6. Biological Specimen

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

Much depends on whether the biological specimens are being moved within the EU (not within the EEA) or from/to outside the EU, in which (latter) case the requirements are likely to be more stringent.

Note that clinical trial applicants may be required to complete a form “Compliance with Member States applicable rules for the collection, storage and future use of human biological samples” as per Art 7.1 (h) of the EU CTR. Alternatively, the template can be found within Chapter I- Application and application documents within Eudralex Volume 10. 

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.

This is a matter for the EU Member State concerned (i.e., a national matter) - please see the relevant country guidebook.

The working assumption is ‘Yes’ – see e.g., Template For informed consent concerning the use of biological samples and related data in biobanks Recommended by the Permanent Working Party of the German Medical Ethics Committees approved by the General Assembly on 21^st June 2019 so that the subject’s participation in the study is not dependent on also agreeing to the retention, etc. of biological specimens.

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

The working assumption is ‘Yes’ – much depends on whether the biological specimens are being moved within the EU (not within the EEA) or from/to outside the EU, in which (latter) case the requirements are likely to be more stringent.