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:
Item 要求的资料 | For imported product 进口产品 | For locally manufactured product 本地制造的产品 |
将在本地销售的产品标签(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) | P | P |
Sample of product to be sold/supplied in Singapore* 在原产国销售的产品样品* | P | P |
Labels of product sold/supplied in country of manufacture, including: 在原产国销售的产品标签,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) | P | |
Manufacturer's Licence or certificate 制造商执照或证书 | P | |
Good Manufacturing Practice (GMP) certificate (if any) GMP证书(若有) | P | |
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 | P | |
Product registration certificate for products from China (if applicable) 产品的批准证书(限于中国生产的产品) | P | |
P | P | |
Storage condition/containers** 贮存条件/容器** | P | P |
P | P | |
Endorsement of product formula (including all active and inactive ingredients) by overseas manufacturer and undertaking by overseas manufacturer that product does not contain any Western drugs or active synthetic substances 外地制造商确认的产品成份表(包括活性和非活性成份),和产品不含任何西药或活性合成物质的书面声明 | P | |
Information on legal classifications of product in countries of sales** 产品在其它销售国家的分类** | P |
* 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
** Form is available during submission of application 表格可在提交产品电子申请时下载
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。
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Please click here for the PRISM guide “Apply for Chinese Proprietary Medicines Product Listing”.
有关中成药产品批准网上申请说明，请点击此处。
Updated-Dec 11
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