Health Science Authority
Home

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

The holder of the import licence shall not sell or supply any CPM to which the licence relates unless and until he has submitted to the CPM Unit the following documents within 2 months of the import of the consignment of the CPM:

  1. A declaration on the absence of any poisons as defined in the Poisons Act (Cap. 234) and any active synthetic substance in the CPM
  2. Test results of toxic heavy metals
  3. Test results of microbial contamination
  4. Such other documents and test results as may be required by the licensing authority
  5. Notification of CPM Import and Test Report Submission (with effect from 1 Nov 2011)

The importer's name, product name, product reference number (as assigned by the CPM Unit) and batch number for each product are to be clearly stated on the copies of the test reports and any other documents submitted.

The above documents are to be faxed to the TradeNet counter (Tel: 6866 3449; Fax: 6478 9035) together with the supplier's invoice during import clearance to support TradeNet permit application.

The supplier's invoice should state correctly (either in print or legible handwriting) the following:

  1. the Import Declaration Unique Reference Number (at the top right hand corner of the invoice),
  2. the CPM import licence number (at the top right hand corner of the invoice) and
  3. the CPM product reference number and batch number for each product (next to the corresponding product name).

Please keep your freight forwarders, cargo agents and carriers informed of the above requirements.

If you are unable to submit the required documents (a) to (e) at the point of import, you are allowed to submit them within 2 months of import to the CPM Unit by fax: 6478 9037 or email: HSA_CPM@hsa.gov.sg. You shall receive an acknowledgement from CPM Unit 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 CPM Unit 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-submisson 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.

进口商执照持有人必须在每一批中成药进口的两个月内呈交以下的文件,否则不得售卖有关药品:

  1. 书面证明药品不含有任何被列入《毒药法令》中毒药名单的物质及任何化合药物

  2. 有毒重金属的检验结果

  3. 卫生学检验结果

  4. 执照签发当局所要求的其它文件和检验结果

  5. 通知表格(自 2011 11 1 日起)

进口商的名称,药品名称,药品编号(由中成药处签发)和每一批药品的批号必须清楚地注明于检验报告以及任何提交的文件上。

 

在进行进口申报时,上述文件和货物的发票应传真到 TradeNet 柜台(电话:6866 3449, 传真号:6478 9035),以配合 TradeNet 的申请。

为了方便进口申报,进口商应:

 

  1. 在发票的右上角注明进口报关编号
  2. 在发票的右上角注明中成药的进口商执照号,
  3. 在发票上药品名称的旁边注明药品的编号及每一批的批号。

进口商需通知货运代理行、货运代理人及承运人有关以上的要求。
 
如果进口商不能在中成药进口的同时呈交以上(a 至(e)所要求的文件,进口商可于进口的两个月内将所要求的文件呈交至中成药处,传真号:6478 9037 或电邮:HSA_CPM@hsa.gov.sg。一旦呈交相关文件合格,进口商将会在一个月内收到中成药处签发的回执单。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(超过进口的二个月)所要求的文件将是违法的。

Updated-Oct 11


Last updated on 31 Oct 2011 16:13:43
Best viewed using Internet Explorer 7.0 and above. | Privacy Statement | Terms of Use | HSA Data Protection Policy | Rate Our Website
Health Sciences Authority © 2007-2011. All Rights Reserved.