Submission of Application 申请产品批准的呈交详情CPM importers, manufacturers and assemblers are also required to obtain product approvals for the CPM products dealt by them.The following items must be submitted during applications for CPM product approvals: 所有中成药进口商、制造商和分装商都必须为他们经销的中成药取得产品批准。
申请中成药产品批准必须提供下表中要求的资料:Sample and labels of product to be sold/supplied inSingapore which meet labelling requirements,including*:将在本地销售的药品样本及标签(需符合标签要求)*,包括:a) Inner label 内标签b) Outer label / carton (if any) 外标签(若有)c) Package insert (if any) 说明书(若有)Sample and labels of product sold/supplied in countryof manufacture, including:在原产国销售的药品样本及标签,包括:a) Inner label 内标签b) Outer label / carton 外标签(若有)c) Package insert (if any) 说明书(若有)Manufacturer's Licence or certificate制造商执照或证书Good Manufacturing Practice (GMP) certificate (ifany)GMP证书(若有)Free sale certificate or equivalent from country ofmanufacture原产国所签发的自由销售证书或同等文件Product registration certificate for products from China(if applicable)药品的批准证书(限于中国生产的产品)Test results of toxic heavy metals and microbialcontamination有毒重金属及卫生学检验报告Endorsement of product formula (including all activeand inactive ingredients) by overseas manufacturer andundertaking by overseas manufacturer that productdoes not contain any Western drugs or active syntheticsubstances外地制造商确认的药品成份表(包括活性和非活性成份),和药品不含任何西药或活性合成物质的书面声明Information on legal classifications of product incountries of sales药品在其它销售国家的分类* Except products imported for local assembly 进口后将在本地进行分装或包装的产品除外In addition to the above items, dealers may be required to furnish any other information as requested by the Licensing Authority.除了以上要求，执照签发当局也可能要求申请人提供其它的资料或文件。
Inner label must state:内标签必须注明：•Trade / brand name 药品商标•Product name 药品名称•Batch number 批号•Expiry date 有效期•Names and quantities of ingredients *成份名称及份量*(except for secret & protected formula) (除非是秘方或保护方)*If inner label is too small, the information may be stated on the outer label.*如内标签的空间有限，这些资料必须注明于外标签。
Outer label must state:外标签必须注明：•Trade / Brand name 药品商标•Product name 药品名称•Batch number 批号•Expiry date 有效期•Importer's or wholesaler's name and address **进口商／批发商的公司名称及地址**•Manufacturer's name and address **制造商的公司名称及地址**•Assembler's name and address (if any) **分装商的公司名称及地址(如有)**•"Allowed for sale as a Chinese Proprietary Medicine based on information submitted to the Authority. Consumer discretion is advised. 根据向当局提呈的资料允许作为中成药销售。
谨慎选用。
"** (Please see below for more details) (请参阅下文了解更多详情)**If there is no outer label, the information may be stated in the inner label.**若无外标签，这些资料必须注明于内标签。
Additional label附加标签:"Allowed for sale as a Chinese Proprietary Medicine based on information submitted to theAuthority. Consumer discretion is advised. 根据向当局提呈的资料允许作为中成药销售。
谨慎选用。
"•The words must be clearly legible and printed in an indelible manner. 文字必须清晰且不易擦除。
•The English words should not be less than 1.5 mm in height and the Chinese characters not less than 2 mm in height. 其英文与中文字体的高度分别不得少于1.5毫米及 2.0毫米。
•The words must be enclosed in a boxed area which is clearly visible. Nothing else should appear in the boxed area other than the words of the label. 文字必须以明显可见的框围住，框内只限附加标签的文字。
•The label must appear conspicuously in a prominent position. 附加标签在产品包装上的位置必须显眼。
Package insert must state:说明书必须注明：•Trade / Brand Name 药品商标•Product Name 药品名称•Manufacturer's name and address 制造商的公司名称及地址•Names & quantities of ingredients 成份名称及份量(except for secret & protected formula) (除非是秘方或保护方)•Dosage ***药品用量***•Indication ***药品的适应症***•Contraindication ***药品的禁忌症***•Side effects ***药品的副作用***•The frequency and method of administration ***药品服食法****** If there is no leaflet, the information may be stated on either the inner or outer label.*** 若无说明书，这些资料必须注明于内或外标签。
Prohibition of Stipulation of Certain Diseases / Conditions 禁止涉及某些疾病／症状The labels, packaging and package inserts of CPM shall not make references to any of the 19 diseases/conditions specified in the First Schedule to the Medicines Act:中成药的标签，包装及说明书都不能提到以下的19种疾病／症状:1. Blindness 失明11. Leprosy 麻风2. Cancer 癌症12. Menstrual disorders 有关月经（月事）疾病3. Cataract 白内障13. Paralysis 瘫痪症4. Drug addiction 毒瘾14. Tuberculosis 结核病5. Deafness 耳聋15. Sexual function 性机能6. Diabetes 糖尿病16. Infertility 不育症7. Epilepsy or fits 癫痫或抽搐17. Impotency 阳萎8. Hypertension 高血压18. Frigidity 性冷感9. Insanity 神经错乱19. Conception and pregnancy 受孕或怀孕10. Kidney diseases 肾病Secret & Protected Formula 秘方及保护方The name of ingredients and their strengths need not be stated in the label and package insert if the formula of the CPM has been certified by the relevant health authority of the exporting country as "secret" or "protected".如果该中成药被出口国卫生或管理当局证明为“秘方”或“保护方”,则不必在标签或说明书上透露药品的成分及份量。