Guidance on importation of investigational medicinal products from approval countries
How the management and oversight of the import of investigational medicinal products from listed countries will work in a no deal scenario.
Leaving the EU with a deal remains the Government’s top priority. This has not changed. However a responsible government must plan for every eventuality, including a no deal scenario.
This guidance follows on from the further guidance note published on 3 January 2019.
If the UK leaves the EU without an agreement, sponsors of UK clinical trials that source investigational medicinal products (IMPs) from an EEA State will need to review their existing supply chains.
If you are the sponsor of a UK clinical trial using IMPs imported from countries on an ‘approved country for import’ list (initially, all EU and EEA countries) you will 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.
IMPs that have been QP certified in a listed country will not require recertification in the UK.
The purpose of this guidance is to describe the principles for the management and oversight of the import of IMPs to the UK from listed countries.
There will be a one-year transition period following the date of the UK’s exit from the EU to implement this guidance.
Published 11 March 2019
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