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This application is a service of the Singapore Government.

Health Sciences Authority

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 listing approvals for the CPM products dealt by them.

The following items must be submitted during applications for CPM product listing 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登记批准。

申请中成药产品登记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

Labels of product to be sold/supplied in Singapore which meet labelling requirements, including:

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)

Photograph of the product's contents (e.g. capsules, tablets) - Examples
Physical sample of product to be sold/supplied in Singapore, only upon request

以照片展示产品样本(如胶囊,片剂等)- 范例
新加坡销售的产品样本在有需要时会要求提交)

 
 

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)

 

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)

 

Product registration certificate (if applicable)#

产品注册证书(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

 

Test results of toxic heavy metals and microbial contamination
 

有毒重金属及卫生学检验报告

Storage condition/containers [Imported products] [Locally manufactured / Primary Assembled products]

贮存条件/容器 [进口的中成药产品] [本地生产的/一级分装的中成药产品]

Quality parameters for CPM products

产品质控指标资料

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

 

Information on legal classifications of product in countries of sales
 

产品在其它销售国家的分类

 

Website undertaking – for products with website stated on label(s)

网站的书面声明 - 限于网址标注于产品标签上的产品

TSE undertaking – for products containing materials (including those used for making capsule shells) derived from ruminants (e.g. cattle, buffalo, sheep, goat, deer, antelope)

传染性海绵状脑病的书面声明 - 限于产品含有来源于反刍动物(如牛、羊、鹿、羚羊等)的成份(包括制作胶囊壳的成份)

Info for Fermented Substance – for products containing fermented substance(s) (e.g. Cordyceps, Red Yeast Rice)

发酵物质的信息 - 限于产品含有发酵成分如冬虫夏草菌粉,红曲米

# If product registration certificate is not available, a FSC, CPP or similar documents would be required 在没有产品注册证书的情况下,则应提交自由销售证书、药品证书或其他的类似文件

Please click here for the guideline on signatory of forms and undertaking for CPM.

有关中成药申请中所使用的表格及书面声明的签名要求,请点击此处

 

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。

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