Regulatory Focus™ > News Articles > 2019 > 4 > MHRA Offers Additional No-Deal Brexit Guidance

MHRA Offers Additional No-Deal Brexit Guidance

Posted 03 April 2019 | By Zachary Brennan 

MHRA Offers Additional No-Deal Brexit Guidance

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.

As for the updated guidance on releasing blood products or vaccines to the market, MHRA has added a section with guidance for the OCABR (Official Control Authority Batch Release) Release and Marketing Information Form processes in the event the UK leaves the EU without a deal.

And for the updated webinar on MHRA Submissions, the regulator says there is a new webinar with new content, including a link to a recording of the webinar and an updated PowerPoint presentation.

Drug Shortages in Scotland

Meanwhile, in an effort to calm concerns about drug shortages in Scotland, the Scottish government offered an update on the work it has undertaken to stockpile medicines and review those stockpiles on a daily basis.

Last August, pharmaceutical companies began stockpiling six weeks of medicine supplies, and later the UK government asked companies to increase stockpiling beyond six weeks where possible.

Most shortages will be managed proactively, a letter from Scotland’s Chief Pharmaceutical Officer said, explaining that the UK government has established a Medicines Shortage Response Group (MSRG) to monitor and respond to developments. The Scottish government also established an equivalent group for Scotland, MSRG (SCO). 

The letter also explains how shortages will be reported, resolved and next steps that may need to be taken.

“Members of the public, GPs, community pharmacies and hospitals should not stockpile medicines,” the government says. “Further information on the strengthened processes for managing medicine shortages in primary and secondary care will follow shortly.”

In the EU, the European Medicines Agency said the risk for Brexit-related medicine supply disruptions has declined as preparations have picked up.

MHRA guidance and publications on a possible no deal scenario

Scottish Government update on medicine supplies

 

© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe