|
1. The import and transhipment of human and zoonotic (infects both human and animals) pathogens, and selected toxins are regulated under the Biological Agents and Toxins Act (BATA) by the Ministry of Health (MOH). These include any sample (clinical or non-clinical samples, kits and proficiency test samples) that are known to contain the controlled pathogens and toxins. The lists of controlled items are classified under 5 BATA Schedules, where pathogens are listed under Schedules 1-4, and selected toxins are listed under Schedule 5.
2. Requirements for Importers (Users) and Carriers
a) A prior “Approval to Possess” granted by MOH to the importer is required for BATA Schedules 1 and 2 high-risk pathogens, and Schedule 5 toxins. For more information on BATA requirements for each Schedule, please visit our website at www.biosafety.moh.gov.sg or email us at MOH_Biosafety@moh.gov.sg.
b) For local transportation of Schedules 1, 2 and 5 pathogens and toxins, carriers must comply with the requirements prescribed in BATA Transportation Regulation (downloadable from our website at http://www.biosafety.moh.gov.sg/home/page.aspx?id=152&pid=73).
3. TradeNet® application submission
An online application for import or transhipment permit is submitted via TradeNet®, and supporting documents (e.g. commercial invoice, airway bill, declaration letter) should be submitted to the Biosafety Legislation Branch by fax for application processing.
For online TradeNet® submissions, ensure the following information are correctly provided in the application:
a) Declarant and Importer fields
- Names of Declarant and Importer
- Declarant telephone number
- Place of Receipt address
b) Shipment Information
- Airway Bill number(s)
- Estimated arrival date
c) Consignment Content Information
- Item Description (as printed in the commercial invoice)
- MOH product code or Import Specific Product (ISP) code
- AVA product code (applicable for MOH-AVA jointly controlled zoonotic pathogens)
d) Additional Remarks
- MOH Approval number for import of Schedules 1 and 2 pathogens and Schedule 5 toxins
- Specific instructions pertaining to consignment logistics / delivery / receipt
- Enduser information
e) Transhipment Details (if applicable)
- Place of temporary storage
- Date of exportation and vessel details
4. The MOH product code is updated regularly, and the current “List of Biological Agents and Toxins” can be downloaded from our website under the Useful Info and Guidelines tab at http://www.biosafety.moh.gov.sg/home/guidelines.aspx.
5. For queries related to import requirements of items that are not listed in the “List of Biological Agents and Toxins”, please send your query to MOH_Biosafety@moh.gov.sg.
|