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This application is a service of the Singapore Government.

Health Sciences Authority

Guidelines on Transfer of CPM Product Listing 转让已登记的中成药产品的指导原则

This document is intended to provide guidance to the industry on the circumstances under which CPM listing could be allowed for transfer from a licensed dealer to another. Such transfers could only be allowed based on the condition that the safety and quality of the product remain the same before and after the transfer. 

本指导原则将为欲将隶属于其执照下的中成药产品转让给其它公司的业者提供指导。只有在不影响产品安全和品质的情况下,才允许转让。

 

Scenarios for Transfer of CPM Listing
中成药产品登记及转让的类型

  Type of CPM
中成药申请类型
Licensed dealers involved in transfer / Type of transfer
转让类型
Is this transfer allowed?
是否允许转让
1 Imported CPM
进口的中成药产品

Transfer between two importers
两间本地进口商之间的转让

Yes

2 Locally Manufactured CPM
本地生产的中成药产品
Transfer between two local manufacturers
两间本地生产商之间的转让
No*
3 Locally Assembled CPM (Primary Assembly)
本地分装的中成药产品(一级分装)
Transfer between two local assemblers
两间本地分装商之间的转让
No*
4 Locally Assembled CPM (Secondary Assembly)
本地分装的中成药产品(二级分装)
Transfer between two local assemblers
两间本地分装商之间的转让
Yes

* In consideration that the starting materials, manufacturing process, production equipment, quality control system and/or management models may be different, as well as that the product’s safety and quality may not remain the same, hence, a new CPM product listing application will be required.

由于不同厂家的原料、生产工艺、设备、品质管控以及管理模式等不可能完全相同,可能会影响到产品的安全和品质,因此,此类中成药产品不允许转让,要求申请新的产品登记。

 

Procedure for Transfer of CPM Listing
产品转让程序

In view that the transfer of CPM listing is currently not a standard process in PRISM, the requesting importer/assembler is required to email the request, accompanied by the documents mentioned below to the HSA at  HSA_CPM@hsa.gov.sg. You may also wish to direct any related enquiries to the above email address. 

由于以上的转让程序目前尚未包括在电子呈报系统,欲转让产品的进口商或分装商,请将下述所要求的文件电邮至:HSA_CPM@hsa.gov.sg。如果您还有任何疑问,也请发电邮至以上地址。

 

Documentary Requirements
要求的文件

Imported CPM  进口的中成药产品

  DOCUMENTS REQUIRED FOR SUBMISSION
需提交的文件
SIGNATORY FOR EACH DOCUMENT
文件签署人
1 Letter of authorisation (printed on transferor company's letterhead) for HSA to conduct the transfer to the other licensed importer, including list of affected CPM
授权卫生科学局进行产品转让的授权信(需使用印有欲转让产品的公司名抬头的信纸),包括欲转让的产品名单
To be signed by both importers, with company stamps of both importers
由双方进口商共同签署,关加盖双方的公司印章
2 Confirmatory letter of acceptance that the product will be supplied to the new importer by the overseas manufacturer directly
同意将所生产的产品直接供货给新进口商的承诺信
To be signed by the overseas manufacturer
由原产国的生产商签署
3 Undertaking (printed on transferee company's letterhead) that the only amendment to the packaging is to change the importer’s name and address
仅更改受转让的产品标签上进口商名称及地址的保证信(需使用印有公司名抬头的信纸)

To be signed by the new importer, with company stamp
由新的进口商签署,关加盖公司印章


Locally Assembled CPM (Secondary Assembly)  本地分装的中成药产品(二级分装)

  DOCUMENTS REQUIRED FOR SUBMISSION
需提交的文件
SIGNATORY FOR EACH DOCUMENT
文件签署人
1 Letter of authorisation (printed on transferor company's letterhead) for HSA to conduct the transfer to the other licensed assembler, including list of affected CPM
授权卫生科学局进行产品转让的授权信(需使用印有欲转让产品的公司名抬头的信纸),包括欲转让的产品名单
To be signed by both assemblers, with company stamps of both assemblers
由双方分装商共同签署,关加盖双方的公司印章
2 Confirmatory letter of acceptance that the product will be supplied to the new assembler directly by local importer or local / overseas manufacturer
同意将其所生产的产品直接供货给新分装商的承诺信
To be signed by the local / overseas manufacturer
由本地进口商或本地 / 原产国的生产商签署
3 Undertaking (printed on transferee company's letterhead) that the only amendment to the packaging is to change the assembler’s name and address
仅更改受转让的产品标签上分装商名称及地址的保证信(需使用印有公司名抬头的信纸)

To be signed by the new assembler, with company stamp
由新的分装商签署,关加盖公司印章