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 in Singapore 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 country of 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 (if any) GMP 证书(若有) Free sale certificate or equivalent from country of manufacture 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 microbial contamination 有毒重金属及卫生学检验报告 Endorsement of produ ct formu la (inclu ding all activ e and inactiv e ingredients) by ov erseas manu factu rer and u ndertaking by ov erseas manu factu rer that produ ct does not contain any Western dru gs or activ e sy nthetic su bstances 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 produ ct in cou ntries of sales 药品在其它销售国家的分类 * Ex cept produ cts imported f...
