More changes coming soon due to Brexit if you are planning to import IMPs into Great Britain

Posted on 12/2/21

The changes are in relation to new regulatory requirements for importation of EU QP certified IMPs into Great Britain (GB).

As from 1st January 2022, the MHRA requires an oversight by a UK Manufacturing and Import Authorisation (MIA(IMP)) license holder to assure IMPs have been certified by Qualified Person (QP) in an approved EEA country before release to clinical sites in Great Britain.

Sounds complicated? Well, it will be certainly more to do moving forward.

In a nutshell, this is what is required to set up the process to ensure compliance with the MHRA requirements:

  1. IMP specification

This document summarises the key details about the IMP including any handling and storage details and any out of temperature allowances.

  1. Manufacturing and distribution supply chain map

Details of the EU QP certifying site, e.g. QP declaration and details of the manufacturing and distribution supply chain.

  1. Clinical Trial application form to MHRA

The application is used to confirm the site/address responsible for final certification of the finished IMP. The application should name the entity as the UK MIA(IMP) holder responsible for the QP oversight of importation into GB.

  1. MHRA Clinical Trial Authorizations / Approvals

Evidence of MHRA approval. This shall include any post approval commitment requirements.

  1. Verification of the licenses and GMP status of the certifying site

The certifying GMP licensed site shall be verified by the UK MIA(IMP) holder responsible for the QP oversight of importation into GB to ensure that the scope is appropriate for the dosage form and associated activities.

  1. Approvals for GB trial sites

Details of the approved trial sites in Great Britain.

  1. Quality Agreement (QTA)

 

When attended a training session on this topic led by our QA Team, I was thinking there is a lot to implement and then I realised that most of these activities are standard in GMP projects, so it is not that the activities are new to us but the additional process that now includes these activities in order to meet the new regulatory requirement.

I’m sure you have already thought about the solution if your IMPs are affected by this change, whether it is in-house operation or via your trusted vendor partner.

However, if you are still searching for a solution, here at Myonex we can help, as we are already set up:

  • Wholly owned UK Operations – a UK MIA (IMP) license holder, already approved by MHRA for this activity
  • In-house QP/QA team
  • In-house Project Management
  • Over 33 years’ experience with well-established transportation network

Our service covers:

  • Comparator / Drug in combination (i.e. commercial packs which are utilized as an IMP in a GB clinical trial) or
  • “True” IMPs (i.e. not commercial, investigational medicinal products),

either via Myonex UK facility or directly from the EEA country to the GB Clinical Trial Site.

A dedicated Myonex Project Manager will help you step-by-step to ensure all aspects of the Set-Up and On-Going Operation run smoothly and no disruption to your IMP importation into GB post 2021.

My colleagues and I are happy to assist:  globalsales@myonex.com


Karolina Shaw, Associate Director, Business Development