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This application is a service of the Singapore Government.

Health Sciences Authority

Submission of Documents for Every Consignment at Point of Import 中成药进口须呈交的文件

All CPM import licence holders are reminded that the following documents are required to be submitted to the Complementary Health Products Branch (CHPB) for the import of every consignment of the CPM:

(a) Supplier’s invoice with the following (either in print or legible handwriting):

  • the CPM import licence number (at the top right hand corner of the invoice) and
  • the CPM product reference number and batch number for each product (next to the corresponding product name)

(b) A declaration on the absence of any poisons as defined in the Poisons Act (Cap. 234) and any active synthetic substance in the CPM

(c) Test results of toxic heavy metals

(d) Test results of microbial contamination

(e) Other documents and test results as may be required by the licensing authority

(f) Notification of CPM Import and Test Report Submission (with effect from 1 Nov 2011)

The required documents (a) to (f) are to be submitted within 2 months of import to the CHPB by fax: 6478 9037 or email: HSA_CPM@hsa.gov.sg. You shall receive an acknowledgement from the CHPB within 1 month from the date of submission of the required documents if they are in order. It is advisable for you to retain the acknowledgement from CHPB till the expiry of the CPM. Please note that there should be no sale / supply of the imported CPM unless and until the required test reports with satisfactory results are submitted.

Please be reminded that non-submission or late submission (exceeding 2 months of import) of the required documents is an offence under the Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 2007.

For the import declaration requirements of health products, please refer to the Import Declaration at TradeNet®. CPM import licence holders should keep their freight forwarders, cargo agents and carriers informed of the requirements.

 

所有进口商执照持有人,在每一批中成药进口时,需要呈交下列文件给辅助医疗保健产品组:

(a) 附有下列信息的供货商发票(打印或手写清楚均可):

  • 在发票的右上角注明中成药进口商的执照号码,以及
  • 在发票上每一种药品的名称旁注明其中成药产品登记编号及其相应的批号

(b) 书面证明中成药中不含有任何被列入《毒药法令》中毒药名单的物质及任何活性合成药物

(c) 有毒重金属的检验结果

(d) 卫生学检验结果

(e) 执照签发当局所要求的其它文件和检验结果

(f) 中成药进口及呈交检验报告的通知表格(自 2011 年 11 月 1 日起生效)

以上(a) 至(f)所要求的文件,进口商需要在中成药进口的2个月内,呈交至辅助医疗保健产品组,传真至:6478 9037 或电邮至:HSA_CPM@hsa.gov.sg。一旦呈交的相关文件合格,进口商将会在一个月内收到辅助医疗保健产品组签发的回执单。请在产品的有效期内,妥善保存此回执单。请注意,进口的中成药在未将合格的检验结果呈交之前 ,将不得售卖。 

依据 2007 年药物(执照,标准条款及证书/执照费)(修正案)条例,不呈交或晚呈交(超过产品进口的二个月)所要求的文件将是违法的。

有关健康产品的进口申报要求,请参阅 Import Declaration at TradeNet®。进口商执照持有人应将相关要求通知货运代理行及承运人。

 

Updated-Jun 16