6. Biological Specimen

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

There is no information on this topic.

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. Any intended future use must be clearly stated in the Informed Consent Form.

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

To obtain marketing authorization for a biological product, the applicant must submit documents including the following:

1. General information
2. Manufacturing process
3. Control of critical and intermediate stages
4. Process validation and/or evaluation
5. Development of the manufacturing process
6. Characterization
7. Specification
8. Assay method of active ingredients
9. Reference standards
10. Packaging specifications and testing
11. Stability data
12. Other information required for drug registration