If you are the Sponsor of a UK clinical trial using IMPs imported into Great Britain from countries on the approved country for import list, 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.

Pharmaceutical Solutions are licensed to perform oversight of importation on all dosage forms of investigational medicinal products.

There are two routes for IMPs to be received into Great Britain from a listed country for use in UK clinical trials following QP certification by the listed country MIA(IMP) holder:

• direct to the Great Britain clinical trial site
• via a Great Britain storage and distribution ‘hub’.

Both require the oversight of a UK MIA(IMP) holder and QP, with systems in place to ensure that:

• IMPs are not made available for use in Great Britain clinical trial sites until appropriate QP certification in a listed country has been verified by the QP named on the UK MIA(IMP)
• IMPs are only shipped to appropriate Great Britain trial sites detailed within the UK trial application
• up-to-date information and documentation relating to the clinical trial and associated Product Specification File are made available by the Sponsor to the QP named on the UK MIA(IMP)
• the clinical trial is authorised by the MHRA before IMP is made available to the Investigator

For more information on this process, please see the MHRA guidelines.

Please contact us if you are interested in discussing Pharmaceutical Solutions' oversight of importation services.