Importation Oversight for Clinical Trials

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Sponsors of UK clinical trials using investigational medicinal products imported into Great Britain from approved countries are required to ensure appropriate regulatory oversight is in place. This includes working with a UK Manufacturer’s and Import Authorisation (MIA(IMP)) holder who maintains systems to confirm that imported IMPs have been certified by a Qualified Person in a recognised country prior to release for use in the trial.

Promedix Labs is authorised to provide oversight of importation across all dosage forms of investigational medicinal products, supporting sponsors in meeting UK regulatory expectations.

There are two permitted pathways for IMPs entering Great Britain from a recognised country for use in UK clinical trials following Qualified Person certification:

• Direct shipment to the approved Great Britain clinical trial site.
• Shipment via an approved Great Britain storage and distribution facility.
   

Both pathways require active oversight by a UK MIA(IMP) holder and Qualified Person, with controls in place to ensure that:

• IMPs are not released for use at Great Britain clinical trial sites until appropriate QP certification in a recognised country has been verified.
• IMPs are supplied only to authorised Great Britain trial sites listed within the approved UK clinical trial application.
• Current and complete clinical trial documentation, including the Product Specification File, is available to the Qualified Person named on the UK MIA(IMP).
• The clinical trial has received the required authorisation from the MHRA prior to IMP release to the Investigator.
   

Further information on regulatory expectations for this process is available within current MHRA guidance.

If you would like to discuss Promedix Labs’ importation oversight services for Great Britain clinical trials, please contact our team.