Regulatory Open Forum

Looking for guidance on import of biologic investigational product into the EU -

Background - biologic product manufactured in US, clinical trials conducted in US/Africa and EU - Germany and Netherlands.  The product is a novel vaccine (whole parasite), and due to investigational nature, QC/release/stability assays are not validated.  Most of the tests are unique to the product and developed internally.

The QP from Netherlands is insisting on performing actual QC release testing on our product on importation into the EU.  For our German site, the QP allowed the product to be released based on our Certificates of Analysis and stability reports. Both QPs visited our manufacturing site in the US and reviewed all the documentation (batch records, SOPs, IMPD, etc.).  the QP from Netherlands is citing the following -Eudralex, Vol 4, Annex 16:Certification by a Qualified Person and Batch Release (following para) as justification for performing QC testing

"1.5.4 The QP certifying the finished product is responsible for ensuring that each finished medicinal product batch has been manufactured in accordance with GMP and the MA. Unless an MRA or similar agreement is in place between the EU and the exporting country, the QP is also responsible for ensuring that the finished medicinal product batch has undergone in a Member State a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products is in accordance with the requirements of the MA."

Question - Is it required to perform (any/all) QC release testing for biologic IMPs not manufactured in the EU?  since our assays are also specialized (in terms of methodology, materials and equipment) we are not comfortable training them because if there are errors in the conduct of the assay by the QP, then that would not allow our lot to be released for clinical use.
Any guidance on this would be greatly appreciated.
Thanks!