Brexit was always going to bring upheaval to our industry, and at the end of the United Kingdom’s transition period, the Medicines and Healthcare Products Regulatory Agency (MHRA) made a number of changes. These led, in turn, to a major overhaul of Investigational Medicinal Products (IMPs), in relation to Qualified Persons (QPs), from January 1st 2022.

Here, we explain the context since transition, detail the revised process and show how Eramol can help you navigate the new waters.

Before Brexit: direct supply between EU and UK
Prior to Brexit, IMPs could be supplied from EU/EEA countries directly to UK clinical investigator sites.

That was an advantageous arrangement for UK-based clinical trials, certainly. But it had other benefits, too – namely that if the trial sponsor required, for the same medicines, a trial base in the UK and one in the EU or EEA, no substantial amendment to the procedure was required.

After Brexit: some changes (but not the last of them)
In the changes of 2021, the UK entered a transitional period for IMP certification and importation.

Clearly, clinical trial activity between Great Britain and the EU could not stop completely, so a new procedure was put in place to enable IMPs to continue to be legally imported.

Accordingly, sponsors of a UK clinical trial using IMPs imported into Great Britain from countries on the ‘approved country for import’ list now required the importer of the IMP - usually the organisation carrying out the clinical trials on behalf of the sponsor, and necessarily a UK Manufacturing and Import Authorisation (MIA(IMP)) holder - to verify that the imported IMPs had previously been certified by a Qualified Person (QP) in a listed country, before release to the trial.

The QP in question could be, for example, the one named on the UK MIA(IMP) and their suitably qualified, delegated staff, or a QP employed by a sponsor holding a UK MIA(IMP), or a contracted third-party UK MIA(IMP) holder.

So, IMPs could still be supplied direct from the EU/EEA MIA(IMP) holder to trial sites in Great Britain without additional oversight or confirmation from this country’s side.

Essentially, the UK MIA(IMP)-compliant process had been slightly modified to enable it to continue to fit into a self-contained and self-powered EU/EEA system.

And then came the end of the transitional arrangement on 31st December 2021…

”All change!” When is authorisation needed now?  
From that point on, the QP named on the UK MIA(IMP) had to expressly confirm that each and every batch of IMP – not just the IMP itself -  had been appropriately certified by the listed country QP, and until this happens, the IMP cannot be made available for use by Great Britain trial sites.

What does this mean, then, if you’re sponsor or similar and you are working with, or planning to work with, a clinical trials company or other IMP importer? What are the requirements you need to be aware of, to ensure your trials complete successfully and aren’t scuppered by IMP supply and compliance issues?

First and foremost, the importer must hold a UK MIA(IMP), specifying: Importation of QP certified IMPs from a country on the ‘approved country for import list’.

This UK MIA(IMP) holder is responsible for the oversight process, and must be named on the Clinical Trial Authorisation, as must the listed country site of final batch certification.

Secondly, the importer must also have in place robust and efficient procedures and systems for the management of importation and QP certification of IMPs from the listed countries, as ultimately this will speed the arrival of finished IMPs from approved countries.

Thirdly, it’s often crucial that the importer is as well versed in the exceptions to the rules as to the rules themselves, as these can ultimately offer options that could save sponsors’ time and budget.

In addition, the importer must be able to demonstrate full oversight compliance with the Pharmaceutical Quality System (PQS)   as described here – a complex and highly detailed set of requirements stretching from the preparation, revision, and control of documents, to training of staff, corrective and preventive actions, and many others.

How can Eramol help?

With our extensive experience of both incumbent and changing regulatory requirements,
at Eramol we have developed proven oversight inspection procedures, both direct to site and via our GB distribution hub, that satisfy all the relevant post-Brexit procedures, and ensure reliable and timely delivery of IMPs to trial sites.

Eramol operates two oversight inspection procedures, either direct to site or via our GB distribution hub, delivering complete process coverage, including:

1. Exchange of Master Service Agreement
2. Exchange of Quality Technical Agreement
3. Obtain regulatory documentation from client to perform checks required by the oversight process
4. Physical import IMP into GB hub (applicable for GB distribution hub route)
5. Receipt of Sponsor order
6. Ship IMP to site
7. Complete oversight process once receiving site confirmed transport condition

Additionally, we are strongly positioned to deliver detailed analysis of new tranches of regulation as and when they emerge, and help you navigate it.

Brexit was before. Eramol is now. In an unpredictable world, let us help you deliver optimal outcomes.