6. Biological Specimen

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment.

"All biological specimens regardless of purpose (diagnostic, research, etc.) must secure a Quarantine Clearance before transportation. This includes domestic transportation, exportation, and importation".

The following documents are required for the processing of the Quarantine Clearance for the transportation of biological specimens:

1. Request Letter addressed to the Bureau Director (if acquiring from BOQ provincial stations, attention to the BOQ Station Chief) and with the following contents:
   1. Type of specimen and net quantity per package
   2. Name and address of facility where the specimen is collected
   3. Name and address of facility where the specimen is to be transported, If multiple facilities/locations, declare up to its final destination
   4. Purpose to which the specimen will be used
   5. A declaration that the specimen is infectious or non-infectious
   6. Date of shipment
2. FDA approval of the study (for clinical research)
3. Accomplished application forms
4. License/document stating that the shipper, courier, or individual who handled and packed the biological specimens is trained and abided by the rules and regulations of IATA and IHR of WHO.
5. Airway bill (for Import)

The Bureau of Quarantine reserves the right to ask for additional documents when deemed necessary.

6.2 Does local regulation require any separate consent for biological specimen collection, storage, and future research? If yes, please explain if there are any templates and/or links to be followed.

Yes, investigators must obtain consent for long-term storage and future research as well as for use in the specific trial. 

Under the Malaysian Guidelines on the Use of Human Biological Samples for Research, IRB/ IEC approval makes it lawful to store and use the samples for the specific trial only. Sponsors who continue to store samples after the trial has ended – both for their own research or to distribute to other researchers – are acting as a tissue bank and must obtain approval from IRB/IEC.

6.3 Does the local authority require any specific documents for customs clearance?

When bringing goods into or out of Malaysia, traders must provide the following documents to customs officials:

1. Customs Export or Import Declaration
2. Commercial Invoice
3. Bill of Lading
4. Packing List
5. Certificate of Origin