1 | Q 问 | If the CPM dealers already hold licences for Western Drugs issued by the Therapeutic Products Division under Medicines Act (eg. wholesale dealer's licence, manufacturer's licence), do they need to apply for separate CPM licences? 如果中成药经销商已经持有西药执照（如批发商，制造商执照），还需要另外申请中成药执照吗？ |
A 答 | Yes 需要 | |
2 | Q 问 | Can licensed importers conduct retail sale? 持有进口商执照可以进行零售吗？ |
A 答 | Yes. However in order to conduct wholesale sale, they need an additional wholesale dealer's licence. Importers and wholesale dealers are required to conform to Good Distribution Practice. Please contact the Good Distribution Practice Audit Unit, Manufacturing Quality Audit Division, 150 Cantonment Road, Cantonment Centre Blk A #01-02 Singapore 089762, Tel: (65) 6866 3518 for further information. 可以。但是如果从事批发，还需要申请另外的批发商执照。进口和批发都需要达到GDP要求。 如需了解详情，请联络生产与品质审核部门。 地址：150 Cantonment Road, Cantonment Centre Blk A #01-02 Singapore 089762，电话：(65) 6866 3518。 | |
3 | Q 问 | Do retailers (e.g. medical hall) require any import and /or wholesales licence? 零售商（如药材店）须持有中成药进口或批发商执照吗？ |
A 答 | No, unless they also import and/or sell CPM by wholesale. 不需要，除非他们也进口或批发中成药。 | |
4 | Q 问 | I intend to set up a factory to manufacture/assemble CPM in Singapore. What are the requirements? 我打算设立一间工厂，在新加坡生产或分装中成药，有什么要求？ |
A 答 | The Manufacturer should apply for a Manufacturer's/Assembler's Licence using PRISM and familiarise himself with the current Good Manufacturing Practices. Please contact the Good Manufacturing Practice Audit Branch，Manufacturing Quality Audit Division, 150 Cantonment Road, Cantonment Centre Blk A #01-02 Singapore 089762, Tel: (65) 6866 3510 for further information. 生产商需要通过PRISM（电子注册系统）申请制造商/分装商执照，并需要了解GMP的要求。 如需了解详情，请联络生产与品质审核部门。 地址：150 Cantonment Road, Cantonment Centre Blk A #01-02 Singapore 089762，电话：(65) 6866 3510。 | |
5 | Q 问 | I have some difficulties with using PRISM. Who can I approach for help? 我在使用PRISM（电子注册）时有困难，如何获得帮助？ |
A 答 | Please see e-Service Help. 请参照e-Service Help。 |
 |
For further clarification, enquiries can be made to:
如有疑问，请联络中成药处:
CPM Unit 中成药处,
Complementary Medicines Branch,
Complementary Health Products Division, Health Products Regulation Group, Health Sciences Authority,
11 Biopolis Way #11-01 Helios Singapore 138667
Tel: (65) 6866 3461 / (65) 6866 3460; Fax: (65) 6478 9037
|
