As a no-deal Brexit appears increasingly likely to occur on 12 April, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday released further guidance for biopharma companies related to substantial amendments to a clinical trial, updated guidance on applying to release a vaccine or a blood product and an updated webinar on making submissions via MHRA Submissions.
The guidance on clinical trials makes clear that in the event of a no-deal Brexit, the UK would require the sponsor or legal representative of a clinical trial to be in the UK or a country on an approved country list, which would initially include EU/European Economic Area (EEA) countries.
“A change in sponsor or legal representative for an UK trial is a substantial amendment requiring submission to both MHRA and the Research Ethics Committee (REC),” MHRA says.
But if the trial sponsor is from the rest of the world and the legal representative is established in the UK and there are sites elsewhere in the EU/EEA, the sponsor will need to assign an EU/EEA legal representative for these sites, MHRA adds.
The regulator also explains how a substantial amendment will be required to be submitted to MHRA to add or replace any investigational medicinal product (IMP) manufacturing, importation or certification site relevant for supply of IMP to an ongoing UK trial.
“If the sponsor chooses to retain an existing UK IMP release site for the ongoing UK trial but includes an additional EU/EEA site for trials in the EU/EEA only, then no substantial amendment to MHRA will be required,” MHRA says…