Reply To: Oversight of a UK MIA(IMP) holder and QP
March 19, 2021 at 6:17 amHi JP,
These are very valid statements, and would add the check in GB can also be performed by a Responsible Person for Inspection GB-RPi not just a GB-QP. These requirements being in force now or at the end of this year also depend upon if the study was approved before or after Jan 1st 2021.
It would also be remiss of me not to point out the EU-GB shipment will also have to navigate Taxes and Duties and Importer of Record requirements to make that shipment directly from an EU LSP to a GB clinical site in GB. Use of the correct rules of origin, Incoterm, HTS code and naming a CRO or other entity to be IoR needs to be determined in parallel to the resolving the Regulatory hurdle you ask about.
With all thing Brexit I feel the answers generally fall into “it is more complex than a simple single answer how to do it” as “it depends” on the trial products, sponsor and clinical sites as well as your LSP what options are available.
KR Paul
