6. Biological specimen

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

The TARIC (Tarif Intégré de la Communauté) assists with determining if a license is required for a particular product. The TARIC is a multilingual database integrating all measures relating to EU customs tariffs, and commercial and agricultural legislation.

It may also be a requirement for Sponsors to complete and submit, under Part II of the clinical trials application, the form “Compliance with member state applicable rules for the collection, storage and future use of human biological samples”. An English template is available within the Ethics Committees Coordination Centre.

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.

No, it does not need separate consent (unless it is for a sub-study). Information on biological collection can be included within the main participant information sheet.

Templates of ICF can be found in the Ethics Committees Coordination Center on the AIFA webpage.

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

Yes, it will depend on where the samples will be shipped to.

The European Commission has some information on customs clearance documents and procedures that may be useful.