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 |
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* 否 |
| 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* 否 |
| 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 是 |
* 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 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，包括欲转让的产品名单 |
To be signed by both importers 由双方进口商共同签署 |
| 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 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 |
To be signed by the new importer |
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 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，包括欲转让的产品名单 |
To be signed by both assemblers 由双方分装商共同签署 |
| 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 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 |
To be signed by the new assembler |