6. Biological Specimen

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

Please refer to Section 2.7 of this guidebook.

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. This must be specifically documented in the ICF for future use.

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

The regulation doesn’t specify the list of documentation needed for custom clearance. However, as explained in Section 2.7 of this guidebook, to obtain an import license, the following documentation must be included with the petition form:

1. Shipment document (includes shipment date, proof of investigational product (IP) deposit to the importer, and carrier/transportation type: Airborne Cargo - Air Waybill (AWB), Aquatic Cargo - Bill Landing (BL), or Land Cargo - Knowledge of International Transport by Highway (CTR))
2. Inspection authorization
3. Commercial invoice
4. Bill of lading
5. Signed statement of responsibility
6. Institutional ethics committee (EC), CEP approval, and where applicable, CONEP approval