Brexit: Importation of IMPs from approved countries in a no deal scenario

Recommendation

16-18 November 2021

Live Online Training: GMP meets Development

The MHRA recently provided guidance on how the management and oversight of the import of investigational medicinal products (IMPs) from listed countries will work in a no deal scenario. If the UK leaves the EU without an agreement, sponsors of UK clinical trials that source IMPs from an EEA State will need to review their existing supply chains.

As reported before in Clinical Trials if there is no Brexit Deal, a sponsor of a UK clinical trial using IMPs imported from countries on an ‘approved country for import’ list (initially, all EU and EEA countries) will require a UK Manufacturing and Import Authorization (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. However, IMPs that have been QP certified in a listed country will not require recertification in the UK.

The MHRA guidance on importation of investigational medicinal products from approved countries is to describe the principles for the management and oversight of the import of IMPs to the UK from listed countries. In addition, there will be a one-year transition period following the date of the UK’s exit from the EU to implement this guidance.