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From MHRA Website:
“MHRA accepts import of IMPs from an approved country. Sponsors require a UK Manufacturing and Import Authorisation (MIA(IMP)) holder to put in place an assurance system to check these IMPs have been certified by a Qualified Person (QP) in a listed country, before release to the trial.This assurance system must be overseen by a QP, however the IMPs would not require recertification. The routine tasks relating to verification of QP certification in a listed country may be delegated by the QP named on the UK MIA(IMP) to appropriate personnel operating within their MIA(IMP) quality system. The QP named on the UK MIA(IMP) that is responsible for this verification process may be resident in the UK or a listed country. Any manufacturing activity or importation from a non-listed country must be certified by a QP who is resident in the UK.
There are two routes for IMPs to be received into Great Britain from a listed country for use in UK clinical trials following QP certification by the listed country MIA(IMP) holder:
1) direct to the Great Britain clinical trial site
2) via a Great Britain storage and distribution ‘hub’.
Both require the oversight of a UK MIA(IMP) holder and QP, with systems in place.”
Question: How can sponsor companies best address above when shipments are made from an LSP outside the UK directly to the investigational site in the UK? What system or record would you recommend to document and track UK QP oversight and release?
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