware term of validity, the treatment marks with the living creature ware term of validity from load separately the date to compute, other drugs term of validities mark from produce the date to compute.
If the term of validity mark till day, should for start counting the date to should exergue day the first 1 day, if mark till month, should for start counting the month to should first month of exergue.
第四章 药品名称和注册商标的使用
A drugs name and register the usage of the trademark
第二十四条 药品说明书和标签中标注的药品名称必须符合国家食品药品监督管理局公布的药品通用名称和商品名称的命名原则，并与药品批准证明文件的相应内容一致。
第二十五条 药品通用名称应当显著、突出，其字体、字号和颜色必须一致，并符合以下要求：
（一）对于横版标签，必须在上三分之一范围内显著位置标出；对于竖版标签，必须在右三分之一范围内显著位置标出；
（二）不得选用草书、篆书等不易识别的字体，不得使用斜体、中空、阴影等形式对字体进行修饰；
（三）字体颜色应当使用黑色或者白色，与相应的浅色或者深色背景形成强烈反差；
（四）除因包装尺寸的限制而无法同行书写的，不得分行书写。
第二十六条 药品商品名称不得与通用名称同行书写，其字体和颜色不得比通用名称更突出和显著，其字体以单字面积计不得大于通用名称所用字体的二分之一。
第二十七条 药品说明书和标签中禁止使用未经注册的商标以及其他未经国家食品药品监督管理局批准的药品名称。
药品标签使用注册商标的，应当印刷在药品标签的边角，含文字的，其字体以单字面积计不得大于通用名称所用字体的四分之一。
The 24th drugs manual is in accordance with the label in mark of the drugs name must match the drugs of the announcement in the national food drugs direct management bureau assign name to of in general use name and merchandise name principle, and with the drugs the approval the certificate correspond the contents.
The 25th name with in general use drugs should show the , outstanding, its form of written, characters is in accordance with the color must, and meet the following request:
( A) for horizontal version label, must show the position of to mark out within the scope of up 1/3;For the version label, must show the position of to mark out within the scope of right 1/3;
( Two) can not choose to use the form of written that cursive, seal script...etc. not easily identify, can not use the italic, hollow, shadow etc. the form carries on the modifier to the form of written;
( Three) the form of written color should use black or white, with homologous shallow color or deep the color background formation mightiness anti- bad;
( Four) in addition to can't go together to write of because of the restrict of the packing size, can not the branch office write.
The 26th drugs merchandise name can not go together with in general use name to write, its form of written and colors can not be more more outstanding than in general use name and show the , its form of written accounts with the word area can not big in 1/2 of the body that in general use name choice of words.
It forbid the usage to have not yet the registered trademark in the 27th drugs manual and labels and other have not yet the drugs name of the approval in the national food drugs direct management bureau.
The drugs label usage registers the trademark of, should print the side Cape in the drugs label, quarter with literalness, its form of written with the word area account can not big in the body that in general use name choice of words.
第五章 其他规定
第二十八条 麻醉药品、精神药品、医疗用毒性药品、放射性药品、外用药品和非处方药品等国家规定有专用标识的，其说明书和标签必须印有规定的标识。
国家对药品说明书和标签有特殊规定的，从其规定。
第二十九条 中药材、中药饮片的标签管理规定由国家食品药品监督管理局另行制定。
第三十条 药品说明书和标签不符合本规定的，按照《中华人民共和国药品管理法》的相关规定进行处罚。
第六章 附 则
第三十一条 本规定自2006年6月1日起施行。国家药品监督管理局于2000年10月15日发布的《药品包装、标签和说明书管理规定（暂行）》同时废止。
Other provision of chapter 5
The 28th anaesthesia drugs, spirit drugs, medical treatment use the toxicity drugs, radio drugs and have the appropriation marking with the nations such as drugs and the non- prescription drugs etc. provision outside of, its manual and labels must print the marking of have the provision.
The nation has special provision to the drugs manual and label of, ruling from it.
The 29th Chinese herbal medicine material, Chinese herbal medicine drinks the label management provision of the slice to be managed the bureau by the national food drugs direct to go another establishment.
The 30th drugs manual out of accordance with label match this provision of, according to 《 the People's Republic of China drugs management method 》 of related the provision carries on the punishment.
Chapter 6 attach then
Article 31 rules to implement since June 1 in 2006 originally.The national drugs direct management bureau releases on October 15 in 2000 《 the drugs packing, label and manuals manage the provision( temporary) 》 abolish at the same time.
看着给吧！！~谢谢
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第1个回答 2007-04-17
Provisions for Drug Insert Sheets and Labels
Chapter I General Provisions
Article 1 The provisions are formulated to standardize insert sheets and labels of drugs, in accordance with Drug Administration Law of the People’s Repubilc of China and Regulations for Implementation of the Drug Administration Law of the People's Republic of China.
Article 2 Insert sheets and labels of drugs which go on the market in the People’s Repubilc of China should conform to requirements of the provisions.
Article 3 Drugs insert sheets and labels should be approved by SFDA.
The label of drugs is based on insert sheets. Its content should nod exceed the range of insert sheets and can’t contain implied curative effect, misleading use and characters and signs which propaganda products improperly.
Article 4 Labels should be printed or labelled on drug package in accordance with regulations, which can’t include any characters or any information that introduce or propaganda products .
Article 5 The characters in insert sheets and labels should be scientific, standard and accurate. Insert sheets of OTC should use understandable writing presentation in order to supply decision ,selection and use by patients.
Article 6 The characters in insert sheets and labels should be clear, and signs should be eye-catching .The characters can’t be ablated or labelled strongly, and can’t be modified or supplemented by pasting, cutting or altering.
Article 7 Insert sheets and labels of drugs should use normalized characters which are publicized by State Language Affairs Commission. The addition of other languages to contrast should be followed by Chinese characters presentation.
Article 8 In order to protect the health of the public and direct rational use of drug, drug manufacturing enterprises should take the initiative to add warning words on the insert sheets and labels. SFDA can also require drug manufacturing enterprises to add warning words on the insert sheets and labels.
Chapter II Drug Insert Sheets
Article 9 Drug insert sheets should include drug safety, important scientific data of efficacy,conclusion and information in order to direct safe and rational use of drug. The specific format ,contents and writing requirements of Drug insert sheets should be established and published by SFDA.
Article 10 Drug insert sheets should use special terms published standerdized by the state to present the name of disease, pharmaceutical special terms, drug name ,clinical test name and result. The unit of weights and measures should conform to the regulations of government standards.
Article 11 Drug insert sheets should list all of the active ingredients. Injection and OTC should also list all of the excipients.
If drug formulation contains the excipients which can cause possible serious adverse effects, it should be specified.
Article 12 Drug manufacturing enterprises should take the initiative to follow post-marketing safety and efficacy . Applications should be presented in time, if the drug insert needs to be amended.
In accordance with the information of adverse drug reaction monitoring, drug reevaluation result ,SFDA also can require drug manufacturing enterprises to amend drug insert sheets.
Article 13 After the amendment of drug insert sheets get approved, drug manufacturing enterprises should inform related drug supply enterprises or other departments, and use amended drug insert sheets and labels in time.
Article 14 Drug insert sheets should include complete information of adverse drug reaction and specify adverse drug reactions. If drug manufacturing enterprises in accordance with post-marketing safety and efficacy can’t amend drug insert sheets in time or can’t list complete information of adverse drug reaction, they should assume possible adverse consequence.
Article 15 The authorization date and amendment date of drug insert sheets should be clear and legible in the insert sheets.
Chapter III Drug labels
Article 16 The drug labels means the content printed or pasted on the package, including internal label and external label. The internal label refers to the label of the package directly contacting the drug.and the external label refers to the label except the internal label.
Article 17 The internal label of the drug should included the generic name, indications, specifications, usage and dosage, production date, lot number, expiration date, manufacturer etc.
If the above mentioned can’t be noted completely due to the package size, the generic name, specifications, lot number and expiration date etc.
Article 18 The drug external label should indicate the drug generic name, compositions, descriptions, indications, specifications, usage and dosage, adverse reactions, contraindications, instructions, storage, lot number, expiration date, approved numbers and manufacturer etc. If the indications, usage and dosage, adverse reactions, contraindications or instructions cannot be completely noted, the main content and “for details please see the drug insert ” must be noted.
Article 19 The labels used for transportation and storage should at least indicate the drug generic name, specifications, storage, production date, lot number, expiration date, approved number, manufacturer. The package amount and instructions of transportation etc can also be indicated according to the requirements.
Article 20 The label of the drug substance should indicate the drug name, storage, production date, lot number, expiration date, executive standerd, approved number, manufacturer and at the same time indicate the package amount and instructions for transportation etc.
Article 21 For the same batch of drug produced by the same drug manufacturer with the same drug specifications and the same package presentation, their label contents, formats and color must be the same. For the drugs with the different drug specifications or the different package presentations their labels should be distinctly different or notablely marked in the specification item.
Article 22 The special storage requirements (if any) should be labelled in a notable place of the label.
Article 23 natureThe expiration date in the drug insert should be labelled in the order of year, month and day, and the year must be expressed in quadbit. The concrete marking format is “expiration date XXXX year XX month” or “expiration date XXXX year XX month XX day”; and can also be expressed by numbers and other sign such as “expiration date XXXX. XX” or “expiration date XXXX./XX/XX ”etc.
For the biologic product for precaution use, the labelling of the expiration dates must conform to the registration standard For the biologic product for treatment use, the expiration dates should be calcutated from the distribution date and for other drugs the expiration dates should be calculated from the production date.
If the expiration date is labelled to the day, it should be the day before the corresponding day which is calculated from. If the expiration date is labelled to the month, it should be the month before the corresponding month which is calculated from.
Chapter IV Use of the drug names and registered tarde mark
Article 24 The drug name in the drug insert sheets and labels must comply with the generic name and trade name published by SFDA.
Article 25 The generic name should be notable and distinct and its font and font style must be consistent, and meet the following requirements:
(1) Horizontal labels must be labelled in a notable place within the 1/3 range of the upper area; Vertical label must be labelled in a notable place within the 1/3 range of the right area;
(2) Script type of calligraphy , seal character and illegible style of calligraphy should not be used. inclined form, medium altitude and shadow characters must not be used.
(3)The colour of the characters should be black or white and form intense contrast with the tint or dark background;
(4)The generic name must not be written in separate lines unless due to the limitation of package size.
Article 26 The drug trade name must not be written in the same line with the generic name and its font and color must not be distincter or more notable than the genric name.
Article 27 The trade marks that haven’t been registered or other drug names that haven’t been approved by the SFDA must not be used in the drug insert sheets and labels.
The registered trademarks used in the drug labels should be printed on the fringe of the drug labels. For he registered trademarks which contain characters, the font area must not more than the 1/4 of font area of the generic name.本回答被提问者采纳
Chapter I General Provisions
Article 1 The provisions are formulated to standardize insert sheets and labels of drugs, in accordance with Drug Administration Law of the People’s Repubilc of China and Regulations for Implementation of the Drug Administration Law of the People's Republic of China.
Article 2 Insert sheets and labels of drugs which go on the market in the People’s Repubilc of China should conform to requirements of the provisions.
Article 3 Drugs insert sheets and labels should be approved by SFDA.
The label of drugs is based on insert sheets. Its content should nod exceed the range of insert sheets and can’t contain implied curative effect, misleading use and characters and signs which propaganda products improperly.
Article 4 Labels should be printed or labelled on drug package in accordance with regulations, which can’t include any characters or any information that introduce or propaganda products .
Article 5 The characters in insert sheets and labels should be scientific, standard and accurate. Insert sheets of OTC should use understandable writing presentation in order to supply decision ,selection and use by patients.
Article 6 The characters in insert sheets and labels should be clear, and signs should be eye-catching .The characters can’t be ablated or labelled strongly, and can’t be modified or supplemented by pasting, cutting or altering.
Article 7 Insert sheets and labels of drugs should use normalized characters which are publicized by State Language Affairs Commission. The addition of other languages to contrast should be followed by Chinese characters presentation.
Article 8 In order to protect the health of the public and direct rational use of drug, drug manufacturing enterprises should take the initiative to add warning words on the insert sheets and labels. SFDA can also require drug manufacturing enterprises to add warning words on the insert sheets and labels.
Chapter II Drug Insert Sheets
Article 9 Drug insert sheets should include drug safety, important scientific data of efficacy,conclusion and information in order to direct safe and rational use of drug. The specific format ,contents and writing requirements of Drug insert sheets should be established and published by SFDA.
Article 10 Drug insert sheets should use special terms published standerdized by the state to present the name of disease, pharmaceutical special terms, drug name ,clinical test name and result. The unit of weights and measures should conform to the regulations of government standards.
Article 11 Drug insert sheets should list all of the active ingredients. Injection and OTC should also list all of the excipients.
If drug formulation contains the excipients which can cause possible serious adverse effects, it should be specified.
Article 12 Drug manufacturing enterprises should take the initiative to follow post-marketing safety and efficacy . Applications should be presented in time, if the drug insert needs to be amended.
In accordance with the information of adverse drug reaction monitoring, drug reevaluation result ,SFDA also can require drug manufacturing enterprises to amend drug insert sheets.
Article 13 After the amendment of drug insert sheets get approved, drug manufacturing enterprises should inform related drug supply enterprises or other departments, and use amended drug insert sheets and labels in time.
Article 14 Drug insert sheets should include complete information of adverse drug reaction and specify adverse drug reactions. If drug manufacturing enterprises in accordance with post-marketing safety and efficacy can’t amend drug insert sheets in time or can’t list complete information of adverse drug reaction, they should assume possible adverse consequence.
Article 15 The authorization date and amendment date of drug insert sheets should be clear and legible in the insert sheets.
Chapter III Drug labels
Article 16 The drug labels means the content printed or pasted on the package, including internal label and external label. The internal label refers to the label of the package directly contacting the drug.and the external label refers to the label except the internal label.
Article 17 The internal label of the drug should included the generic name, indications, specifications, usage and dosage, production date, lot number, expiration date, manufacturer etc.
If the above mentioned can’t be noted completely due to the package size, the generic name, specifications, lot number and expiration date etc.
Article 18 The drug external label should indicate the drug generic name, compositions, descriptions, indications, specifications, usage and dosage, adverse reactions, contraindications, instructions, storage, lot number, expiration date, approved numbers and manufacturer etc. If the indications, usage and dosage, adverse reactions, contraindications or instructions cannot be completely noted, the main content and “for details please see the drug insert ” must be noted.
Article 19 The labels used for transportation and storage should at least indicate the drug generic name, specifications, storage, production date, lot number, expiration date, approved number, manufacturer. The package amount and instructions of transportation etc can also be indicated according to the requirements.
Article 20 The label of the drug substance should indicate the drug name, storage, production date, lot number, expiration date, executive standerd, approved number, manufacturer and at the same time indicate the package amount and instructions for transportation etc.
Article 21 For the same batch of drug produced by the same drug manufacturer with the same drug specifications and the same package presentation, their label contents, formats and color must be the same. For the drugs with the different drug specifications or the different package presentations their labels should be distinctly different or notablely marked in the specification item.
Article 22 The special storage requirements (if any) should be labelled in a notable place of the label.
Article 23 natureThe expiration date in the drug insert should be labelled in the order of year, month and day, and the year must be expressed in quadbit. The concrete marking format is “expiration date XXXX year XX month” or “expiration date XXXX year XX month XX day”; and can also be expressed by numbers and other sign such as “expiration date XXXX. XX” or “expiration date XXXX./XX/XX ”etc.
For the biologic product for precaution use, the labelling of the expiration dates must conform to the registration standard For the biologic product for treatment use, the expiration dates should be calcutated from the distribution date and for other drugs the expiration dates should be calculated from the production date.
If the expiration date is labelled to the day, it should be the day before the corresponding day which is calculated from. If the expiration date is labelled to the month, it should be the month before the corresponding month which is calculated from.
Chapter IV Use of the drug names and registered tarde mark
Article 24 The drug name in the drug insert sheets and labels must comply with the generic name and trade name published by SFDA.
Article 25 The generic name should be notable and distinct and its font and font style must be consistent, and meet the following requirements:
(1) Horizontal labels must be labelled in a notable place within the 1/3 range of the upper area; Vertical label must be labelled in a notable place within the 1/3 range of the right area;
(2) Script type of calligraphy , seal character and illegible style of calligraphy should not be used. inclined form, medium altitude and shadow characters must not be used.
(3)The colour of the characters should be black or white and form intense contrast with the tint or dark background;
(4)The generic name must not be written in separate lines unless due to the limitation of package size.
Article 26 The drug trade name must not be written in the same line with the generic name and its font and color must not be distincter or more notable than the genric name.
Article 27 The trade marks that haven’t been registered or other drug names that haven’t been approved by the SFDA must not be used in the drug insert sheets and labels.
The registered trademarks used in the drug labels should be printed on the fringe of the drug labels. For he registered trademarks which contain characters, the font area must not more than the 1/4 of font area of the generic name.本回答被提问者采纳
第2个回答 2007-04-16
我觉得我英文挺好，但是关于药的，我看汉语都读不下去，更别说花时间看英文的了，50分太少。
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